PREMIER—A Trial of Lifestyle Interventions for Blood Pressure Control: Intervention Design and Rationale
Identifieur interne : 002740 ( Istex/Corpus ); précédent : 002739; suivant : 002741PREMIER—A Trial of Lifestyle Interventions for Blood Pressure Control: Intervention Design and Rationale
Auteurs : Kristine L. Funk ; Patricia J. Elmer ; Victor J. Stevens ; David W. Harsha ; Shirley R. Craddick ; Pao-Hwa Lin ; Deborah Rohm Young ; Catherine M. Champagne ; Phillip J. Brantley ; Phyllis B. Mccarron ; Denise G. Simons-Morton ; Lawrence J. AppelSource :
- Health Promotion Practice [ 1524-8399 ] ; 2008-07.
English descriptors
- Teeft :
- Activity patterns, African american, African american participants, African americans, Alcohol intake, American cancer society, American college, American journal, Appel, Associate professor, Baseline characteristics, Behavior change, Behavioral, Behavioral strategies, Blood institute, Blood pressure, Blood pressure control, Body mass index, Caloric intake, Calorie, Calorie intake, Cancer journal, Cancer prevention, Cardiovascular disease, Chronic disease, Clinical nutrition, Clinical psychology, Clinical trial, Comparison condition, Comprehensive lifestyle modification, Dairy products, Dash, Dash diet, Dash group, Dash interventions, Deborah rohm, Dietary, Dietary approaches, Dietary goals, Dietary guidelines, Dietary patterns, Dietary sodium intake, Drug therapy, Duke university, Extensive selfmonitoring, Fifth report, Focus groups, Food intake, Group activities, Group session, Group sessions, Guideline, Health promotion practice july, Health research, Healthy food choices, Heart disease, High blood pressure, Higher risk, Human services, Human services department, Hypertension, Hypertension prevention, Individual targetb, Individual visits, Intake, Internal medicine, Intervention, Intervention development, Kaiser permanente, Kcal, Lifestyle, Lifestyle change interventions, Lifestyle changes, Lifestyle interventions, Lifestyle modifications, Lifestyle targets, Limited sodium, Main results, Minority populations, Modification, Motivational enhancement techniques, Multicomponent lifestyle change interventions, Multiple lifestyle changes, National guidelines, National heart, National institutes, Next steps, Obarzanek, Participant, Physical activity, Physical fitness, Premier intervention design, Premier interventions, Premier participants, Premier study, Premier trial, Progress check, Randomization visit, Randomized trial, Research center, Research group, Senior investigator, Seventh report, Social interactions, Social support, Sports medicine, Vigorous activity, Weight control, Weight loss.
Abstract
Interventions encouraging adoption of healthy diets and increased physical activity are needed to achieve national goals for preventing and treating hypertension, cardiovascular disease, diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.
Url:
DOI: 10.1177/1524839906289035
Links to Exploration step
ISTEX:A6B5856C0CD6DACE03FBDE4567C0F16143493AD5Le document en format XML
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Elmer</name><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation></author><author><name sortKey="Stevens, Victor J" sort="Stevens, Victor J" uniqKey="Stevens V" first="Victor J." last="Stevens">Victor J. Stevens</name><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</mods:affiliation></affiliation><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</mods:affiliation></affiliation></author><author><name sortKey="Harsha, David W" sort="Harsha, David W" uniqKey="Harsha D" first="David W." last="Harsha">David W. 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Funk</name><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation></author><author><name sortKey="Elmer, Patricia J" sort="Elmer, Patricia J" uniqKey="Elmer P" first="Patricia J." last="Elmer">Patricia J. Elmer</name><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation></author><author><name sortKey="Stevens, Victor J" sort="Stevens, Victor J" uniqKey="Stevens V" first="Victor J." last="Stevens">Victor J. Stevens</name><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</mods:affiliation></affiliation><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</mods:affiliation></affiliation></author><author><name sortKey="Harsha, David W" sort="Harsha, David W" uniqKey="Harsha D" first="David W." last="Harsha">David W. Harsha</name><affiliation><mods:affiliation>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</mods:affiliation></affiliation><affiliation><mods:affiliation>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</mods:affiliation></affiliation></author><author><name sortKey="Craddick, Shirley R" sort="Craddick, Shirley R" uniqKey="Craddick S" first="Shirley R." last="Craddick">Shirley R. Craddick</name><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation><affiliation><mods:affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</mods:affiliation></affiliation></author><author><name sortKey="Lin, Pao Hwa" sort="Lin, Pao Hwa" uniqKey="Lin P" first="Pao-Hwa" last="Lin">Pao-Hwa Lin</name><affiliation><mods:affiliation>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</mods:affiliation></affiliation><affiliation><mods:affiliation>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</mods:affiliation></affiliation></author><author><name sortKey="Young, Deborah Rohm" sort="Young, Deborah Rohm" uniqKey="Young D" first="Deborah Rohm" last="Young">Deborah Rohm Young</name><affiliation><mods:affiliation>Department of Kinesiology at the University of Maryland in College Park, Maryland</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Kinesiology at the University of Maryland in College Park, Maryland</mods:affiliation></affiliation></author><author><name sortKey="Champagne, Catherine M" sort="Champagne, Catherine M" uniqKey="Champagne C" first="Catherine M." last="Champagne">Catherine M. 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Simons-Morton</name><affiliation><mods:affiliation>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</mods:affiliation></affiliation><affiliation><mods:affiliation>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</mods:affiliation></affiliation></author><author><name sortKey="Appel, Lawrence J" sort="Appel, Lawrence J" uniqKey="Appel L" first="Lawrence J." last="Appel">Lawrence J. 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PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.</div></front></TEI><istex><corpusName>sage</corpusName><keywords><teeft><json:string>lifestyle</json:string><json:string>hypertension</json:string><json:string>physical activity</json:string><json:string>guideline</json:string><json:string>weight loss</json:string><json:string>appel</json:string><json:string>obarzanek</json:string><json:string>national institutes</json:string><json:string>group sessions</json:string><json:string>kcal</json:string><json:string>blood pressure</json:string><json:string>national heart</json:string><json:string>blood institute</json:string><json:string>high blood pressure</json:string><json:string>blood pressure control</json:string><json:string>health 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Funk</name><affiliations><json:string>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</json:string><json:string>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</json:string></affiliations></json:item><json:item><name>Patricia J. Elmer</name><affiliations><json:string>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</json:string><json:string>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</json:string></affiliations></json:item><json:item><name>Victor J. Stevens</name><affiliations><json:string>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</json:string><json:string>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</json:string></affiliations></json:item><json:item><name>David W. Harsha</name><affiliations><json:string>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</json:string><json:string>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</json:string></affiliations></json:item><json:item><name>Shirley R. Craddick</name><affiliations><json:string>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</json:string><json:string>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</json:string></affiliations></json:item><json:item><name>Pao-Hwa Lin</name><affiliations><json:string>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</json:string><json:string>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</json:string></affiliations></json:item><json:item><name>Deborah Rohm Young</name><affiliations><json:string>Department of Kinesiology at the University of Maryland in College Park, Maryland</json:string><json:string>Department of Kinesiology at the University of Maryland in College Park, Maryland</json:string></affiliations></json:item><json:item><name>Catherine M. Champagne</name><affiliations><json:string>Analysis Core Department at Pennington Biomedical Research Center in Baton Rouge, Louisiana</json:string><json:string>Analysis Core Department at Pennington Biomedical Research Center in Baton Rouge, Louisiana</json:string></affiliations></json:item><json:item><name>Phillip J. Brantley</name><affiliations><json:string>Behavioral Medicine Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</json:string><json:string>Behavioral Medicine Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</json:string></affiliations></json:item><json:item><name>Phyllis B. McCarron</name><affiliations><json:string>Welch Center for Prevention, Epidemiology and Clinical Research in Baltimore, Maryland</json:string><json:string>Welch Center for Prevention, Epidemiology and Clinical Research in Baltimore, Maryland</json:string></affiliations></json:item><json:item><name>Denise G. Simons-Morton</name><affiliations><json:string>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</json:string><json:string>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</json:string></affiliations></json:item><json:item><name>Lawrence J. Appel</name><affiliations><json:string>Johns Hopkins School of Medicine in Baltimore, Maryland</json:string><json:string>Johns Hopkins School of Medicine in Baltimore, Maryland</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>hypertension</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>diet</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>physical activity</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>behavioral intervention</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>blood pressure</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>DASH</value></json:item></subject><articleId><json:string>10.1177_1524839906289035</json:string></articleId><arkIstex>ark:/67375/M70-7WSB6XLG-6</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Interventions encouraging adoption of healthy diets and increased physical activity are needed to achieve national goals for preventing and treating hypertension, cardiovascular disease, diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.</abstract><qualityIndicators><score>8.716</score><pdfWordCount>5733</pdfWordCount><pdfCharCount>38158</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>10</pdfPageCount><pdfPageSize>612.283 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>143</abstractWordCount><abstractCharCount>1111</abstractCharCount><keywordCount>6</keywordCount></qualityIndicators><title>PREMIER—A Trial of Lifestyle Interventions for Blood Pressure Control: Intervention Design and Rationale</title><pmid><json:string>16803935</json:string></pmid><genre><json:string>research-article</json:string></genre><host><title>Health Promotion 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xml:id="author-0000"><persName><forename type="first">Kristine L.</forename><surname>Funk</surname></persName><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Patricia J.</forename><surname>Elmer</surname></persName><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation></author><author xml:id="author-0002"><persName><forename type="first">Victor J.</forename><surname>Stevens</surname></persName><affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</affiliation><affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</affiliation></author><author xml:id="author-0003"><persName><forename type="first">David W.</forename><surname>Harsha</surname></persName><affiliation>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><affiliation>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation></author><author xml:id="author-0004"><persName><forename type="first">Shirley R.</forename><surname>Craddick</surname></persName><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation></author><author xml:id="author-0005"><persName><forename type="first">Pao-Hwa</forename><surname>Lin</surname></persName><affiliation>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</affiliation><affiliation>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</affiliation></author><author xml:id="author-0006"><persName><forename type="first">Deborah Rohm</forename><surname>Young</surname></persName><affiliation>Department of Kinesiology at the University of Maryland in College Park, Maryland</affiliation><affiliation>Department of Kinesiology at the University of Maryland in College Park, Maryland</affiliation></author><author xml:id="author-0007"><persName><forename type="first">Catherine M.</forename><surname>Champagne</surname></persName><affiliation>Analysis Core Department at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><affiliation>Analysis Core Department at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation></author><author xml:id="author-0008"><persName><forename type="first">Phillip J.</forename><surname>Brantley</surname></persName><affiliation>Behavioral Medicine Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><affiliation>Behavioral Medicine Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation></author><author xml:id="author-0009"><persName><forename type="first">Phyllis B.</forename><surname>McCarron</surname></persName><affiliation>Welch Center for Prevention, Epidemiology and Clinical Research in Baltimore, Maryland</affiliation><affiliation>Welch Center for Prevention, Epidemiology and Clinical Research in Baltimore, Maryland</affiliation></author><author xml:id="author-0010"><persName><forename type="first">Denise G.</forename><surname>Simons-Morton</surname></persName><affiliation>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</affiliation><affiliation>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</affiliation></author><author xml:id="author-0011"><persName><forename type="first">Lawrence J.</forename><surname>Appel</surname></persName><affiliation>Johns Hopkins School of Medicine in Baltimore, Maryland</affiliation><affiliation>Johns Hopkins School of Medicine in Baltimore, Maryland</affiliation></author><idno type="istex">A6B5856C0CD6DACE03FBDE4567C0F16143493AD5</idno><idno type="ark">ark:/67375/M70-7WSB6XLG-6</idno><idno type="DOI">10.1177/1524839906289035</idno><idno type="article-id">10.1177_1524839906289035</idno></analytic><monogr><title level="j">Health Promotion Practice</title><idno type="pISSN">1524-8399</idno><idno type="eISSN">1552-6372</idno><idno type="publisher-id">HPP</idno><idno type="PublisherID-hwp">sphpp</idno><imprint><publisher>SAGE Publications</publisher><pubPlace>Sage CA: Los Angeles, CA</pubPlace><date type="published" when="2008-07"></date><biblScope unit="volume">9</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" 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PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>hypertension</term></item><item><term>diet</term></item><item><term>physical activity</term></item><item><term>behavioral intervention</term></item><item><term>blood pressure</term></item><item><term>DASH</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2008-07">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/M70-7WSB6XLG-6/fulltext.txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus sage not found" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article" dtd-version="2.3" xml:lang="EN"><front><journal-meta><journal-id journal-id-type="hwp">sphpp</journal-id><journal-id journal-id-type="publisher-id">HPP</journal-id><journal-title>Health Promotion Practice</journal-title><issn pub-type="ppub">1524-8399</issn><publisher><publisher-name>SAGE Publications</publisher-name><publisher-loc>Sage CA: Los Angeles, CA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1177/1524839906289035</article-id><article-id pub-id-type="publisher-id">10.1177_1524839906289035</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject></subj-group></article-categories><title-group><article-title>PREMIER—A Trial of Lifestyle Interventions for Blood Pressure Control: Intervention Design and Rationale</article-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Funk</surname><given-names>Kristine L.</given-names></name><aff>Center for Health Research, Kaiser Permanente Northwest,
in Portland, Oregon</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Elmer</surname><given-names>Patricia J.</given-names></name><aff>Center for Health Research, Kaiser Permanente Northwest,
in Portland, Oregon</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Stevens</surname><given-names>Victor J.</given-names></name><aff>Center for Health Research, Kaiser Permanente Northwest
in Portland, Oregon</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Harsha</surname><given-names>David W.</given-names></name><aff>Body Composition Laboratory at Pennington Biomedical
Research Center in Baton Rouge, Louisiana</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Craddick</surname><given-names>Shirley R.</given-names></name><aff>Center for Health Research, Kaiser Permanente Northwest,
in Portland, Oregon</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Lin</surname><given-names>Pao-Hwa</given-names></name><aff>Sarah Stedman Center for Nutritional Studies at Duke
University Medical Center in Durham, North Carolina</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Young</surname><given-names>Deborah Rohm</given-names></name><aff>Department of Kinesiology at the University of Maryland
in College Park, Maryland</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Champagne</surname><given-names>Catherine M.</given-names></name><aff>Analysis Core Department at Pennington Biomedical Research
Center in Baton Rouge, Louisiana</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Brantley</surname><given-names>Phillip J.</given-names></name><aff>Behavioral Medicine Laboratory at Pennington Biomedical
Research Center in Baton Rouge, Louisiana</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>McCarron</surname><given-names>Phyllis B.</given-names></name><aff>Welch Center for Prevention, Epidemiology and Clinical
Research in Baltimore, Maryland</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Simons-Morton</surname><given-names>Denise G.</given-names></name><aff>Division of Epidemiology and Clinical Applications,
National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda,
Maryland</aff></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Appel</surname><given-names>Lawrence J.</given-names></name><aff>Johns Hopkins School of Medicine in Baltimore, Maryland</aff></contrib></contrib-group><pub-date pub-type="ppub"><month>07</month><year>2008</year></pub-date><volume>9</volume><issue>3</issue><fpage>271</fpage><lpage>280</lpage><abstract><p><italic>Interventions encouraging adoption of healthy diets and increased physical activity are needed to achieve national goals for preventing and treating hypertension, cardiovascular disease, diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.</italic></p></abstract><kwd-group><kwd>hypertension</kwd>
<kwd>diet</kwd>
<kwd>physical activity</kwd>
<kwd>behavioral intervention</kwd>
<kwd>blood pressure</kwd>
<kwd>DASH</kwd></kwd-group><custom-meta-wrap><custom-meta xlink:type="simple"><meta-name>sagemeta-type</meta-name><meta-value>Journal Article</meta-value></custom-meta><custom-meta xlink:type="simple"><meta-name>search-text</meta-name><meta-value>271
PREMIER—A
Trial of Lifestyle Interventions for Blood Pressure Control: Intervention
Design and Rationale
SAGE Publications, Inc.200810.1177/1524839906289035
Kristine L.Funk
MS, RD
Center for Health Research, Kaiser Permanente Northwest,
in Portland, Oregon
Patricia J.Elmer
PhD
Center for Health Research, Kaiser Permanente Northwest,
in Portland, Oregon
Victor J.Stevens
PhD
Center for Health Research, Kaiser Permanente Northwest
in Portland, Oregon
David W.Harsha
PhD
Body Composition Laboratory at Pennington Biomedical
Research Center in Baton Rouge, Louisiana
Shirley R.Craddick
MHA, RD
Center for Health Research, Kaiser Permanente Northwest,
in Portland, Oregon
Pao-HwaLin
PhD
Sarah Stedman Center for Nutritional Studies at Duke
University Medical Center in Durham, North Carolina
Deborah RohmYoung
PhD
Department of Kinesiology at the University of Maryland
in College Park, Maryland
Catherine M.Champagne
PhD, RD
Analysis Core Department at Pennington Biomedical Research
Center in Baton Rouge, Louisiana
Phillip J.Brantley
PhD
Behavioral Medicine Laboratory at Pennington Biomedical
Research Center in Baton Rouge, Louisiana
Phyllis B.McCarron
MS, RD
Welch Center for Prevention, Epidemiology and Clinical
Research in Baltimore, Maryland
Denise G.Simons-Morton
MD, PhD
Division of Epidemiology and Clinical Applications,
National Heart, Lung
Blood Institute, National Institutes of Health, in Bethesda,
Maryland
Lawrence J.Appel
MD
Johns Hopkins School of Medicine in Baltimore, Maryland
Interventions encouraging
adoption of healthy diets and increased physical activity are needed to achieve
national goals for preventing and treating hypertension, cardiovascular disease,
diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial
testing the effects of two lifestyle interventions on blood pressure control,
compared with advice only. Both interventions implemented established national
guidelines for blood pressure control (weight loss, reduced sodium and alcohol
intake, and increased physical activity), and one intervention also included
the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions
focused on behavioral self-management, motivational enhancement, and personalized
feedback. This article describes the design and evaluation approaches for
these interventions. Evaluation of multicomponent lifestyle change interventions
can help us understand the benefits and difficulties of making multiple lifestyle
changes concurrently and the effects such changes can have on blood pressure,
particularly in minorities at higher risk for hypertension.
hypertension
diet
physical activity
behavioral intervention
blood pressure
DASH
Authors'
Note: This work is supported by National Institutes of Health grants UO1 HL60570,
UO1 HL60571, UO1 HL60573, UO1 HL60574, UO1 HL62828. We thank the following
members of the PREMIER research group for their contributions. From National
Heart, Lung, & Blood Institute: Eva Obarzanek, PhD; Jeffrey A. Cutler,
MD; and Lawton S. Cooper, MD. We also thank consultants Siriki Kumanyiuka,
PhD, MPH; Abby King, PhD; Jerome Williams, PhD; and Leslie Pruitt, PhD, for
contributions to the intervention. From the Center for Health Research Clinical
Center, Portland, OR: Adrianne Feldstein, MD, MS; Daniel Laferriere, RN, MSN; Dana Larson, RD, MS; Diane Cook, RD, MPH; Carol Young; Susan Arnold, RN, BSN; Donna Clark; Stanley Postlethwaite; Titza Suvalcu-Constantin; Carol Maul; Donna Gleason; Cheryl Johnson, EdM; Pamela McNeal; Debra Burch. From Duke
University Medical Center, Durham, NC: Laura Svetkey, MD; Colleen McBride,
PhD; Jamy Ard, MD; Kathleen Aicher; Blondeaner Brown; Denise Ernst; Jeanne
Gresko; Madhuri Kesari; Femke Lamers; LaTonya Nealon; Tori Phelps; LaVerne
Pruden; LaChanda Reams; Patrice Reams; Benjamin Reese, PhD; Fran Rukenbrod; Sonia Steele; Natalie Thorpe; Olaunda Williams; Chenghua (Cherry) Yang. From
Pennington Biomedical Research Center, Baton Rouge, LA: Allison Worthen; Betty
Kennedy; Emily Griffin; Erma Levy; Terri Keller; Shantell Jones; Katherine
Lastor. From Johns Hopkins Medical Center, Baltimore, MD: Barbara Bailey,
MS, RD; Jeanne Charleston, RN, MSN; Sharrone Cypress; Arlene Dalcin, MS, RD; Maura Deeley; Charalett Diggs, RN; Thomas ~ Erlinger, MD, MPH; Ann Fouts,
RN; Angela Hall; Charles Harris; Joy Peterson; Tara Harrison; Shirley Kritt; Estelle Levitas; Edgar Miller, MD, PhD; Pauline Patrick, LD; Charles Powell; Thomas Shields; LeeLana Thomas, MS, RD; Letitia Thomas; Bobbie Weiss; Deborah
Young, PhD. From the Coordinating Center, Center for Health Research, Portland,
OR: William M. Vollmer, PhD; Mikel Aickin, PhD; Jack Hollis, PhD; Njeri Karanja,
PhD; Fran Heinith, BSN;
272
Michael
Allison, BS; Gayle Meltesen, MS; Carrie Meeks. Data Safety & Monitoring
Board: Jerome D. Cohen, MD (Chair); Nancy R. Cook, ScD; Patricia M. Dubbert,
PhD; Keith C. Ferdinand, MD; James M. Raczynski, PhD; Linda Van Horn, PhD,
RD.
ypertension
(high blood pressure) affects about H50 million U.S. adults (Chobanian et
al., 2003) and is a major risk factor for heart disease and stroke. Framingham
Heart Study data conclude that 55-year-old nonhypertensive individuals have
a 90% risk of developing hypertension (Vasan et al., 2002) in their lifetimes.
Less than one half of all adults have optimal blood pressure (BP), defined
as systolic blood pres- sure (SBP) <120 mmHg and diastolic blood pressure
(DBP) < 80 mmHg. Although drug therapy can effec- tively lower BP and prevent
stroke and heart disease, it does not address the underlying causes of elevated
BP, including obesity, unhealthy dietary habits, and lim- ited physical activity.
Lifestyle modifications can address these underlying causes, reducing blood
pres- sure, and preventing or delaying incidence of hyper- tension (Chobanian
et al., 2003). This article describes the development and implementation of
the lifestyle change interventions used in the PREMIER clinical trial. The
PREMIER interventions were innovative in their combination of multiple lifestyle
change goals to be implemented simultaneously. ~ BACKGROUND According to national
clinical practice guidelines from the Joint National Committee on Detection,
Evaluation, and Treatment of High Blood Pressure (JNC), five primary lifestyle
modifications should be used for the initial treatment of stage 1 hypertension
(SBP = 140-159 mmHg, DBP = 90-99 mmHg). These lifestyle modifications also
may be used as an adjunct to drug therapy for all stages of hypertension and
for the primary prevention of hypertension in those with above-optimal BP
(Chobanian et al., 2003). The JNC recommends reducing weight and maintaining
a body mass index of 18.4 to 24.9 kg, adopting a Dietary Approaches to Stop
Hypertension (DASH) eating pat- tern (American Cancer Society, 1996; Appel
et al., 1997), reducing dietary sodium intake, engaging in reg- ular aerobic
physical activity, and moderating alcohol intake. Lifestyle modifications—controlling
obesity, increasing physical activity, and maintaining healthy dietary patterns—also
are recommended in national guidelines to prevent and control cancer and diabetes
(Byers et al., 2002; U.S. Department of Health and Human Services & U.S.
Department of Agriculture [USDHHS & DoA], 2000, 2005). Yet few (if any)
com- prehensive descriptions and evaluations of interven- tions that combine
all of these lifestyle modifications have been published.
The Authors
273
METHOD
Overview of PREMIER The design and rationale of the PREMIER trial have been
described elsewhere (Svetkey et al., 2003). Briefly, PREMIER was a multicenter,
randomized, con- trolled trial to determine the BP-lowering effects of two
18-month-long multicomponent lifestyle interventions. The Established Guidelines
(EG) and Established Guidelines + DASH (EG + DASH) interventions were compared
to an advice-only comparison condition. Both interventions included the most
current estab- lished guidelines from JNC at the time of the interven- tion
development, JNC V (weight loss, limited sodium and alcohol intake, and increased
physical activity; National Institutes of Health [NIH], 1992). After the start
of the PREMIER trial, the DASH diet was added to the JNC VII guidelines (U.S.
Department of Health and Human Services, National Institutes of Health, & National Heart, Lung, and Blood Institute, 2004). PRE- MIER participants were
generally healthy men and women age 25 years and older with high-normal BP
(SBP = 130-139, DBP = 85-89) or stage 1 hypertension (SBP = 140-159, DBP =
90-99) but not taking BP med- ication, and who met JNC V (NIH, 1992) criteria
for a 6-month trial of nonpharmocologic therapy. Outcomes were measured at
baseline and 6 and 18 months and included SBP, DBP, serum lipids, and prevalence
of hypertension. The main results at 6 months of the PRE- MIER clinical trial
have been reported elsewhere (Appel et al., 2003). Briefly, the trial concluded
that individuals can make multiple lifestyle changes to effectively lower
BP and control hypertension. In addi- tion, participants in the EG and EG
+ DASH interventions lost weight, reduced sodium intake, and increased phys-
ical fitness. Those in the EG + DASH group increased intake of fruits, vegetables,
and dairy products. Participants were recruited through mass mailings, advertisements,
and news stories. Given the burden of hypertension in minority populations
(Burt et al., 1995; Kramer et al., 2004), we overrecruited minori- ties, especially
African Americans. Baseline character- istics were similar for each randomized
group. Overall, 34% of participants were African American and 62% were women; the mean age was 50 years. Complete demographic data have been previously
reported (Appel et al., 2003; Svetkey et al., 2003). Clinical cen- ters were
located in Portland, Oregon; Baltimore, Maryland; Baton Rouge, Louisiana; and Raleigh- Durham, North Carolina; the coordinating center was located in
Portland, Oregon. The project office was at the National Heart, Lung, and
Blood Institute (NHLBI),
located
in Bethesda, Maryland. The Institutional Review Boards of the participating
centers approved the pro- tocol. Written informed consent was obtained from
all participants. Formative Activities for Intervention Development Background
and Conceptual Framework Our goal was to design and develop lifestyle inter-
ventions that could be readily transferred into general health care settings.
The interventions were designed to encourage lifestyle changes by focusing
on motivation and support and to be culturally relevant for African American
and other minority participants. We devel- oped an intervention format and
delivery approach that integrated diet and physical activity components and
balanced information with behavioral strategies. The interventions were based
on key theoretical con- structs developed to guide health behavior change
and on practical lessons learned from previous trials of weight loss, dietary
change, and cardiovascular disease (CVD) risk reduction (Elmer, Fosdick, et
al., 1995; Elmer, Grimm, et al., 1995; Stevens et al., 1993; Stevens et al.,
2001; Trials of Hypertension Prevention Collaborative Research Group, 1997; Whelton et al., 1998). The interventions were derived from social cognitive
theory (Bandura, 1986) and behavioral self-management (Watson & Tharp,
2002) and were constructed using the stages-of-change model (Prochaska & DiClemente, 1983) and motivational enhancement approaches (Miller & Rollnick,
2002). These approaches emphasize the indi- vidual's ability to achieve success
by setting goals, devel- oping behavior change plans, monitoring progress
toward the goals, and attaining skills necessary to reach the goals. Successful
approaches enhance self-efficacy and outcome expectancies, which are critical
mediators of behavior change (Bandura, 1997). Cultural Relevance Hypertension
continues to disproportionately affect African Americans (Burt et al., 1995; Kramer et al., 2004); consequently, the PREMIER interventions were designed
with specific attention to African American cultural relevance. Previous BP,
weight control, and life- style studies suggest that behavioral programs have
less success with African American participants (Kumanyika, Obarzanek, Stevens,
Hebert, & Whelton, 1991). To attempt a greater degree of cultural relevance
in the PREMIER interventions, a Minority Implementation Committee addressed
cultural issues for all aspects of
274
the
trial and provided guidance and review for inter- vention development, delivery,
and training. Members of this Committee included African American investi-
gators and staff, intervention experts, and an external consultant nationally
recognized as an expert in African American cultural and intervention issues.
The Committee made specific suggestions for inter- vention development, including
allowing time for social interactions, sharing food, discussing barriers to
changing food and activity patterns, and creating shared experiences among
group members, such as exercising together. These suggestions were incorpo-
rated into the intervention programs. Pretest and Formative Data Collection
for Refinement of Interventions We conducted an 8-week pretest of the EG and
EG + DASH interventions to evaluate the sequencing of the content, feasibility
of the self-monitoring approaches, and acceptability of materials and activities.
Each clin- ical center delivered the first six sessions of the planned PREMIER
interventions as a pretest to a total of 96 participants study-wide. Interventionists
pro- vided written evaluations of the sessions and the par- ticipants' interest
in and response to the program. At the end of the pretest, focus groups were
conducted with all participants about their experience. Additional focus groups
conducted with African American partic- ipants addressed cultural aspects
of the interventions. These focus groups addressed how relevant the programs
were to individuals, if they reflected their cultural perspective, how practical
the interventions were, and what barriers participants encountered. As a result,
the final protocol streamlined the self- monitoring tools and allowed more
time during early sessions to assist participants with self-monitoring. Group
problem-solving activities were incorporated wherein participants led discussions
about the pros and cons of self-monitoring and how to make self-monitor- ing
more efficient. Food demonstrations at group ses- sions were developed to
provide healthy adaptations or alternatives to common foods. We also included
more physical activity in the group sessions to help partici- pants meet their
weekly goal, and learning activities to focus on problem solving around barriers
to physical activity. The theoretical elements, including the deliv- ery format
and lifestyle guidelines, were acceptable to pretest participants. Few differences
in satisfaction or adherence were observed between EG and EG + DASH. Response
to the DASH dietary pattern was positive. Implementation of the final intervention
protocol began in 1999 and continued through 2002.
Description
and Implementation of Interventions Overview of Lifestyle Interventions—EG
and EG + DASH Table 1 shows the lifestyle targets and intervention delivery
approaches for the three arms of the trial. The intervention delivery, contact
schedules, and sequenc- ing of curriculum content were the same for EG and
EG + DASH. The lifestyle targets for the EG intervention were based on the
JNC V guidelines (NIH, 1992; weight loss if overweight, limited sodium and
alcohol intake, and increased physical activity). Weight loss was to be achieved
by restricting calorie intake and increasing energy expenditure through physical
activity. The EG dietary recommendation was consistent with the Dietary Guidelines
for Americans (USDHHS & DoA, 2000). The lifestyle targets for EG + DASH
included the same weight loss, sodium, physical activity, and alcohol tar-
gets as the EG intervention, plus the DASH dietary pat- tern. The DASH diet,
shown in Table 2, has been shown to significantly lower BP and reduce other
important car- diovascular risk factors (Appel et al., 1997; NIH, 1997; Obarzanek
et al., 2000). Weight loss was to be achieved by reducing calorie and fat
intake; substituting fruits, vegetables, and whole grains for high-fat and
high-calorie foods; and increasing physical activity. Contact Schedule for
EG and EG + DASH Interventions The intervention schedules for EG and EG +
DASH were identical. The intervention sequencing included three phases. Phase
I Intensive consisted of 3 months of weekly contacts (eight group sessions
and three indi- vidual visits) beginning at the randomization visit, when
each participant met with an interventionist to establish goals for calorie
intake, weight loss, and phys- ical activity. These early intensive contacts
focused on acquisition of behavioral skills and information related to the
PREMIER lifestyle guidelines. Phase 2 Interme- diate consisted of 3 months
of biweekly contacts (six group sessions and one individual visit) focusing
on consolidation of new behaviors and problem solving. Phase 3 Maintenance
consisted of 12 months of monthly group sessions supplemented with three indi-
vidual visits. The individual 30-minute to 60-minute sessions focused on the
participant's specific concerns, behavior change goals, and ways to maintain
motiva- tion during challenging situations. Interventionists used motivational
enhancement techniques to assess the participant's current stage of change
relative to dietary and physical activity behavior. Participants received
individualized graphs of attendance, weight change,
275
TABLE
1 Intervention Lifestyle Targets and Delivery Approaches for PREMIER Treatment
Groups
NOTE:
JNC V = The Fifth Report of the Joint National Committee on Detection, Evaluation,
and Treatment of High Blood Pressure (National Institutes of Health, 1992); DASH = Dietary Approaches to Stop Hypertension (Appel et al., 1997); FGP =
Food Guide Pyramid (U.S. Department of Health and Human Services & U.S.
Department of Agriculture, 2000); Na = Sodium; PA = physical activity; F&V
= fruits & vegetables; ME = motivational enhancement. a. Weight loss for
those with body mass index ≤ 25. b. Individual target set for caloric intake
to achieve weight loss. c. Servings are adjusted based on caloric intake.
physical
activity, and dietary goals to use as resources for goal setting and problem
solving. Group sessions, 1½ to 2 hours in length, were inter- active, with
group activities to foster problem solving, support, and program ownership.
Behavior-change techniques (checking progress, problem solving, action planning,
goal setting, and self-monitoring) occurred at each session. The components
of each group session included (a) Taste It!, (b) Progress Check, (c) Try
It!, and
(d) Next Steps. During Taste It!, participants were intro- duced to new foods,
recipes, and products that met the study dietary targets. The Progress Check
used a discus- sion format to encourage exploration of supportive behav- ioral
strategies and set the stage for the rest of the group session. During Try
It!, small-group activities reinforced the topical discussions with social
support and physical activity. During Next Steps, participants drafted plans
for the upcoming week(s) and set self-monitoring goals.
276
TABLE
2 Original DASH Dietary Pattern Targets for Nutrient Amounts and Servings
From Food Groups (at the 2100 kcal level; Appel et al., 1997)
NOTE:
DASH = Dietary Approaches to Stop Hypertension (Appel et al., 1997). a. Margarine,
low-fat mayonnaise, or salad dressing, vegetable oils. b. Sugar, jelly, jam,
syrups, sorbets, ices. Lifestyle Targets Common to EG and EG + DASH Physical
activity. The physical activity goal for EG and EG + DASH was 180 minutes
per week of moderate- intensity aerobic activity, which was consistent with
the national physical activity guidelines at the time of the intervention
development (Pate et al., 1995). Physical activity recommendations have been
increased in the 2005 Dietary Guidelines for Americans (USDHHS & DoA,
2005). Our objectives for the physical activity targets were to maximize the
BP-lowering effects of the inter- ventions, enhance maintenance of weight
loss, and high- light other benefits of physical activity (energy, mood, sleep,
self-esteem) that could reinforce behavior change. The interventions emphasized
moderate-intensity activ- ity (50% to 69% maximal heart rate), as many adults
pre- fer moderate over vigorous activity (Curry, McBride, Grothaus, Louie,
& Wagner, 1995), and moderate exercise is associated with lower injury
rates than vigorous exer- cise. Consistent with national recommendations,
vigor- ous activity was permitted for participants who had no
medical
contraindications (American College of Sports Medicine, 2000). When a regular
routine of exercise was established, bouts of moderate-to-vigorous activity
last- ing 20 minutes or longer contributed to the daily physi- cal activity
target. During group sessions, participants learned how to determine target
heart rate ranges for moderate- and vigorous-intensity activity. Behavioral
strategies for increasing physical activity included weekly monitoring of
minutes of activity, identifying pleasurable activities, scheduling daily
time to be physi- cally active, goal setting, identifying barriers to physical
activity, and problem solving strategies to deal with barriers. Physical activity
was incorporated into group sessions—participants exercised along with
videos, took group walks, and watched demonstrations of stretching, weight
training, and aerobics. Sodium. The goal was to reduce intake to ≤ 2400
mg per day. Key behavioral strategies included learning the sodium content
of foods using the program materials and food labels, using sodium-modified
food products, using sodium-free herbs and spices in food preparation, substi-
tuting different items for high-sodium foods, altering food choices in restaurants,
and becoming aware of changing taste preferences (Loria, Obarzanek, & Ernst, 2001). Alcohol. The goal for alcohol intake was ≤ 1 oz./day (≤ 2 drinks/day) for men and ≤ .5 oz./day (≤ 1 drink/day) for women. Baseline
eligibility criteria excluded indi- viduals who were heavy or binge drinkers.
Participants received information about the effects of alcohol on BP and learned
strategies for reducing alcohol intake, such as substituting nonalcoholic
beverages, drinking more slowly, and self-monitoring. Weight loss. The weight
goal for EG and EG + DASH was to help overweight participants (defined as
body mass index [BMI] ≥ 25 kg/m2) lose 15 lb. or more in the first 6 months
and maintain this weight loss for the duration of the 18-month trial. Ninety-six
percent of PREMIER participants entered the study with a BMI ≥ 25. Previous
investigations have demonstrated that 15 lbs. of weight loss has a clinically
meaningful impact on BP and on other CVD risk factors and chronic disease
(NIH, 1998). Self-monitoring. Keeping track of food intake and physi- cal
activity was a key element in both active interven- tions. Participants recorded
food intake for at least 3 days each week and physical activity every day.
Participants in EG monitored calories, sodium, and physical activity. Those
in EG + DASH monitored these same items plus daily servings of fruits, vegetables,
and low-fat dairy, and grams of total fat. Participants completed diaries
and
277
brought
them to intervention visits. The interventionists reviewed the self-monitoring
records and provided written and oral feedback. Written materials. Participants
in both interventions received written materials that contained information
on physical activity, sodium, alcohol, and weight loss. The dietary sections
differed, with the DASH dietary recommendations featured prominently in all
materials for the EG + DASH group. The complete curriculum for PREMIER is
available on the Internet at http://www .kpchr.org/public/premier/intervention/
DASH Dietary Pattern—EG + DASH The nutrient and food group targets for
the original DASH diet are shown in Table 2. The aspects of the DASH dietary
pattern most emphasized in PREMIER included eating 9 to 12 servings of fruits
and vegetables and 2 to 3 servings of low-fat dairy products per day, limiting
fat intake to ≤ 25% kcal, and reducing satu- rated fat. In the EG + DASH
intervention, learning activities, food taste tests, and cooking demonstrations
highlighted the DASH diet. By serving some type of fruit and/or vegetable
at every group session, we mod- eled fruit and vegetable intake with particular
empha- sis on vegetables and fruits that are good sources of potassium and
magnesium. Overview of the Advice-Only Comparison Participants assigned to
the advice-only comparison condition received advice and materials on lifestyle
modifications, including printed educational materials published by The National
High Blood Pressure Education Program for patients with high normal BP and
stage 1 hypertension (JNC V; NIH, 1992). Recommendations included reducing
weight if over- weight, limiting alcohol and dietary sodium intake, engaging
in regular physical activity, and eating a healthful diet for general cardiovascular
health as rec- ommended in Dietary Guidelines for Americans (USD- HHS & DoA, 2000). The 2005 Dietary Guidelines are now available (USDHHS & DoA,
2005). An interven- tionist discussed these recommendations with partici-
pants at two 30-minute individual visits, the first immediately following
the randomization visit and the second following the 6-month data collection
visit. DISCUSSION The PREMIER trial faced numerous challenges during development
and implementation of the interventions. These challenges included designing
an intervention
that
incorporated multiple lifestyle changes to be made simultaneously, including
DASH diet components in a calorie-controlled weight loss eating plan, and
creating an intervention that would be culturally relevant espe- cially for
African American participants. Most lifestyle change interventions have focused
on one or two changes, usually calorie or fat reduction and/or increasing
physical activity. Because the several lifestyle changes recommended by the
JNC had not been tested together as components of an all-inclusive program
to lower BP, the PREMIER trial's active inter- ventions included a comprehensive
list of lifestyle changes to be made all at once. For obvious reasons, we
were concerned that participants trying to make simul- taneous multiple changes
would find the intervention daunting and become overwhelmed, potentially reduc-
ing adherence and retention. We addressed this con- cern in a variety of ways,
including structured content delivery and individualized feedback. First of
all, we prioritized the change recommendations and incre- mentally introduced
the lifestyle goals over the first month of group sessions. The incremental
additions were reflected in the self-monitoring goals. For example, initially,
participants kept food records of what they ate and drank by recording the
food and por- tion size only. Over time, participants were instructed and
encouraged to use the program Food and Fitness Guide or product food labels
to look up and tally calo- ries and sodium. In addition, EG + DASH tracked
fat and incrementally added a tally of fruit, vegetable, and dairy serving
intake during the first few weeks. In addition to incrementally introducing
dietary goals through the self-monitoring techniques, the cur- riculum used
the concept of dietary patterns to sim- plify the complexity of making multiple
changes. Rather than attack the whole daily diet at once, each weekly group
session focused on a particular mealtime and eating pattern. We began with
morning, afternoon, and evening meals and proceeded to snacks, eating out,
and special occasions. Organizing the content around patterns allowed participants
to look at personal eating patterns and make small changes within the pattern,
eventually resulting in multiple dietary changes. We approached making changes
around exercise in a simi- lar way. We encouraged participants to add exercise
minutes in small increments, starting with 10 minutes for those who were not
exercising at all. We also addressed exercise patterns, using weekday and
week- end patterns as a basis for adjusting routines to incor- porate more
exercise. Group sessions were the main avenue of intervention content delivery,
in part to keep overall costs down. However, to customize the intervention
and to ensure
278
each
participant made progress in all lifestyle change areas, we incorporated periodic
individual visits, which allowed further tailoring of the intervention to
the indi- vidual participant. The complexity of adopting multiple lifestyle
changes was addressed on an individual level at these appointments. Using
motivational enhancement techniques, the interventionists helped participants
make action plans for the following weeks. Participants prac- ticed each change
and gained confidence before moving on to the next change. The concept of
making small incre- mental changes over time is consistent with behavior change
theory and addressed the overwhelming nature of implementing many simultaneous
lifestyle changes. A second challenge of this intervention was the inclu-
sion of the DASH dietary pattern. The DASH diet is com- plex, and we were
concerned that the large number of servings of specific food groups required
by the DASH diet would be unacceptable to participants, especially those with
the additional goal of calorie reduction for weight loss. We addressed this
issue by simplifying the diet targets that focus on the DASH-specific nutrients.
We chose the simplified targets for scientific, behavioral, and practical
reasons. The servings specified for fruits and vegetables and for dairy products
provide a substantial proportion of the micronutrient levels of the DASH diet,
and fruits and vegetables accounted for about one half of the BP-lowering
effect demonstrated in the DASH feed- ing studies (Appel et al., 1997). By
emphasizing fruits, vegetables, and dairy products, we provided participants
with positive messages to add healthy foods to the diet instead of focusing
only on limiting or eliminating cer- tain foods as a way to reduce calorie
and fat intake. As a practical matter, we encouraged participants to eat a
vari- ety of fruits and vegetables rather than target specific fruits and
vegetables. The challenge of creating an intervention that was cul- turally
relevant and useful to a diverse group of partici- pants also required our
attention. We specifically focused on African Americans who are at high risk
of hyperten- sion (Burt et al., 1995; Kramer et al., 2004). We learned important
lessons from pretest participant focus groups and consultation from experts.
These lessons included a better understanding of the cultural context for
African Americans that underlie diet and activity patterns, food preferences,
and attitudes and barriers regarding physical activity and weight loss. The
expert panel helped us understand cultural ideas of the role of food in social
interactions and disease prevention. As a result, we included intervention
activities that emphasized social support networks, especially family and
peer groups. Families were invited to come to group sessions and par- ticipate
alongside the participant as a form of social sup- port. In addition, group
sessions included celebrations,
small
group discussions, and social time before or after. The group facilitators
encouraged participants to share contact information, plan activities together
outside of the group session, and include family and friend support whenever
possible. Despite multiple challenges, the potential positive impact of lifestyle
change interventions from a public health perspective is worth exploring.
Current public health goals emphasize long-term weight loss mainte- nance
(USDHHS & DoA, 2005). Maintaining weight loss can help remedy the underlying
causes of elevated BP not addressed by drug therapy, including unhealthy dietary
habits, and limited physical activity. Maintaining healthy BP can help reduce
health care costs and loss of productivity and quality of life. Although 18
contacts in the first 6 months is more intensive than some lifestyle change
interventions and less than others, new evidence exists that longer terms
of intensive treatment result in better weight loss results (Wadden, Butryn,
& Byrne, 2004). The potential public health benefit of maintaining even
modest weight loss during 18 months is an impor- tant reason to encourage
such interventions. CONCLUSION Evaluation of multicomponent interventions
such as evaluated in PREMIER can help refine our understand- ing of the complexities
involved in making multiple lifestyle changes simultaneously and the impact
such changes have on BP, especially in minority populations at higher risk
for hypertension. The approaches described here provide a useful framework
and practical model for implementing lifestyle change interventions in health
care settings and link known diet and physical activity research recommendations
to everyday practice. The 18-month results of the PREMIER study, reported
elsewhere (Elmer et al., 2006) demonstrate that individ- uals with prehypertension
and stage 1 hypertension can make and sustain, during a period of 18 months,
multiple lifestyle modifications that have the potential to control BP and
reduce the risk of chronic disease. In addition, participants maintained a
4% weight reduction during the18 months of intervention. Such results lend
support to health care organizations to choose this model for implementing
multicomponent lifestyle change inter- ventions to reduce BP in diverse populations.
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J.</namePart><namePart type="family">Elmer</namePart><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Victor J.</namePart><namePart type="family">Stevens</namePart><affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</affiliation><affiliation>Center for Health Research, Kaiser Permanente Northwest in Portland, Oregon</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David W.</namePart><namePart type="family">Harsha</namePart><affiliation>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><affiliation>Body Composition Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Shirley R.</namePart><namePart type="family">Craddick</namePart><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation><affiliation>Center for Health Research, Kaiser Permanente Northwest, in Portland, Oregon</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Pao-Hwa</namePart><namePart type="family">Lin</namePart><affiliation>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</affiliation><affiliation>Sarah Stedman Center for Nutritional Studies at Duke University Medical Center in Durham, North Carolina</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Deborah Rohm</namePart><namePart type="family">Young</namePart><affiliation>Department of Kinesiology at the University of Maryland in College Park, Maryland</affiliation><affiliation>Department of Kinesiology at the University of Maryland in College Park, Maryland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Catherine M.</namePart><namePart type="family">Champagne</namePart><affiliation>Analysis Core Department at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><affiliation>Analysis Core Department at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Phillip J.</namePart><namePart type="family">Brantley</namePart><affiliation>Behavioral Medicine Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><affiliation>Behavioral Medicine Laboratory at Pennington Biomedical Research Center in Baton Rouge, Louisiana</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Phyllis B.</namePart><namePart type="family">McCarron</namePart><affiliation>Welch Center for Prevention, Epidemiology and Clinical Research in Baltimore, Maryland</affiliation><affiliation>Welch Center for Prevention, Epidemiology and Clinical Research in Baltimore, Maryland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Denise G.</namePart><namePart type="family">Simons-Morton</namePart><affiliation>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</affiliation><affiliation>Division of Epidemiology and Clinical Applications, National Heart, Lung, Blood Institute, National Institutes of Health, in Bethesda, Maryland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lawrence J.</namePart><namePart type="family">Appel</namePart><affiliation>Johns Hopkins School of Medicine in Baltimore, Maryland</affiliation><affiliation>Johns Hopkins School of Medicine in Baltimore, Maryland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>SAGE Publications</publisher><place><placeTerm type="text">Sage CA: Los Angeles, CA</placeTerm></place><dateIssued encoding="w3cdtf">2008-07</dateIssued><copyrightDate encoding="w3cdtf">2008</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract lang="en">Interventions encouraging adoption of healthy diets and increased physical activity are needed to achieve national goals for preventing and treating hypertension, cardiovascular disease, diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.</abstract><subject><genre>keywords</genre><topic>hypertension</topic><topic>diet</topic><topic>physical activity</topic><topic>behavioral intervention</topic><topic>blood pressure</topic><topic>DASH</topic></subject><relatedItem type="host"><titleInfo><title>Health Promotion Practice</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">1524-8399</identifier><identifier type="eISSN">1552-6372</identifier><identifier type="PublisherID">HPP</identifier><identifier type="PublisherID-hwp">sphpp</identifier><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>9</number></detail><detail type="issue"><caption>no.</caption><number>3</number></detail><extent unit="pages"><start>271</start><end>280</end></extent></part></relatedItem><identifier type="istex">A6B5856C0CD6DACE03FBDE4567C0F16143493AD5</identifier><identifier type="ark">ark:/67375/M70-7WSB6XLG-6</identifier><identifier type="DOI">10.1177/1524839906289035</identifier><identifier type="ArticleID">10.1177_1524839906289035</identifier><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-0J1N7DQT-B">sage</recordContentSource></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/M70-7WSB6XLG-6/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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