Lifestyle Interventions To Reduce Cardiovascular Risk .
LifestyleInterventionsto ReduceCardiovascular RiskSystematic Evidence Review Fromthe Lifestyle Work Group, 2013
ContentsForeword. viiLifestyle Work Group . ixSection 1: Background and Description of the NHLBI Cardiovascular Risk ReductionProject. 1A. Background . 1B. Lifestyle Work Group Report. 2Section 2: Process and Methods Overview . 3A. Evidence-Based Approach . 3i. Overview of the Evidence-Based Methodology . 3ii. System for Grading the Body of Evidence . 4B. Critical Question-Based Approach . 5Section 3: CQ1—Dietary Patterns and Macronutrients: Blood Pressure and Lipids . 7A. Introduction/Rationale . 7B. Selection of Inclusion/Exclusion Criteria . 7C. Literature Search Yield . 8i. Dietary Pattern Evidence . 9D. CQ1 Evidence Statements. 9i. Dietary Patterns . 9ii. Dietary Fat and Cholesterol . 17Section 4: CQ2—Sodium and Potassium: Blood Pressure and CVD Outcomes . 21A. Introduction/Rationale . 21B. Selection of Inclusion/Exclusion Criteria . 21C. Literature Search Yield . 23D. CQ2 Evidence Statements. 23i. Sodium and Blood Pressure . 23ii. Sodium and CHD/CVD Outcomes . 30iii. Potassium and Blood Pressure and CHD/CVD Outcomes . 33Section 5: CQ3—Physical Activity: Lipids and Blood Pressure . 35A. Introduction/Rationale . 35B. Selection of Inclusion/Exclusion Criteria . 35C. Literature Search Yield . 36D. CQ3 Evidence Statements. 37i. Physical Activity and Lipids . 37ii. Physical Activity and Blood Pressure . 40Section 6: Gaps in Evidence and Future Research Needs . 45A. Diet. 45B. Physical Activity . 45AppendixesAppendix A.Methods for Lifestyle Questions . A–1Appendix B.Critical Question 1 Methods . B–1Appendix C.Critical Question 2 Methods . C–1Appendix D.Critical Question 3 Methods . D–1Appendix E.Abbreviations and Acronyms. E–1References . R–1LIFESTYLE INTERVENTIONS TO REDUCE CARDIOVASCULAR RISK: SYSTEMATIC EVIDENCE REVIEW FROM THE LIFESTYLE WORK GROUP, 2013iii
List of TablesTable 1. Evidence Quality Grading System . 4Table 2. PICOTS Approach for CQ1 . 8Table 3. Summary of Supporting Evidence for ES1 and ES2 . 11Table 4. Summary of Supporting Evidence for ES1 and ES2 . 12Table 5. Food Composition of DASH Diet vs. Control Diet. 13Table 6. Macronutrient Composition of DASH Diet vs. Control Diet . 13Table 7. Macronutrient Composition and Lipid Effects in DASH, DASH-Sodium, andDELTA . 18Table 8. PICOTS Approach for CQ2 . 22Table 9. Effects of Sodium Reduction on Systolic/Diastolic Blood Pressure (mmHg) inthe DASH-Sodium Trial . 26Table 10. PICOTS Approach for CQ3 . 36Table A–1. Quality Assessment Tool for Controlled Intervention Studies . A–6Table A–2. Quality Assessment Tool for Systematic Reviews and Meta-Analyses . A–10Table A–3. Quality Assessment Tool for Observational Cohort and Cross-SectionalStudies . A–13Table A–4. Quality Assessment Tool for Case-Control Studies . A–20Table A–5. Evidence Quality Grading System. A–30Table A–6. Examples of Simple Queries . A–32Table A–7. Attributes and Their Values . A–34Table A–8. Common Macro Queries Used in Search Strategies . A–35CQ1 Summary Table B–1. Mediterranean Style Dietary Pattern . B–6CQ1 Summary Table B–2. DASH Dietary Pattern and DASH Variations. B–13CQ1 Summary Table B–3. DASH Pattern Subgroups: Sex . B–18CQ1 Summary Table B–4. DASH Pattern Subgroups: Race/Ethnicity. B–22CQ1 Summary Table B–5. DASH Pattern Subgroup: Hypertension Status . B–27CQ1 Summary Table B–6. DASH Pattern Subgroup: Age . B–32CQ1 Summary Table B–7. Glycemic Index/Load . B–35CQ1 Summary Table B–8. Dietary Fat and Cholesterol . B–39Table B–9. Critical Question 1 Studies Rated as Poor, With Rationale. B–45CQ2 Summary Table C–1. Overall Sodium and Blood Pressure Outcomes . C–6CQ2 Summary Table C–2. Different Levels of Sodium . C–11CQ2 Summary Table C–3. Sodium and Other Dietary Changes . C–13CQ2 Summary Table C–4a. Sodium and Subpopulation: Sex . C–18CQ2 Summary Table C–4b. Sodium and Subpopulation: Race/Ethnicity . C–27CQ2 Summary Table C–4c. Sodium and Subpopulation: Age . C–36ivLIFESTYLE INTERVENTIONS TO REDUCE CARDIOVASCULAR RISK: SYSTEMATIC EVIDENCE REVIEW FROM THE LIFESTYLE WORK GROUP, 2013
CQ2 Summary Table C–4d. Sodium and Subpopulation: Hypertension Status . C–40CQ2 Summary Table C–5. Sodium and CVD Outcomes: Trials or ObservationalFollowup of Trials . C–46CQ2 Summary Table C–6. Sodium and CVD Outcomes: Observational Data . C–51CQ2 Summary Table C–7. Potassium and Blood Pressure and CVD Outcomes . C–64CQ2 Summary Table C–8. Potassium and CVD Outcomes. C–68Table C–9. Critical Question 2 Studies Rated as Poor, With Rationale . C–81CQ3 Summary Table D–1. Aerobic Exercise and LDL-C . D–3CQ3 Summary Table D–2. Resistance Exercise and LDL-C . D–4CQ3 Summary Table D–3. Aerobic Exercise and HDL-C . D–4CQ3 Summary Table D–4. Resistance Exercise and HDL-C . D–5CQ3 Summary Table D–5. Aerobic Exercise and Blood Pressure . D–5CQ3 Summary Table D–6. Resistance Exercise and Blood Pressure . D–6Table D–7. Critical Question 3 Studies Rated as Poor, With Rationale . D–7List of FiguresFigure B–1. PRISMA Diagram Showing Selection of Articles for Lifestyle CriticalQuestion 1 . B–5Figure C–1. PRISMA Diagram Showing Selection of Articles for Lifestyle CriticalQuestion 2 . C–5Figure D–1. PRISMA Diagram Showing Selection of Articles for Lifestyle CriticalQuestion 3 . D–2LIFESTYLE INTERVENTIONS TO REDUCE CARDIOVASCULAR RISK: SYSTEMATIC EVIDENCE REVIEW FROM THE LIFESTYLE WORK GROUP, 2013v
ForewordIn 1977, the National Heart, Lung, and Blood Institute (NHLBI) issued the first of several clinical practiceguidelines (CPGs) as part of its core mission, which is to provide global leadership for a research, training, andeducation program to promote the prevention and treatment of heart, lung, and blood diseases and enhance thehealth of all individuals so that they can live longer and more fulfilling lives. Guidelines from the National HighBlood Pressure Education Program, the National Cholesterol Education Program, the Obesity EducationInitiative, as well as from other similar programs and initiatives, have addressed a variety of topics, including,but not limited to, cholesterol, blood pressure, obesity, asthma, and von Willebrand disease. Over the years,health care systems and providers have used these guidelines for the prevention, detection, evaluation, andtreatment of cardiovascular disease risk factors, and lung and blood diseases.In 2008, NHLBI convened expert panels to update the existing clinical guidelines on cholesterol, blood pressure,and overweight/obesity, by conducting rigorous systematic evidence reviews. At the same time, threecrosscutting work groups—on lifestyle, risk assessment, and implementation—were convened to developadditional systematic evidence reviews to support the work of the expert panels. The impetus for theseguidelines was the recognition that despite the enormous progress over the last 60 years, cardiovascular diseaseremains the leading cause of death in the United States.While the updates were underway, the Institute of Medicine (IOM) issued two reports that established new "bestpractice" standards for generating systematic evidence reviews and developing clinical guidelines. The reportsunderscore that these are two distinct, yet related, activities that require careful intersection and coordination.Accordingly, NHLBI’s role in the guidelines updates transitioned to completing a systematic evidence review foreach topic and collaborating with other organizations to prepare and issue the related clinical guidelines.Since implementing the new collaborative partnership model for developing guidelines based upon NHLBIsponsored systematic evidence reviews, four of the five Expert Panels/Work Groups have worked successfullywith the American Heart Association (AHA), the American College of Cardiology (ACC), The Obesity Society(TOS), and other professional societies to develop new cardiovascular disease prevention CPGs for lifestyle,risk assessment, cholesterol, and obesity. The new guidelines—published in November 2013 by the AHA,ACC, and TOS, and endorsed by other professional societies—provide a valuable updated roadmap to helpclinicians and patients manage CVD prevention and treatment challenges.We appreciate the outstanding work and dedication of the expert panels and work groups that developed thesystematic evidence reviews that formed the basis for the guidelines. These systematic evidence reviews are theproducts of one of the most rigorous evidence-based systematic reviews conducted to date. We look forward tocontinuing to develop accurate and timely evidence reviews, fueled by our investment in primary research on theprevention and treatment of cardiovascular disease as well as implementation science, to improve public health.The following systematic evidence report is available as a public resource.Gary H. Gibbons, M.D.DirectorNational Heart, Lung, and Blood InstituteLIFESTYLE INTERVENTIONS TO REDUCE CARDIOVASCULAR RISK: SYSTEMATIC EVIDENCE REVIEW FROM THE LIFESTYLE WORK GROUP, 2013vii
Lifestyle Work GroupCo-ChairsRobert H. Eckel, M.D.University of Colorado Anschutz Medical CampusAurora, COJohn M. Jakicic, Ph.D.University of PittsburghPittsburgh, PAMembersJamy D. Ard, M.D.Wake Forest UniversityWinston-Salem, NCThomas A. Wadden, Ph.D.University of Pennsylvania School of MedicinePhiladelphia, PANancy Houston Miller, R.N., B.S.N.Stanford University School of MedicineStanford, CASidney C. Smith, Jr., M.D.University of North Carolina at Chapel HillChapel Hill, NCI-Min Lee, M.D., Sc.D.Harvard School of Public HealthBoston, MAEx-Officio (National Institutes of Health) VotingMembersAlice H. Lichtenstein, D.Sc.Tufts UniversityMedford, MABarbara E. Millen, Dr.P.H., R.D., F.A.D.A.Boston University School of MedicineBoston, MACathy Nonas, M.S., R.D.New York City Department of Health and MentalHygieneNew York, NYFrank M. Sacks, M.D.Harvard School of Public HealthBoston, MALaura P. Svetkey, M.D., M.H.S.Duke University Medical CenterDurham, NCVan S. Hubbard, M.D., Ph.D.Catherine M. Loria, Ph.D.Susan Z. Yanovski, M.D.National Heart, Lung, and Blood InstituteJanet M. de Jesus, M.S., R.D.Glen Bennett, M.P.H.Kathryn Y. McMurry, M.S.Denise G. Simons-Morton, M.D., Ph.D.Methodology TeamRTI InternationalLaura C. Morgan, M.A.Michael G. Trisolini, Ph.D., M.B.A.Science Applications International CorporationKarima A. Kendall, Ph.D.George VelascoJanusz Wnek, Ph.D.LIFESTYLE INTERVENTIONS TO REDUCE CARDIOVASCULAR RISK: SYSTEMATIC EVIDENCE REVIEW FROM THE LIFESTYLE WORK GROUP, 2013ix
Section 1: Background andDescription of the NHLBICardiovascular Risk Reduction ProjectA. BackgroundSince the 1970s, the National Heart, Lung, and Blood Institute (NHLBI) has sponsored the development ofclinical practice guidelines that have helped to accelerate the application of health research to strategies andprograms for the prevention, detection, and treatment of cardiovascular, lung, and blood diseases. In 2005,NHLBI recognized the need to update the most recent cardiovascular guidelines, namely those on high bloodcholesterol, high blood pressure (BP), and overweight/obesity in adults. NHLBI convened stakeholder groupsto provide input on the development process for the next generation of clinical practice guidelines.The stakeholders emphasized the following needs: Maintain guidelines that focus on specific risk factors.Take a standardized and coordinated approach to updating the risk factors.Take a more evidence-based approach to development and implementation.Give more attention to dissemination and implementation issues.Work closely with stakeholders in health care and community systems to translate and disseminate theevidence base.In 2008, NHLBI established three expert panels that would use a rigorous systematic evidence review process toupdate the guidelines for high blood cholesterol, high BP, and overweight/obesity. Additionally, three workgroups were formed around risk assessment, lifestyle, and implementation to develop reports and providecrosscutting input to the expert panels. A Guidelines Executive Committee—comprised of co-chairs from theexpert panels and work groups—coordinated the work of the expert panels and work groups. Efforts resulted insix topic-specific yet complementary reports: blood cholesterol, BP, overweight/obesity, lifestyle, risk assessment, andimplementation. This report summarizes the evidence review findings of the Lifestyle Work Group.While the expert panels and work groups were undertaking a rigorous, systematic, evidence-based approach toupdating the guidelines, the Institute of Medicine (IOM) convened experts to examine the methodology fordeveloping guidelines. In 2011, IOM issued two reports that established new “best practices” for generatingsystematic evidence reviews1 and developing clinical practice guidelines.2 The reports from IOM stress thatthese are two distinct but related activities that require careful intersection and coordination.Because of these developments and the changing approaches to developing guidelines, in June 2012, the NHLBIAdvisory Council recommended that the Institute transition to a new model in accordance with the best practicestandards established by IOM. In mid-2013, NHLBI adopted a new collaborative partnership model whereby it willfocus on generating high-quality systematic evidence reviews and developing subsequent clinical practiceguidelines by partnering with professional societies and other organizations.3 The systematic review components ofthe five adult clinical practice guidelines (including this systematic evidence review by the Lifestyle Work Group) will beLIFESTYLE INTERVENTIONS TO REDUCE CARDIOVASCUL
LIFESTYLE INTERVENTIONS TO REDUCE CARDIOVASCULAR RISK: SYSTEMATIC EVIDENCE REVIEW FROM THE LIFESTYLE WORK GROUP, 2013 ix Lifestyle Work Group Co-Chairs Robert H. Eckel, M.D. University of Colorado Anschutz Medical Campus Aurora, CO John M. Jakicic, Ph.D. University of Pittsburgh Pittsburgh, PA Members Jamy D. Ard, M.D. Wake Forest University
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