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Behavioral Counseling Interventions to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Cardiovascular Disease Risk FactorsUpdated Evidence Report and Systematic Review for the US Preventive Services Task Force

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Importance  Unhealthful dietary patterns, low levels of physical activity, and high sedentary time increase the risk of cardiovascular disease.

Objective  To synthesize the evidence on benefits and harms of behavioral counseling interventions to promote a healthy diet and physical activity in adults without known cardiovascular disease (CVD) risk factors to inform a US Preventive Services Task Force recommendation.

Data Sources  MEDLINE, PsycINFO, and the Cochrane Central Register of Controlled Trials through February 2021, with ongoing surveillance through February 2022.

Study Selection  Randomized clinical trials (RCTs) of behavioral counseling interventions targeting improved diet, increased physical activity, or decreased sedentary time among adults without known elevated blood pressure, elevated lipid levels, or impaired fasting glucose.

Data Extraction and Synthesis  Independent data abstraction and study quality rating and random effects meta-analysis.

Main Outcomes and Measures  CVD events, CVD risk factors, diet and physical activity measures, and harms.

Results  One-hundred thirteen RCTs were included (N = 129 993). Three RCTs reported CVD-related outcomes: 1 study (n = 47 179) found no significant differences between groups on any CVD outcome at up to 13.4 years of follow-up; a combined analysis of the other 2 RCTs (n = 1203) found a statistically significant association of the intervention with nonfatal CVD events (hazard ratio, 0.27 [95% CI, 0.08 to 0.88]) and fatal CVD events (hazard ratio, 0.31 [95% CI, 0.11 to 0.93]) at 4 years. Diet and physical activity behavioral counseling interventions were associated with small, statistically significant reductions in continuous measures of blood pressure (systolic mean difference, −0.8 [95% CI, −1.3 to −0.3]; 23 RCTs [n = 57 079]; diastolic mean difference, −0.4 [95% CI, −0.8 to −0.0]; 24 RCTs [n = 57 148]), low-density lipoprotein cholesterol level (mean difference, 2.2 mg/dL [95% CI, −3.8 to −0.6]; 15 RCTs [n = 6350]), adiposity-related outcomes (body mass index mean difference, −0.3 [95% CI, −0.5 to −0.1]; 27 RCTs [n = 59 239]), dietary outcomes, and physical activity at 6 months to 1.5 years of follow-up vs control conditions. There was no evidence of greater harm among intervention vs control groups.

Conclusions and Relevance  Healthy diet and physical activity behavioral counseling interventions for persons without a known risk of CVD were associated with small but statistically significant benefits across a variety of important intermediate health outcomes and small to moderate effects on dietary and physical activity behaviors. There was limited evidence regarding the long-term health outcomes or harmful effects of these interventions.

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Article Information

Corresponding Author: Carrie D. Patnode, PhD, MPH, Kaiser Permanente Evidence-based Practice Center, The Center for Health Research, Kaiser Permanente Northwest, 3800 N Interstate Ave, Portland, OR 97227 (Carrie.D.Patnode@kpchr.org).

Accepted for Publication: April 19, 2022.

Author Contributions: Dr Patnode had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Patnode.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Patnode, Iacocca.

Critical revision of the manuscript for important intellectual content: Patnode, Redmond, Henninger.

Statistical analysis: Patnode, Redmond.

Obtained funding: Patnode.

Administrative, technical, or material support: All authors.

Supervision: Patnode.

Conflict of Interest Disclosures: None reported.

Funding/Support: This research was funded under contract HHSA 290201500007I-EPC5, Task Order 9, from the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services, under a contract to support the US Preventive Services Task Force (USPSTF).

Role of the Funder/Sponsor: Investigators worked with USPSTF members and AHRQ staff to develop the scope, analytic framework, and key questions for this review. AHRQ had no role in study selection, quality assessment, or synthesis. AHRQ staff provided project oversight, reviewed the report to ensure that the analysis met methodological standards, and distributed the draft for peer review. Otherwise, AHRQ had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript findings. The opinions expressed in this document are those of the authors and do not reflect the official position of AHRQ or the US Department of Health and Human Services.

Additional Contributions: We gratefully acknowledge the following individuals for their contributions to this project: Justin A. Mills, MD, MPH (AHRQ); current and former members of the USPSTF who contributed to topic deliberations; and Evidence-based Practice Center staff members Melinda Davies, MA, and Jill Pope for technical and editorial assistance at the Kaiser Permanente Center for Health Research. USPSTF members, peer reviewers, and federal partner reviewers did not receive financial compensation for their contributions.

Additional Information: A draft version of this evidence report underwent external peer review from 4 content experts (Tess Harris, MD [St George’s University of London]; Penny Kris-Etherton, PhD, RD [Penn State University]; Karen Goldstein, MD [Duke University]; and Jill Huber, MD [Mayo Clinic]) and 4 federal partners (Centers for Disease Control and Prevention; Office of Research on Women’s Health; National Heart, Lung, and Blood Institute; and National Institute of Nursing Research). Comments were presented to the USPSTF during its deliberation of the evidence and were considered in preparing the final evidence review.

Editorial Disclaimer: This evidence report is presented as a document in support of the accompanying USPSTF recommendation statement. It did not undergo additional peer review after submission to JAMA.

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