Purpose: We conducted a systematic evidence review of the benefits and harms of behavioral counseling interventions to prevent cardiovascular disease (CVD) in persons with established risk factors to assist the U.S. Preventive Services Task Force (USPSTF) in updating its previous recommendation statements.
We searched MEDLINE, PsycInfo, the Database of Abstracts of Reviews of Effects, and the Cochrane Central Register of Controlled Trials from 2001 through October 2013 to locate relevant trials for all key questions published since the previous reviews in support of prior recommendations. We supplemented our searches with reference lists from relevant existing systematic reviews, suggestions from experts, and information from
Study Selection: Two investigators independently reviewed 7,218 abstracts and 553 articles against a set of a priori inclusion criteria. Investigators also independently critically appraised each study using design-specific quality criteria based on USPSTF methods. We included fair- or good-quality trials evaluating behavioral counseling interventions to promote a healthy diet, physical activity, or both in persons with CVD risk factors, including hypertension, dyslipidemia, metabolic syndrome, and impaired fasting glucose or glucose tolerance. We resolved discrepancies by consensus.
Data Extraction and Analysis: One investigator abstracted data from 74 included studies into evidence tables and a second reviewer checked these data. We conducted meta-analyses on 57 of the 71 trials that provided necessary data to estimate the effect size of counseling on intermediate health outcomes (lipids, blood pressure, weight measures, and glucose measures). We qualitatively summarized the evidence for effects on health outcomes, behavioral outcomes, and harms.
Data Synthesis: Key Question 1. Do healthy lifestyle counseling interventions improve CVD health outcomes in adults with known CVD risk factors? Only a subset of trials (k=16) reported measures of patient health outcomes, including CVD events (k=5) and self-reported measures of quality of life (QOL) or depression symptoms (k=11). In general, intensive interventions that combined lifestyle interventions did not reduce CVD events or mortality at up to 10 years of followup, although event rates were generally low. In one early good-quality trial, a high-intensity behavioral counseling intervention in conjunction with a protocol to start medication reduced CVD events at 6.6 years compared with usual care (relative risk [RR], 0.71 [95% CI, 0.51 to 0.99]). This study was conducted in Swedish men at high risk for CVD (which included persons with diabetes and known CVD). Overall, combined lifestyle interventions did not appear to improve self-reported depression symptoms (k=4) in persons with impaired fasting glucose or glucose tolerance at 6 to 12 months. Findings that showed a benefit on self-reported QOL measures were mixed. While three combined lifestyle counseling trials showed improvement on selected QOL measures, two combined lifestyle counseling trials and two physical activity–only counseling trials showed no benefit on self-reported QOL at 6 to 12 months. Key Question 2. Do healthy lifestyle counseling interventions improve intermediate CVD outcomes in adults with known CVD risk factors? Medium- (31 to 360 minutes) to high-intensity (>360 minutes) combined lifestyle counseling in persons selected for CVD risk factors reduces total cholesterol, low-density lipoprotein (LDL) cholesterol, blood pressure, fasting glucose, diabetes incidence, and weight outcomes. Overall, at 12 to 24 months, behavioral counseling appears to reduce total cholesterol (k=34) by an average of 4.48 mg/dL (95% CI, 6.36 to 2.59), LDL cholesterol (k=25) by 3.43 mg/dL (95% CI, 5.37 to 1.49), systolic blood pressure (k=31) by 2.03 mm Hg (95% CI, 2.91 to 1.15), diastolic blood pressure (k=24) by 1.38 mm Hg (95% CI, 1.92 to 0.84), fasting glucose (k=22) by 2.08 mg/dL (95% CI, 3.29 to 0.88), diabetes incidence (k=8) by an RR of 0.58 (95% CI, 0.37 to 0.89), and weight outcomes (k=34) by a pooled mean difference of 0.26, using standardized units (95% CI, 0.35 to 0.16). There was substantial statistical heterogeneity for weight outcomes. High-intensity combined lifestyle counseling in persons with impaired fasting glucose or glucose tolerance (k=5) can reduce diabetes incidence in the long term (RR, 0.55 [95% CI, 0.45 to 0.67]). Intensive diet-only counseling interventions primarily in persons with dyslipidemia who are not yet taking medications can also modestly lower total (k=8) and LDL (k=7) cholesterol at 12 to 24 months. In contrast, medium-intensity (k=8) physical activity–only counseling interventions (k=10) did not appear to improve intermediate CVD outcomes at 12 to 24 months. Findings from trials that could not be included in quantitative analyses were generally consistent with pooled findings. Key Question 3. Do healthy lifestyle counseling interventions improve diet and physical activity behavioral outcomes in adults with known CVD risk factors? Overall, objectively measured and self-reported changes in dietary intake and physical activity were concordant with intermediate outcome findings. Only three of the 61 trials that reported behavioral outcomes did not also report intermediate health outcomes. In selected trials conducted in persons who were already taking medications to lower cholesterol or blood pressure, counseling interventions appeared to improve dietary intake and physical activity despite a lack of benefit on lipid or blood pressure outcomes. Many physical activity–only counseling trials (k=9) had less than 12 months of followup. Four of five trials reporting behavioral outcomes at 12 to 24 months found statistically significant improvements in self-reported physical activity (i.e., number of persons meeting the recommended 150 minutes of moderate activity per week, minutes per week of total or moderate physical activity). Key Question 4. What are the adverse effects of healthy lifestyle counseling in adults with known CVD risk factors? We examined all included counseling trials for harms, including any paradoxical change in outcomes. While we searched for additional studies examining harms of healthy lifestyle counseling interventions, we did not find any. Overall, harms (or lack thereof) were not commonly reported (k=10). In general, included interventions did not have significant adverse effects, except for two persons who had serious events resulting from physical activity in one trial targeting older adults. Reported increases in carbohydrate intake (k=8) were accompanied by dietary improvements in fat, saturated fat, fiber, or fruits and vegetables, without an overall increase in sugar or total calories consumed.
Limitations: Only a small subset of trials reported patient health outcomes, longer-term followup of intermediate and behavioral outcomes, and harms. We were unable to identify important contributors to statistical heterogeneity other than gross categorizations of type of population or intervention.
Conclusions: Medium- and high-intensity diet and physical activity behavioral counseling in overweight or obese persons with CVD risk factors resulted in consistent improvements across a variety of important cardiovascular intermediate health outcomes up to 2 years. High-intensity combined lifestyle counseling reduced diabetes incidence in the longer term. The applicability of these findings depends largely on the availability of intensive counseling in practice and real-world fidelity and adherence to these interventions.
- Appendix A Detailed Methods
- Appendix B Ongoing or Recently Completed Studies
- Appendix C Excluded Studies
- Appendix D Detailed Results of Intermediate Outcomes
- Appendix E Intervention Descriptions of Included Studies by Intervention Focus and Intensity
- Appendix F Additional Meta-Analysis Figures
- Appendix G Detailed Results of Final Health Outcomes and Behavioral Outcomes
Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Cardiovascular Disease Risk Factors: Updated Systematic Review for the U.S. Preventive Services Task Force [Internet]CD Patnode et al. PMID 29364620. - ReviewThe results of our updated systematic review are generally consistent in magnitude with our 2010 review on this topic. In general, diet and physical activity behavioral i …
Behavioral Counseling to Promote Physical Activity and a Healthful Diet to Prevent Cardiovascular Disease in Adults: Update of the Evidence for the U.S. Preventive Services Task Force [Internet]JS Lin et al. PMID 21595100. - ReviewMedium- to high-intensity dietary behavioral counseling resulted in small but statistically significant changes in adiposity, blood pressure, and cholesterol, as well as …
Lipid Screening in Childhood for Detection of Multifactorial Dyslipidemia: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]P Lozano et al. PMID 27559550. - ReviewWe found no direct evidence for an effect of cholesterol screening on intermediate or health outcomes. Only one study provided a diagnostic yield for TC screening (5.8%). …
Behavioral and Pharmacotherapy Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults: An Updated Systematic Review for the U.S. Preventive Services Task Force [Internet]EL LeBlanc et al. PMID 30354042. - ReviewWe found that behavior-based weight-loss interventions with or without weight loss medications resulted in more weight loss than usual care conditions. The degree of weig …
Lipid Screening in Childhood and Adolescence for Detection of Familial Hypercholesterolemia: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]P Lozano et al. PMID 27559556. - ReviewWe found no direct evidence of the effect of screening on intermediate or health outcomes. The evidence describing the diagnostic yield of screening for FH in children is …
Cited by 9 PubMed Central articles
Effectiveness of the Blended-Care Lifestyle Intervention 'PerfectFit': A Cluster Randomised Trial in Employees at Risk for Cardiovascular DiseasesTA Kouwenhoven-Pasmooij et al. BMC Public Health 18 (1), 766. PMID 29921255. - Randomized Controlled TrialThere were no effects on self-rated health, body weight, and BMI. However, within the group with web-based tailored Health Risk Assessment including personalized advice b …
Impact of a 12-week Wellness Coaching on Self-Care Behaviors Among Primary Care Adult Patients With PrediabetesRS DeJesus et al. Prev Med Rep 10, 100-105. PMID 29850394.This single arm prospective study assessed the impact of individualized wellness coaching intervention for primary care patients with prediabetes on self-reported changes …
Design of a Lifestyle Intervention to Slow Menopause-Related Progression of Intra-Abdominal Adipose Tissue in Women: The Women in the Southside Health and Fitness (WISHFIT) StudySA Dugan et al. Contemp Clin Trials Commun 4, 74-83. PMID 29736471.WISHFIT is a multi-component, multi-level intervention aimed at producing a sustained improvement in physical activity, diet, and psychological well-being early in the me …
Does Lifestyle Exercise After a Cardiac Event Improve Metabolic Syndrome Profile in Older Adults?KD Wright et al. J Cardiovasc Nurs 33 (3), E1-E9. PMID 29634648. - Randomized Controlled TrialAfter a cardiac event, older patients who engage in lifestyle exercise at the recommended amount have improvement in their metabolic syndrome profile.
The Triple Challenges of Low and Middle-Income CountriesA Haileamlak. Ethiop J Health Sci 28 (1), 1-2. PMID 29622901.