Draft Recommendation Statement
Healthy Diet and Physical Activity to Prevent Cardiovascular Disease in Adults With Risk Factors: Behavioral Counseling Interventions
May 12, 2020
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
- Update in Progress for Healthy Diet and Physical Activity to Prevent Cardiovascular Disease in Adults With Risk Factors: Behavioral Counseling Interventions
|Adults with cardiovascular disease (CVD) risk factors||The USPSTF recommends offering or referring adults with CVD risk factors to behavioral counseling interventions to promote a healthy diet and physical activity.||B|
- Behavioral Counseling Interventions to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults With Cardiovascular Risk Factors (Consumer Guide): Draft Recommendation | Link to File
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
CVD is a leading cause of death in the United States.1 Known modifiable risk factors for CVD include smoking, overweight and obesity, diabetes, elevated blood pressure or hypertension, dyslipidemia, lack of physical activity, and unhealthy diet. Adults who adhere to national guidelines for a healthy diet2 and physical activity3 have lower cardiovascular morbidity and mortality than those who do not. All persons, regardless of their CVD risk status, can gain health benefits from healthy eating behaviors and appropriate physical activity.
The USPSTF concluded with moderate certainty that behavioral health interventions have a moderate net benefit on CVD risk in adults at increased risk for CVD.
Patient Population Under Consideration
This recommendation applies to adults age 18 years or older with known hypertension or elevated blood pressure, with dyslipidemia, or who have mixed or multiple risk factors such as metabolic syndrome or an estimated 10-year CVD risk of 7.5% or greater. Adults with other known modifiable cardiovascular risk factors such as abnormal blood glucose levels, obesity, and smoking are not included in this recommendation.5-7 Interventions to reduce CVD risk in these adults are covered in other USPSTF recommendations.
Definitions of Healthy Diet and Physical Activity
The term “healthy diet” is defined as a balance and variety of foods and beverages that assist an individual in achieving and maintaining a healthy weight, supports health, and prevents disease. Dietary counseling to promote a healthy diet focuses on increasing consumption of fruits, vegetables, whole grains, fat-free or low-fat dairy, lean proteins, and oils, and decreasing consumption of foods with high sodium levels, saturated or trans fats, and added sugars, as recommended by the U.S. Department of Agriculture and the U.S. Food and Drug Administration.2 Physical activity is broadly defined as any bodily activity that enhances or maintains overall health and physical fitness. The U.S. Department of Health and Human Services recommends that adults age 18 years or older engage in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week in addition to engaging in strengthening activities at least twice per week.3
Assessment of Risk
Cardiovascular risk can be characterized as the elevation of a single risk factor or multiple risk factors (e.g., metabolic syndrome). It can also be estimated through the use of CVD risk tools such as the Pooled Cohort Equations and Framingham Risk Score.8,9 CVD risk factors covered in this recommendation include dyslipidemia, elevated blood pressure or hypertension, and multiple or mixed risk factors.
Behavioral Counseling Interventions
Behavioral counseling interventions usually combine counseling on a healthy diet and physical activity and are usually intensive, with multiple contacts that include either individual or group counseling sessions over extended periods. Interventions usually involve a median of 12 contacts, with an estimated 6 hours of contact time over 6 to 18 months. Interventions typically involve some one-on-one time with an interventionist and include motivational interviewing and behavioral change techniques such as goal setting, problem solving, and self-monitoring. Primary care clinicians as well as a wide range of specially trained professionals, including nurses, registered dietitians, nutritionists, exercise specialists, masters- and doctoral-level counselors trained in behavioral methods, and lifestyle coaches, can deliver these interventions. Common dietary counseling advice includes reductions in saturated fats, sodium, and sweets/sugars, and increased consumption of fruits, vegetables, and whole grains. The Dietary Approaches to Stop Hypertension (DASH) diet, low-sodium diet, and the Mediterranean diet are commonly recommended diets. Physical activity counseling focuses on patients achieving 90 to 180 minutes per week of moderate to vigorous activity.10
Primary care clinicians can deliver in-person behavioral counseling interventions, refer patients to behavioral counseling interventions in other settings, or inform patients about media-based interventions. For more information about risk assessment methods and behavioral counseling interventions, see the “Additional Tools and Resources” section and Table 2.
Additional Tools and Resources
- The Community Preventive Services Task Force recommends several community-based interventions to promote a healthy diet (https://www.thecommunityguide.org/topic/nutrition) and physical activity (https://www.thecommunityguide.org/topic/physical-activity), including community-wide campaigns, social support interventions, school-based interventions, and environmental and policy approaches.
- The U.S. Department of Health and Human Services and the U.S. Department of Agriculture have developed dietary (https://health.gov/dietaryguidelines/2015/) and physical activity (https://health.gov/paguidelines/second-edition/) guidelines. Resources for clinicians can be found at https://health.gov/dietaryguidelines/2015/resources.asp and https://health.gov/paguidelines/moveyourway/.
Other Related USPSTF Recommendations
The USPSTF has several recommendations related to behavioral counseling interventions and the prevention of CVD. This includes recommendations on behavioral counseling to promote a healthful diet and physical activity for CVD prevention in adults without cardiovascular risk factors (C recommendation),11 behavioral weight loss interventions to prevent obesity-related morbidity and mortality in adults (B recommendation),12 behavioral and pharmacotherapy interventions for tobacco smoking cessation in adults, including pregnant women (B recommendation),7 and screening for abnormal blood glucose and type 2 diabetes mellitus (B recommendation).5
This recommendation replaces the 2014 USPSTF recommendation on behavioral counseling to promote a healthy diet and physical activity for CVD prevention in adults with cardiovascular risk factors. At that time, the USPSTF recommended intensive behavioral counseling interventions for overweight and obese adult patients with known CVD risk factors, including hypertension, dyslipidemia, impaired fasting glucose or glucose intolerance, and metabolic syndrome.13 This new recommendation targets adults with known hypertension or elevated blood pressure, elevated lipid levels or dyslipidemia, and mixed or multiple risk factors (e.g., metabolic syndrome or estimated 10-year CVD risk of ≥7.5%). In contrast to the previous review, the current recommendation does not cover adults with impaired glucose tolerance or type 2 diabetes mellitus. This population is covered in a separate recommendation.
Scope of Review
The USPSTF commissioned a systematic evidence review10 to update its 2014 recommendation13 on behavioral counseling to promote healthy diet and physical activity for CVD prevention in adults with cardiovascular risk factors. The scope of this review is similar to that of the prior systematic review, except in the current review the USPSTF excluded studies limited to or predominantly conducted in persons with diabetes or prediabetes. The evidence review did not include interventions specifically focused on weight loss in general populations; however, weight loss trials that targeted adults with relevant CVD risk factors were included in this review.
Benefits of Behavioral Counseling Interventions
The USPSTF considered 94 trials (n=52,174) in its review.10 Interventions that combined a healthy diet and physical activity were evaluated in 81 trial groups, diet-only interventions were evaluated in 33 trial groups, and interventions involving physical activity only were evaluated in six trial groups. Of the interventions reviewed, 6% were considered low-intensity, 49% were medium-intensity, and 45% were high-intensity. Interventions were defined as low-, medium-, or high-intensity based on the amount of interaction with a provider (≤30, 31 to 360, and >360 minutes, respectively). Risk factors targeted in the interventions included abnormal lipid levels (16 trials), elevated blood pressure (32 trials), and multiple or mixed risk factors (46 trials). Most participants in the included trials were overweight or obese, with a mean body mass index (BMI) of 29.8 kg/m2 across all trials.10
Twenty-nine trials reported on patient health outcomes such as CVD events, mortality, or quality of life.10 Twelve of these trials reported cardiovascular events, and among the trials with a composite outcome of any CVD event (e.g., myocardial infarction, stroke, and incidence of peripheral artery disease), the pooled effect showed lower risk among patients receiving behavioral health counseling (pooled relative risk [RR], 0.80 [95% CI, 0.73 to 0.87]; 9 randomized, controlled trials; n=12,551; I2=0%). Intervention groups also demonstrated lower event rates for both myocardial infarction (pooled RR, 0.85 [95% CI, 0.70 to 1.02]; 6 trials; n=10,375; I2=0%) and stroke (pooled RR, 0.52 [95% CI, 0.25 to 1.10]; 4 trials; n=9,800; I2=0%); however, results were not statistically significant for either outcome. Eighteen trials of medium- to high-intensity interventions reported on all-cause mortality. The pooled effect did not demonstrate a statistically significant benefit (pooled RR, 0.89 [95% CI, 0.71 to 1.11]; 18 trials; n=17,939; I2=0%), although many of these studies were not adequately powered to assess this outcome.10 A variety of self-reported quality of life measures were reported in 11 trials. Most findings favored the intervention group; however, group differences were generally very small and statistically nonsignificant.10
The USPSTF considered 91 trials (n=47,951) that reported intermediate health outcomes.10 Commonly reported intermediate outcomes included objective measures of blood pressure, lipid levels, weight/adiposity, glucose level, and composite cardiovascular risk score. Overall, interventions involving counseling on diet and physical activity led to statistically significant improvements in systolic blood pressure level (-1.8 mm Hg [95% CI, -2.5 to -1.1]), diastolic blood pressure level (-1.2 mm Hg [95% CI, -1.6 to -0.8]), total cholesterol level (-3.5 mg/dL [95% CI, -5.6 to -1.4]), low-density lipoprotein cholesterol level (-2.1 mg/dL [95% CI, -4.1 to-0.2]), fasting glucose level (-2.3 mg/dL [95% CI -3.6 to -1.0]), and adiposity-related outcomes such as weight (-1.6 kg [95% CI, -2.1 to -1.1]) and BMI (-0.5 kg/m2 [95% CI, -0.7 to -0.3]). For all outcomes, improvements were seen at 12 to 24 months of followup. The data showed no clear effect modifiers, including intervention intensity, for most outcomes, although weight loss interventions were associated with greater weight loss.
The USPSTF considered 70 trials (n=43,243) reporting outcomes related to health behaviors such as healthy eating habits and increased physical activity. There was substantial variability in the measures reported, and most outcomes were reported in fewer than 15 trials.10 Most trials included medium- or high-intensity interventions. Overall, behavioral counseling resulted in small, statistically significant improvements in saturated fat consumption (percentage of calories from saturated fat) (pooled mean difference, -1.5% [95% CI, -1.9 to -1.1]), increased consumption of fruits and vegetables (pooled mean difference, 0.7 servings/day [95% CI, 0.1 to 1.3]), and increased fiber intake (pooled mean difference, 1.3 g/day [95% CI, 0.1 to 2.6]). Nine trials among adults with hypertension or elevated blood pressure who were counseled to reduce sodium intake showed reduced urinary sodium (pooled mean difference, -18.0 mmol/L [95% CI, -34.8 to -1.2]).10
Fifty trials of behavioral counseling interventions reported some type of physical activity outcome (n=34,028); however, there was no consistent evidence of benefit.10 Outcome reporting was highly variable for the type of measurement reported (e.g., any activity or moderate to vigorous activity) and the unit of measurement (e.g., minutes/week or kJ/kg/day). The pooled effect of continuous outcomes was not statistically significant (pooled standardized mean difference, 0.06 [95% CI, -0.03 to 0.14]). However, among trials where there was a study-defined physical activity goal (usually 90 to 180 minutes/week of moderate to vigorous physical activity), intervention groups had a higher likelihood of meeting that goal (pooled relative risk, 1.22 [95% CI, 1.00 to 1.50]; 11 trials; n=5,887; I2=91%]).10
Harms of Behavioral Counseling Interventions
Of the 94 trials reviewed by the USPSTF, only 20 specifically reported on harms, and eight of these specifically reported no adverse events.10 Few trials reported details about the adverse events, but most were minor. In trials evaluating physical activity interventions, a few participants reported minor musculoskeletal injuries. Serious adverse events were rare.10 There was no consistent evidence that behavioral counseling interventions led to paradoxical changes in intermediate or behavioral outcomes.
The USPSTF identified several gaps in the evidence where more research is needed.
- Very few trials had sufficient sample size and followup to assess the effect on CVD events such as myocardial infarction or stroke and mortality. Larger studies with longer-term followup would be valuable to assess the effect of interventions on these outcomes.
- Reporting of behavioral outcomes was highly variable and often incomplete. Greater consistency and standardization of outcomes, specifically those for physical activity and diet, are needed to better understand the range of effects and interpret the pooled effects.
- There was little literature on the use of technologies such as wearable activity trackers. These may be useful tools to increase engagement in physical activity as well as for providing objective data on physical activity outcomes. In addition, more studies are needed that include online resources such as daily caloric intake applications or other low-intensity approaches that may be valuable in low-resource settings.
- Despite the large number of included trials reviewed by the USPSTF, there were few replication studies. Large replication studies of interventions showing reductions in CVD events are urgently needed.
Numerous organizations, including the American Heart Association/American College of Cardiology, the Academy of Nutrition and Dietetics, and the U.S. Department of Veterans Affairs/Department of Defense have recommendations on behavioral counseling for adults with CVD risk factors.14-16 Most recommend that adults adhere to a healthy diet that includes a balanced diet low in sodium and saturated fats, and regular exercise. For example, the American Heart Association and the American College of Cardiology recommend that clinicians use counseling interventions to promote a healthy diet and physical activity (consistent with U.S. Food and Drug Administration/Department of Health and Human Services guidelines) for all adults.14 For adults with elevated blood pressure or hypertension, these organizations specifically recommend weight loss, a heart-healthy dietary pattern, sodium reduction, dietary potassium supplementation, increased physical activity with a structured exercise program, and limited alcohol consumption.
The American Association of Clinical Endocrinologists and the American College of Endocrinology have recommendations for adults with dyslipidemia and metabolic syndrome that include 30 minutes of moderate-intensity aerobic activity 4 to 6 times weekly with strength training 2 times weekly.17 Dietary goals should include a reduced-calorie diet consisting of fruits and vegetables, grains, fish, and lean meats. The intake of saturated fats, trans fats, and cholesterol should be limited.17 The Academy of Nutrition and Dietetics recommends nutritional counseling provided by a registered dietitian nutritionist as well as regular aerobic activity to reduce blood pressure in adults with hypertension.15
The American Academy of Family Physicians refers to and affirms the American Heart Association/American College of Cardiology 2014 guidelines on lifestyle management to reduce cardiovascular risk.18 The American College of Physicians does not currently have a clinical recommendation on behavioral counseling to promote a healthy diet or physical activity in adults.
1. Centers for Disease Control and Prevention. Heart Disease Facts. 2015; https://www.cdc.gov/heartdisease/facts.htm. Accessed April 17, 2020.
2. U.S. Department of Health and Human Services, U.S. Department of Agriculture. 2015-2020 Dietary Guidelines for Americans. 8th ed. 2015. https://health.gov/our-work/food-nutrition/2015-2020-dietary-guidelines/guidelines/. Accessed April 17, 2020.
3. U.S. Department of Health and Human Services. Physical Activity Guidelines for Americans. 2nd ed. 2018; https://health.gov/sites/default/files/2019-09/Physical_Activity_Guidelines_2nd_edition.pdf. Accessed April 17, 2020.
4. U.S. Preventive Services Task Force. Procedure Manual. https://www.uspreventiveservicestaskforce.org/uspstf/procedure-manual. Accessed April 17, 2020.
5. U.S. Preventive Services Task Force. Screening for abnormal blood glucose and type 2 diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;163(11):861-868.
6. US Preventive Services Task Force. Behavioral weight loss interventions to prevent obesity-related morbidity and mortality in adults: US Preventive Services Task Force recommendation statement. JAMA. 2018;320(11):1163-1171.
7. U.S. Preventive Services Task Force. Behavioral and pharmacotherapy interventions for tobacco smoking cessation in adults, including pregnant women: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;163(8):622-634.
8. American Heart Association, American College of Cardiology. Atherosclerotic Cardiovascular Disease Risk Calculator. 2013; https://professional.heart.org/professional/GuidelinesStatements/PreventionGuidelines/UCM_457698_ASCVD-Risk-Calculator.jsp. Accessed April 17, 2020.
9. Framingham Heart Study. Cardiovascular Disease (10-Year Risk) Calculator. 2020; https://www.framinghamheartstudy.org/fhs-risk-functions/cardiovascular-disease-10-year-risk/. Accessed April 17, 2020.
10. O’Connor EA, Evans CV, Rushkin MC, Redmond N, Lin JS. Behavioral Counseling Interventions to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults With Cardiovascular Risk Factors: Updated Systematic Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 195. AHRQ Publication No. 20-05263-EF-1. Rockville, MD: Agency for Healthcare Quality and Research; 2020.
11. US Preventive Services Task Force. Behavioral counseling to promote a healthful diet and physical activity for cardiovascular disease prevention in adults without cardiovascular risk factors: US Preventive Services Task Force recommendation statement. JAMA. 2017;318(2):167-174.
12. US Preventive Services Task Force. Behavioral weight loss interventions to prevent obesity-related morbidity and mortality in adults: US Preventive Services Task Force recommendation statement. JAMA. 2018;320(11):1163-1171.
13. U.S. Preventive Services Task Force. Behavioral counseling to promote a healthful diet and physical activity for cardiovascular disease prevention in adults with cardiovascular risk factors: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(8):587-593.
14. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646.
15. Academy of Nutrition and Dietetics. Hypertension Evidence-Based Nutrition Practice Guideline. Chicago: Academy of Nutrition and Dietetics; 2015.
16. U.S. Department of Veterans Affairs, U.S. Department of Defense. VA/DoD Clinical Practice Guidelines: Management of Hypertension (HTN) in Primary Care (2020). https://www.healthquality.va.gov/guidelines/CD/htn/. Accessed April 17, 2020.
17. Jellinger PS, Handelsman Y, Rosenblit PD, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease. Endocr Pract. 2017;23(Suppl 2):1-87.
18. American Academy of Family Physicians. Clinical Practice Guidelines: Cardiovascular Risk. 2018. https://www.aafp.org/patient-care/clinical-recommendations/all/cardiovascular-risk.html . Accessed April 17, 2020.
19. National Institutes of Health. DASH Eating Plan. https://www.nhlbi.nih.gov/health-topics/dash-eating-plan. Accessed April 17, 2020.
20. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. N Engl J Med. 2018;378(25):e34.
|Adults With Known CVD Risk Factors*|
|Benefits of counseling interventions to promote a healthy diet and physical activity||
|Harms of counseling interventions to promote a healthy diet and physical activity||There is inadequate direct evidence to determine the harms of counseling interventions, although they can be bound as no greater than small in magnitude based on the nature of the interventions|
|USPSTF Assessment||The USPSTF concludes with moderate certainty that intensive counseling interventions to promote a healthy diet and physical activity in adults with CVD risk factors has a moderate net benefit.|
Abbreviation: CVD=cardiovascular disease.
|Dietary Counseling||Physical Activity Counseling|
|Behavior change goals||
||Physical activity counseling typically advised 90 to 180 minutes per week of moderate to vigorous activity.|
|Materials for practice||
||U.S. DHHS physical activity guidelines and resources (https://health.gov/our-work/physical-activity/move-your-way-campaign)3|
|Behavior change techniques||Behavior change techniques included goal setting, active use of self-monitoring, and addressing barriers related to diet, physical activity, or weight change. Motivational interviewing was commonly employed. A small number of trials included family members as well as the individual with CVD risk factors.|
|Intervention modality||Face-to-face sessions with or without additional telephone or web-based or other technology-enhanced components. Group sessions typically included an additional individual meeting for each person.|
|Intervention intensity||The median number of contacts was 12 (range, 5 to 27 contacts), with an estimated 6 hours (range, 2.1 to 16.5 hours) of contact over 12 months (range, 6 to 18 months).10|
|Intervention recipient||Adults with hypertension, prehypertension, dyslipidemia, or any of multiple CVD risk factors; most participants were overweight or obese (mean BMI, 29.8 kg/m2). The mean age of study participants was 56 years.|
|Intervention settings||Most interventions took place in primary care settings.|
|Person delivering intervention||
Abbreviations: BMI=body mass index; CI=confidence interval; CVD=cardiovascular disease; DASH=Dietary Approaches to Stop Hypertension; DHHS=Department of Health and Human Services; RR=relative risk; USDA=U.S. Department of Agriculture.