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Clinical Guideline

Annals of Internal Medicine

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
Michael L. LeFevre, MD, MSPH, on behalf of the U.S. Preventive Services Task Force*

Description: Update and refinement of the 2003 U.S. Preventive

Services Task Force (USPSTF) recommendation on dietary counseling for adults with risk factors for cardiovascular disease (CVD).
Methods: The USPSTF reviewed the evidence on whether primary
carerelevant counseling interventions for a healthful diet and physical activity modify self-reported behaviors, intermediate physiologic
outcomes, diabetes incidence, and cardiovascular morbidity or mortality in adults with CVD risk factors, as well as the adverse effects
of counseling interventions.
Population: This recommendation applies to adults aged 18 years
or older in primary care settings who are overweight or obese and

he U.S. Preventive Services Task Force (USPSTF) makes

recommendations about the effectiveness of specific preventive care services for patients without related signs or symptoms.
It bases its recommendations on the evidence of both the
benefits and harms of the service and an assessment of the
balance. The USPSTF does not consider the costs of providing
a service in this assessment.
The USPSTF recognizes that clinical decisions involve
more considerations than evidence alone. Clinicians should
understand the evidence but individualize decision making to
the specific patient or situation. Similarly, the USPSTF notes
that policy and coverage decisions involve considerations in
addition to the evidence of clinical benefits and harms.

SUMMARY

OF

RECOMMENDATION

AND

EVIDENCE

The USPSTF recommends offering or referring adults

who are overweight or obese and have additional cardiovascular disease (CVD) risk factors to intensive behavioral
counseling interventions to promote a healthful diet and
physical activity for CVD prevention. (B recommendation)
See the Clinical Considerations section for more information about CVD risk factors.
See the Figure for a summary of the recommendation
and suggestions for clinical practice.
Appendix Table 1 describes the USPSTF grades, and
Appendix Table 2 describes the USPSTF classification of

have known CVD risk factors (hypertension, dyslipidemia, impaired

fasting glucose, or the metabolic syndrome).
Recommendation: The USPSTF recommends offering or referring
adults who are overweight or obese and have additional CVD risk
factors to intensive behavioral counseling interventions to promote
a healthful diet and physical activity for CVD prevention. (B
recommendation)
Ann Intern Med. doi:10.7326/M14-1796
www.annals.org
For author affiliation, see end of text.
* For a list of USPSTF members, see the Appendix (available at
www.annals.org).
This article was published online first at www.annals.org on 26 August 2014.

levels of certainty about net benefit (both tables are available at www.annals.org).

RATIONALE
Importance

Cardiovascular disease, primarily in the forms of heart

disease and stroke, is a leading cause of death in the United
States (1). Obesity is associated with increased CVD mortality (2). Adults who adhere to national guidelines for a
healthful diet (3) and physical activity (4) have lower cardiovascular morbidity and mortality than those who do
not. All persons, regardless of CVD risk status, can accrue
the health benefits of improved nutrition, healthy eating
behaviors, and increased physical activity (5).
Benefits of Behavioral Counseling Interventions

The USPSTF found adequate evidence that intensive

behavioral counseling interventions have moderate benefits
See also:
Related article. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Summary for Patients . . . . . . . . . . . . . . . . . . . . . . . . . 2
Web-Only
CME quiz
Consumer Fact Sheet

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This online-first version will be replaced with a final version when it is included in the issue. The final version may differ in small ways.

Clinical Guideline

Behavioral Counseling in Adults With Cardiovascular Risk Factors

Figure. Behavioral counseling to promote a healthful diet and physical activity for cardiovascular disease prevention in adults with
cardiovascular risk factors: clinical summary of U.S. Preventive Services Task Force recommendation.

BEHAVIORAL COUNSELING TO PROMOTE A HEALTHFUL DIET AND PHYSICAL ACTIVITY FOR

CARDIOVASCULAR DISEASE PREVENTION IN ADULTS WITH CARDIOVASCULAR RISK FACTORS
CLINICAL SUMMARY OF U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATION
Adults in primary care who are overweight or obese
and have known cardiovascular risk factors

Population

Recommendation

Offer or refer to intensive behavioral counseling interventions to

promote a healthful diet and physical activity.
Grade: B

Risk Assessment

Well-established risk factors for cardiovascular disease (CVD) include obesity, hypertension,
hyperlipidemia, diabetes, and tobacco use.

Behavioral Counseling
Interventions

Intensive behavioral counseling interventions are effective in making small but important changes in health behavior
outcomes (dietary intake and physical activity) and selected intermediate clinical outcomes (lipid levels, blood pressure,
fasting glucose levels, diabetes incidence, and weight) after 12 to 24 mo.
Many types of intensive counseling interventions are effective. Such interventions focus on behavior change;
include didactic education plus other components, such as audit and feedback, problem-solving skills, and
individualized care plans; and are typically delivered by specially trained health professionals.

Balance of Benefits and Harms

Other Relevant USPSTF
Recommendations

The USPSTF concludes with moderate certainty that intensive behavioral counseling interventions to promote a healthful
diet and physical activity have a moderate net benefit in adults who are overweight or obese and at increased risk for CVD.
The USPSTF has a wide range of recommendations focusing on CVD prevention, including tobacco cessation; aspirin use;
screening and counseling for obesity; and screening for lipid disorders, blood pressure, and diabetes. These
recommendations are available on the USPSTF Web site (www.uspreventiveservicestaskforce.org).

CLINICAL CONSIDERATIONS

for CVD risk in overweight or obese adults who are at

increased risk for CVD, including decreases in blood pressure, lipid and fasting glucose levels, and body mass index
(BMI) and increases in levels of physical activity. The reduction in glucose levels was large enough to decrease the
incidence of a diabetes diagnosis. The USPSTF found inadequate direct evidence that intensive behavioral counseling interventions lead to decreases in mortality or CVD
rates.

This recommendation applies to adults aged 18 years

or older in primary care settings who are overweight or
obese and have known CVD risk factors (hypertension,
dyslipidemia, impaired fasting glucose, or the metabolic
syndrome). In the studies reviewed by the USPSTF, a substantial majority of participants had a BMI greater than
25 kg/m2.

Harms of Behavioral Counseling Interventions

Behavioral Counseling Interventions

The USPSTF found adequate evidence that the harms

of behavioral counseling interventions are small to none.
None of the dietary intervention studies explicitly reported
adverse events. Studies of physical activity interventions
reported mostly minor adverse events, and intense physical
activity was rarely associated with cardiovascular events.
USPSTF Assessment

The USPSTF concludes with moderate certainty that

intensive behavioral counseling interventions to promote a
healthful diet and physical activity have a moderate net
benefit in overweight or obese adults who are at increased
risk for CVD.
2

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Patient Population Under Consideration

Most studies evaluated interventions that combined

counseling on a healthful diet and physical activity and
were intensive, with multiple contacts (which may have
included individual or group counseling sessions) over extended periods. Interventions involved an average of 5 to
16 contacts over 9 to 12 months depending on their intensity (6). Most of the sessions were in-person, and many
included additional telephone contacts. Interventions generally focused on behavior change, and all included didactic education plus additional support. Most included audit
and feedback, problem-solving skills, and individualized
care plans. Some trials also focused on medication adherwww.annals.org

This online-first version will be replaced with a final version when it is included in the issue. The final version may differ in small ways.
Behavioral Counseling in Adults With Cardiovascular Risk Factors

reduction in a composite measure of CVD events at 6.6

years of follow-up (relative risk, 0.62 [95% CI, 0.42 to
0.92]). The trial combined counseling on a healthful diet
and physical activity with medications to manage CVD
risk factors in Swedish men. Participants had notably high
rates of smoking, diabetes, and previous myocardial infarctions and a 21% mortality rate during the trial (17).
Overall, 4 trials of combined lifestyle interventions did
not seem to alleviate self-reported depression symptoms in
persons with impaired fasting glucose or glucose tolerance
at 6 to 12 months. The results for self-reported quality-oflife measures were mixed. Three trials of combined lifestyle
counseling showed improvement in selected measures of
quality of life; however, 2 trials of combined lifestyle counseling and 2 trials involving physical activity only showed
no benefit at 6 to 12 months (6).
Intermediate Health Outcomes

The USPSTF considered 71 trials, with more than

32 000 participants, that reported intermediate health outcomes (6). Commonly reported intermediate outcomes included objective measures of lipid levels, blood pressure,
glucose levels, weight, composite cardiovascular risk scores,
medication use, and diabetes incidence. Overall, mediumto high-intensity interventions involving counseling on
diet and physical activity decreased total and LDL cholesterol levels, blood pressure, fasting glucose level, diabetes
incidence, and weight. Improvements were most robust at
12 to 24 months; few studies followed participants for
more than 24 months.
Intensive combined lifestyle interventions reduced total cholesterol levels by 0.14 mmol/L (5.43 mg/dL) (CI,
0.07 to 0.21 mmol/L [2.89 to 7.97 mg/dL]), LDL cholesterol levels by 0.10 mmol/L (3.69 mg/dL) (CI, 0.04 to
0.15 mmol/L [1.40 to 5.98 mg/dL]), triglyceride levels by
0.09 mmol/L (8.33 mg/dL) (CI, 0.03 to 0.16 mmol/L
[2.86 to 13.80 mg/dL]), systolic blood pressure by 2.06
mm Hg (CI, 1.08 to 3.03 mm Hg), diastolic blood pressure by 1.30 mm Hg (CI, 0.68 to 1.93 mm Hg), fasting
glucose levels by 0.10 mmol/L (1.86 mg/dL) (CI, 0.03 to
0.18 mmol/L [0.49 to 3.24 mg/dL]), weight by a standardized mean difference of 0.24 (CI, 0.14 to 0.35), and diabetes incidence by a relative risk of 0.54 (CI, 0.34 to 0.88).
These effects were assessed across all trials that reported
each outcome at 12 to 24 months.
Intensive diet-only interventions reduced total cholesterol levels by 0.10 mmol/L (3.75 mg/dL) (CI, 0.03 to
0.17 mmol/L [1.01 to 6.50 mg/dL]), LDL cholesterol levels by 0.11 mmol/L (4.27 mg/dL) (CI, 0.02 to 0.20
mmol/L [0.70 to 7.84 mg/dL]), and triglyceride levels by
0.20 mmol/L (17.86 mg/dL) (CI, 0.03 to 0.37 mmol/L
[2.62 to 33.10 mg/dL]). Few trials that evaluated only
physical activity reported intermediate outcomes, making
it difficult to estimate average effects. Most of these interventions were medium-intensity, and there were important
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Clinical Guideline

differences among populations, interventions, and outcomes. Overall, there is no consistent evidence of benefit
on intermediate health outcomes for interventions involving physical activity only.
Health Behavior Outcomes

The USPSTF considered 61 trials (n 31 751) reporting outcomes related to health behaviors (6). Three of
these trials reported only health behavior outcomes and not
intermediate health outcomes. Overall, objectively measured and self-reported changes in dietary intake (such as
decreased total and saturated fat, increased fruits and vegetables, and total calories) and physical activity were consistent with intermediate outcome findings. Several trials in
persons already receiving medication to decrease blood
pressure or cholesterol level reported statistically significant
improvements in dietary intake and physical activity but
found no benefit on intermediate outcomes.
The DPP was a good-quality, high-intensity trial of a
combined behavioral counseling intervention aimed at preventing diabetes in overweight persons with impaired fasting glucose (11) (see the Implementation section for more
detail). It was one of the few trials included in the review
that assessed health, intermediate, and behavioral outcomes. The trial enrolled 2161 participants in the intervention and placebo groups (mean age, 51 years). More than
one quarter (26.9%) and one third (34.6%) of participants
had hypertension or dyslipidemia, respectively, and the
mean BMI was 34 kg/m2 (6). Overall, at 3 years, persons
in the intervention group had a 0.22-mmol/L (4-mg/dL)
decrease in fasting blood glucose level, a 58% reduction in
diabetes incidence, and decreases in blood pressure and
lipid measures.
PREMIER was a good-quality trial aimed at decreasing blood pressure in persons who were not yet receiving
medication (13) (see the Implementation section for more
detail). The trial enrolled 304 participants in the hypertension subgroup (mean age, 52 years; mean systolic blood
pressure, 144 mm Hg) (6). Approximately two thirds of
participants had a BMI greater than 30 kg/m2. After 18
months, only 21% of persons in the intensive counseling
intervention group versus 41% in the usual care group
were receiving hypertension medication. Participants in the
intervention group also had decreases in blood pressure
and lipid measures after 6 months; however, the improvements generally decreased after 18 months.
Summary

The evidence reviewed by the USPSTF shows the effectiveness of intensive behavioral counseling interventions
in making small but important changes in health behavior
outcomes and selected intermediate clinical outcomes after
12 to 24 months. Total cholesterol levels decreased by approximately 0.08 to 0.16 mmol/L (3 to 6 mg/dL), and
LDL cholesterol levels decreased by approximately 0.04 to
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Clinical Guideline

Behavioral Counseling in Adults With Cardiovascular Risk Factors

once every 2 months and talked by telephone at least once

between visits. The DPP study documents, including
coach and participant materials, are available online in
English and Spanish (https://dppos.bsc.gwu.edu/web
/dppos/lifestyle). At least 1 trial included in the review (12)
used an adapted DPP lifestyle intervention in patients recruited from a primary care setting. The trial was conducted in a large multispecialty group practice. Investigators tested a coach-led intervention and a home-based,
DVD-facilitated intervention, as well as a Web-based portal for goal setting and self-monitoring. The materials used
for the intervention are available online from the University of Pittsburgh Diabetes Prevention Support Center
(www.diabetesprevention.pitt.edu).
PREMIER tested whether counseling on comprehensive lifestyle changes could prevent or control high blood
pressure (13). Participants in the intensive intervention
group were counseled over 6 months to track their diet
(including calorie and sodium consumption) and physical
activity and received printed materials about blood pressure and lifestyle changes. In addition, they were taught to
follow the Dietary Approaches to Stop Hypertension
(DASH) diet, which is rich in fruits, vegetables, and lowfat dairy products and emphasizes reduced intake of saturated and total fat. The intervention was delivered by dietitians or health educators with a masters degree. The
materials from this intervention, including participant
manuals, food and fitness guides, and food diaries, are
available online at www.kpchr.org/research/public/premier
/premier.htm. Information about the DASH diet is available from the National Heart, Lung, and Blood Institute
(14).
Research Needs and Gaps

Trials examining the effectiveness of less intensive

counseling that can be delivered in the primary care setting, including the minimum intensity, number of interactions, and duration necessary for effectiveness, are needed,
as are trials studying the duration of effect beyond 2 to 3
years of follow-up or beyond the intensive counseling intervention period. The effectiveness of interventions for
physical activity alone has not been well-studied. Trials
examining the interaction or potentiation of clinical counseling and community-based lifestyle interventions are
needed. Finally, the lack of direct evidence of effect on
CVD events is an important research gap. Advances in
management of CVD risk factors and relatively low rates of
CVD events in study populations present a challenge to
researchers trying to assess differences in CVD outcomes.

DISCUSSION
Burden of Disease

Cardiovascular disease is a leading cause of death in

the United States, and well-established CVD risk factors,
such as obesity, hypertension, hyperlipidemia, and diabetes, are common in adults. The Centers for Disease Con4

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trol and Prevention estimates that nearly half of all U.S.

adults aged 20 years or older have at least 1 of the following CVD risk factors: uncontrolled hypertension, uncontrolled elevated low-density lipoprotein (LDL) cholesterol
level, or current smoking (15). It also estimates that nearly
70% of U.S. adults are overweight or obese (16).
Scope of Review

The evidence review (6) for this recommendation addressed whether primary carerelevant counseling interventions for a healthful diet and/or physical activity modify
self-reported behaviors, intermediate physiologic outcomes
(such as lipid levels, blood pressure, glucose tolerance,
weight, and BMI), diabetes incidence, and cardiovascular
morbidity or mortality in adults with known cardiovascular risk factors (hypertension, dyslipidemia, impaired fasting glucose or glucose intolerance, or the metabolic syndrome). The adverse effects of counseling interventions
were also reviewed.
This recommendation is intended to complement the
USPSTFs 2012 recommendation on behavioral counseling interventions to promote a healthful diet and physical
activity for CVD prevention in persons without cardiovascular risk factors (C recommendation). The evidence review did not include interventions specifically focused on
weight loss, which are addressed in the USPSTFs recommendation on screening and counseling for obesity (B recommendation). Trials conducted exclusively in persons
with diabetes were excluded.
Effectiveness of Behavioral Counseling Interventions

The USPSTF considered 74 trials (with 77 intervention groups) in its review (6). Interventions that combined
a healthful diet and physical activity were evaluated in 49
trial groups, diet-only interventions were evaluated in
18, and interventions involving physical activity only
were evaluated in 10. Of the interventions reviewed,
2 were low-intensity, 48 were medium-intensity, and 37
were high-intensity. Interventions were defined as low-,
medium-, or high-intensity on the basis of the amount of
interaction with a provider (30, 31 to 360, and 360
minutes, respectively). Interventions targeted various risk
factors, including dyslipidemia (17 trials), hypertension
(18 trials), impaired fasting glucose or glucose tolerance
(16 trials), and a combination of risk factors (26 trials). A
substantial majority of trial participants had a BMI greater
than 25 kg/m2. The median BMI was 29.8 kg/m2 (interquartile range, 28.4 to 31.2 kg/m2).
Patient Health Outcomes

The USPSTF considered 16 trials reporting effects on

patient health outcomes (such as CVD events, mortality,
quality of life, or depression symptoms) (6). Five of these
trials reported cardiovascular events, including mortality;
of these, 4 found no reduction in CVD events or mortality
at 6 to 79 months. However, CVD event rates were low.
One trial, the Risk Factor Intervention Study, showed a
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Behavioral Counseling in Adults With Cardiovascular Risk Factors

reduction in a composite measure of CVD events at 6.6

years of follow-up (relative risk, 0.62 [95% CI, 0.42 to
0.92]). The trial combined counseling on a healthful diet
and physical activity with medications to manage CVD
risk factors in Swedish men. Participants had notably high
rates of smoking, diabetes, and previous myocardial infarctions and a 21% mortality rate during the trial (17).
Overall, 4 trials of combined lifestyle interventions did
not seem to alleviate self-reported depression symptoms in
persons with impaired fasting glucose or glucose tolerance
at 6 to 12 months. The results for self-reported quality-oflife measures were mixed. Three trials of combined lifestyle
counseling showed improvement in selected measures of
quality of life; however, 2 trials of combined lifestyle counseling and 2 trials involving physical activity only showed
no benefit at 6 to 12 months (6).
Intermediate Health Outcomes

The USPSTF considered 71 trials, with more than

32 000 participants, that reported intermediate health outcomes (6). Commonly reported intermediate outcomes included objective measures of lipid levels, blood pressure,
glucose levels, weight, composite cardiovascular risk scores,
medication use, and diabetes incidence. Overall, mediumto high-intensity interventions involving counseling on
diet and physical activity decreased total and LDL cholesterol levels, blood pressure, fasting glucose level, diabetes
incidence, and weight. Improvements were most robust at
12 to 24 months; few studies followed participants for
more than 24 months.
Intensive combined lifestyle interventions reduced total cholesterol levels by 0.14 mmol/L (5.43 mg/dL) (CI,
0.07 to 0.21 mmol/L [2.89 to 7.97 mg/dL]), LDL cholesterol levels by 0.10 mmol/L (3.69 mg/dL) (CI, 0.04 to
0.15 mmol/L [1.40 to 5.98 mg/dL]), triglyceride levels by
0.09 mmol/L (8.33 mg/dL) (CI, 0.03 to 0.16 mmol/L
[2.86 to 13.80 mg/dL]), systolic blood pressure by 2.06
mm Hg (CI, 1.08 to 3.03 mm Hg), diastolic blood pressure by 1.30 mm Hg (CI, 0.68 to 1.93 mm Hg), fasting
glucose levels by 0.10 mmol/L (1.86 mg/dL) (CI, 0.03 to
0.18 mmol/L [0.49 to 3.24 mg/dL]), weight by a standardized mean difference of 0.24 (CI, 0.14 to 0.35), and diabetes incidence by a relative risk of 0.54 (CI, 0.34 to 0.88).
These effects were assessed across all trials that reported
each outcome at 12 to 24 months.
Intensive diet-only interventions reduced total cholesterol levels by 0.10 mmol/L (3.75 mg/dL) (CI, 0.03 to
0.17 mmol/L [1.01 to 6.50 mg/dL]), LDL cholesterol levels by 0.11 mmol/L (4.27 mg/dL) (CI, 0.02 to 0.20
mmol/L [0.70 to 7.84 mg/dL]), and triglyceride levels by
0.20 mmol/L (17.86 mg/dL) (CI, 0.03 to 0.37 mmol/L
[2.62 to 33.10 mg/dL]). Few trials that evaluated only
physical activity reported intermediate outcomes, making
it difficult to estimate average effects. Most of these interventions were medium-intensity, and there were important
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Clinical Guideline

differences among populations, interventions, and outcomes. Overall, there is no consistent evidence of benefit
on intermediate health outcomes for interventions involving physical activity only.
Health Behavior Outcomes

The USPSTF considered 61 trials (n 31 751) reporting outcomes related to health behaviors (6). Three of
these trials reported only health behavior outcomes and not
intermediate health outcomes. Overall, objectively measured and self-reported changes in dietary intake (such as
decreased total and saturated fat, increased fruits and vegetables, and total calories) and physical activity were consistent with intermediate outcome findings. Several trials in
persons already receiving medication to decrease blood
pressure or cholesterol level reported statistically significant
improvements in dietary intake and physical activity but
found no benefit on intermediate outcomes.
The DPP was a good-quality, high-intensity trial of a
combined behavioral counseling intervention aimed at preventing diabetes in overweight persons with impaired fasting glucose (11) (see the Implementation section for more
detail). It was one of the few trials included in the review
that assessed health, intermediate, and behavioral outcomes. The trial enrolled 2161 participants in the intervention and placebo groups (mean age, 51 years). More than
one quarter (26.9%) and one third (34.6%) of participants
had hypertension or dyslipidemia, respectively, and the
mean BMI was 34 kg/m2 (6). Overall, at 3 years, persons
in the intervention group had a 0.22-mmol/L (4-mg/dL)
decrease in fasting blood glucose level, a 58% reduction in
diabetes incidence, and decreases in blood pressure and
lipid measures.
PREMIER was a good-quality trial aimed at decreasing blood pressure in persons who were not yet receiving
medication (13) (see the Implementation section for more
detail). The trial enrolled 304 participants in the hypertension subgroup (mean age, 52 years; mean systolic blood
pressure, 144 mm Hg) (6). Approximately two thirds of
participants had a BMI greater than 30 kg/m2. After 18
months, only 21% of persons in the intensive counseling
intervention group versus 41% in the usual care group
were receiving hypertension medication. Participants in the
intervention group also had decreases in blood pressure
and lipid measures after 6 months; however, the improvements generally decreased after 18 months.
Summary

The evidence reviewed by the USPSTF shows the effectiveness of intensive behavioral counseling interventions
in making small but important changes in health behavior
outcomes and selected intermediate clinical outcomes after
12 to 24 months. Total cholesterol levels decreased by approximately 0.08 to 0.16 mmol/L (3 to 6 mg/dL), and
LDL cholesterol levels decreased by approximately 0.04 to
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Clinical Guideline

Behavioral Counseling in Adults With Cardiovascular Risk Factors

0.13 mmol/L (1.5 to 5 mg/dL). Systolic and diastolic

blood pressures decreased by 1 to 3 mm Hg and 1 to 2 mm
Hg, respectively. Fasting glucose levels decreased by approximately 0.06 to 0.17 mmol/L (1 to 3 mg/dL). Diabetes incidence decreased by as much as 42% in trials reporting outcomes after 3 years. Weight decreased by a
standardized mean difference of 0.26, which is roughly
equivalent to a BMI reduction of 0.5 to 1.5 kg/m2, or
approximately 3 kg. Based on self-reported physical
activity, the proportion of persons who participated in
moderate-intensity exercise for 150 minutes per week increased from 10% to 25%. Epidemiologic data suggest that
even small improvements in lipid levels, blood pressure,
glycemic control, and weight can decrease the risk for heart
disease and stroke in persons at increased risk for CVD
(18).
Potential Harms of Behavioral Counseling Interventions

Of the 74 trials reviewed by the USPSTF, only 6 specifically reported adverse events during the trial and 6 specifically reported no adverse events (6). Few trials reported
details about the adverse events, but most were minor,
including musculoskeletal and gastrointestinal symptoms.
In trials evaluating physical activity interventions, a few
participants reported fatigue, muscle soreness, or other minor musculoskeletal injuries. Serious adverse events were
rare. There was no consistent evidence that behavioral
counseling interventions led to paradoxical changes in intermediate or behavioral outcomes.
Estimate of Magnitude of Net Benefit

The USPSTF assessed the overall effectiveness of intensive behavioral counseling interventions on intermediate and behavioral health outcomes to be moderate. The
changes in lipid and blood pressure measures were generally small, but these effects were combined with reductions
in weight and sustained improvements in healthy lifestyle
behaviors. The effects are consistent across a substantive
body of evidence for various CVD risk factors and interventions. The USPSTF concludes that, because a substantial majority of trial participants were overweight or obese,
these persons will accrue benefits from these interventions.
The potential harms are small at most; therefore, the
USPSTF concludes that these interventions have a moderate net benefit.
Response to Public Comments

A draft version of this recommendation statement was

posted for public comment on the USPSTF Web site from
13 May to 9 June 2014. Thirty-three comments were received. In response to these comments, the USPSTF clarified how this recommendation fits with related ones on
healthy lifestyles and screening for obesity. It clarified the
population under consideration throughout the recommendation statement and more explicitly defined the connections between the populations studied and the target
population of the recommendation. The USPSTF also
provided more detail on the evidence gap for CVD out6

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comes and added to the Research Needs and Gaps section.

In addition, it added or updated several references and
made other minor editorial changes.

UPDATE

OF

PREVIOUS USPSTF RECOMMENDATION

This recommendation is an update and refinement of

the USPSTFs 2003 recommendation on dietary counseling for adults with CVD risk factors (B recommendation).
At that time, the USPSTF recommended intensive behavioral dietary counseling for adult patients with known
CVD risk factors, including hyperlipidemia and other
diet-related chronic diseases. In contrast, this new recommendation targets overweight or obese adults who have
additional CVD risk factors (such as hypertension, dyslipidemia, impaired fasting glucose, or the metabolic syndrome). Interventions assessed for this recommendation
focused on improving healthy eating, increasing physical
activity, or combined approaches to developing a healthier
lifestyle.

RECOMMENDATIONS

OF

OTHERS

The American Heart Association recommends that clinicians use counseling interventions to promote a healthful
diet and physical activity that include a combination of 2
or more of the following strategies: setting specific, proximal goals; providing feedback on progress; providing strategies for self-monitoring; establishing a plan for frequency
and duration of follow-up; using motivational interviews;
and building self-efficacy (19).
The American College of Sports Medicine has published recommendations for health professionals who
counsel healthy adults on individualized exercise programs.
It recommends 150 minutes of moderate-intensity exercise
per week and 2 to 3 days of resistance, flexibility, and
neuromotor exercises per week (20). Previous statements
by the American Academy of Family Physicians about
counseling for diet and physical activity have been consistent with those of the USPSTF; it is currently updating its
recommendations (21).
From the U.S. Preventive Services Task Force, Rockville, Maryland.
Disclaimer: 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.
Financial Support: The USPSTF is an independent, voluntary body.

The U.S. Congress mandates that the Agency for Healthcare Research
and Quality support the operations of the USPSTF.
Disclosures: Authors followed the policy regarding conflicts of interest
described at www.uspreventiveservicestaskforce.org/methods.htm. Disclosures can also be viewed at www.acponline.org/authors/icmje/Conflict
OfInterestForms.do?msNumM14-1796.
Requests for Single Reprints: Reprints are available from the USPSTF

Web site (www.uspreventiveservicestaskforce.org).

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Behavioral Counseling in Adults With Cardiovascular Risk Factors

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3. U.S. Department of Health and Human Services, U.S. Department of
Agriculture. Dietary Guidelines for Americans, 2010. 7th ed. Washington, DC:
U.S. Government Printing Office; 2010.
4. U.S. Department of Health and Human Services. 2008 Physical Activity
Guidelines for Americans. ODPHP publication no. U0036. Washington, DC:
U.S. Department of Health and Human Services; 2008.
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Annals of Internal Medicine

This online-first version will be replaced with a final version when it is included in the issue. The final version may differ in small ways.

APPENDIX: U.S. PREVENTIVE SERVICES TASK FORCE

Members of the U.S. Preventive Services Task Force at the
time this recommendation was finalized are Michael L. LeFevre,
MD, MSPH, Chair (University of Missouri School of Medicine,
Columbia, Missouri); Albert L. Siu, MD, MSPH, Co-Vice Chair
(Mount Sinai School of Medicine, New York, and James J. Peters
Veterans Affairs Medical Center, Bronx, New York); Kirsten
Bibbins-Domingo, PhD, MD, Co-Vice Chair (University of California, San Francisco, San Francisco, California); Linda Ciofu
Baumann, PhD, RN (University of Wisconsin, Madison, Wisconsin); Susan J. Curry, PhD (University of Iowa College of
Public Health, Iowa City, Iowa); Karina W. Davidson, PhD,
MASc (Columbia University, New York, New York); Mark
Ebell, MD, MS (University of Georgia, Athens, Georgia); Francisco A.R. Garca, MD, MPH (Pima County Department of

Health, Tucson, Arizona); Matthew Gillman, MD, SM (Harvard

Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts); Jessica Herzstein, MD, MPH (Air Products,
Allentown, Pennsylvania); Alex R. Kemper, MD, MPH, MS
(Duke University, Durham, North Carolina); Ann E. Kurth,
PhD, RN, MSN, MPH (New York University, New York, New
York); Douglas K. Owens, MD, MS (Veterans Affairs Palo Alto
Health Care System, Palo Alto, and Stanford University, Stanford, California); William R. Phillips, MD, MPH (University of
Washington, Seattle, Washington); Maureen G. Phipps, MD,
MPH (Brown University, Providence, Rhode Island); and Michael P. Pignone, MD, MPH (University of North Carolina,
Chapel Hill, North Carolina).
For a list of current Task Force members, go to www
.uspreventiveservicestaskforce.org/members.htm.

Appendix Table 1. What the USPSTF Grades Mean and Suggestions for Practice
Grade

Definition

Suggestions for Practice

The USPSTF recommends the service. There is high certainty that the net benefit is
substantial.
The USPSTF recommends the service. There is high certainty that the net benefit is
moderate or there is moderate certainty that the net benefit is moderate to
substantial.
The USPSTF recommends selectively offering or providing this service to individual
patients based on professional judgment and patient preferences. There is at least
moderate certainty that the net benefit is small.
The USPSTF recommends against the service. There is moderate or high certainty
that the service has no net benefit or that the harms outweigh the benefits.
The USPSTF concludes that the current evidence is insufficient to assess the balance
of benefits and harms of the service. Evidence is lacking, of poor quality, or
conflicting, and the balance of benefits and harms cannot be determined.

Offer/provide this service.

D
I statement

Offer/provide this service.

Offer/provide this service for selected patients depending on

individual circumstances.
Discourage the use of this service.
Read the Clinical Considerations section of the USPSTF
Recommendation Statement. If the service is offered,
patients should understand the uncertainty about the
balance of benefits and harms.

Appendix Table 2. USPSTF Levels of Certainty Regarding Net Benefit

Level of Certainty*

Description

High

The available evidence usually includes consistent results from well-designed, well-conducted studies in representative
primary care populations. These studies assess the effects of the preventive service on health outcomes. This
conclusion is therefore unlikely to be strongly affected by the results of future studies.
The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but
confidence in the estimate is constrained by such factors as:
the number, size, or quality of individual studies;
inconsistency of findings across individual studies;
limited generalizability of findings to routine primary care practice; and
lack of coherence in the chain of evidence.
As more information becomes available, the magnitude or direction of the observed effect could change, and this
change may be large enough to alter the conclusion.
The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
the limited number or size of studies;
important flaws in study design or methods;
inconsistency of findings across individual studies;
gaps in the chain of evidence;
findings that are not generalizable to routine primary care practice; and
a lack of information on important health outcomes.
More information may allow an estimation of effects on health outcomes.

Moderate

Low

* The USPSTF defines certainty as likelihood that the USPSTF assessment of the net benefit of a preventive service is correct. The net benefit is defined as benefit minus
harm of the preventive service as implemented in a general primary care population. The USPSTF assigns a certainty level on the basis of the nature of the overall evidence
available to assess the net benefit of a preventive service.
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