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Behavioral Counseling to Promote a Healthy Dietand Physical Activity for Cardiovascular Disease Preventionin Adults With Cardiovascular Risk FactorsUpdated Evidence Report and Systematic Reviewfor the US Preventive Services Task ForceElizabeth A. O’Connor, PhD; Corinne V. Evans, MPP; Megan C. Rushkin, MPH; Nadia Redmond, MSPH; Jennifer S. Lin, MD, MCR
IMPORTANCE Cardiovascular disease is the leading cause of death in the US, and poor dietand lack of physical activity are major factors contributing to cardiovascular morbidityand mortality.
OBJECTIVE To review the benefits and harms of behavioral counseling interventions toimprove diet and physical activity in adults with cardiovascular risk factors.
DATA SOURCES MEDLINE, PubMed, PsycINFO, and the Cochrane Central Register ofControlled Trials through September 2019; literature surveillance through July 24, 2020.
STUDY SELECTION English-language randomized clinical trials (RCTs) of behavioral counselinginterventions to help people with elevated blood pressure or lipid levels improve their dietand increase physical activity.
DATA EXTRACTION AND SYNTHESIS Data were extracted from studies by one reviewer andchecked by a second. Random-effects meta-analysis and qualitative synthesis were used.
MAIN OUTCOMES AND MEASURES Cardiovascular events, mortality, subjective well-being,cardiovascular risk factors, diet and physical activity measures (eg, minutes of physicalactivity, meeting physical activity recommendations), and harms. Interventions werecategorized according to estimated contact time as low (�30 minutes), medium (31-360minutes), and high (>360 minutes).
RESULTS Ninety-four RCTs were included (N = 52 174). Behavioral counseling interventionsinvolved a median of 6 contact hours and 12 sessions over the course of 12 months and variedin format and dietary recommendations; only 5% addressed physical activity alone.Interventions were associated with a lower risk of cardiovascular events (pooled relative risk,0.80 [95% CI, 0.73-0.87]; 9 RCTs [n = 12 551]; I2 = 0%). Event rates were variable; in thelargest trial (Prevención con Dieta Mediterránea [PREDIMED]), 3.6% in the interventiongroups experienced a cardiovascular event, compared with 4.4% in the control group.Behavioral counseling interventions were associated with small, statistically significantreductions in continuous measures of blood pressure, low-density lipoprotein cholesterollevels, fasting glucose levels, and adiposity at 12 to 24 months’ follow-up. Measurement ofdiet and physical activity was heterogeneous, and evidence suggested small improvements indiet consistent with the intervention recommendation targets but mixed findings and a morelimited evidence base for physical activity. Adverse events were rare, with generally no groupdifferences in serious adverse events, any adverse events, hospitalizations, musculoskeletalinjuries, or withdrawals due to adverse events.
CONCLUSIONS AND RELEVANCE Medium- and high-contact multisession behavioral counselinginterventions to improve diet and increase physical activity for people with elevated bloodpressure and lipid levels were effective in reducing cardiovascular events, blood pressure,low-density lipoproteins, and adiposity-related outcomes, with little to no risk of serious harm.
JAMA. 2020;324(20):2076-2094. doi:10.1001/jama.2020.17108
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Author Affiliations: KaiserPermanente Evidence-based PracticeCenter, Center for Health Research,Kaiser Permanente, Portland,Oregon.
Corresponding Author: ElizabethO’Connor, PhD, Kaiser PermanenteEvidence-based Practice Center, TheCenter for Health Research, KaiserPermanente Northwest, 3800 NInterstate Ave, Portland, OR 97227(Elizabeth.O’Connor@kpchr.org).
Clinical Review & Education
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R isk factors for cardiovascular disease (CVD), such as highblood pressure and high cholesterol and lipid levels, arecommon in the US and contribute to excess mortality.1Counseling to encourage a healthy diet and physical activity in popu-lations with CVD risk factors can improve blood pressure, choles-terol levels, and other outcomes.2 While observational evidenceshows associations between lower levels of CVD risk factors andlower cardiovascular-related mortality,3-5 trial evidence regarding theeffectiveness of behavioral counseling on reducing CVD events andmortality is sparse.
This systematic review was conducted to provide updated evi-dence on the benefits and harms of behavioral counseling forhealthy diet and physical activity in adults with CVD risk factors toinform an update of the 2014 US Preventive Services Task Force(USPSTF) recommendation.6 In 2014, the task force recommendedoffering or referring adults who were overweight or had obesityand had additional CVD risk factors to intensive behavioral counsel-ing interventions to promote a healthy diet and physical activity forCVD prevention (B recommendation). This review was conductedin parallel with a review addressing abnormal blood glucose levels7
and complements other USPSTF reviews related to primary pre-vention of CVD.8-13
MethodsScope of ReviewThis review addressed 4 key questions (KQs) (Figure 1). Method-ological details including study selection, a list of excluded studies,additional data analysis methods, detailed study-level results for alloutcomes, and contextual observational data are available in the fullevidence report.15
Data Sources and SearchesMEDLINE, PubMed (publisher-supplied records only), PsycINFO, andthe Cochrane Central Register of Controlled Trials were searched toidentify literature published after the previous review for theUSPSTF.16 Searches covered literature published January 2013through September 2019 (eMethods in the Supplement). All stud-ies in the prior review16 were also evaluated, as well as reference listsof related systematic reviews.9,17
ClinicalTrials.gov and the World Health Organization Interna-tional Clinical Trials Registry Platform were searched for relevant on-going trials. Active surveillance was conducted through July 24,2020, via article alerts and targeted journal searches to identify ma-jor studies that might affect the conclusions or understanding of theevidence. None were identified.
Study SelectionInvestigators reviewed 14 409 unique citations and 466 full-textarticles against a priori inclusion criteria (Figure 2; eTable 1 in theSupplement). Disagreements were resolved via discussion andconsultation with another reviewer. Eligible studies were fair- andgood-quality RCTs that evaluated the effectiveness of primarycare–relevant interventions of behavioral counseling for dietand nutrition, physical activity (including sedentary behavior), orboth in adults with CVD risk factors. Studies had to target popula-tions at increased risk of CVD due to hypertension or elevated
blood pressure, dyslipidemia, or through examination of multiplerisk factors. These could include estimated 10-year CVD riskof 7.5% or higher (eg, using the Pooled Cohort Equations18
or Framingham risk calculators19), presence of metabolic syn-drome, or having any of multiple CVD risk factors as long ashypertension/elevated blood pressure and dyslipidemia wereamong them. In contrast to the review to support the 2014 rec-ommendation, the current review excluded studies limited to orpredominantly in populations with diabetes or prediabetesbecause a separate systematic review will address thesepopulations.7 In addition, weight loss trials targeting people withrelevant CVD risk factors were included in this review but not inthe previous review.
Interventions could be delivered alone or as part of a larger in-tervention that also addressed other health behaviors (eg, smok-ing cessation). Additionally, interventions had to have been con-ducted in countries with “very high” human development accordingto the United Nations20 and take place or be feasible in a health caresetting. Studies had to report a health outcome (eg, CVD events, mor-tality), intermediate outcome (eg, blood pressure, lipid levels, glu-cose levels, adiposity), or behavioral outcome (eg, dietary intake,physical activity) or report adverse events related to the interven-tion. Comparative effectiveness trials without a true control groupwere excluded.
Data Extraction and Quality AssessmentTwo reviewers independently assessed the methodological qual-ity of eligible studies using criteria outlined by the USPSTF(eTable 2 in the Supplement).14 Each study was assigned a qualityrating of “good,” “fair,” or “poor,” and disagreements betweeninvestigators were resolved through consensus after discussionwith additional investigators. Studies rated as poor wereexcluded.14 Poor-quality studies typically had several major risksof bias, including very high attrition (generally >40%), differentialattrition between intervention groups (generally >20%), substan-tial lack of baseline comparability between groups without adjust-ment for those variables, or other issues judged to considerablybias the results (eg, possible selective reporting, inappropriateexclusion of participants from analyses, questionable validity ofrandomization and allocation concealment procedures). Onereviewer abstracted descriptive and outcome data from eachincluded study into standardized evidence tables; a secondchecked for accuracy and completeness.
Data Synthesis and AnalysisSummary tables were created for study characteristics, populationcharacteristics, intervention characteristics, and outcomes.Methods consistent with the previous review were used to esti-mate and categorize the total contact time of each interventiongroup as low (�30 minutes), medium (31-360 minutes [6 hours]),or high (>360 minutes).
All outcomes were quantitatively pooled except forpatient-reported measures of subjective well-being (KQ1), dietarypattern scores (KQ3), and adverse events (KQ4), which weresummarized descriptively. For mortality and cardiovascularevent outcomes (KQ1), results for multiple intervention groupswere combined because the absolute number of events was gen-erally small.
USPSTF Report: Behavioral Counseling to Promote Healthy Lifestyle in Adults With CV Risk Factors US Preventive Services Task Force Clinical Review & Education
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Meta-analyses for intermediate (KQ2) and behavioral (KQ3)outcomes were conducted using the most comprehensive orhighest-contact intervention group if a study had multiple inter-vention groups and using the follow-up time point closest to 12months if there were multiple follow-up assessments. Adjustedeffect estimates reported by primary studies were used overunadjusted values, and crude effect estimates were calculated ifbetween-group results were not reported. For pooling, theRestricted Maximum Likelihood model with the Knapp-Hartungcorrection21,22 was used. The presence of statistical heteroge-neity among the studies was assessed using standard χ2 tests,and the magnitude of heterogeneity was estimated using theI2 statistic. Meta-regression and stratified analyses were con-ducted to explore whether there were methodologic, population,
or intervention characteristics at the study level that were associ-ated with effect size for the most commonly reported outcomesof systolic blood pressure (SBP), total cholesterol, and weight. Inaddition, small-study effects were evaluated using funnel plotsand the Egger test.23
Stata version 15.1 (StataCorp) and R version 3.5.2 (R Founda-tion for Statistical Computing) were used for all quantitative analy-ses. All significance testing was 2-sided, and results were consid-ered statistically significant at P < .05.
The aggregate strength of evidence was assessed for each KQusing the approach described in the Methods Guide for Effective-ness and Comparative Effectiveness Reviews,24 based on the num-ber, quality, and size of studies and the consistency and precisionof results between studies.
Figure 1. Analytic Framework: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in AdultsWith Cardiovascular Risk Factors
Key questions
Do primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentary behavior improvecardiovascular disease (CVD) and related health outcomes (eg, morbidity, mortality) in adults with known CVD risk factors (hypertension orelevated blood pressure, dyslipidemia, or mixed or multiple risk factors [eg, 10-y CVD risk >7.5%, metabolic syndrome])?
1
What are the harms of primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentarybehavior in adults with known CVD risk factors (eg, hypertension or elevated blood pressure, dyslipidemia, or mixed or multiple risk factors[eg, 10-y CVD risk >7.5%, metabolic syndrome])?
4
Do primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentary behavior improveintermediate outcomes associated with CVD (eg, blood pressure, lipid levels, blood glucose, body mass index) in adults with known CVD risk factors(hypertension or elevated blood pressure, dyslipidemia, or mixed or multiple risk factors [eg, 10-y CVD risk >7.5%, metabolic syndrome])?
2
Do primary care–relevant behavioral counseling interventions to improve diet, increase physical activity, and reduce sedentary behavior improvebehavioral outcomes (eg, diet, physical activity, sedentary behavior) in adults with known CVD risk factors (hypertension or elevated blood pressure,dyslipidemia, or mixed or multiple risk factors [eg, 10-y CVD risk >7.5%, metabolic syndrome])?
3
Adults and older adults with knownCVD risk factors defined as• Hypertension or elevated BP• Dyslipidemia• Mixed or multiple risk factors
(eg, 10-y CVD risk >7.5%,metabolic syndrome)
Intermediate outcomesChange in CVD risk factors:• BP• Lipids• Blood glucose• BMI, weight circumference• Dichotomized versions of
CVD risk factors• Calculated 10-y risk
Behavioralcounseling
intervention
Health outcomes• Cardiovascular events and related
morbidity• Cardiovascular and all-cause mortality• Quality-of-life measures
1
2
Harms ofintervention
4
Behavioral outcomes• Dietary intake• Physical activity• Sedentary behavior
3
Evidence reviews for the US Preventive Services Task Force (USPSTF) use ananalytic framework to visually display the key questions that the review willaddress to allow the USPSTF to evaluate the effectiveness and safety of apreventive service. The questions are depicted by linkages that relate
interventions and outcomes. A dashed line indicates a health outcome thatimmediately follows an intermediate outcome. Details available in the USPSTFProcedure Manual.14 BMI indicates body mass index; BP, blood pressure;CVD, cardiovascular disease.
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Results
Ninety-four randomized and cluster-randomized clinical trials re-ported in 227 publications were included (N = 52 174) (Figure 2;eTable 3 in the Supplement).25-250 Fifty-two trials were carried for-ward from the previous review30,31,35,37,40-42,45,53,55,56,61-63,72,74,80,
87,90,99,121,123,130,131,134,138,145,147,149,155,174,176-178,180,181,192,193,208,210,215,
217,223,225,227,229,231,234,238,242,244,247 and were synthesized with 42newly identified trials.36,46-48,51,69-71,73,92,97,110,111,115,118,124,127,132,139,
142,144,148,152,158,163,165,182,183,187,190,194,196,200,203,205,207,216,220,221,237,
241,245 Of 94 studies, 32 (34.0%) were limited to people with hyper-tension or elevated blood pressure, 16 (17.0%) were limited to thosewith dyslipidemia or elevated lipid levels, and the remaining 46(49.0%) included people with any of multiple risk factors (Table 1).Most participants were overweight or had obesity, and the meanbaseline body mass index (BMI) was 29.8 (calculated as weight inkilograms divided by height in meters squared) (eTable 4 in theSupplement). Forty-three trials (45.7%) were conducted in the US;of these, 16 trials appeared to include majority Hispanic or non-White samples. The majority of trials recruited participants fromhealth care settings, but most interventions did not involve a pri-mary care clinician. Almost all trials addressed diet, with or withoutphysical activity, and had at least 30 minutes of contact time (eTable 5
in the Supplement). Very few intervention groups (6/120 [5.0%])addressed physical activity alone. The median number of contactswas 12 (interquartile range [IQR], 5-27), with an estimated 6 (IQR,2.2-15.8) hours of contact over 12 (IQR, 6-18) months. Interven-tions varied widely in format and dietary recommendations, and 23(19.2%) also included medication management.
Benefits of InterventionsKey Question 1. Do primary care–relevant behavioral counselinginterventions to improve diet, increase physical activity, andreduce sedentary behavior improve CVD and related health out-comes (eg, morbidity, mortality) in adults with known CVD riskfactors (hypertension or elevated blood pressure, dyslipidemia,or mixed or multiple risk factors [eg, 10-year CVD risk >7.5%,metabolic syndrome])?
Twenty-nine of the 94 studies reported health outcomes. Ofthese, 12 trials reported CVD events, with follow-up ranging from 6months to 16 years.37,46,47,55,97,99,124,127,220,221,241,242 All had me-dium or high intervention contact time. Behavioral counseling wasassociated with lower risk of the composite outcomes of any CVDevents (risk ratio [RR], 0.80 [95% CI, 0.73 to 0.87]; 9 RCTs[n = 12 551]; I2 = 0%), myocardial infarction (RR, 0.85 [95% CI, 0.70to 1.02]; 6 RCTs [n = 10 375]; I2 = 0%), and stroke (RR, 0.52 [95%CI, 0.25 to 1.10]; 4 RCTs [n = 9800]; I2 = 0%), although the pooled
Figure 2. Literature Search Flow Diagram: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular DiseasePrevention in Adults With Cardiovascular Risk Factors
466 Full-text articles assessed for eligibility
14 409 Citations screened after duplicates removed
13 943 Citations excluded at title andabstract stage
99 Articles (29 studies) includedfor KQ1
212 Articles (91 studies) includedfor KQ2
182 Articles (70 studies) includedfor KQ3
70 Articles (20 studies) includedfor KQ4
24 683 Citations identified throughliterature database searches
175 Relevant studies identified fromthe previous systematic review
184 Relevant studies identified fromother relevant USPSTF systematicreviews
67 Citations identifed through othersources (eg, reference lists, peerreviewers)
367 Articles excluded for KQ1a1 Aim
15 Setting148 Outcomes103 Population
24 Intervention51 Study design14 Quality
2 Date of publication9 Publication type
254 Articles excluded for KQ2a1 Aim
15 Setting34 Outcomes
103 Population24 Intervention52 Study design14 Quality
2 Date of publication9 Publication type
284 Articles excluded for KQ3a1 Aim
15 Setting65 Outcomes
103 Population24 Intervention51 Study design14 Quality
2 Date of publication9 Publication type
396 Articles excluded for KQ4a1 Aim
15 Setting177 Outcomes103 Population
24 Intervention51 Study design14 Quality
2 Date of publication9 Publication type
KQ indicates key question.a Reasons for exclusion: Aim: Study aim not relevant. Setting: Study was not
conducted in a country relevant to US practice or study was conducted inintermediate care facility or otherwise unrepresentative setting. Outcomes:Study did not report relevant outcomes. Population: Symptomatic, 50% ormore with coronary heart disease or diabetes; 50% or more with prediabetes;
age not 18 years or older. Intervention: Study used an excluded intervention orintervention aim was irrelevant. Study design: Not an included study design.Comparative effectiveness: follow-up 6 months or less. Quality: Study did notmeet criteria for fair or good quality. Publication type: Ancillary study toexcluded primary study.
USPSTF Report: Behavioral Counseling to Promote Healthy Lifestyle in Adults With CV Risk Factors US Preventive Services Task Force Clinical Review & Education
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effect size showed a statistically significant association only for thecomposite outcome of any CVD events (Figure 3). Only 3 of thesetrials were included in the previous review.37,99,242 The newly in-cluded Prevención con Dieta Mediterránea (PREDIMED) study97 washeavily weighted in this analysis because of its large sample size; how-ever, the association remained statistically significant in a sensitiv-ity analysis excluding PREDIMED (RR, 0.79 [95% CI, 0.70 to 0.90];8 RCTs [n = 5104]). Event rates were variable; in PREDIMED 3.6%in the intervention groups experienced a cardiovascular event, com-pared with 4.4% in the control group.
Few studies were powered for mortality, and neither individuallarge studies nor the pooled estimate showed a beneficial associa-tion with all-cause mortality (RR, 0.89 [95% CI, 0.71 to 1.11]; 18 RCTs[n = 17 939]; I2 = 0%) with follow-up of 6 months to 16 years.Among 3 large trials,97,99,221 findings for both all-cause and cardio-vascular mortality indicated greater benefit for intervention partici-pants relative to control participants; however, results were statisti-cally significant in only 1 trial.99 Patient-reported well-being
measures were reported in 11 trials,36,37,42,62,99,110,115,124,148,200,231
but group differences were generally very small and statisti-cally nonsignificant.Key Question 2. Do primary care–relevant behavioral counsel-ing interventions to improve diet, increase physical activity, andreduce sedentary behavior improve intermediate outcomesassociated with CVD (eg, blood pressure, lipid levels, bloodglucose levels, body mass index) in adults with known CVD risk fac-tors (hypertension or elevated blood pressure, dyslipidemia, ormixed or multiple risk factors [eg, 10-year CVD risk >7.5%, meta-bolic syndrome])?
All but 3 trials reported intermediate outcomes.87,180,231
Behavioral counseling interventions were associated withsmall, statistically significant reductions in continuous measuresof blood pressure, low-density l ipoprotein cholesterol(LDL-C) and total cholesterol levels, fasting glucose levels, andadiposity-related outcomes at 12 to 24 months’ follow-up(Table 2).
Table 1. Summary of Study Characteristics of All Included Studies (94 Studies, N = 52 174),Overall and by Risk Focus
Characteristics
Studies, No. (%)
All studies Hypertensiona Dyslipidemiab Mixed risk factorsAll studies 94 (100) 32 (100) 16 (100) 46 (100)
Study design
RCT 78 (83.0) 27 (84.4) 11 (68.8) 40 (87.0)
Cluster RCT 16 (17.0) 5 (15.6) 5 (31.2) 6 (13.0)
Good quality ratingc 19 (20.2) 9 (28.1) 1 (6.2) 10 (21.7)
Conducted in the US 43 (45.7) 19 (59.4) 9 (56.2) 15 (32.6)
Recruitment setting
Primary care 38 (40.4) 12 (37.5) 5 (31.2) 21 (45.6)
Other health care 20 (21.3) 3 (9.4) 5 (31.2) 12 (26.1)
Other (eg, media,community settings,research center,epidemiologic surveys)
36 (38.3) 17 (53.1) 6 (37.5) 13 (28.3)
Risk group
Hypertensiona 32 (34.0)
Dyslipidemiab 16 (17.0)
Multiple risk factors 46 (48.9)
Medication userestrictions
Limited to those takingmedications to managerisk factors
11 (11.7) 9 (28.1) 0 2 (4.4)
Excluded those takingmedications to managerisk factors
21 (22.3) 9 (28.1) 10 (62.5) 2 (4.4)
No restrictions 62 (66.0) 14 (43.8) 6 (37.5) 42 (91.3)
Control group
No intervention/usual care
73 (77.7) 22 (68.8) 14 (87.5) 37 (80.4)
Minimal intervention 19 (20.2) 9 (28.1) 1 (6.2) 9 (19.6)
Attention control 2 (2.1) 1 (3.1) 1 (6.2) 0
Control groupinstructed to maintaintypical habits
7 (7.4) 2 (6.3) 3 (18.8) 2 (4.4)
Sample size, median(IQR) [range]
314 (154-601)[24-7447]
272 (197-762)[24-2382]
222 (133-420)[80-1197]
342 (154-601)[37-7447]
Follow-up at 12 moor closest, median(IQR) [range], %
86 (79-92)[63-100]
88 (80-92)[69-100]
88 (78-96)[73-99]
84 (78-91)[63-100]
Abbreviations: IQR, interquartilerange; RCT, randomized clinical trial;SBP, systolic blood pressure.a Includes trials limited to persons
with hypertension or elevatedblood pressure.
b Includes trials limited to personswith dyslipidemia or elevated lipidlevels.
c Twelve additional studies wererated as poor quality and excludedfrom the review; the remainderwere rated fair quality.
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There was a mean 1.8-mm Hg/1.2-mm Hg greater reduction inblood pressure in intervention groups vs control groups after 12to 24 months (pooled SBP mean difference, –1.8 [95% CI, –2.5 to–1.1]; 42 RCTs [44 effects, n = 14 580]; I2 = 37.3%; pooled dia-stolic blood pressure mean difference, –1.2 [95% CI, –1.6 to –0.8];38 RCTs [40 effects, n = 13 098]; I2 = 32.5%). In addition, in trialsreporting incidence of hypertension, intervention groups had a26% lower risk of onset (pooled RR, 0.74 [95% CI, 0.58 to 0.94];5 RCTs [n = 2707]; I2 = 12%).
For lipid levels, the pooled mean difference in change betweengroups was –3.5 mg/dL for total cholesterol, –2.1 mg/dL for LDL-C,and 0.6 mg/dL for high-density lipoprotein cholesterol (pooled totalcholesterol mean difference, –3.5 [95% CI, –5.6 to –1.4]; 36 RCTs [38effects, n = 11 414]; I2 = 65.9%; pooled LDL-C mean difference, –2.1[95% CI, –4.1 to –0.2]; 30 RCTs [32 effects, n = 8894]; I2 = 55.9%;pooled high-density lipoprotein cholesterol mean difference, 0.6[95% CI, 0.2 to 1.0]; 32 RCTs [34 effects, n = 8974]; I2 = 33.7%).Among 20 trials reporting fasting glucose levels, there was a mean2.3-mg/dL greater reduction in fasting blood glucose in the inter-vention groups compared with the control groups at 12 to 24 months’follow-up (mean difference, –2.3 [95% CI, –3.6 to –1.0]; 20 RCTs [22effects, n = 5950]; I2 = 82.5%).
At 12 to 24 months, the intervention groups showed slightlygreater reductions in all 3 adiposity-related measures: pooled BMImean difference, –0.5 (95% CI, –0.7 to –0.3); 30 RCTs (n = 9909);I2 = 83.3%; pooled weight mean difference, –1.6 kg (95% CI, –2.1 to–1.1); 37 RCTs (n = 16 345); I2 = 88.1%; pooled waist circumferencemean difference, –1.7 cm (95% CI, –2.4 to –1.1); 23 RCTs (n = 11 708);I2 = 87.3%). Incidence of diabetes and metabolic syndrome weresparsely reported; findings usually favored the intervention group,although they were generally not statistically significant (eTable 6in the Supplement).
Very few intervention or population characteristics wereclearly associated with effect size consistently across outcomes.Meta-regression and stratified analyses were conducted for themost commonly reported outcomes: SBP, total cholesterol level,and weight. Total cholesterol was chosen over LDL-C because itwas more commonly reported; however, absolute effect sizeswere typically very similar between these 2 outcomes, suggestingthat most of the change in total cholesterol was due to changes inLDL-C. In these analyses, there was no clear indication for anyoutcome that high-contact (>360-minute) trials showed largereffects than medium-contact (31- to 360-minute) trials, nor wasthere an association between continuous measures of contact
Figure 3. CVD Events (Key Question 1)
Favorsintervention
Favorscontrol
0.01 101 1000.1Risk ratio (95% CI)
Population risk focusContacttimea
Timepoint,mo
No./total (%)
Intervention ControlSourceMyocardial infarction
Risk ratio(95% CI)
Hypertension High 1/537 (0.2)6 1/273 (0.4)Appel et al,37 2003 0.51 (0.03-8.03)Multiple risk factors High 68/4997 (1.4)60 38/2450 (1.6)Estruch et al,97 2018 0.88 (0.59-1.30)Multiple risk factors High 18/253 (7.1)40 22/255 (8.6)Fagerberg et al,99 1998 0.80 (0.46-1.39)Multiple risk factors Medium 1/160 (0.6)6 0/154 (0.0)Haufe et al,124 2019 2.89 (0.12-70.44)Multiple risk factors High 0/131 (0.0)24 1/130 (0.8)Wadden et al,241 2011 0.33 (0.01-8.04)Hypertension High 6/664 (0.9)36 4/371 (1.1)Whelton et al,242 1998 0.84 (0.24-2.93)
Overall heterogeneity: τ2 = 0, I2 = 0%, P = .95 0.85 (0.70-1.02)Stroke
Hypertension High 0/537 (0.0)6 1/273 (0.4)Appel et al,37 2003 0.17 (0.01-4.16)Multiple risk factors High 81/4997 (1.6)60 58/2450 (2.4)Estruch et al,97 2018 0.68 (0.49-0.95)Multiple risk factors High 5/253 (2.0)40 17/255 (6.7)Fagerberg et al,99 1998 0.30 (0.11-0.82)Hypertension High 2/664 (0.3)36 2/371 (0.5)Whelton et al,242 1998 0.56 (0.08-3.97)
CVD eventsb
Hypertension High 0/180 (0.0)24 1/185 (0.5)Bennett et al,47 2012 0.34 (0.01-8.37)Multiple risk factors Medium 5/176 (2.8)12 6/175 (3.4)Bennett et al,46 2018 0.83 (0.26-2.68)Multiple risk factors Medium 12/169 (7.1)108 19/166 (11.4)Bo et al,55 2007 0.62 (0.31-1.23)Multiple risk factors High 179/4997 (3.6)60 109/2450 (4.4)Estruch et al,97 2018 0.80 (0.63-1.02)Multiple risk factors High 63/253 (24.9)79 84/255 (32.9)Fagerberg et al,99 1998 0.71 (0.51-0.99)Hypertension High 17/231 (7.4)192 32/311 (10.3)TOHP I CRG,220 1992 0.71 (0.40-1.26)Hypertension High 71/938 (7.6)192 80/935 (8.6)TOHP II CRG,221 1997 0.89 (0.65-1.21)Hypertension High 88/664 (13.3)36 57/371 (15.4)Whelton et al,242 1998 0.86 (0.63-1.18)
Overall heterogeneity: τ2 = 0, I2 = 0%, P = .96 0.80 (0.73-0.87)
Overall heterogeneity: τ2 = 0.12, I2 = 0%, P = .40 0.52 (0.25-1.10)
CVD indicates cardiovascular disease; RR, risk ratio; TOHP I CRG, Trials ofHypertension Prevention–Phase I Collaborative Research Group; TOHP II CRG,Trials of Hypertension Prevention–Phase II Collaborative Research Group.
Random-effects restricted maximum likelihood model with Knapp-Hartungconfidence intervals. Size of data markers indicates weight of each studyin the analysis.
a Intervention contact time defined as low (0-30 minutes), medium(31-360 minutes), or high (>360 minutes).
b Hinderliter et al127 reported no CVD events in both groups (not shownon plot).
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(number of sessions, total estimated minutes of contact) andeffect size. However, very few trials offered low-contact (
dyslipidemia, or mixed or multiple risk factors [eg, 10-year CVDrisk >7.5%, metabolic syndrome])?
Seventy of the 94 included trials reported some type of behav-ioral outcome (n = 43 243).30,31,35,37,40,41,45-48,51,53,55,61,63,70-72,74,
80,87,90,92,97,110,115,121,123,124,127,130-132,142,145,148,149,152,155,158,163,165,174,177,
180,182,190,193,196,200,205,207,208,210,215-217,220,221,223,225,229,231,234,237,
238,241,244,245,247 Specific behavioral outcomes were typicallyreported by fewer than 15 trials per outcome, and there was sub-stantial variability in measurement for most. Overall, behavioral coun-seling interventions were associated with dietary improvements, in-cluding reductions in saturated fat consumption and increases in theconsumption of fruits, vegetables, and fiber (Table 3). The meandifference in reduction in the percentage of calories from saturatedfat was 1.5% after 12 to 24 months (pooled mean difference, –1.5%[95% CI, –1.9% to –1.1%]; 15 RCTs [17 effects, n = 6229]; I2 = 72%).For fruits and vegetables, the intervention groups increased con-sumption by a mean of 0.7 servings per day more than the controlgroups (pooled mean difference, 0.7 [95% CI, 0.1 to 1.3]; 11 RCTs[n = 4310]; I2 = 90%). The mean increase in fiber consumption was1.3 g per day (95% CI, 0.1 to 2.6; 5 RCTs [n = 1350]; I2 = 42%) morethan control groups. In addition, trials among people with hyper-tension or elevated blood pressure who were counseled to reducesodium consumption did show reduced urinary sodium levels(pooled mean difference, –18.0 mmol/L [95% CI, –34.8 to –1.2]; 9RCTs [n = 3583]; I2 = 89%). Dietary pattern scores generallyshowed statistically significantly greater improvement in interven-tion groups, but measurement was heterogeneous and interpreta-tion of effect sizes was unclear.
Physical activity outcomes were highly variable in terms of bothmeasurement and results, with minimal evidence to suggest that in-
terventions were associated with increased physical activity. In the50 trials reporting some type of physical activity outcome, the re-ported measures and the units of measure were disparate, and al-most all outcomes were self-reported. Pooled analyses of continu-ous physical activity outcomes did not show statistically significantassociation, with high statistical heterogeneity (pooled standard-ized mean difference, 0.06 [95% CI, —0.03 to 0.14]; 30 RCTs [32effects, n = 19 834]; I2 = 64%), and a pooled estimate of physical ac-tivity minutes per week showed an increase of 9.1 minutes in inter-vention groups compared with control groups that was not statis-tically significant (pooled minutes per week mean difference, 9.1[95% CI, –4.6 to 22.8]; 10 RCTs [11 effects, n = 9746]; I2 = 48%). Di-chotomous outcome reporting in terms of meeting study-definedphysical activity goals occurred in a small subset of 11 trials, and thepooled effect size suggested a statistically significant benefit asso-ciated with intervention groups (pooled RR, 1.22 [95% CI, 1.00 to1.50]; 11 RCTs [n = 5887]; I2 = 91%).
Harms of InterventionsKey Question 4. What are the harms of primary care–relevant be-havioral counseling interventions to improve diet, increase physi-cal activity, and reduce sedentary behavior in adults with known CVDrisk factors (hypertension or elevated blood pressure, dyslipid-emia, or mixed or multiple risk factors [eg, 10-year CVD risk >7.5%,metabolic syndrome])?
Twenty of the 94 included trials reported harms(n = 18 263).36,37,46,47,55,63,87,97,118,152,187,193,194,200,241,242,247 Seven ofthese 20 trials reported that there were no adverse events or no se-rious adverse events,55,87,97,118,148,152,247 and other trials reported 1or more of the following: serious adverse events, any adverse events,
Table 3. Pooled Difference in Mean Change for Dietary Fats, Fruit Vegetable, Urinary Sodium Levels, and Physical Activity Outcomesat 12 to 24 Months’ Follow-up
Outcome Unit Effect size (95% CI)a
No. ofeffectsanalyzed
No. ofparticipantsanalyzed I2, %
Median (IQR) change
Intervention group Control groupSaturated fat % of energy −1.5 (−1.9 to −1.1) 15 6229 72 −1.9 (−3.0 to −1.4) −0.6 (−1.0 to −0.1)
Saturated fat(fat-modified dietinterventions only)
% of energy −1.5 (−2.3 to −0.8) 8 3951 72 −2.2 (−3.0 to −1.6) −0.5 (−1.0 to −0.01)
Polyunsaturated fat % of energy −0.4 (−1.0 to 0.3) 7 2032 90 −0.9 (−1.2 to −0.1) 0 (−0.3 to 0)
Monounsaturated fat % of energy −1.7 (−2.5 to −0.9) 7 1827 83 −2.0 (−2.1 to −1.9) −0.2 (−0.4 to 0)
Fruits and vegetables Servings/d 0.7 (0.1 to 1.3) 11 4310 90 0.5 (−0.01 to 1.2) 0.1 (0 to 0.3)
Fruits Servingsor pieces/d
0.2 (0.04 to 0.3) 9 3698 71 0.2 (0.1 to 0.5) 0 (0 to 0.1)
Vegetables Standardizedmean difference
0.1 (0.02 to 0.2) 9 3555 50 Servings/d: 0.5(0 to 0.8)
Servings/d: 0.3(0.2 to 0.3)
g/d: 11 (9 to 16) g/d: 2 (−3 to 12)
Fiber g/d 1.3 (0.1 to 2.6) 5 1350 42 1.7 (0 to 3.0) 0.1 (−0.7 to 0.2)
Urinary sodium mmol/L −18.0 (−34.8 to −1.2) 9 3583 89 −18.4 (−45.4 to −5.3) −6.0 (−10.0 to −3.4)
Physical activity Standardizedmean difference
0.06 (−0.03 to 0.14) 32 19 834 64 - -
min/wk 9.1 (−4.6 to 22.8) 11 9746 48 44.4 (−2.5 to 97.0) 31.2 (−13.0 to 74.7)
MET-min/wk 83 (−83 to 249) 7 4958 62 130 (33 to 289) 70 (−16 to 112)
% Meetingphysical activitygoal
RR, 1.22 (1.00 to 1.50) 11 5887 91 36.0 (28.1 to 52.8)b 23.8 (22.9 to 50.8)b
Abbreviations: IQR, interquartile range; MET, metabolic equivalent; RR, risk ratio.a Between-group mean difference in change unless otherwise specified.b Median (IQR) percent meeting physical activity goal.
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hospitalizations, musculoskeletal injuries, withdrawals due to ad-verse events, gallbladder disease, and headaches. Adverse eventsrelated to diet and physical activity counseling were exceedingly rare,with generally no statistically significant differences in any study forharms outcomes. There was no consistent evidence of paradoxicaleffects for intermediate or behavioral outcomes.
DiscussionConsistent with the prior review that was conducted to support the2014 USPSTF recommendation,16 this review found that medium-and high-contact behavioral counseling interventions in people withcardiovascular risk factors were associated with improvements in in-termediate and behavioral outcomes. The evidence is summarizedin Table 4. No single optimal or representative intervention was iden-tified; a wide range of behavioral counseling approaches improvedhealth profiles. Similar effect sizes were found for most outcomes,compared with the previous review. This was observed despite theinclusion of weight loss studies in adults with relevant CVD risk fac-tors and the exclusion of studies conducted predominantly in adultswith prediabetes or diabetes (the latter are addressed in a separateUSPSTF review).7
The finding that behavioral counseling interventions wereassociated with a lower likelihood of CVD events is new since theprevious review. The overall pooled effect size showed a 20%lower risk of CVD events, which translates to a number needed totreat of 100 (95% CI, 74 to 154) to prevent 1 CVD event, assuminga baseline rate of 5%. Population risks of 7.5% and 10% translateto numbers needed to treat of 67 (95% CI, 49 to 103) and 50(95% CI, 37 to 77), respectively.
The largest study was PREDIMED, which accounted for morethan one-half of the participants in the analysis and was notincluded in the previous review.97 PREDIMED investigators issued aretraction of the original publication after the discovery of protocolviolations regarding enrollment of household members withoutrandomization and inconsistent use of randomization tables. Thepublished updated analyses, including extensive sensitivity analy-ses to explore the effect of the violations, found that effect sizeswere only minimally affected. Results reported here are from theupdated version of the results. The association was still statisticallysignificant in a sensitivity analysis excluding this study. The findingof no consistent evidence of benefit for physical activity outcomesis surprising and may reflect limitations in the evidence. The differ-ence in results between continuous outcomes showing no benefitand dichotomous outcomes showing marked improvement sug-gests that physical activity reporting is not representative in thisbody of literature, which included few trials exclusively addressingphysical activity. The results of this review stand in contrast tothose of another commissioned by the USPSTF that addressedbehavioral counseling for diet and physical activity in adults with-out CVD risk factors.
That review found that behavioral counseling was associatedwith approximately 35 more minutes per week of physical activity.8
That review also included substantially more trials only addressingphysical activity. Indeed, studies whose primary inclusion criterionwas suboptimal physical activity were included in that review andnot in the present review. The clinical significance of modest
improvements in intermediate and behavioral outcomes is chal-lenging to quantify, given that behavioral changes may not bemaintained. This may be particularly true for dietary outcomes forwhich the effect of individual diet components is difficult to evalu-ate and there is sparse reporting on overall dietary patterns.Regardless, there is observational evidence linking lower levels ofCVD risk factors as well as improved diet and physical activitybehaviors to better cardiovascular and mortality outcomes. Suchevidence is reinforced by trial data suggesting that behavioralcounseling for healthy diet and physical activity in adults with CVDrisk factors is associated with lower risk of CVD events and by datathat suggest little to no harm.
Further understanding is needed regarding the contribution ofweight loss in the context of complex behavioral interventions tar-geting CVD risk factors. Robust analyses of the importance ofweight loss on intermediate outcomes are best provided by indi-vidual patient–level data and direct within-study comparisons ofinterventions with and without weight loss goals, both of which aresparse. While many interventions in this review had weight lossgoals for all or some participants, some within-study comparisonssuggested that CVD risk reduction can occur in the absence ofweight loss,132,158,220,221 consistent with a recent comparativeeffectiveness trial not included in this review because it did notinclude a true control group.251 While evidence from clinical trialsremains limited, observational evidence also supports the benefitsof a healthy diet and physical activity for people with excessweight, even in the absence of weight loss. The Nurses’ HealthStudy and the Health Professionals Follow-up Study252 found thatall-cause mortality was lower in people with BMIs of 30.0 to 39.9who had engaged in at least 3 healthy behaviors (including healthydiet, physical activity, moderate alcohol consumption, and notsmoking) than in people of healthy weight who reported only 1 ofthese behaviors. Thus, for people with excess weight, particularlythose with a history of unsuccessful or unhealthy weight lossapproaches, promoting diet and physical activity goals without tar-geting weight loss is likely to improve health.
There are important limitations in the research that should beconsidered. First, only a small proportion of trials had sufficientsample size and follow-up time to evaluate CVD events and mortal-ity. Continued follow-up and large replication studies are needed.
Second, there was highly variable reporting of behavioral out-comes, particularly for physical activity. The variability in specific mea-sures, as well as the lack of behavioral outcomes in studies report-ing intermediate outcomes, make it difficult to interpret pooled effectsizes. Third, for dietary outcomes it is difficult to understand the clini-cal importance of changes in a single aspect of diet. Given the im-portance of substitutions when modifying diet,253 validated mea-sures of overall diet pattern would be a more valuable outcome;however, the field lacks a consistent measure of overall optimal dietpattern. The Healthy Eating Index is a validated measure of overalldiet quality that assesses alignment with the Dietary Guidelines forAmericans and is associated with all-cause, CVD, and cancermortality.254 However, only 2 included studies reported thismeasure,215,216 and the field would benefit from a set of core out-come measures of diet and physical activity. Fourth, data were verylimited for persons 75 years and older. The PREDIMED study had anmean age of 67 years, however, supporting the benefits of dietarycounseling adults 65 years and older.
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Tabl
e4.
Sum
mar
yof
Evid
ence
No.
ofst
udie
s(N
o.of
obse
rvat
ions
)st
udy
desi
gns
Sum
mar
yof
findi
ngs
Cons
iste
ncy
and
prec
isio
nO
ther
limita
tions
Stre
ngth
ofev
iden
ceAp
plic
abili
ty
KQ1:
Bene
fitso
fint
erve
ntio
nson
CVD
and
rela
ted
heal
thou
tcom
es
CVD
even
ts:1
2RC
Ts(1
510
7)M
orta
lity:
18RC
Ts(1
814
6)Su
bjec
tive
wel
l-be
ing:
11RC
Ts(5
684)
CVD
even
tsw
ere
repo
rted
in12
tria
lsof
med
ium
-orh
igh-
cont
acti
nter
vent
ions
,and
pool
edan
alys
essh
owed
low
erra
teso
ftot
alCV
Dev
ents
(poo
led
RR,0
.80
[95%
CI,0
.73
to0.
87];
9st
udie
s)an
dfa
irly
larg
ebu
tst
atis
tical
lyno
nsig
nific
anta
ssoc
iatio
nsw
ithm
yoca
rdia
linf
arct
ion
(poo
led
RR,0
.85
[95%
CI,0
.70
to1.
02];
6st
udie
s)an
dst
roke
(RR,
0.52
[95%
CI,0
.25
to1.
10];
4st
udie
s)Ev
entr
ates
wer
eva
riabl
e,bu
tthe
larg
est
tria
lrep
orte
dth
at3.
6%of
inte
rven
tion
part
icip
ants
had
CVD
even
ts,c
ompa
red
with
4.4%
ofco
ntro
lpar
ticip
ants
Few
stud
iesw
ere
pow
ered
form
orta
lity;
neith
erth
ose
few
larg
est
udie
snor
the
pool
edes
timat
ecl
earl
yde
mon
stra
ted
anef
fect
onm
orta
lity
(poo
led
RR,0
.89
[95%
CI,0
.71
to1.
11])
Patie
nt-r
epor
ted
mea
sure
sofs
ubje
ctiv
ew
ell-
bein
gw
ere
spar
sely
repo
rted
and
show
edno
clea
rpat
tern
ofcl
inic
ally
impo
rtan
tben
efit
Mor
talit
y:Re
ason
ably
cons
iste
nt,i
mpr
ecis
eCV
Dev
ents
:rea
sona
bly
cons
iste
nt,r
easo
nabl
ypr
ecis
eSu
bjec
tive
wel
l-be
ing:
inco
nsis
tent
,im
prec
ise
Spar
sely
repo
rted
,few
tria
lsha
dsu
ffic
ient
pow
eran
dle
ngth
offo
llow
-up
for
mor
talit
yan
dCV
Dev
ents
Tria
lwith
the
stro
nges
tev
iden
ceha
dpr
otoc
olvi
olat
ions
inal
loca
tion;
how
ever
,ext
ensi
vese
nsiti
vity
anal
yses
show
edlim
ited
effe
cton
resu
lts
CVD
even
ts:m
oder
ate
forb
enef
itM
orta
lity:
low
fors
mal
lto
nobe
nefit
Subj
ectiv
ew
ell-
bein
g:in
suff
icie
nt
CVD
even
ts:M
ostt
rials
cond
ucte
din
the
US;
how
ever
,the
larg
estt
rialp
rovi
ding
the
stro
nges
tevi
denc
ew
asco
nduc
ted
inSp
ain
Mos
tpar
ticip
ants
acro
ssal
ltria
lsw
ere
mid
dle-
aged
and
olde
radu
ltsw
how
ere
pred
omin
antly
Whi
tean
dno
tso
cioe
cono
mic
ally
disa
dvan
tage
d
KQ2:
Bene
fitso
fint
erve
ntio
nson
inte
rmed
iate
outc
omes
asso
ciat
edw
ithCV
D
Cont
inuo
uscl
inic
alm
easu
res:
89RC
Ts(4
635
4)H
yper
tens
ion
inci
denc
e:5
RCTs
(270
7)Di
abet
esin
cide
nce:
4RC
Ts(6
701)
Met
abol
icsy
ndro
me:
5RC
Ts(3
103)
Beha
vior
alco
unse
ling
inte
rven
tions
wer
eas
soci
ated
with
smal
l,st
atis
tical
lysi
gnifi
cant
redu
ctio
nsin
bloo
dpr
essu
re,
tota
lcho
lest
erol
and
LDL-
C,fa
stin
ggl
ucos
e,an
dad
ipos
ity-r
elat
edou
tcom
esat
12to
24m
ofo
llow
-up
Hyp
erte
nsio
nin
cide
nce
was
low
erw
ithin
terv
entio
nsde
sign
edto
prev
ent
hype
rten
sion
inth
ose
who
did
noth
ave
ital
read
y(p
oole
dRR
,0.7
4[9
5%CI
,0.5
8to
0.94
];5
RCTs
[n=
2707
];I2
=12
%)
No
inte
rven
tion
fact
orsw
ere
clea
rly
asso
ciat
edw
ithef
fect
size
,but
amon
gtr
ials
with
the
larg
este
ffec
tsac
ross
mul
tiple
dom
ains
,mos
toff
ered
mor
eth
an6
hof
inte
rven
tion
cont
acta
ndm
any
offe
red
grou
pas
wel
lasi
ndiv
idua
lcon
tact
Sele
cted
pool
edm
ean
diff
eren
ces:
SBP,
–1.8
(95%
CI,–
2.5
to–1
.1);
44st
udie
sDB
P,–1
.2(9
5%CI
,–1.
6to
–0.8
);40
stud
ies
Tota
lcho
lest
erol
,–3.
5(9
5%CI
,–5.
6to
–1.4
);38
stud
ies
LDL-
C,–2
.1(9
5%CI
,–4.
1to
–0.2
);32
stud
ies
fast
ing
bloo
dgl
ucos
e,–2
.3(9
5%CI
,–3.
6to
–1.0
);22
stud
ies
BMI,
–0.5
(95%
CI,–
0.7
to–0
.2);
30st
udie
sEv
iden
cepr
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USPSTF Report: Behavioral Counseling to Promote Healthy Lifestyle in Adults With CV Risk Factors US Preventive Services Task Force Clinical Review & Education
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Tabl
e4.
Sum
mar
yof
Evid
ence
(con
tinue
d)
No.
ofst
udie
s(N
o.of
obse
rvat
ions
)st
udy
desi
gns
Sum
mar
yof
findi
ngs
Cons
iste
ncy
and
prec
isio
nO
ther
limita
tions
Stre
ngth
ofev
iden
ceAp
plic
abili
ty
KQ3:
Bene
fitso
fint
erve
ntio
nsin
beha
vior
alou
tcom
es
70RC
Ts(4
324
3)In
terv
entio
nsw
ere
asso
ciat
edw
ithsm
all
redu
ctio
nsin
satu
rate
dfa
tand
smal
lin
crea
sesi
nfr
uit,
vege
tabl
e,an
dfib
erco
nsum
ptio
n;fo
rexa
mpl
e,fr
uita
ndve
geta
bles
cons
umpt
ion
incr
ease
dby
am
ean
of0.
7se
rvin
gs/d
mor
ein
the
inte
rven
tion
than
inth
eco
ntro
lgro
ups(
pool
edm
ean
diff
eren
ce,0
.7[9
5%CI
,0.1
to1.
3];1
4ef
fect
s[11
RCTs
][n
=43
10];
I2=
90%
)Th
em
ean
incr
ease
infib
erco
nsum
ptio
nw
as1.
3g/
d(9
5%CI
,0.1
to2.
6;5
tria
ls[n
=13
50];
I2=
42%
)In
addi
tion,
tria
lsof
pers
onsw
ithhy
pert
ensi
onor
elev
ated
bloo
dpr
essu
rew
how
ere
coun
sele
dto
redu
ceso
dium
cons
umpt
ion
show
edgr
eate
rred
uctio
nsin
urin
ary
sodi
um(p
oole
dm
ean
diff
eren
ce,
–18.
0[9
5%CI
,–34
.8to
–1.2
];9
RCTs
[n=
3583
];I2
=89
%)
Find
ings
wer
em
ixed
forp
hysi
cala
ctiv
ityM
ostt
rials
incl
uded
med
ium
-or
high
-con
tact
inte
rven
tions
Diet
:rea
sona
bly
cons
iste
nt,
impr
ecis
ePh
ysic
alac
tivity
:in
cons
iste
nt,i
mpr
ecis
e
Spar
sere
port
ing,
with
subs
tant
ialv
aria
bilit
yin
mea
sure
suse
d,pa
rtic
ular
lyfo
rphy
sica
lact
ivity
Clin
ical
impo
rtan
ceof
effe
ctsi
zesc
ould
notb
ecl
earl
yde
term
ined
Diet
:low
forb
enef
itPh
ysic
alac
tivity
:low
forn
obe
nefit
Subs
tant
ialn
umbe
roft
rials
cond
ucte
din
the
USan
dco
nduc
ted
inor
recr
uite
dfr
ompr
imar
yca
reM
ostp
artic
ipan
tsac
ross
allt
rials
wer
em
iddl
e-ag
edan
dol
dera
dults
who
wer
epr
edom
inan
tlyW
hite
and
not
soci
oeco
nom
ical
lydi
sadv
anta
ged
KQ4:
Har
mso
fint
erve
ntio
ns
20RC
Ts(1
826
3)Ad
vers
eev
ents
rela
ted
todi
etan
dph
ysic
alac
tivity
coun
selin
gw
ere
very
rare
,with
gene
rally
nost
atis
tical
lysi
gnifi
cant
diff
eren
cesi
nan
yst
udy
fors
erio
usad
vers
eev
ents
,any
adve
rse
even
ts,h
ospi
taliz
atio
ns,
mus
culo
skel
etal
inju
ries,
with
draw
alsd
ueto
adve
rse
even
ts,g
allb
ladd
erdi
seas
e,an
dhe
adac
hes
Ther
ew
asno
cons
iste
ntev
iden
ceof
para
doxi
cale
ffec
tsfo
rint
erm
edia
teor
beha
vior
alou
tcom
es
Reas
onab
lyco
nsis
tent
,im
prec
ise
Spar
sely
repo
rted
,as
cert
ainm
entt
ypic
ally
not
desc
ribed
Low
forn
oha
rms
Subs
tant
ialn
umbe
roft
rials
cond
ucte
din
the
USan
dco
nduc
ted
inor
recr
uite
dfr
ompr
imar
yca
reM
ostp
artic
ipan
tsac
ross
allt
rials
wer
em
iddl
e-ag
edan
dol
dera
dults
who
wer
epr
edom
inan
tlyW
hite
and
not
soci
oeco
nom
ical
lydi
sadv
anta
ged
Abbr
evia
tions
:BM
I,bo
dym
assi
ndex
;CVD
,car
diov
ascu
lard
iseas
e;D
BP,d
iast
olic
bloo
dpr
essu
re;K
Q,k
eyqu
estio
n;LD
L-C,
low
-den
sity
lipop
rote
inch
oles
tero
l;RC
T,ra
ndom
ized
clin
ical
tria
l;RR
,risk
ratio
;SBP
,sys
tolic
bloo
dpr
essu
re.
Clinical Review & Education US Preventive Services Task Force USPSTF Report: Behavioral Counseling to Promote Healthy Lifestyle in Adults With CV Risk Factors
2086 JAMA November 24, 2020 Volume 324, Number 20 (Reprinted) jama.com
© 2020 American Medical Association. All rights reserved.
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LimitationsThis review has several limitations. First, the review included stud-ies conducted over approximately 30 years, a range of time overwhich the clinical context has changed. Changes in eating patterns,treatment guidelines, and understanding of nutrition science in-crease the clinical heterogeneity of participants and the interven-tions used in these trials. Treatment guidelines for hypertension anddyslipidemia have changed, generally recommending treatment atlower lipid and blood pressure levels. Rates of smoking have de-clined. Dietary messages and technology platforms have changed,yet evidence for technology-driven interventions without supportfrom a health care professional is scarce. Moreover, the sparse re-porting of baseline estimated 10-year CVD risk—coupled with the rar-ity of trials powered for CVD events—makes it difficult to character-ize the risk levels of participants in terms consistent with treatmentguidelines informed by 10-year risk.
Second, the wide-ranging study populations and sparsity ofwithin-study subgroup analyses precluded robust analysis of differ-
ential effectiveness across patient characteristics. Meta-analytictechniques were used to address effect modification when pos-sible, but such analyses were limited because of the risk of ecologi-cal bias; the best analysis of effect modification across patient sub-populations uses individual-level data. Similarly, controlling for theconfounding effects of medication use is best addressed in individual-level analyses. Individual studies rarely controlled for this poten-tially important confounding variable.
Third, statistical heterogeneity was high in many of the in-cluded meta-analyses. This likely reflected the underlying clinical andmethodological heterogeneity in the included studies.
ConclusionsMedium- and high-contact multisession behavioral counseling inter-ventions to improve diet and increase physical activity for people withelevated blood pressure and lipid levels were effective in reducing car-diovascular events, blood pressure, low-density lipoproteins, andadiposity-related outcomes, with little to no risk of serious harm.
ARTICLE INFORMATION
Accepted for Publication: August 21, 2020.
Author Contributions: Dr O’Connor had full accessto all of the data in the study and takesresponsibility for the integrity of the data and theaccuracy of the data analysis.Concept and design: O’Connor, Evans, Rushkin, Lin.Acquisition, analysis, or interpretation of data:O’Connor, Evans, Rushkin, Redmond.Drafting of the manuscript: O’Connor, Evans.Critical revision of the manuscript for importantintellectual content: Rushkin, Redmond, Lin.Statistical analysis: O’Connor, Rushkin, Redmond.Obtained funding: O’Connor, Lin.Administrative, technical, or material support:Evans, Rushkin, Redmond.Supervision: Evans, Lin.
Conflict of Interest Disclosures: None reported.
Funding/Support: This research was funded undercontract HHSA-290-2012- 00015-I-EPC4, TaskOrder 6, from the Agency for Healthcare Researchand Quality (AHRQ), US Department of Health andHuman Services, under a contract to support theUS Preventive Services Task Force (USPSTF).
Role of the Funder/Sponsor: Investigators workedwith USPSTF members and AHRQ staff to developthe scope, analytic framework, and key questionsfor this review. AHRQ had no role in study selection,quality assessment, or synthesis. AHRQ staffprovided project oversight; reviewed the report toensure that the analysis met methodologicalstandards, and distributed the draft for peer review.Otherwise, AHRQ had no role in the conduct of thestudy; collection, management, analysis, andinterpretation of the data; and preparation, review,or approval of the manuscript findings. Theopinions expressed in this document are those ofthe authors and do not reflect the official positionof AHRQ or the US Department of Health andHuman Services.
Additional Contributions: We acknowledge thefollowing individuals for their contributions to thisproject: Justin A. Mills, MD, MPH (AHRQ); currentand former members of the USPSTF whocontributed to topic deliberations; andEvidence-based Practice Center staff membersAndy Zhu, BS, for assistance with contextual
questions, and Smyth Lai, MLS, and KatherineEssick, BS, for technical and editorial assistance atthe Kaiser Permanente Center for Health Research.USPSTF members, peer reviewers, and federalpartner reviewers did not receive financialcompensation for their contributions.
Additional Information: A draft version of thisevidence report underwent external peer reviewfrom 3 content experts (Alice H. Lichtenstein, DSc,PhD [Tufts University]; Penny M. Kris-Etherton,PhD [Penn State University]; and Crystal C. Tyson,MD [Duke University]) and 5 federal partners(National Center for Chronic Disease Preventionand Health Promotion; National Institute onMinority Health and Health Disparities; NationalHeart, Lung, and Blood Institute; National Instituteof Nursing Research ;and National Institute of ChildHealth and Human Development). Comments werepresented to the USPSTF during its deliberation ofthe evidence and were considered in preparing thefinal evidence review.
Editorial Disclaimer: This evidence report ispresented as a document in support of theaccompanying USPSTF RecommendationStatement. It did not undergo additional peerreview after submission to JAMA.
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