Respond to all of these questions in your post: In the paper by Lin, what is the most compelling evidence for primary care providers to provide physical activity or dietary counseling to their patients? Considering the evidence, do you feel this type of counseling should actually be implemented in practice and compensated? Why or why not?
Clinical Guideline
Annals of Internal Medicine
Behavioral Counseling to Promote Physical Activity and a Healthful
Diet to Prevent Cardiovascular Disease in Adults: A Systematic Review
for the U.S. Preventive Services Task Force
Jennifer S. Lin, MD, MCR; Elizabeth O’Connor, PhD; Evelyn P. Whitlock, MD, MPH; and Tracy L. Beil, MS
Background: Poor diet and lack of physical activity can worsen
cardiovascular health, yet most Americans do not meet diet and
physical activity recommendations.
Purpose: To assist the U.S. Preventive Services Task Force in updating its previous recommendations by systematically reviewing
trials of physical activity or dietary counseling to prevent cardiovascular disease.
Data Sources: MEDLINE, PsycINFO, Cochrane Central Register of
Controlled Trials (2001 to January 2010), experts, and existing
systematic reviews.
Study Selection: Two investigators independently reviewed 13 562
abstracts and 481 articles against a set of a priori inclusion criteria
and critically appraised each study by using design-specific quality
criteria.
Data Extraction and Analysis: Data from 73 studies (109 articles)
were abstracted by one reviewer and checked by a second reviewer. Random-effects meta-analyses were conducted for multiple
intermediate health and behavioral outcomes.
Data Synthesis: Long-term observational follow-up of intensive
sodium reduction counseling showed a decrease in the incidence of
cardiovascular disease; however, other direct evidence for reduction
Editor’s Note: As part of the U.S. Preventive Services Task
Force’s (USPSTF) ongoing commitment to clarity about its
work and methods, the USPSTF is inviting public comment
on all draft recommendation statements. The USPSTF’s draft
recommendation statement on behavioral counseling to promote physical activity and a healthful diet to prevent cardiovascular disease will soon be available for public comment at
www.uspreventiveservicestaskforce.org/. As a result, the recommendation on behavioral counseling to promote physical
activity and a healthful diet to prevent cardiovascular disease
does not appear with this accompanying background review.
Once finalized, the recommendation statement will reflect any
changes made based on the public comments received. A summary of these changes will be included in a new section of the
final recommendation statement.
See also:
Web-Only
Appendix Figure
Conversion of graphics into slides
736 © 2010 American College of Physicians
in disease morbidity is lacking. High-intensity dietary counseling,
with or without physical activity counseling, resulted in changes of
⫺0.3 to ⫺0.7 kg/m2 in body mass index (adiposity), ⫺1.5 mm Hg
(95% CI, ⫺0.9 to ⫺2.1 mm Hg) in systolic blood pressure, ⫺0.7
mm Hg (CI, ⫺0.6 to ⫺0.9 mm Hg) in diastolic pressure, ⫺0.17
mmol/L (CI, ⫺0.09 to ⫺0.25 mmol/L) (⫺6.56 mg/dL [CI, ⫺3.47
to ⫺9.65 mg/dL]) in total cholesterol level, and ⫺0.13 mmol/L (CI,
⫺0.06 to ⫺0.21 mmol/L) (⫺5.02 mg/dL [CI, ⫺2.32 to ⫺8.11
mg/dL]) in low-density lipoprotein cholesterol level. Medium- and
high-intensity counseling resulted in moderate to large changes in
self-reported dietary and physical activity behaviors.
Limitations: Meta-analyses for some outcomes had large statistical
heterogeneity or evidence for publication bias. Only 11 trials followed outcomes beyond 12 months.
Conclusion: Counseling to improve diet or increase physical activity
changed health behaviors and was associated with small improvements in adiposity, blood pressure, and lipid levels.
Primary Funding Source: Agency for Healthcare Research and
Quality.
Ann Intern Med. 2010;153:736-750.
For author affiliations, see end of text.
D
www.annals.org
iseases associated with physical inactivity and poor
diet rank among the leading causes of illness and
death in the United States (1, 2) and are well-established
determinants in many chronic diseases, including cardiovascular and cerebrovascular disease, hypertension, dyslipidemia, and type 2 diabetes (1, 3–5). Although persons of
all ages benefit from regular exercise (5), Americans generally do not meet recommended levels of physical activity
(6, 7). Americans’ diets are also drastically out of line with
the generally accepted dietary recommendations published
by many organizations, such as the U.S. Department of
Health and Human Services (8, 9).
In 2002 and 2003, the USPSTF concluded that evidence was insufficient to recommend for or against behavioral counseling in primary care settings to promote physical activity (I recommendation) or behavioral counseling
to promote a healthful diet in unselected patients in primary care (I recommendation). We therefore performed
this review to assist in the updating of these recommendations. This review combines counseling for both physical
activity and dietary change with a focus on the prevention
of cardiovascular disease in adults without known diabetes,
hypertension, dyslipidemia, or coronary heart disease. To
conduct this review, we developed an analytic framework
Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
with 4 key questions (Appendix Figure, available at www
.annals.org) that included the effect of dietary or physical
activity counseling on health outcomes (key question 1),
intermediate cardiovascular disease–related outcomes (key
question 2), behavioral outcomes (key question 3), and
harms of the counseling interventions (key question 4).
METHODS
The full report (10) provides a detailed description of
our methods, including search strategies and excluded
studies.
Data Sources and Searches
To identify literature published for each key question
since the previous recommendations, we searched MEDLINE, PsycINFO, and the Cochrane Central Register of
Controlled Trials from January 2001 to January 2010. We
supplemented our searches with suggestions from experts and
reference lists from other relevant publications, including the
2 previous USPSTF systematic reviews and 9 related existing
reviews (11–21).
Study Selection
Two investigators independently reviewed 13 562 abstracts and 481 articles against the specified inclusion criteria (Figure). We included trials with primary care–
relevant counseling on physical activity (for example, aerobic
activities, such as walking, cycling, or swimming, or resistance training) or healthful diet interventions (for example,
appropriate calorie intake; increased intake of fruits and
vegetables, whole grains, and fiber; balanced intake of fats;
or decreased sodium). We excluded interventions primarily
aimed at weight loss or those that provided controlled diets
or supervised physical activity. Primary care–relevant counseling included interventions that were conducted in,
judged feasible to be conducted in (such as phone or electronic interventions), or potentially referable from a primary care setting. Interventions had to be compared with
usual care, a minimal intervention, or an attention-control
group. We excluded interventions that targeted persons
with known hypertension, hyperlipidemia, diabetes, or cardiovascular disease and trials in which more than 50% of
the population had known heart disease or any one or a
combination of these risk factors. We required a minimum
follow-up of 6 months after randomization. A priori outcomes included true health outcomes (morbidity or mortality related to cardiovascular disease); intermediate outcomes and physiologic changes associated with health
outcomes (blood pressure, lipid profile, fasting glucose
level and glucose tolerance, and adiposity); and behavioral
outcomes (any self-reported change in physical activity or
dietary intake). We did not include cost-effectiveness or
cost-related outcomes. For harms, we included any observational studies that reported serious cardiovascular harms,
such as acute cardiac events during or immediately after
physical activity.
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Clinical Guideline
Data Extraction and Quality Assessment
Articles that met our inclusion criteria were critically
appraised by 2 reviewers using the USPSTF and National
Institute for Health and Clinical Excellence design-specific
quality criteria (22). The reviewers were each blinded to
the other’s initial ratings, and discrepancies were resolved
by consensus. Articles were rated as good, fair, or poor
quality. Good-quality studies met all of the specified
quality criteria, whereas fair-quality studies did not but
had no fatal flaws in the design, execution, or reporting
of the study. Poor-quality studies were excluded from
this review.
For included studies, 1 investigator extracted data on
study setting, populations, interventions, and prespecified
outcomes into standardized evidence tables and a second
investigator verified all extracted data.
Data Synthesis and Analysis
We conducted random-effects meta-analyses to estimate the effect size of counseling on all intermediate health
outcomes and behavioral outcomes. We combined all trials
with a given outcome and conducted separate analyses for
each of the 3 intervention targets (physical activity, healthful diet, and combined) and, if applicable, for the specific
dietary message (sodium reduction, focus on fruits and
vegetables only, or general low-fat or heart-healthy dietary
counseling). Analyses were stratified by estimated intervention intensity (low [ⱕ30 minutes], medium [between 31
minutes and 6 hours of contact], or high [⬎6 hours of
contact]). Trials were also categorized by population risk as
being unselected or selected only on the basis of age; selected for suboptimal behavior (such as sedentary behavior
or poor dietary intake); or selected for individual or population risk factors for increased incidence of cardiovascular
disease (such as mildly elevated diastolic blood pressure or
fasting glucose or serum lipid levels, obesity, or poverty or
poor access to health care).
We assessed the presence of statistical heterogeneity
among the studies by using standard chi-square tests and
estimated the magnitude of heterogeneity by using the I2
statistic (23). Tests of publication bias to determine
whether the distribution of the effect sizes was symmetric
with respect to the precision measure were performed by
using funnel plots and the Egger linear regression method
(24, 25). Meta-regressions were performed on the basis of
the random-effects models to examine the effect of 4 a
priori variables of heterogeneity (intervention intensity, intervention target, study population risk, and recruitment
method [volunteer vs. study-identified]) on effect size. To
interpret effect sizes of standardized mean differences, we
used the Cohen d statistic, in which an effect size of 0.2 to
0.3 generally represents a small effect; 0.5, a moderate effect; and 0.8, a large effect (26).
All analyses were performed by using Stata, version
10.0 (StataCorp, College Station, Texas).
7 December 2010 Annals of Internal Medicine Volume 153 • Number 11 737
Clinical Guideline Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
Figure. Summary of evidence search and selection.
Identification
Records identified
by database
searches
(n = 15 490)
Additional records
identified with
other searches
(n = 643)
Duplicates
removed
(n = 2571)
Screening
Records screened
(n = 13 562)
Excluded
(n = 13 088)
Inclusion
Eligibility
Full-text articles assessed for
eligibility (n = 481)
Excluded (n = 379)*
Relevance: 18
Setting: 6
Population: 100
Outcomes: 35
Interventions: 98
Design: 104
Quality: 46
Healthful diet
Physical activity
Combined lifestyle
Included studies (n = 25
[40 articles])†
KQ 1 (health): 3
KQ 2 (intermediate): 16
KQ 3 (behavioral): 25
KQ 4 (harms): 0‡
Included studies (n = 37
[52 articles])†
KQ 1 (health): 0
KQ 2 (intermediate): 8
KQ 3 (behavioral): 30
KQ 4 (harms): 7‡
Included studies (n = 17
[26 articles])†
KQ 1 (health): 0
KQ 2 (intermediate): 14
KQ 3 (behavioral): 17
KQ 4 (harms): 0‡
Included in quantitative
synthesis (n = 37)
KQ 2 (intermediate): 15
KQ 3 (behavioral): 22
Included in quantitative
synthesis (n = 35)
KQ 2 (intermediate): 9
KQ 3 (behavioral): 26
Included in quantitative
synthesis (n = 28)
KQ 2 (intermediate): 13
KQ 3 (behavioral): 15
KQ ⫽ key question.
* We excluded 28 articles for different reasons in different areas; 7 were excluded for 1 area and included for another.
† We included 8 studies in more than 1 area.
‡ Additional studies identified for harms (not including trials included for KQs 1 to 3).
Role of the Funding Source
We worked with 4 USPSTF liaisons at key points
throughout the review process to develop and refine the
scope and resolve other issues. The Agency for Healthcare
Research and Quality funded this research under a contract
to support the USPSTF. The funding source had no role
in study selection, quality assessment, or synthesis, although they provided project oversight, reviewed the draft
738 7 December 2010 Annals of Internal Medicine Volume 153 • Number 11
evidence synthesis, and assisted in external review of the
draft evidence synthesis.
RESULTS
We identified 66 trials that reported the effects of
counseling for physical activity, healthful diet, or both.
Thirty trials (27–71), comprising 15 265 patients, tested
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Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
the effect of counseling persons to increase physical activity, and 26 of these (14 172 patients) were included in our
meta-analyses (27–29, 31, 33, 35–37, 42, 45, 47, 48, 50,
51, 53–57, 59, 61, 63– 65, 67, 69, 70). Twenty-five trials
(29, 30, 37, 38, 42, 43, 48, 72–103), comprising 71 267
patients, tested the effect of counseling persons to eat a
healthful diet; 24 of these studies (70 969 patients) were
included in our meta-analyses (37, 42, 48, 72–78, 81, 82,
85–93, 96, 99, 103). Seventeen trials (42– 44, 76, 104 –
125), comprising 5105 patients, examined the effects of
counseling persons for both physical activity and healthful
diet; we included 15 of these (4475 patients) in our metaanalyses (42, 76, 104, 106, 108, 111, 113–118, 121, 124,
125). Some trials were not included in our meta-analyses
because they did not provide necessary data; for example,
some reported results only in figures without providing
group means and others did not provide SEs or SDs. In
addition, we identified 7 studies (126 –132), comprising
4354 patients, that addressed the harms of physical activity. The tables in the Supplement (available at www.annals
.org) provide study details for counseling trials.
Of the 66 counseling trials, only 13 were good-quality
trials (31, 45, 53–55, 57, 59, 82, 96, 99, 116, 118, 125).
Fair-quality trials often did not report randomization procedures, allocation concealment, or blinding of outcomes
assessment. Many fair-quality trials also limited analyses to
persons who completed the study. Some trials did not have
allocation concealment of randomization or blinded outcome assessment. Some fair-quality trials, as opposed to
good-quality trials, had higher attrition (for example,
⬎20%), differential attrition, or differences in baseline
characteristics between groups. Most trials, including the
good-quality ones, did not report fidelity of or adherence
to counseling interventions.
Trials included a representative range of persons. Men
accounted for approximately 17% of all trial participants,
or about 35% of trial participants excluding the largest trial
that enrolled only women (99). Eleven trials included only
women (48, 54, 61, 69, 70, 78, 92, 99, 115, 118, 121),
and 5 trials included only men (42, 59, 64, 65, 103). Trials
were primarily conducted in middle-aged adults (weighted
mean age, 59 years [range, 20 to 78 years]). Nine trials (37,
39, 45, 53, 59, 64, 66, 75, 87) were explicitly conducted in
older adults, and most of these trials involved only physical
activity counseling (37, 39, 45, 53, 59, 64, 66). Among the
38 trials conducted in the United States, approximately
18% of participants were nonwhite (range in individual
trials, 3% to 100%).
Counseling interventions ranged from low-intensity
(such as those conducted in a single session or by mail
alone) to very high-intensity (such as those with up to 20
sessions over 2 years). Trials were not evenly distributed
across categories of study population risk (Table 1).
Among diet counseling trials, low-intensity interventions were almost all conducted in general-risk persons and
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Clinical Guideline
medium- to high-intensity interventions were mostly conducted in selected persons. In contrast, almost all of the
physical activity counseling trials were conducted in persons who did not meet recommended levels of physical
activity, and only 1 counseling intervention was highintensity. The combined lifestyle counseling interventions
showed a very different distribution, in that mediumintensity trials tended to target patients selected for risk
factors related to cardiovascular disease, whereas highintensity trials primarily involved unselected populations.
Key Question 1: Health Outcomes
Data on the morbidity or mortality related to cardiovascular disease were limited to 3 large, good-quality trials
(Table 2). In the Women’s Health Initiative Dietary Modification Trial (48 835 participants), postmenopausal
women who were randomly assigned to intensive low-fat
dietary counseling had no difference in major coronary
heart disease events (hazard ratio [HR], 0.97 [95% CI,
0.90 to 1.06]), stroke (HR, 1.02 [CI, 0.90 to 1.15], or
death (HR, 0.98 [CI, 0.91 to 1.07]) after approximately
8.1 years of follow-up (100, 101). Long-term observational
follow-up of TOHP (Trials of Hypertension Prevention) I
and II (3126 participants) showed that persons with mildly
elevated diastolic blood pressure (80 to 89 mm Hg) who
were randomly assigned to intensive sodium restriction
counseling had fewer cardiovascular events and revascularization (2415 participants; HR, 0.70 [CI, 0.53 to 0.94]),
but no difference in total mortality (3126 participants;
HR, 0.80 [CI, 0.51 to 1.26]) after 10 to 15 years of
follow-up (134). A more conservative cardiovascular disease composite outcome (without revascularization) was
not statistically significant, although the point estimate was
similar (2415 participants; HR, 0.72 [CI, 0.50 to 1.03]).
Visual inspection of cumulative incidence curves of cardiovascular disease events in TOHP I and II suggests that the
intervention and control groups began to diverge at approximately 8 to 9 years of follow-up.
Key Question 2: Intermediate Outcomes
Medium- to high-intensity dietary interventions (with
or without concomitant physical activity counseling) decreased body mass index at about 12 months. Statistical
heterogeneity was high (I2 ⬎ 70%), making interpretation
of pooled effect sizes questionable (Table 3). Two thirds of
the trials of high-intensity dietary interventions, however,
reported statistically significant group differences, suggesting that although the amount of weight change varied
greatly from study to study, these interventions are likely to
reduce weight (decrease in body mass index of approximately 0.3 to 0.7 kg/m2). Physical activity counseling trials
were limited to primarily medium-intensity interventions
for this outcome and generally did not reduce adiposity.
Five trials evaluating high-intensity counseling had
follow-up longer than 12 months; the reduction in body
mass index persisted up to 72 months, although this result
was slightly attenuated (99, 113, 117, 118, 121).
7 December 2010 Annals of Internal Medicine Volume 153 • Number 11 739
Clinical Guideline Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
Table 1. Counseling Trials, by Intervention Intensity and Population Risk
Intervention Intensity and PCP Role
Low-intensity intervention (estimated 0–30 min)
Substantial PCP role in intervention
No PCP role in intervention
Conducted in or recruited from primary care or
health plan
Not conducted in or recruited from primary care or
health plan
Medium-intensity intervention (estimated 31–360 min)
PCP role in intervention
No PCP role in intervention
Conducted in or recruited from primary care or
health plan
Not conducted in or recruited from primary care or
health plan
High-intensity intervention (estimated >360 min)
No PCP role in intervention
Conducted in or recruited from primary care or
health plan
Not conducted in or recruited from primary care or
health plan
Unselected Population
Population Selected for
Suboptimal Diet or Exercise
Behavior
Beresford et al, 1997 (74)*
Sacerdote et al, 2006 (90)*
Katz et al, 2008 (47)†
Aittasalo et al, 2006 (27)†
Goldstein et al, 1999 (33)†
Grandes et al, 2009 (35)†
Carpenter et al, 2004 (77)*
Fries et al, 2005 (81)*
John et al, 2002 (85)*
Kristal et al, 2000 (86)*
Lutz et al, 1999 (87)*
Roderick et al, 1997 (89)*
De Vet et al, 2009 (28)†
Stensel et al, 1994 (65)†
Jeffery and French, 1999 (114)‡
Prochaska et al, 2005 (88)*
Halbert et al, 2000 (39)†
Population Selected for
Increased Cardiovascular Risk
Marcus et al, 2007 (55)†
Marshall et al, 2003 (56)†
Napolitano et al, 2006 (61)†
Pekmezi et al, 2009 (70)†
Baron et al, 1990 (73)*
Green et al, 2002 (36)†
Norris et al, 2000 (63)†
Elley et al, 2003 (31)†
Lawton et al, 2008 (54)†
Pinto et al, 2005 (64)†
Kallings et al, 2009 (45)†
Morey et al, 2009 (59)†
Delichatsios et al,
2001 (29)*†
Harland et al, 1999 (41)†
Kinmonth et al, 2008 (51)†
Kolt et al, 2007 (53)†
Connell and Janevic, 2009 (69)†
Martinson et al, 2008 (57)†
Franko et al, 2008 (110)‡
Vandelanotte et al, 2005 (124)‡
Greene et al, 2008 (37)*†
Bernstein et al, 2002 (75)*
King et al, 2002 (48)*†
King et al, 2007 (50)†
Marcus et al, 2007 (55)†
Hellénius et al, 1993 (42)*†‡
Stevens et al, 2003 (92)*
Yates et al, 2009 (133)†
Babazono et al, 2007 (106)‡
Eakin et al, 2007 (108)‡
Hardcastle et al, 2008 (111)‡
Keyserling et al, 2008 (115)‡
Mosca et al, 2008 (116)‡
Wister et al, 2007 (125)‡
Brekke et al, 2005 (76)*‡
Watanabe et al, 2003 (103)*
Stewart et al, 2001 (66)†
Carpenter et al, 2004 (77)*
Aldana et al, 2006 (104)‡
Hivert et al, 2007 (113)‡
Simkin-Silverman et al,
1995 (119)‡
Thompson et al, 2008 (121)‡
Coates et al, 1999 (78)*
Tinker et al, 2008 (99)*
Edelman et al, 2006 (109)‡
Oldroyd et al, 2001 (117)‡
Shah et al, 1990 (83)*
TOHP, phase I, 1992 (93)*
TOHP, phase II, 1997 (96)*
Stefanick et al, 1998 (91)*
Anderson et al, 1992 (72)*
PCP ⫽ primary care provider; TOHP ⫽ Trials of Hypertension Prevention.
* Healthful diet counseling.
† Physical activity counseling.
‡ Combined healthful diet and physical activity counseling.
High-intensity diet and lifestyle interventions decreased systolic and diastolic blood pressure by 1.5 mm Hg
(CI, 0.9 to 2.1 mm Hg) (78, 82, 91, 93, 96, 99, 104, 118,
121) and 0.7 mm Hg (CI, 0.6 to 0.9 mm Hg) (78, 82, 91,
93, 96, 99, 104, 117, 118, 121), respectively, at 12 months
(Table 3). The largest reduction in blood pressures occurred in 3 intensive salt-restriction counseling interventions in persons with mildly elevated diastolic blood pressure, resulting in a change of approximately ⫺1.9 mm Hg
(CI, ⫺1.2 to ⫺2.5 mm Hg) in systolic blood pressure and
⫺1.0 mm Hg (CI, ⫺0.5 to ⫺1.6 mm Hg) in diastolic
740 7 December 2010 Annals of Internal Medicine Volume 153 • Number 11
blood pressure at 12 months (Table 3) (82, 93, 96). Reductions in blood pressure were still statistically significant,
although slightly attenuated, at up to 36 months (82,
93, 96). Four other trials reported follow-up beyond 12
months, but none showed a statistically significant reduction by the end of the trials (99, 113, 118, 121).
Meta-analyses of 6 trials showed that medium-intensity
physical activity interventions did not improve blood
pressure.
High-intensity trials targeting diet and combined lifestyle counseling decreased total and low-density lipoprotein
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Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
Clinical Guideline
Table 2. Summary of Evidence
Key Question
Studies and
Participants
Design
Overall Quality
Consistency
Applicability
1. Do primary care–relevant behavioral counseling interventions for physical activity or healthful diet reduce CVD in adults?
3 studies, 51 961 RCT
Fair; only 3 HD trials, all of Fair; trials evaluated Fair; largest trial in
participants
good quality; 2 trials
different interpostmenopausal
with observational
ventions in differwomen; 2 trials
follow-up after trials
ent populations
in prehyperwere completed
tension
Summary of Findings
In WHI, high-intensity general
low-fat counseling did not
significantly decrease major
CVD events at 8.1 y.
Observational follow-up of
TOHP I and II showed that
high-intensity sodium reduction
counseling in prehypertensive
patients decreased CVD events
and revascularization at 10 to
15 y.
2. Do primary care–relevant behavioral counseling interventions for physical activity or healthful diet improve intermediate outcomes (e.g., adiposity, blood
pressure, lipids) in adults?
Evidence for
PA only: 8
RCT
Fair; intermediate
Good
Fair; only 1 trial
Sparsely reported findings. Pooled
physical
studies, 3731
outcomes not commonly
conducted in
estimates showed that mostly
activity
participants
reported; limited
the United
medium-intensity counseling
counseling
evidence beyond 12 mo
States
did not improve adiposity,
alone
blood pressure, or lipid levels.
Two trials showed statistically
significant group differences in
adiposity, blood pressure, or
lipid levels; however, the
remaining trials did not.
Fair; HD and CL
Good
High-intensity counseling for
Evidence for
HD only: 16
RCT
Fair; very high I2 value for
adiposity meta-analyses;
trials were not
healthful diet resulted in
healthful
studies, 58 557
limited evidence beyond
distributed
statistically significant
diet
participants
12 mo
consistently by
reductions in adiposity, blood
counseCL: 14 studies,
intervention
pressure, and total and LDL
ling, with
3855 particiintensity and
cholesterol. Body mass index
or without
pants
population risk
was reduced by approximately
physical
0.3 to 0.7 kg/m2. Systolic and
activity
diastolic blood pressure were
counseling
reduced by 1.5 and 0.7 mm
Hg. Total and LDL cholesterol
were reduced by 0.17 and 0.13
mmol/L (6.56 and 5.02
mg/dL). No statistically
significant changes were seen
for HDL cholesterol or
triglycerides.
3. Do primary care–relevant behavioral counseling interventions for physical activity or healthful diet change associated health behaviors in adults?
Evidence for
PA only: 30
RCT
Fair; wide variety in
Fair; PA and CL
Good; most trials
Medium- to high-intensity
change in
studies, 15 265
measurement of physical
trials were not
conducted in
interventions improved
physical
participants
activity; mostly
distributed
persons selected
self-reported measures of
activity
CL: 15 studies,
self-reported measures;
consistently by
for sedentary
physical activity by
4975 participositive Egger result;
intervention
behavior or
approximately 38 min/wk. This
pants
limited evidence beyond
intensity and
some increased
modest increase meant that
12 mo
population risk
risk for CVD
most persons exercised for at
least 1 h/wk. Results for the
effectiveness of low-intensity
counseling were mixed.
Although the pooled estimate
was not statistically significant,
4 trials (2 of which were not in
the meta-analysis) showed
statistically significant
improvements in self-reported
activity levels.
Continued on following page
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7 December 2010 Annals of Internal Medicine Volume 153 • Number 11 741
Clinical Guideline Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
Table 2—Continued
Key Question
Studies and
Participants
Design
Overall Quality
Consistency
Applicability
Summary of Findings
Evidence for
change in
dietary
intake
HD only: 25
studies, 71 267
participants
CL: 16 studies,
4951 participants
RCT
Fair; high I2 value for all
dietary intake metaanalyses; mostly selfreported measures;
positive Egger result for
total fat dietary intake;
limited evidence beyond
12 mo
Fair; HD and CL
trials were not
distributed
consistently by
intervention
intensity and
population risk
Good
High-intensity counseling resulted
in moderate to large reductions
in self-reported fat intake, a
5.9% to 11% decrease in
energy from total fat, and a
2.8% to 3.7% decrease in
energy from saturated fat.
Low- to medium-intensity
interventions resulted in smaller
changes. Low- to high-intensity
counseling yielded moderate to
large increases in fruit and
vegetable intake ranging from
about 0.4 to 2 servings/d.
4. What are the adverse effects of primary care–relevant behavioral counseling interventions for physical activity or healthful diet in adults?
Evidence for
Trials: 2 studies,
RCT (caseFair; adverse events rarely
Good
Fair; observational
In 2 trials, almost 25% of
harms of
483 particicrossover)
reported in trials;
studies often
participants reported mild
physical
pants
case-crossover design;
limited to
muscular fatigue, strain, or
activity or
Observational
difficult to measure
nonfatal cases;
soreness. In observational
counseling
studies: 7
habitual PA; only 1
most case
studies, risk for serious cardiac
to improve
studies, 4354
study reported absolute
patients were
events was increased during
physical
cases
risk for cardiac event
men
vigorous physical activity. This
activity
during vigorous physical
increased risk was much greater
activity
in people with low levels of
habitual physical activity.
However, the absolute risk for a
cardiac event is very small.
Evidence for
HD only: 25
RCT
Fair; explicit adverse events Good
Good
No specific examination of
harms of
studies, 71 267
not reported in trials
adverse effects; however, 2
healthful
participants
trials showed an increased
diet or
CL: 16 studies,
intake of carbohydrates with no
counseling
4951 particiincrease in overall energy
to improve
pants
intake. Overall, few trials
diet
reported dietary intake of
monounsaturated or
polyunsaturated fats,
carbohydrates, or sugars.
CL ⫽ combined lifestyle counseling; CVD ⫽ cardiovascular disease; HD ⫽ healthful diet counseling; HDL ⫽ high-density lipoprotein; LDL ⫽ low-density lipoprotein;
PA ⫽ physical activity counseling; RCT ⫽ randomized, controlled trial; TOHP ⫽ Trials of Hypertension Prevention; WHI ⫽ Women’s Health Initiative.
cholesterol levels; changes were ⫺0.17 mmol/L (CI, ⫺0.09
to ⫺0.25) (⫺6.56 mg/dL [CI, ⫺3.47 to ⫺9.65 mg/dL])
and ⫺0.13 mmol/L (CI, ⫺0.06 to ⫺0.21) (⫺5.02 mg/dL
[CI, ⫺2.32 to ⫺8.11 mg/dL]), respectively (Table 3) (72,
91, 104, 117, 118, 121). Of the 3 trials that reported
follow-up beyond 12 months, 2 trials conducted exclusively in women demonstrated a persistent decrease in total
cholesterol or low-density lipoprotein cholesterol levels at
18 or 54 months (118). There was no statistically significant increase in high-density lipoprotein cholesterol levels.
Medium-intensity trials did not improve lipid levels on
average. Very few trials that targeted physical activity alone
reported lipid levels.
We found no evidence of statistically significant publication bias for any of the intermediate outcomes, on the
basis of the Egger test and visual inspection of funnel plots.
Trials that focused on physical activity– only counseling
did not often report measures of adiposity, blood pressure,
or lipids (8 studies; 3731 participants).
742 7 December 2010 Annals of Internal Medicine Volume 153 • Number 11
Key Question 3: Behavioral Outcomes
In general, counseling resulted in small increases in
participants’ physical activity levels, especially in trials
that provided at least medium-intensity interventions.
Twenty-four (27–29, 31, 33, 35–37, 42, 47, 48, 50, 51,
53–55, 57, 59, 61, 63, 64, 69, 70, 133) of the 30 trials
of physical activity interventions (12 938 participants)
and 13 (42, 104, 106, 108, 111, 113–116, 118, 121,
124, 125) of the 17 combined lifestyle trials (4150 participants) were included in the meta-analyses of physical
activity level. Pooled standardized mean differences for
medium- and high-intensity interventions at approximately 12 months were 0.18 (CI, 0.12 to 0.24) and
0.26 (CI, 0.14 to 0.37), respectively (Table 4). These
pooled estimates represent small changes in physical activity levels: for example, an increase in physical activity
level by 38.3 min/wk (CI, 25.9 to 50.7 min/wk) (Table
4). Longer-term follow-up was very rare, but changes in
activity level were maintained in 1 trial of mediumwww.annals.org
Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
intensity physical activity (71) and 1 trial of highintensity physical activity plus lifestyle counseling that
reported follow-up beyond 12 months (118). The data
for low-intensity interventions were mixed. Although
the meta-analysis of the trials of low-intensity physical
activity showed no overall effect, 4 of the 11 trials of
low-intensity interventions increased some measure of
physical activity (35, 39, 55, 65); 2 of these 4 trials were
not included in the meta-analysis because of limitations
in reporting of outcomes at the individual study level.
Only 1 of the combined lifestyle trials with this outcome involved a low-intensity intervention, and it
showed no effect (114). The Egger test of small study
effects was statistically significant for the mediumintensity trials; however, sensitivity analyses without the
smallest trials showed similar results.
Meta-analyses showed statistically significant reductions in self-reported total fat intake at all levels of intervention intensity; however, statistical heterogeneity
was high (I2 ⬎ 70%) (Table 4). For high-intensity tri-
Clinical Guideline
als, 7 of 10 trials showed statistically significant reductions in total fat, suggesting a robust finding of group
differences. High-intensity counseling resulted in moderate to large reductions in self-reported fat intake,
ranging from a 5.9% to 11% decrease in energy from
total fat and a 2.8% to 3.7% decrease in energy from
saturated fat (72, 78, 91, 99, 104, 117, 118). Four trials
had longer-term follow-up (up to 72 months), during
which reductions in total fat and saturated fat were still
significant (99, 117, 118, 121). Low- and mediumintensity interventions resulted in smaller reductions in
fat intake (42, 48, 74 –77, 81, 86, 89, 92, 111, 114,
116, 124). None of the low- or medium-intensity counseling trials had follow-up beyond 12 months.
Healthful dietary counseling increased fruit and
vegetable consumption at all levels of intervention intensity, although statistical heterogeneity was high in
some subgroups (Table 4). Three fair-quality trials of
behavioral counseling interventions focusing on fruit
and vegetable consumption were successful in increasing
Table 3. Pooled Effect Sizes for Intermediate Outcomes
Intervention Target
Low-Intensity Interventions
Medium-Intensity Interventions
2
High-Intensity Interventions
2
Effect Size (95% CI)
Trials,
n
I ,
%
Effect Size (95% CI)
Trials,
n
I ,
%
Effect Size (95% CI)
Trials,
n
I2 ,
%
Adiposity (standardized effect size)
All
Physical activity
Healthful diet (general)
Combined lifestyle
⫺0.10 (⫺0.22 to 0.02)
⫺0.15 (⫺0.66 to 0.36)
⫺0.16 (⫺0.33 to 0.00)
⫺0.04 (⫺0.17 to 0.10)
5*
1
2
1
69.6
–
77.0
–
⫺0.14 (⫺0.27 to ⫺0.01)†
⫺0.09 (⫺0.24 to 0.06)
⫺0.57 (⫺0.93 to ⫺0.21)†
⫺0.34 (⫺0.61 to ⫺0.07)†
12‡
7
2
6
71.2
72.2
0.0
78.1
⫺0.48 (⫺0.64 to ⫺0.32)†
–
⫺0.37 (⫺0.52 to ⫺0.22)†
⫺0.54 (⫺0.82 to ⫺0.25)†
9
0
4
5
89.8
–
85.4
80.9
Systolic blood pressure, mm Hg
All
Physical activity
Healthful diet (low-salt)
Healthful diet (general)
Combined lifestyle
⫺1.2 (⫺3.3 to 1.0)
–
–
0.1 (⫺0.8 to 1.0)
–
3*
0
0
2
0
79.5
–
–
0.0
–
⫺0.5 (⫺1.8 to 0.8)
⫺0.57 (⫺1.9 to 0.7)
–
⫺6.0 (⫺11.0 to ⫺1.0)†
⫺0.8 (⫺3.0 to 1.5)
13
6
0
1
6
46.5
14.0
–
–
59.4
⫺1.5 (⫺2.1 to ⫺0.9)†
–
⫺1.9 (⫺2.5 to ⫺1.2)†
⫺1.0 (⫺1.6 to ⫺0.3)†
⫺1.9 (⫺3.2 to ⫺0.5)†
10
0
3
3
4
49.0
–
0.0
26.0
2.7
Diastolic blood pressure, mm Hg
All
Physical activity
Healthful diet (low-salt)
Healthful diet (general)
Combined lifestyle
⫺0.5 (⫺1.2 to 0.2)
–
–
⫺0.2 (⫺0.9 to 0.6)
–
3
0
0
2
0
7.3
–
–
0.0
–
⫺0.3 (⫺1.4 to 0.8)
⫺0.5 (⫺1.9 to 0.8)
–
⫺5.0 (⫺7.8 to ⫺2.2)†
⫺0.3 (⫺2.3 to 1.7)
9‡
5
0
1
5
63.2
58.5
–
–
71.9
⫺0.7 (⫺0.9 to ⫺0.6)†
–
⫺1.0 (⫺1.6 to ⫺0.5)†
⫺0.7 (⫺0.8 to ⫺0.6)†
⫺1.1 (⫺2.4 to 0.2)
10
0
3
3
4
0.0
–
0.0
0.0
36.5
Total cholesterol level, mmol/L§
All
Physical activity
Healthful diet (general)
Combined lifestyle
0.02 (⫺0.09 to 0.13)
–
–
–
1
0
0
0
–
–
–
–
⫺0.04 (⫺0.11 to 0.02)
⫺0.05 (⫺0.13 to 0.04)
⫺0.05 (⫺0.11 to 0.01)
⫺0.05 (⫺0.20 to 0.10)
14‡
6
4
7
44.6
23.9
0.0
64.5
⫺0.17 (⫺0.25 to ⫺0.09)†
–
⫺0.23 (⫺0.35 to ⫺0.11)†
⫺0.13 (⫺0.25 to 0.00)
6
0
2
4
30.9
–
0.0
50.0
Low-density lipoprotein cholesterol
level, mmol/L§
All
Physical activity
Healthful diet (general)
Combined lifestyle
–
–
–
–
0
0
0
0
–
–
–
–
⫺0.01 (⫺0.10 to 0.08)
⫺0.02 (⫺0.18 to 0.14)
⫺0.08 (⫺0.23 to 0.07)
0.00 (⫺0.13 to 0.12)
9‡
3
3
6
34.4
31.2
20.3
46.5
⫺0.13 (⫺0.21 to ⫺0.06)†
–
⫺0.19 (⫺0.31 to ⫺0.08)†
⫺0.10 (⫺0.20 to 0.00)
6
0
2
4
32.1
–
11.7
38.1
* Includes an additional trial of healthful diet counseling that targeted fruit and vegetable intake (not shown separately).
† P ⱕ 0.05.
‡ Total number of trials is fewer than the sum of the subgroups because some trials had multiple groups with different intervention targets and are therefore included in
multiple subgroups.
§ To convert mmol/L to mg/dL, divide by 0.0259.
www.annals.org
7 December 2010 Annals of Internal Medicine Volume 153 • Number 11 743
Clinical Guideline Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
Table 4. Pooled Effect Sizes of Behavioral Outcomes
Intervention Target
Low-Intensity Interventions
Effect Size (95% CI)
Medium-Intensity Interventions
2
Trials,
n
I ,
%
Effect Size (95% CI)
High-Intensity Interventions
2
Trials,
n
I ,
%
Effect Size (95% CI)
Trials,
n
I 2,
%
Self-reported physical
activity,
standardized
All
Physical activity
Combined lifestyle
0.07 (0.0 to 0.15)*
0.08 (⫺0.01 to 0.18)
0.06 (⫺0.08 to 0.19)
9
8
1
32.2
40.7
–
0.18 (0.12 to 0.24)*
0.19 (0.12 to 0.27)*
0.20 (0.08 to 0.33)*
24†
17
8
41.9
49.9
45.7
0.26 (0.14 to 0.37)*
–
0.26 (0.14 to 0.37)*
4
0
4
0.0
–
0.0
Self-reported physical
activity in the
subset reporting
min/wk, min/wk
All
Physical activity
Combined lifestyle
33.6 (1.7 to 65.6)*
33.6 (1.7 to 65.6)*
–
6
6
0
38.6
38.6
–
40.9 (19.5 to 62.3)*
38.3 (25.9 to 50.7)*
50.4 (⫺23.9 to 124.6)
12
9
3
78.7
0.0
82.4
51.5 (⫺62.6 to 165.8)
–
51.5 (⫺62.6 to 165.8)
1
0
1
–
–
–
⫺0.23 (⫺0.29 to ⫺0.18)*
⫺0.25 (⫺0.31 to ⫺0.19)*
6
5
0.0
0.0
⫺0.28 (⫺0.61 to 0.04)*
⫺0.46 (⫺0.81 to ⫺0.11)*
8†
5
91.5
73.3
⫺0.81 (⫺1.13 to ⫺0.50)*
⫺1.05 (⫺1.36 to ⫺0.74)*
10
5
97.5
96.3
⫺0.15 (⫺0.29 to ⫺0.01)*
1
–
⫺0.24 (⫺0.65 to 0.16)
5
91.7
⫺0.61 (⫺1.11 to ⫺0.11)*
5
93.6
0.34 (0.17 to 0.52)*
0.60 (0.08 to 1.11)*
6
2
92.2
93.8
0.36 (0.10 to 0.62)*
0.36 (0.22 to 0.50)*
6
1
88.0
–
0.57 (0.33 to 0.81)*
–
5
0
94.9
–
0.19 (0.14 to 0.23)*
4
0.0
0.65 (0.38 to 0.92)*
3
44.0
0.68 (0.37 to 0.99)*
3
96.8
–
0
–
0.00 (⫺0.14 to 0.14)
2
0.0
0.40 (⫺0.16 to 0.96)
2
90.0
Self-reported fat intake,
standardized
All
Healthful
diet (general)
Combined lifestyle
Self-reported fruit and
vegetable intake,
standardized
All
Healthful diet (fruit
and vegetable
intake)
Healthful
diet (general)
Combined lifestyle
* P ⱕ 0.05.
† Total number of trials is fewer than the sum of the subgroups because some trials had multiple groups with different intervention targets and therefore are included in
multiple subgroups.
fruit and vegetable intake (37, 85, 87). Meta-analyses of
the low- and medium-intensity general low-fat/hearthealthy counseling trials had low to modest heterogeneity and were statistically significant (48, 75, 77, 86, 88,
90, 92). Although statistical heterogeneity was very large
in the high-intensity trials, intervention group participants showed greater increases in fruit and vegetable
consumption in 4 of the 5 trials (77, 78, 99, 104, 121).
Overall, the mean change in fruit and vegetable intake
ranged from 0.4 to 2 servings per day. Only 2 trials had
follow-up beyond 12 months; these showed a persistent
increase in fruit and vegetable intake at 24 and 72
months (37, 99).
Key Question 4: Harms
Adverse effects were rarely noted in physical activity
counseling trials. Two trials reported minor muscular
symptoms (27, 50), and 3 trials reported falls related to
physical activity (31, 53, 54). We also found 7 casecrossover analyses, which showed that the risk for a cardiac
event is increased 2-fold to 17-fold during vigorous exercise (126 –132). This increased risk was much greater for
people with low baseline levels of regular activity. Never744 7 December 2010 Annals of Internal Medicine Volume 153 • Number 11
theless, the absolute risk for a cardiac event during physical
activity was very low. One of these studies estimated that
the incidence of sudden death associated with vigorous
physical activity was 1 per 1.42 million person-hours of
exercise (126).
We found no studies designed to assess the adverse
effects of dietary counseling or the adverse effects of increasing intake of fruits and vegetables or fiber and decreasing intake of sodium or fat. None of the healthful diet
counseling trials reported specific adverse events.
DISCUSSION
Medium- to high-intensity dietary behavioral counseling, with or without physical activity counseling, resulted in small but statistically significant improvements
in adiposity, blood pressure, and cholesterol level, as
well as moderate to large changes in self-reported dietary
and physical activity behaviors. The evidence for
changes in physiologic outcomes was strongest for highintensity counseling interventions. The reductions in
blood pressure, about 1.5 mm Hg (systolic) and 0.7 mm
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Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
Hg (diastolic), were smaller than those seen in hypertension drug trials and feeding trials (134, 135). However, epidemiologic data suggest that even changes as
small as 2 mm Hg in systolic blood pressure can decrease the risk for coronary heart disease by 6% or
stroke by 16% (136). Direct evidence from observational follow-up of the large hypertension prevention
trials that used sodium reduction counseling suggest
that these small changes in blood pressure can result in
a 30% reduction in cardiovascular disease events and
revascularization in persons with mildly elevated diastolic blood pressure (137). Reductions in cholesterol
level were also small (about 0.17 mmol/L [5.02 mg/dL]
in total cholesterol level). On the basis of randomized,
controlled trials in primary prevention, a sustained reduction of 0.6 mmol/L (23.17 mg/dL) in total serum
cholesterol level—an average decrease of 10%— can reduce coronary heart disease by about 25% (138). However, it is unclear whether smaller reductions in total
cholesterol level due to dietary changes can affect cardiovascular disease.
Medium- to high-intensity physical activity counseling also resulted in small changes in self-reported
physical activity (an increase of about 40 minutes per
week). Evidence suggests that even low-intensity dietary
counseling results in moderate increases in fruit and
vegetable intake (up to 2 servings a day) and small decreases in dietary fat intake (about 1.5% decrease in
energy intake from total fat). Evidence for low-intensity
physical counseling interventions for increasing selfreported physical activity was mixed.
Evidence for maintenance of any behavioral or
physiologic effects beyond 12 months was very limited.
The interventions with significant benefit beyond 12
months were all high-intensity counseling interventions
with group, phone, or mail contact throughout the trial.
Most trials for high-intensity interventions that had
follow-up beyond 12 months showed persistent beneficial changes in adiposity and lipid levels (but not blood
pressure), as well as improvements in self-reported behavioral outcomes.
Intervention intensity was the most important factor for differences in effect size among different trials.
However, the effects of counseling intensity could not
be fully disentangled from the risk among the populations studied. Although trials in populations with
known traditional cardiovascular risk factors or risk
equivalents were excluded, many of the medium- to
high- intensity interventions were conducted in participants selected for suboptimal lifestyle behaviors or factors associated with increased cardiovascular disease
(Table 2). In multivariate meta-regression, both intervention intensity and risk in the population predicted
larger effects. In addition, some participant populations
were volunteers. Exploratory meta-regressions suggested
that use of volunteer participants was also predictive of
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Clinical Guideline
larger effect sizes, although in multivariate analyses this
was significant only for dietary fat intake. Almost all of
the effective medium- to high-intensity interventions
were delivered by specially trained health educators or
nurses, counselors or psychologists, dietitians or nutritionists, or exercise instructors or physiologists; very few
involved the primary care provider (Table 2). Many of
the high-intensity interventions used 12 or more sessions and therefore required resources that may not
be available or paid for in the current health care system
(in addition to raising issues of real-world patient
adherence).
No increase in serious injuries occurred from physical activity or unintended adverse changes in dietary
intake, on the basis of available counseling trials (Table
3). Two trials reported a paradoxical increase in carbohydrate intake but not overall caloric intake. The clinical significance of these dietary changes is unclear. In
the Women’s Health Initiative, the replacement of fat
intake with complex carbohydrates over 6 years was not
associated with adverse effects on lipid profiles (139).
Observational studies suggest an increased risk for serious cardiac events during vigorous physical activity, primarily in persons with low levels of habitual activity.
However, the absolute risk for serious cardiac events
related to physical activity seems very small. The U.S.
Department of Health and Human Services’ 2008 report on physical activity (6) details additional information regarding harms of physical activity.
In addition to limited confidence in the pooled estimates of effect sizes for some outcomes due to the
heterogeneity of the trials, this body of evidence has
other limitations. Our updated review represents only a
subset of the diet and physical activity counseling literature; important omissions include counseling in persons with known disease (including hypertension, dyslipidemia, diabetes, or coronary heart disease); diet or
physical activity counseling for other types of disease
prevention or weight management; trials to evaluate the
comparative effectiveness of different types of counseling interventions; related behavioral interventions conducted through worksites, schools, and communities;
and public health, economic- and policy-oriented, or
media-based interventions (140).
Most of the trials relied on self-reported behavioral
outcome measures; only 36% of trials reported any objectively measured intermediate outcomes. Measurement of behavioral outcomes varied across trials, and
both dietary and physical activity behaviors can be difficult to measure validly and reliably (Table 4). Dietary
intake was generally measured by food-frequency questionnaires, food diaries, and 24-hour food recalls, each
of which can be prone to bias (141). For physical activity, the various forms of physical activity, the episodic
nature of some types of activity, and the subjective nature of a person’s assessment of intensity make it diffi7 December 2010 Annals of Internal Medicine Volume 153 • Number 11 745
Clinical Guideline Healthy Lifestyle Counseling to Prevent Cardiovascular Disease
cult to get precise information on physical activity levels. Only 7 of the studies that reported physical activity
outcomes used objective measures, such as a pedometer,
accelerometer, or actigraph (45, 48, 50, 64, 67, 106,
115, 118), and this measure was always used in addition
to a self-reported measure. However, the behavioral outcome results in our review were generally consistent
with those that used intermediate outcomes.
Other limitations include risk for bias due to inclusion only of published data, potential selective reporting
of outcomes, and inclusion of trials that used volunteer
participants. The Egger statistical test for small-study
effects was significant only for self-reported total dietary
fat intake and self-reported physical activity level among
the physical activity counseling trials. However, sensitivity analyses that excluded the small studies with large
effects still demonstrated a positive effect of physical
activity counseling.
Although the body of literature is already very large,
good-quality trials that fully evaluate the longer-term
health effects of these types of counseling interventions
across a range of patients and use counseling interventions
that are most applicable to primary care are needed. More
trials are needed to evaluate low-intensity counseling interventions that could be more readily implemented in primary care, or medium-intensity interventions that could be
referred to from primary care. The effective high-intensity
interventions should be studied for reproducibility, to determine whether they would work in other populations
and what intensity of intervention is effective in lower-risk
populations. More trials with longer-term follow-up are
crucial to understanding how to maintain behavioral
change and changes in physiologic outcomes over time. In
addition to self-reported behavioral outcomes, trials should
also collect and report objectively measured physiologic
outcomes. Greater use of objective measures to assess physical activity would probably provide more accurate estimates of changes in physical activity level, which is especially important when the changes are small.
From the Center for Health Research, Kaiser Permanente Northwest,
Portland, Oregon.
Acknowledgment: The authors thank Daphne Plaut, MLS, for conducting the literature searches; Kevin Lutz, MFA, for editorial support; Sarah Zuber, MSW, and Leslie Perdue, MPH, for assistance in
conducting the evidence review; and Caitlyn Senger, MPH, for assistance in preparing the manuscript. They also thank the Agency for
Healthcare Research and Quality and the USPSTF, as well as the
expert reviewers (Miriam C. Morey, PhD; Michele M. Doucette,
PhD; Charlotte A. Pratt, PhD, RD; Janet M. de Jesus, MS, RD;
Brian Martinson, PhD; Stephen P. Fortmann, MD; David R. Brown,
PhD; and David P. Hopkins, MD, MPH), for their contribution to
this evidence review.
Grant Support: By the Agency for Healthcare Research and Quality,
Rockville, Maryland (contract HHS-290-2007-10057-I, task order 3).
746 7 December 2010 Annals of Internal Medicine Volume 153 • Number 11
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline
.org/authors/icmje/ConflictOfInterestForms.do?msNum⫽M10-1648.
Requests for Single Reprints: Copies of the full report on which this
article is based are available at www.uspreventiveservicestaskforce.org/.
Current author addresses and author contributions are available at www
.annals.org.
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www.annals.org
Annals of Internal Medicine
Current Author Addresses: Drs. Lin, O’Connor, and Whitlock and Ms.
Beil: Center for Health Research, Kaiser Permanente Northwest, 3800
North Interstate Avenue, Portland, OR 97227.
Author Contributions: Conception and design: J.S. Lin, E. O’Connor,
E.P. Whitlock, T.L. Beil.
Analysis and interpretation of the data: J.S. Lin, E. O’Connor, E.P.
Whitlock.
Drafting of the article: J.S. Lin, E. O’Connor.
Critical revision of the article for important intellectual content: J.S. Lin,
E.P. Whitlock.
Final approval of the article: J.S. Lin, E. O’Connor, T.L. Beil.
Provision of study materials or patients: T.L. Beil.
Statistical expertise: E. O’Connor.
Obtaining of funding: E.P. Whitlock.
Administrative, technical, or logistic support: T.L. Beil.
Collection and assembly of data: J.S. Lin, E. O’Connor, T.L. Beil.
Appendix Figure. Analytic framework and key questions.
KQ 1
KQ 2
Unselected
Adults
Older adults
Counseling
intervention
KQ 3
Selected
Intermediate Outcomes
CVD risk factors (such as
lipid levels, blood pressure,
glucose tolerance, or body
mass index)
Health Outcomes
Decreased cardiovascular and related
morbidity or mortality
Behavioral Outcomes
Physical activity and
dietary intake
KQ 4
Adverse
effects
Key Questions
1. Do primary care–relevant behavioral counseling interventions for physical activity or healthful diet improve cardiovascular disease health outcomes (prevent
morbidity and mortality) in adults?
2. Do primary care–relevant behavioral counseling interventions for physical activity or healthful diet improve intermediate outcomes associated with
cardiovascular disease (such as lipid levels, blood pressure, glucose tolerance, weight, or body mass index) in adults (including older adults)?
3. Do primary care–relevant behavioral counseling interventions for physical activity or healthful diet change associated health behaviors in adults?
4. What are the adverse effects of primary care–relevant behavioral counseling interventions for physical activity or healthful diet in adults?
CVD ⫽ cardiovascular disease; KQ ⫽ key question.
W-244 7 December 2010 Annals of Internal Medicine Volume 153 • Number 11
www.annals.org
Copyright © American College of Physicians 2010.
KAREN JACQUELINE COLEMAN1, EUNIS NGOR1, KRISTI REYNOLDS1, VIRGINIA P. QUINN1, CORINNA
KOEBNICK1, DEBORAH ROHM YOUNG1, BARBARA STERNFELD2, and ROBERT E. SALLIS3
1
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA; 2Division of Research,
Kaiser Permanente Northern California, Oakland, CA; and 3Department of Family Medicine Fontana Medical Center,
Kaiser Permanente Southern California, Fontana, CA
ABSTRACT
COLEMAN, K. J., E. NGOR, K. REYNOLDS, V. P. QUINN, C. KOEBNICK, D. R. YOUNG, B. STERNFELD, and R. E. SALLIS.
Initial Validation of an Exercise ‘‘Vital Sign’’ in Electronic Medical Records. Med. Sci. Sports Exerc., Vol. 44, No. 11, pp. 2071–2076,
2012. Purpose: The objective of this study is to describe the face and discriminant validity of an exercise vital sign (EVS) for use in an
outpatient electronic medical record. Methods: Eligible patients were 1,793,385 adults 18 yr and older who were members of a large
health care system in Southern California. To determine face validity, median total self-reported minutes per week of exercise as
measured by the EVS were compared with findings from national population-based surveys. To determine discriminant validity, multivariate Poisson regression models with robust variance estimation were used to examine the ability of the EVS to discriminate between
groups of patients with differing physical activity (PA) levels on the basis of demographics and health status. Results: After 1.5 yr of
implementation, 86% (1,537,798) of all eligible patients had an EVS in their electronic medical record. Overall, 36.3% of patients were
completely inactive (0 min of exercise per week), 33.3% were insufficiently active (more than 0 but less than 150 minIwkj1), and 30.4%
were sufficiently active (150 min or more per week). As compared with national population-based surveys, patient reports of PA were
lower but followed similar patterns. As hypothesized, patients who were older, obese, of a racial/ethnic minority, and had higher disease
burdens were more likely to be inactive, suggesting that the EVS has discriminant validity. Conclusions: We found that the EVS has
good face and discriminant validity and may provide more conservative estimates of PA behavior when compared with national surveys.
The EVS has the potential to provide information about the relationship between exercise and health care use, cost, and chronic disease
that has not been previously available at the population level. Key Words: PHYSICAL ACTIVITY COUNSELING, PRIMARY CARE,
PHYSICIAN, POPULATION
A
One of the focus areas in the National Physical Activity
Plan is the health care sector. Health care providers have
contact with the majority of Americans and have a unique
opportunity to encourage PA among their patients through
PA assessment and brief counseling. Recommendations
for assessment include a PA ‘‘vital sign’’ that is incorporated
into patients’ routine health screening and is kept as a health
indicator in their medical record (8). This indicator can be
monitored over time as are blood pressure and weight to
provide continued opportunities for counseling and support
for adopting a healthy lifestyle. In response to these recommendations, the American Medical Association in partnership
with the American College of Sports Medicine developed the
Exercise is Medicinei initiative (9). Specific details about the
initiative can be found at the program Web site (4). Briefly,
the vision for the initiative is as follows:
‘‘For physical activity to be considered by all health care
providers as a vital sign in every patient visit, the patients are
effectively counseled and referred as to their physical activity
and health needs, thus leading to overall improvement in the
public’s health and long-term reduction in health care cost.’’
In response to the Exercise is Medicinei initiative, Kaiser
Permanente Southern California (KPSC), a large health
care system, has incorporated questions about PA into the
lthough the benefits of regular physical activity (PA)
have been well documented, including those for prevention and treatment of cardiovascular disease,
cancer, and depression (7), the high prevalence of physical
inactivity remains a major public health concern. The national 2008 Physical Activity Guidelines for Americans (7),
recommend that Americans engage in at least 150 minIwkj1
of moderate-to-vigorous intensity PA to receive maximal
health benefits. Recent estimates using objective PA assessment found that only 8% of the US adult population
achieved the recommended levels of PA (11), although selfreport measures found the prevalence to be considerably
higher than this (60%) (11).
Address for correspondence: Karen Jacqueline Coleman, Ph.D., Department of
Research and Evaluation, Southern California Permanente Medical Group, 100
S. Los Robles, 2nd Floor, Pasadena, CA; E-mail: Karen.J.Coleman@kp.org.
Submitted for publication March 2012.
Accepted for publication June 2012.
0195-9131/12/4411-2071/0
MEDICINE & SCIENCE IN SPORTS & EXERCISEÒ
Copyright Ó 2012 by the American College of Sports Medicine
DOI: 10.1249/MSS.0b013e3182630ec1
2071
Copyright © 2012 by the American College of Sports Medicine. Unauthorized reproduction of this article is prohibited.
CLINICAL SCIENCES
Initial Validation of an Exercise ‘‘Vital Sign’’
in Electronic Medical Records
CLINICAL SCIENCES
measurement of traditional vital signs (blood pressure, pulse,
temperature, and respirations), which are currently assessed
for every patient during an outpatient visit. This exercise
vital sign (EVS) was designed to identify patients who are
not meeting PA recommendations and to assist health care
providers in promoting PA among patients.
This article describes the initial results from efforts to
validate the KPSC EVS. Face validity for the KPSC EVS
was established by comparing exercise levels found with
this measure to those found in US population surveys. We
also examined the ability of the KPSC EVS to discriminate
between groups of patients with differing activity levels on
the basis of demographics and health status. We hypothesized
that women would be less active than men, older patients
would be less active than younger patients, ethnic minority patients would be less active than non-Hispanic white
patients, obese patients would be less active than patients
having a healthy weight, and those patients with a higher
disease burden would be less active than those without
chronic health conditions.
METHODS
Participants and Setting
KPSC provides comprehensive health care services for
approximately 3.4 million residents of Southern California.
Members enroll through the Kaiser Foundation Health Plan
for prepaid health care insurance. KPSC provides care at 14
hospitals and nearly 200 medical offices through a partnership of more than 4000 physicians who comprise the entire
range of medical specialists. Data were examined for the
period of April 2010 to March 2011. This time frame was
chosen to reflect 1 yr of full implementation of the EVS after
a 6-month implementation phase (18 months total). During
this time, there were 2,149,800 adult patients who were
KPSC members. Of these patients, 1,793,385 (83%) had at
least one outpatient medical visit and were eligible for the
study. Study procedures were approved by the KPSC Institutional Review Board for Human Subjects. The KPSC Institutional Review Board approved a waiver of informed
consent for this study.
EVS. Use of the EVS began in October of 2009, with
every patient being asked two questions during their intake procedures as part of an outpatient visit: 1) ‘‘On average, how many days per week do you engage in moderate to
strenuous exercise (like a brisk walk)?’’ and 2) ‘‘On average,
how many minutes do you engage in exercise at this level?’’
These questions are typically asked by medical assistants
and licensed vocational nurses who enter patients’ responses
into the electronic medical record. Response choices for
days are categorical (0–7). Minutes are recorded in blocks
of 10: 0, 10, 20, 30, 40, 50, 60, 90, 120, and 150 or greater.
The electronic medical record system software then multiplies the two self-reported responses to display minutes per
week of moderate or strenuous exercise for the health care
2072
Official Journal of the American College of Sports Medicine
provider to review. There is a comment section to note any
issues with the assessment. The EVS is embedded in the
‘‘vital sign’’ section of the electronic medical record, which
also contains height, weight, body mass index (BMI), blood
pressure, pulse, respirations, and body temperature.
The EVS was developed with assistance from leading
experts in the PA promotion and assessment community as
part of the national Exercise is Medicinei initiative and is a
modified version of the Behavioral Risk Factor Surveillance
System (BRFSS) PA questions (1,12). When modifying these
questions for clinical use, key considerations were made for
implementation so that the EVS would be easy to use and
acceptable to medical staff. This meant combining intensity categories into one question (moderate to strenuous) and
categorizing minute responses to minimize errors in data
entry. On average, the EVS takes less than 1 min to administer. A set of training materials also accompany the EVS
to assist health care professionals in asking these questions
consistently, as well as probing patients about their answers
if the patient seems uncertain or provides an answer that is
unreasonable (e.g., ‘‘I exercise five hours every day’’). These
training materials are available upon request.
A median total minutes per week of moderate to strenuous
exercise was used for each patient across the study period of
April 2010 to March 2011. The median was used instead of
the mean to control for extreme differences in self-reported
exercise across multiple visits.
Demographic and Health Variables
Demographics. Date of birth (for calculation of age),
race/ethnicity, and gender were obtained from electronic
membership files. These data are collected when patients
enroll in the KPSC health plan. Self-reported race/ethnicity
is also collected when patients have a health care visit. All
demographic variables were obtained at the beginning of the
study period (April 2010).
BMI. BMI was assessed using measured height and
weight and calculated as weight in kilograms divided by
height in meters squared. Height and weight are measured
and entered into the electronic medical record by health care
professionals each time a patient has a health care visit. We
directly accessed electronic records to obtain all BMI values
during the study period (April 2010 to March 2011) and then
calculated a median value for analyses.
Disease burden. Disease burden was assessed by calculating a modified Charlson Comorbidity Index for each
patient in the study population. The modified Charlson
Comorbidity Index was created using diagnosis codes assessed in the 3 yr before enrollment in the study to provide
a summary score assessing a patient’s risk for 10 yr of mortality based upon 22 different health conditions (3).
Analyses. Data on patient demographics and health
are presented as descriptive frequencies. To establish the
face validity of the KPSC EVS, we further consolidated
data into categories to compare with the estimates reported by the 2005–2006 Nutrition Health and Examination
http://www.acsm-msse.org
Copyright © 2012 by the American College of Sports Medicine. Unauthorized reproduction of this article is prohibited.
RESULTS
Patient characteristics. From the 1,793,385 KPSC
adult patients with an outpatient medical visit during April
2010 to March 2011, we identified 1,537,798 (86%) with
an EVS measure. Table 1 presents patient characteristics for
those patients who did and did not have an EVS measure. In
general, patients with an EVS were older, were female, had
TABLE 1. Characteristics of KPSC adult patients 18 yr and older with a medical outpatient visit during the study period of …
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