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Comparative Effectiveness of Weight-Loss Interventions in Clinical Practice

November 2011
The New-England Medical Review and Journal 365(21):1959-68

DOI:10.1056/NEJMoa1108660

Source
PubMed

Authors:

Jeanne M Clark

Johns Hopkins Medicine

Hsin-Chieh Yeh

Johns Hopkins Medicine

Nae-Yuh Wang

Johns Hopkins University

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Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse. We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely--through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was -0.8 kg in the control group, -4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and -5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups. In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00783315.).

. Baseline Characteristics of the Study Participants*

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n engl j med 365;21 nejm.org november 24, 2011

1959

The new england

journal of medicine

established in 1812

november 24, 2011

vol. 365 no. 21

Comparative Effectiveness of Weight-Loss Interventions

in Clinical Practice

Lawrence J. Appel, M.D., M.P.H., Jeanne M. Clark, M.D., M.P.H., Hsin-Chieh Yeh, Ph.D., Nae-Yuh Wang, Ph.D.,

Janelle W. Coughlin, Ph.D., Gail Daumit, M.D., M.H.S., Edgar R. Miller III, M.D., Ph.D., Arlene Dalcin, R.D.,

Gerald J. Jerome, Ph.D., Steven Geller, M.D., Gary Noronha, M.D., Thomas Pozefsky, M.D., Jeanne Charleston, R.N.,

Jeffrey B. Reynolds, M.S., Nowella Durkin, Richard R. Rubin, Ph.D., Thomas A. Louis, Ph.D.,

and Frederick L. Brancati, M.D., M.H.S.

A BS T R AC T

From the Welch Center for Prevention,

Epidemiology, and Clinical Research,

Johns Hopkins University (L.J.A., J.M.C.,

H.-C.Y., N.-Y.W., G.D., E.R.M., F.L.B.); the

Divisions of General Internal Medicine

(L.J.A., J.M.C., H.-C.Y., N.-Y.W., G.D.,

E.R.M., A.D., G.J.J., G.N., T.P., J.B.R.,

N.D., F.L.B.) and Endocrinology (T.P.)

and the Departments of Psychiatry and

Behavioral Sciences (J.W.C.) and Pediat-

rics (R.R.R.), Johns Hopkins University

School of Medicine; the Departments of

Epidemiology (L.J.A., J.M.C., H.-C.Y., J.C.,

F.L.B.) and Biostatistics (N.-Y.W., T.A.L.),

Johns Hopkins Bloomberg School of

Public Health; and Johns Hopkins Com-

munity Physicians (G.N.) — all in Balti-

more; and the Department of Kinesiology,

Towson University, Towson (G.J.J.); the

Centennial Medical Group, Elkridge (S.G.);

and Park Medical Associates, Timonium

(T.P.) — all in Maryland. Address reprint

requests to Dr. Appel at lappel@jhmi.edu.

This article (10.1056/NEJMoa1108660)

was published on November 15, 2011, at

NEJM.org.

N Engl J Med 2011;365:1959-68.

Background

Obesity and its cardiovascular complications are extremely common medical problems,

but evidence on how to accomplish weight loss in clinical practice is sparse.

Methods

We conducted a randomized, controlled trial to examine the effects of two behavioral

weight-loss interventions in 415 obese patients with at least one cardiovascular risk fac-

tor. Participants were recruited from six primary care practices; 63.6% were women,

41.0% were black, and the mean age was 54.0 years. One intervention provided pa-

tients with weight-loss support remotely — through the telephone, a study-specific Web

site, and e-mail. The other intervention provided in-person support during group

and individual sessions, along with the three remote means of support. There was

also a control group in which weight loss was self-directed. Outcomes were compared

between each intervention group and the control group and between the two interven-

tion groups. For both interventions, primary care providers reinforced participation

at routinely scheduled visits. The trial duration was 24 months.

Results

At baseline, the mean body-mass index (the weight in kilograms divided by the square

of the height in meters) for all participants was 36.6, and the mean weight was

103.8 kg. At 24 months, the mean change in weight from baseline was −0.8 kg in the

control group, −4.6 kg in the group receiving remote support only (P<0.001 for the

comparison with the control group), and −5.1 kg in the group receiving in-person

support (P<0.001 for the comparison with the control group). The percentage of par-

ticipants who lost 5% or more of their initial weight was 18.8% in the control group,

38.2% in the group receiving remote support only, and 41.4% in the group receiving

in-person support. The change in weight from baseline did not differ significantly

between the two intervention groups.

Conclusions

In two behavioral interventions, one delivered with in-person support and the other

delivered remotely, without face-to-face contact between participants and weight-loss

coaches, obese patients achieved and sustained clinically significant weight loss over

a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and

others; ClinicalTrials.gov number, NCT00783315.)

The New England Journal of Medicine

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besity is an important and grow-

ing public health problem around the

world. In the United States, approximately

one third of adults are obese.

Obesity adversely

affects each of the major cardiovascular risk fac-

tors — blood pressure, lipid profile, and diabetes.

As a consequence, obese persons have an increased

risk of death, especially from cardiovascular dis-

ease.

2,3

The economic burden of the obesity epi-

demic is enormous; the estimated direct and indi-

rect costs related to obesity exceed $110 billion

annually in the United States.

An extensive body of evidence from efficacy

trials has shown that weight loss is achievable

and that modest weight loss has beneficial effects

on cardiovascular risk factors.

5-7

However, virtually

all these trials tested intensive in-person inter-

ventions in highly selected participants. Typically,

primary care providers (PCPs) were not directly

involved in the intervention. Few weight-loss tri-

als have examined the effect of behavioral inter-

ventions in clinical practice,

and the results of

these trials have been inconsistent. Consequently,

even though it is recommended that clinicians

offer intensive counseling and behavioral support

to their obese patients,

practicing physicians lack

effective, empirically supported models of treat-

ment to guide their efforts in helping obese pa-

tients lose weight.

To address the need for treatment models, we

conducted a randomized, controlled trial to deter-

mine the effectiveness of two behavioral weight-

loss interventions — including one without in-

person contact — in obese patients with at least

one cardiovascular risk factor. The intervention

without in-person contact provided patients with

support by means of the telephone, the Internet,

and e-mail. The other intervention offered these

remote sources of support but reflected common

practice in efficacy trials by also providing face-to-

face group and individual sessions conducted by

health coaches. Participants in the control group

received brief advice but none of the above re-

sources. We hypothesized that patients assigned

to both active interventions would achieve great-

er weight loss than those in the control group. We

further hypothesized that patients in the group

receiving in-person support would achieve greater

weight loss than those in the group receiving only

remote support.

Methods

Oversight

This trial is one of three independent trials in the

Practice-based Opportunities for Weight Reduction

(POWER) trials, each supported by a grant from the

National Heart, Lung, and Blood Institute.

10,11

For this trial, Healthways, a disease-management

company, also provided support. The Prevention

and Control Core of the Baltimore Diabetes Re-

search and Training Center contributed to the data

analysis. An institutional review board approved

the trial, as did an independent data and safety

monitoring board. All participants provided writ-

ten informed consent. Healthways employees con-

tributed to the study design, particularly on

technical matters related to the design of the study-

specific Web site. The first author wrote the article

and vouches for the accuracy of the data and the

analyses. The National Heart, Lung, and Blood In-

stitute and Healthways had opportunities to com-

ment on the manuscript. The final decisions re-

garding the content and composition of the

manuscript and the decision to submit it for pub-

lication were made by the academic investigators.

The study was conducted according to the proto-

col (available with the full text of this article at

NEJM.org).

Study Population

The study population consisted of obese adults who

were at least 21 years of age and had one or more

cardiovascular risk factors (hypertension, hyper-

cholesterolemia, or diabetes). To be eligible for the

trial, potential participants had to be a patient at

one of the participating primary care practices,

have regular access to a computer, and have basic

computer skills (i.e., could enter data into a Web

site and send and receive e-mail). We excluded pa-

tients who had recently lost 5% or more of their

body weight or were taking medications that cause

weight gain or prevent weight loss (e.g., glucocor-

ticoids or second-generation antipsychotic medi-

cations). In general, the eligibility criteria for the

trial were less stringent than those typically used in

efficacy trials.

6,12-14

There was no run-in period,

no test given before randomization to determine

adherence to study procedures, and no requirement

that participants attend group sessions. Our ap-

proach to enrollment was to accept a person for

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study participation even if there were doubts about

the likelihood that the person would adhere to the

study protocol or be available for follow-up. (See the

protocol for a complete list of enrollment criteria.)

Participants were recruited from primary care

practices in the Baltimore metropolitan area be-

tween February 2008 and February 2009 through

physician referral, brochures, and targeted mail-

ings. Eight clinics were invited to participate in the

study, and six accepted. At the participating clinics,

46 PCPs enrolled participants; only 1 physician

declined.

Study Groups

Randomization was stratified according to sex and

was generated in blocks of 3 and 6 with the use of

a Web-based program. The research staff who no-

tified participants of their assignment were not in-

volved in the collection of follow-up data.

Participants had an equal chance of being as-

signed to any one of the three study groups. The

theoretical framework for the two active inter-

ventions was based on social cognitive theory and

incorporated behavioral self-management ap-

proaches designed to help participants set weight-

related goals, self-monitor weight and weight-

related behaviors (exercise and reduced calorie

intake), increase self-efficacy and social support,

and solve problems. These approaches were mod-

eled on those tested in previous trials.

15-17

Moti-

vational interviewing was the primary approach to

interactions with participants. Participants in the

two intervention groups were encouraged to lose

5% of their baseline weight within 6 months and

to maintain the reduced weight until the end of the

study.

Table 1

shows the key features of the two

intervention groups. (For more information on the

interventions, see the protocol and the Supplemen-

tary Appendix, available at NEJM.org.)

Participants in both intervention groups were

encouraged to log on to the study-specific Web site

weekly. The Web site contained learning modules;

opportunities for self-monitoring of weight, calorie

intake, and exercise; and feedback on progress in

these key behaviors. Each participant who was as-

signed to an active intervention received automated

monthly e-mail messages summarizing his or her

progress. Automated re-engagement e-mail mes-

sages were sent to participants who had not logged

on to the Web site in the preceding 7 days.

Weight-loss coaches encouraged participants to

complete the learning modules and provided posi-

tive reinforcement of key behaviors, with an em-

phasis on self-monitoring of weight, calorie intake,

and exercise. Individual sessions (in person or by

telephone) were approximately 20 minutes long;

group sessions conducted for the group receiving

in-person support typically lasted 90 minutes.

Participants in both intervention groups were

offered weekly contact with coaches during the

first 3 months (nine group sessions and three

individual sessions for participants receiving in-

person support, and 12 weekly calls for those

receiving only remote support). During the next

Table 1. Features of Both Interventions.*

Coaches

Delivered the interventions in collaboration with the PCP to promote weight

loss

Focused on key weight-management behaviors (reduced calorie intake as

part of the DASH diet, increased exercise, regular log-in to the study Web

site, and use of food records)

Used motivational interviewing techniques (e.g., asking open-ended ques-

tions, exploring participants’ feelings of ambivalence, supporting their

optimism regarding change, and directing conversations toward the

desired behavioral goals)

Followed re-engagement procedures when participants did not log in to the

study Web site (automated e-mail message sent after 7 to 10 days with-

out log-in and telephone call made after 14 days without log-in)

Received case-management support

Web-based support

Provided learning modules consisting of objectives, educational content,

quizzes, and worksheets

Provided self-monitoring tools and graphs (to record weight, minutes of exer-

cise per day, and calories consumed per day), with a recommendation to

record weight at least weekly on the study Web site

Provided feedback regarding weight-loss progress (e.g., change in weight

since last log-in and weight trend)

PCPs

Reviewed one-page report on patient’s weight-loss progress at each routine

office visit

Encouraged participation in the intervention

Reported events that might affect patient’s ability to participate in the inter-

vention

Sent letters to participants as part of the re-engagement strategy after pro-

longed periods with no participant contact

For patients with diabetes, provided assistance with self-monitoring of glu-

cose levels and medication adjustment

* DASH denotes Dietary Approaches to Stop Hypertension, and PCP primary

care provider.

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3 months, participants receiving in-person support

were offered three monthly contacts (one group

session and two individual sessions), whereas the

group receiving only remote support were offered

1 call each month. For the remainder of the study,

participants in the group receiving in-person sup-

port were offered two monthly contacts (one group

session and one individual session, with the latter

conducted either in person or by telephone), and

the group receiving only remote support continued

to be offered monthly calls.

The coaches for the group receiving in-person

support were employees of Johns Hopkins Univer-

sity, and the coaches for the group receiving only

remote support were employees of Healthways.

Coaches were trained before enrollment of the first

participant and on a quarterly basis thereafter. The

topics covered included behavioral theory and

strategies, basic nutritional and exercise guide-

lines, motivational interviewing techniques, and

study procedures, including use of the intervention

Web site. To assess fidelity to the protocol and to

promote motivational interviewing techniques, a

case-management team observed the coaches and

provided feedback monthly for the first 3 months

of the study and quarterly thereafter.

Participants in the control group met with a

weight-loss coach at the time of randomization

and, if desired, after the final data-collection visit,

at 24 months. They also received brochures and

a list of recommended Web sites promoting

weight loss.

Role of the PCP

PCPs played a supportive role in the study. At rou-

tinely scheduled visits, each PCP received and re-

viewed a progress report on any of their patients

who had been assigned to an intervention group

(see the sample report in the Supplementary Ap-

pendix). PCPs used this report to provide patients

with basic guidance (i.e., reduce calorie intake and

increase exercise) and to motivate their patients.

The report included a graph from the Web site

showing the patient’s baseline, target, and self-

reported weights. If patients were not actively par-

ticipating in their assigned intervention, the coach-

es sent re-engagement letters on behalf of the PCP.

Data Collection

Eligibility, baseline, and follow-up data were col-

lected by telephone, through the Web, and through

in-person visits. The enrollment process involved a

Web-based contact, an in-person visit during which

baseline data were collected, and a second in-

person visit at which participants were notified

of their assigned group. Participants were asked

to make in-person follow-up visits 6, 12, and 24

months after randomization. At each of these vis-

its, weight was measured on a high-quality, cali-

brated digital scale, with the participant wearing

light, indoor clothes and no shoes. Height was

measured once, at study entry. Blood pressure was

recorded at each of the three visits; waist circum-

ference and fasting levels of blood glucose and lip-

ids were measured at baseline and 6 and 24 months

after randomization. Trained research staff who

were not informed of the group assignment per-

formed the measurements.

Statistical Analysis

The primary outcome was change in weight from

baseline to 24 months. Other weight-related out-

comes were percentage of weight change from

baseline, percentage of participants without weight

gain, percentage of participants who lost at least

5% of their initial weight, and change from base-

line in body-mass index (BMI, the weight in kilo-

grams divided by the square of the height in me-

ters). The primary analysis was based on the

intention-to-treat principle. All weights obtained

before a protocol-defined censoring event (i.e.,

pregnancy, bariatric surgery, or amputation) were

included in the analysis, which was conducted with

the use of a saturated-means, repeated-measures,

mixed-effects model for visit-specific weight, with

indicators for missing data. Means were modeled

as a function of the group assignment and study

visit (at baseline and at 6, 12, and 24 months). The

model included adjustment for clinic, sex, age, and

race or ethnic group. An unstructured covariance

structure was used to relate the repeated measures.

In addition, robust standard errors were comput-

ed. This approach produces valid estimates if data

are missing at random.

The same modeling approach was used for the

dependent variables of percentage change in weight

and change in BMI. In addition, percentages of

participants in each of the three study groups who

met various weight-loss thresholds were compared

with the use of a binomial model. Analyses were

conducted with the use of SAS software, version

9.2 (SAS Institute) or the statistical software sys-

tem R, version 2.10.0. The Holm procedure was

used to adjust for multiple comparisons.

The

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trial was designed to have 80% power to detect

a between-group difference in weight change of

2.75 kg for at least one of the two primary com-

parisons (the group receiving remote support only

vs. the control group and the group receiving in-

person support vs. the control group), each at a

two-sided significance level of 0.025.

Result s

Study Participants

A total of 1370 persons registered at the recruit-

ment Web site, and 415 underwent randomization

(for details, see Fig. 1 in the Supplementary Appen-

dix). Of the 415 participants, 63.6% were women

and 41.0% were black; the mean age was 54.0 years

(

Table 2

). At baseline, the mean BMI was 36.6.

Most participants (83.6%) had attempted to lose

weight during the 12 months preceding the study.

Weight Loss

After randomization, weight was recorded for 366

participants (88.2%) at 6 months, for 355 (85.5%) at

12 months, and for 392 (94.5%) at 24 months. At

6 months, the mean (±SE) adjusted change in

weight from baseline was −1.4±0.4 kg in the control

group, −6.1±0.5 kg in the group receiving remote

support only, and −5.8±0.6 kg in the group receiv-

ing in-person support. At 24 months, the mean

change in weight from baseline was −0.8±0.6 kg

in the control group, −4.6±0.7 kg in the group

receiving remote support only, and −5.1±0.8 kg in

the group receiving in-person support, correspond-

ing to a weight change of −1.1%, −5.0%, and −5.2%,

respectively (Fig. 1, and Tables 1 and 2 in the

Supplementary Appendix). The net weight change

at 24 months in the two intervention groups (the

change in each intervention group minus the

change in the control group) was −3.8 kg (95%

confidence interval [CI], −5.7 to −1.9; P<0.001) in

the group receiving remote support only and

−4.3 kg (95% CI, −6.3 to −2.3; P<0.001) in the

group receiving in-person support. There was no

significant difference in weight change between

the intervention groups at any time point. At 24

months, the mean difference in weight change

between these two groups (the mean change in

the group receiving in-person support minus the

mean change in the group receiving remote sup-

port) was −0.5 kg (95% CI, −2.5 to 1.5; P = 0.63).

Table 3 shows the percentage of participants

who met certain weight-change thresholds 6 and

24 months after randomization. At 24 months, the

percentage of participants in the control group

with a weight that was lower than their weight

at baseline was 52.3% as compared with 74.4% in

the group receiving in-person support and 77.1% in

the group receiving remote support only. The per-

centage of participants whose weight at 24 months

was at least 5% below their baseline weight was

18.8% in the control group, 41.4% in the group

receiving in-person support, and 38.2% in the

group receiving remote support only.

Participation Rates

Table 4 shows the actual and recommended rates

of study participation in the intervention groups.

In the group receiving remote support only, the

median number of completed phone calls was 14

in the first 6 months and 16 for the remainder of

the trial. In the group receiving in-person sup-

port, most contact with coaches during the first

6 months occurred in face-to-face group sessions.

Participation in group sessions, although strongly

encouraged, was initially low and declined further

over the course of the study. The median number

of group sessions attended was 6.5 in the first

6 months and 1 in the next 18 months, and the

median number of individual sessions attended

was 4 in the first 6 months and 1 in the last 18

months. In the group receiving in-person sup-

port only, the median number of phone calls was

4 in the first 6 months and 11 in the last 18

months. Both intervention groups used the Web

site frequently. The number of reports reviewed

by the PCPs was similar in the two groups. The

percentage of participants who dropped out of the

intervention (defined as having no contact with a

coach and no use of study Web site for 2 months)

was 5.0% at 6 months and 13.0% at 24 months

for the group receiving remote support and 8.7%

at 6 months and 15.9% at 24 months for the

group receiving in-person support.

Adverse Events

There was one serious adverse event that may have

been related to the study. One participant in the

group receiving in-person support was assaulted

while exercising and had musculoskeletal injuries.

At data-collection visits, 48 hospitalizations were

reported (15 in the control group, 15 in the group

receiving remote support, and 18 in the group re-

ceiving in-person support). There were no deaths

or serious hypoglycemic events.

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Table 2. Baseline Characteristics of the Study Participants*

Characteristic Control

(N = 138) Remote Support Only

(N = 139) In-Person Support

(N = 138) All Participants

(N = 415)

Age — yr 52.9±10.1 55.8±9.7 53.3±10.5 54.0±10.2

Weight — kg 104.4±18.6 102.1±13.9 105.01±20.7 103.4±17.9

BMI† 36.8±5.14 36.0±4.7 36.8±5.2 36.6±5.0

Waist circumference — cm 118.2±13.7 117.9±12.7 118.2±14.4 118.1±13.6

Race or ethnic group — no. (%)‡§

Asian 2 (1.4) 2 (1.4) 0 (0.0) 4 (1.0)

Black 59 (42.8) 52 (37.4) 59 (42.8) 170 (41.0)

White 72 (52.2) 83 (59.7) 78 (56.5) 233 (56.1)

Other 5 (3.6) 2 (1.4) 1 (0.7) 8 (1.9)

Hispanic 3 (2.2) 3 (2.2) 3 (2.2) 9 (2.2)

Education — no. (%)

High-school graduate or less 18 (13.0) 15 (10.8) 11 (8.0) 44 (10.6)

Some college 45 (32.6) 43 (30.9) 37 (26.8) 125 (30.1)

College graduate 75 (54.3) 81 (58.3) 90 (65.2) 246 (59.3)

Female sex — no. (%) 88 (63.8) 88 (63.3) 88 (63.8) 264 (63.6)

Household income — no. (%)

<$50,000 33 (23.9) 28 (20.1) 30 (21.7) 91 (21.9)

$50,000–99,999 52 (37.7) 53 (38.1) 50 (36.2) 155 (37.3)

≥$100,000 53 (38.4) 58 (41.7) 58 (42.0) 169 (40.7)

Employment status — no. (%)

Employed 106 (76.8) 101 (72.7) 105 (76.1) 312 (75.2)

Retired 17 (12.3) 28 (20.1) 20 (14.5) 65 (15.7)

Other 15 (10.9) 10 (7.2) 13 (9.4) 38 (9.2)

Health insurance — no. (%)§

Private or HMO 133 (96.4) 136 (97.8) 135 (97.8) 404 (97.3)

Medicare 11 (8.0) 20 (14.4) 13 (9.4) 44 (10.6)

Medicaid 0 (0.0) 0 (0.0) 2 (1.4) 2 (0.5)

Uninsured 3 (2.2) 1 (0.7) 0 (0.0) 4 (1.0)

Medical conditions — no. (%)

Hypertension¶ 106 (77.4) 112 (80.6) 98 (71.0) 316 (76.3)

Diabetes 32 (23.2) 31 (22.3) 33 (23.9) 96 (23.1)

Hypercholesterolemia 94 (68.1) 99 (71.2) 88 (63.8) 281 (67.7)

Daily Internet use — % 119 (86.2) 120 (86.3) 121 (87.7) 360 (86.7)

Weight loss attempted in last 12 mo — no. (%) 117 (84.8) 113 (81.3) 117 (84.8) 347 (83.6)

* Plus–minus values are means ±SD. With the exception of age (P = 0.03 by analysis of variance) there were no significant differences in base-

line characteristics among the three study groups. HMO denotes health maintenance organization.

† The body-mass index (BMI) is the weight in kilograms divided by the square of the height in meters.

‡ Race or ethnic group was self-reported.

§ The categories listed under race or ethnic group and under health insurance are not mutually exclusive, and the percentages for these cate-

gories therefore do not sum to 100.

¶ Data on hypertension were not available for one participant in the control group.

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Weight-L oss Interventions i n Cl inical Pr act ice

n engl j med 365;21 nejm.org november 24, 2011

1965

Discussion

In this comparative effectiveness trial, in which

obese medical patients with at least one cardio-

vascular risk factor were enrolled, two behavioral

interventions — one involving no in-person contact

with weight-loss coaches associated with the study

or with other participants — achieved clinically

relevant weight loss. The extent of weight loss was

similar to that achieved in many efficacy stud-

ies.

12-14

In contrast with the findings in most

weight-loss trials,

19,20

however, participants sus-

tained weight loss to the end of the trial. A large

percentage of participants lost 5% or more of their

initial body weight, an amount of weight loss that

has been associated with numerous health bene-

fits, including improved control of diabetes and

hypertension, a reduced risk of incident diabetes

and hypertension, and lower levels of risk factors

for cardiovascular disease.

5-7,12,13

In contrast with most weight-loss trials, this

was a trial of effectiveness rather than efficacy. At

each point in its design and implementation, we

tailored our approach to reflect the setting —

namely, primary care practices. For example, we

did not have a run-in period or conduct an adher-

ence test before randomization, required only two

visits by potential participants to determine eligi-

bility, and modified our interventions considerably,

mostly by reducing the intensity of the intervention

and increasing flexibility. For the participants in

the group receiving in-person support, we encour-

aged but did not mandate participation in group

sessions and gave these participants the option of

maintaining individual contact by phone rather

than in person. Unlike efficacy trials, in which one







Remote support only

In-person support

Control

Weight Change (kg)

−1

−2

−4

−5

−7

−3

−6

−8

60 12 24

Months since Randomization

Figure 1. Mean Weight Change According to Randomized Group.

Table 3. Proportion of Participants Who Met Various Weight-Loss Criteria at 6 and 24 Months of Follow-up.

Criterion Control Remote Support

Only In-Person

Support P Value

Remote

Support Only

vs. Control

In-Person

Support

vs. Control

In-Person

Support vs.

Remote

Support Only

no. of participants/total no. (%)

At or below baseline weight

6 mo 75/113 (66.4) 110/129 (85.3) 105/124 (84.7) <0.001 0.001 0.84

24 mo 67/128 (52.3) 101/131 (77.1) 99/133 (74.4) <0.001 <0.001 0.81

At least 5% below baseline weight

6 mo 16/113 (14.2) 68/129 (52.7) 57/124 (46.0) <0.001 <0.001 0.23

24 mo 24/128 (18.8) 50/131 (38.2) 55/133 (41.4) <0.001 <0.001 0.73

At least 10% below baseline weight

6 mo 4/113 (3.5) 30/129 (23.3) 31/124 (25.0) <0.001 <0.001 0.92

24 mo 11/128 (8.6) 24/131 (18.3) 26/133 (19.5) 0.02 0.01 0.69

BMI <30

6 mo 12/113 (10.6) 36/129 (27.9) 27/124 (21.8) <0.001 0.02 0.22

24 mo 10/128 (7.8) 36/131 (27.5) 25/133 (18.8) <0.001 0.01 0.07

The New England Journal of Medicine

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The

ne w eng l an d jour na l

o f

me di ci ne

n engl j med 365;21 nejm.org november 24, 2011

1966

eligibility criterion is confirmed availability for

group sessions, we imposed no such requirement,

a policy that no doubt contributed to low atten-

dance at group sessions.

Few trials have attempted behavioral weight-

loss strategies in the primary care setting, and

none have implemented interventions similar to

those tested in the POWER trial. Tsai and Wadden

Table 4. Numbers of Recommended and Actual Contacts According to Intervention Group.

Type of Contact Beginning of Study to 6 Mo 7 Mo to End of Study*

Remote Support Only In-Person Support Remote Support Only In-Person Support

Recommended† Actual‡ Recommended† Actual‡ Recommended† Actual‡ Recommended† Actual‡

Coach

Total no. of contacts 15 21 18 36

Median 14 14 16 16

Quartile 1 13 9 12 10

Quartile 3 15 17 18 20

Telephone calls (no.) 15 3 18 12

Median 14 4 16 11

Quartile 1 13 2 12 6

Quartile 3 15 5 18 14

In-person sessions (no.)

Individual 6 6

Median 4 1

Quartile 1 2 0

Quartile 3 5 4

Group 12 18

Median 6.5 1

Quartile 1 2 0

Quartile 3 9 4

Study Web site

No. of wk with log-ins 26 26 72 72

Median 23 20.5 35 32

Quartile 1 17 14 16 11

Quartile 3 25 25 59 58

No. of modules completed 12 12 18 18

Median 12 12 16 8

Quartile 1 12 6 5 0

Quartile 3 12 12 17 16

PCP

No. of reports reviewed

with participant NA NA NA NA

Median 1 1 1 1

Quartile 1 0 0 0 0

Quartile 3 1 1 2 2

* The end of the study occurred 22 to 26 months after randomization. NA denotes not applicable.

† The recommended number of contacts was determined on the basis of a 24-month intervention period.

‡ The actual number of contacts was determined between 22 and 26 months after randomization.

The New England Journal of Medicine

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Weight-L oss Interventions i n Cl inical Pr act ice

n engl j med 365;21 nejm.org november 24, 2011

1967

conducted a systematic review of the literature

on this topic.

Of the 10 trials identified, 4 trials

tested the use of PCP counseling alone, 3 tested

PCP counseling with pharmacotherapy, and 3 test-

ed a collaborative approach in which the interven-

tion was delivered by care providers other than

PCPs. The results of these trials were inconsistent,

and most of them had one or more limitations

(e.g., small sample size, brief duration, low rate of

follow-up, or a combination thereof).

21-23

Our trial has limitations. Its duration, although

longer than that of many weight-loss trials, was

only 2 years. Still, to our knowledge, it is one of

the longest trials of a remote (telephone- or Web-

based) intervention.

24,25

Second, the study was a

single-center trial, although it did involve six clin-

ics. Third, the relative contribution of each compo-

nent of the interventions (personalized counseling,

reinforcement by PCPs, and Web-based support) is

difficult to assess. Fourth, although we collected

data on cardiovascular risk factors (in the Supple-

mentary Appendix), we did not design the trial to

reconfirm the well-established relationship be-

tween weight reduction and improvements in

blood pressure, lipid profile, and glucose levels.

Consequently, nonsignificant relationships should

be interpreted cautiously. The trial also had several

strengths, including a diverse population and high

rates of adherence and follow-up.

Our results have implications for the delivery of

behavioral interventions. First, in contrast with

previous interventions involving only telephone- or

Web-based interventions, the weight loss achieved

in the group receiving remote support only was

substantial and similar in magnitude to that

achieved in the group receiving in-person support

in addition to remote support. The effectiveness of

remote support is particularly noteworthy because

of the flexibility it offers to both participants and

coaches and because it is scalable.

Second, im-

plementing programs similar to those used in the

intervention groups in primary care could help

stem the tide of obesity-related disease, but it

would also require changes in health care delivery

systems and reimbursement policies.

Although

in our study a disease-management company de-

livered the intervention restricted to remote sup-

port only, other groups, including large physician

practices and insurers, could implement such pro-

grams, which could also be part of patient-centered

medical home initiatives. Finally, the paradigm of

remote counseling, reinforcement of patient change

by PCPs, and use of a Web site with portals for

patients, counselors, and physicians could improve

the management of other chronic conditions.

Supported by grants from the National Heart, Lung, and Blood

Institute (HL087085), the Prevention and Control Core of the Balti-

more Diabetes Research and Training Center (P60DK079637), and

the National Center for Research Resources (UL1RR025005) and

by Healthways.

Dr. Louis reports receiving consulting fees from Bristol-Myers

Squibb and Merck and royalties from Taylor and Francis Pub-

lishing. Johns Hopkins University has an institutional consult-

ing agreement with Healthways. No other potential conf lict of

interest relevant to this article was reported.

Disclosure forms provided by the authors are available with

the full text of this article at NEJM.org.

We thank the participants in the POWER trial, who made this

study possible; the members of the data and safety monitoring

board; several organizations that provided assistance with the

conduct of the trial — Johns Hopkins ProHealth, Healthways,

Centennial Medical Center, Johns Hopkins Community Physi-

cians, and Park Medical Associates; and a number of persons

(listed in the Supplementary Appendix) who contributed to the

success of the trial but are not authors.

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Christina Holzapfel

Prevalence and trends in obesity among U.S. adults

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Sep 2010
ARCH INTERN MED

Background: Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes mellitus, but no long-term data are available. We examined the effects of lifestyle intervention on changes in weight, fitness, and CVD risk factors during a 4-year study. Methods: The Look AHEAD (Action for Health in Diabetes) trial is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention (ILI) and diabetes support and education (DSE; the control group) on the incidence of major CVD events in 5145 overweight or obese individuals (59.5% female; mean age, 58.7 years) with type 2 diabetes mellitus. More than 93% of participants provided outcomes data at each annual assessment. Results: Averaged across 4 years, ILI participants had a greater percentage of weight loss than DSE participants (-6.15% vs -0.88%; P < .001) and greater improvements in treadmill fitness (12.74% vs 1.96%; P < .001), hemoglobin A(1c) level (-0.36% vs -0.09%; P < .001), systolic (-5.33 vs -2.97 mm Hg; P < .001) and diastolic (-2.92 vs -2.48 mm Hg; P = .01) blood pressure, and levels of high-density lipoprotein cholesterol (3.67 vs 1.97 mg/dL; P < .001) and triglycerides (-25.56 vs -19.75 mg/dL; P < .001). Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants (-11.27 vs -12.84 mg/dL; P = .009) owing to greater use of medications to lower lipid levels in the DSE group. At 4 years, ILI participants maintained greater improvements than DSE participants in weight, fitness, hemoglobin A(1c) levels, systolic blood pressure, and high-density lipoprotein cholesterol levels. Conclusions: Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial. Trial registration: clinicaltrials.gov Identifier: NCT00017953.

Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure - The trials of hypertension prevention, phase II

Article

Mar 1997
ARCH INTERN MED

Objective: To provide a firmer basis for preventing high blood pressure (BP), we tested interventions to promote weight loss, dietary sodium reduction, and their combination for lowering diastolic BP, systolic BP, and the incidence of hypertension during a 3- to 4-year period. Methods: We conducted a randomized, 2x2 factorial, clinical trial, with BP levels measured by blinded observers. Nine academic medical centers recruited 2382 men and women (age range, 30-54 years) not taking antihypertensive drugs, with a diastolic BP of 83 to 89 mm Hg, a systolic BP lower than 140 mm Hg, and a body mass index (the weight in kilograms divided by the square of the height in meters) representing 110% to 165% of desirable body weight. Counseling aimed at helping participants achieve their desirable weight or a 4.5-kg or more weight reduction (in the weight loss and combined groups) and/or sodium intake of 80 mmol/d (in the sodium reduction and combined groups) was provided. Results: From baseline, participants' weight decreased by 4.3 to 4.5 kg at 6 months and by approximately 2 kg at 36 months in the weight loss and combined groups compared with weight changes in the usual care group (all groups, P<.001). Sodium excretion decreased 50 and 40 mmol/d at 6 and 36 months, respectively, in the sodium reduction group and about 15 mmol/d less at each time point in the combined group compared with the usual care group (all groups, P<.01). Compared with the usual care group, BP decreased 3.7/2.7 mm Hg in the weight loss group, 2.9/1.6 mm Hg in the sodium reduction group, and 4.0/2.8 mm Hg in the combined group at 6 months (all groups, P<.001). At 36 months, BP decreases remained greater in the active intervention groups than in the usual care group (weight loss group, 1.3/0.9 mm Hg; sodium reduction group, 1.2/0.7 mm Hg; combined group, 1.1/0.6 mm Hg). Differences were statistically significant for systolic and diastolic BP in the weight loss group and for systolic BP in the sodium reduction group. Through 48 months, the incidence of hypertension (BP greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic or the use of antihypertensive drugs) was significantly less in each active intervention group than the usual care group (average relative risks, 0.78-0.82). Conclusions: In overweight adults with high-normal BP, weight loss and reduction in sodium intake, individually and in combination, were effective in lowering systolic and diastolic BP, especially in the short-term (6 months). Although the effects on average BP declined over time, reductions in hypertension incidence were achieved.

Comparison of Methods for Delivering a Lifestyle Modification Program for Obese Patients

Article

Feb 2009

Andres G. Digenio

The combination of sibutramine and lifestyle counseling induced a clinically and statistically significant weight loss at 6 months in all intervention groups ranging from 5.2% (SELF) to 8.9% (HF-F2F) of initial weight (from 4.5% to 7.5% by using the last observation carried forward). Therefore, we confirmed our hypothesis that overweight and obese patients lost the most weight when exposed to frequent face-to-face dietitian contact and lost the least weight when assigned to a self-help intervention. The HF-F2F group also had the highest percentage of participants who lost at least 5% of their baseline body weight (62%). These results are consistent with those of a recent study (4) that also combined sibutramine with a lifestyle modification program. The higher frequency of the behavioral intervention, which included weekly meetings during the first 18 weeks, the group format of the counseling sessions, and a higher dose of sibutramine (15 mg/d), could explain the greater weight loss seen in that study (estimated at about 11% at 6 months) (4). Contact frequency proved to be an important factor for weight-loss success in our study because for the same type of contact, the LF-F2F group, which had only monthly counseling, yielded statistically significantly lower weight loss (6.4% for repeated-measures approach and 5.4% for last observation carried forward) than did the HF-F2F group at 6 months.

Treatment of Obesity in Primary Care Practice: The Practice Based Opportunities for Weight Reduction (POWER) Trial at Johns Hopkins

Article

Oct 2009

Effects of Comprehensive Lifestyle Modification on Diet, Weight, Physical Fitness, and Blood Pressure Control: 18-Month Results of a Randomized Trial

Article

Apr 2006

Patricia J. Elmer

Background: The main 6-month results from the PREMIER trial showed that comprehensive behavioral intervention programs improve lifestyle behaviors and lower blood pressure. Objective: To compare the 18-month effects of 2 multicomponent behavioral interventions versus advice only on hypertension status, lifestyle changes, and blood pressure. Design: Multicenter, 3-arm, randomized trial conducted from January 2000 through November 2002. Setting: 4 clinical centers and a coordinating center. Patients: 810 adult volunteers with prehypertension or stage 1 hypertension (systolic blood pressure, 120 to 159 mm Hg; diastolic blood pressure, 80 to 95 mm Hg). Interventions: A multicomponent behavioral intervention that implemented long-established recommendations ("established"); a multicomponent behavioral intervention that implemented the established recommendations plus the Dietary Approaches to Stop Hypertension (DASH) diet ("established plus DASH"); and advice only. Measurements: Lifestyle variables and blood pressure status. Follow-up for blood pressure measurement at 18 months was 94%. Results: Compared with advice only, both behavioral interventions statistically significantly reduced weight, fat intake, and sodium intake. The established plus DASH intervention also statistically significantly increased fruit, vegetable, dairy, fiber, and mineral intakes. Relative to the advice only group, the odds ratios for hypertension at 18 months were 0.83 (95% Cl, 0.67 to 1.04) for the established group and 0.77 (Cl, 0.62 to 0.97) for the established plus DASH group. Although reductions in absolute blood pressure at 18 months were greater for participants in the established and the established plus DASH groups than for the advice only group, the differences were not statistically significant. Limitations: The exclusion criteria and the volunteer nature of this cohort may limit generalizability. Although blood pressure is a well-accepted risk factor for cardiovascular disease, the authors were not able to assess intervention effects on clinical cardiovascular events in this limited time and with this sample size. Conclusions: Over 18 months, persons with prehypertension and stage 1 hypertension can sustain multiple lifestyle modifications that improve control of blood pressure and could reduce the risk for chronic disease.

Screening and Interventions for Obesity in Adults: Summary of the Evidence for the U.S. Preventive Services Task Force

Article

Dec 2003

Kathleen M Mctigue

Background: Obesity poses a considerable and growing health burden. This review examines evidence for screening and treating obesity in adults. Data Sources: MEDLINE and Cochrane Library (January 1994 through February 2003). Study Selection: Systematic reviews; randomized, controlled trials; and observational studies of obesity's health outcomes or efficacy of obesity treatment. Data Extraction: Two reviewers independently abstracted data on study design, sample, sample size, treatment, outcomes, and quality. Data Synthesis: No trials evaluated mass screening for obesity, so the authors evaluated indirect evidence for efficacy. Pharmacotherapy or counseling interventions produced modest (generally 3 to 5 kg) weight loss over at least 6 or 12 months, respectively. Counseling was most effective when intensive and combined with behavioral therapy. Maintenance strategies helped retain weight loss. Selected surgical patients lost substantial weight (10 to 159 kg over 1 to 5 years). Weight reduction improved blood pressure, lipid levels, and glucose metabolism and decreased diabetes incidence. The internal validity of the treatment trials was fair to good, and external validity was limited by the minimal ethnic or gender diversity of volunteer participants. No data evaluated counseling harms. Primary adverse drug effects included hypertension with sibutramine (mean increase, 0 mm Hg to 3.5 mm Hg) and gastrointestinal distress with orlistat (1% to 37% of patients). Fewer than 1% (pooled samples) of surgical patients died; up to 25% needed surgery again over 5 years. Conclusions: Counseling and pharmacotherapy can promote modest sustained weight loss, improving clinical outcomes. Pharmacotherapy appears safe in the short term; long-term safety has not been as strongly established. In selected patients, surgery promotes large amounts of weight loss with rare but sometimes severe complications.

Long-Term Weight Loss and Changes in Blood Pressure: Results of the Trials of Hypertension Prevention, Phase II

Article

Jan 2001

Victor J Stevens

Background: Weight loss appears to be an effective method for primary prevention of hypertension. However, the long-term effects of weight loss on blood pressure have not been extensively studied. Objective: To present detailed results from the weight loss arm of Trials of Hypertension Prevention (TOHP) II. Design: Multicenter, randomized clinical trial testing the efficacy of lifestyle interventions for reducing blood pressure over 3 to 4 years. Participants in TOHP II were randomly assigned to one of four groups. This report focuses only on participants assigned to the weight loss (n = 595) and usual care control (n = 596) groups. Patients: Men and women 30 to 54 years of age who had nonmedicated diastolic blood pressure of 83 to 89 mm Hg and systolic blood pressure less than 140 mm Hg and were 110% to 165% of their ideal body weight at baseline. Intervention: The weight loss intervention included a 3-year program of group meetings and individual counseling focused on dietary change, physical activity, and social support. Measurements: Weight and blood pressure data were collected every 6 months by staff who were blinded to treatment assignment Results: Mean weight change from baseline in the intervention group was -4.4 kg at 6 months, -2.0 kg at 18 months, and -0.2 kg at 36 months. Mean weight change in the control group at the same time points was 0.1, 0.7, and 1.8 kg. Blood pressure was significantly lower in the intervention group than in the control group at 6, 18, and 36 months. The risk ratio for hypertension in the intervention group was 0.58 (95% Cl, 0.36 to 0.94) at 6 months, 0.78 (Cl, 0.62 to 1.00) at 18 months, and 0.81 (Cl, 0.70 to 0.95) at 36 months. In subgroup analyses, intervention participants who lost at least 4.5 kg at 6 months and maintained this weight reduction for the next 30 months had the greatest reduction in blood pressure and a relative risk for hypertension of 0.35 (Cl, 0.20 to 0.59). Conclusions: Clinically significant long-term reductions in blood pressure and reduced risk for hypertension can be achieved with even modest weight loss.