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Weight Control in the Physician's Office
Judith M. Ashley, PhD, RD;
Sachiko T. St Jeor, PhD;
Jon P. Schrage, MD, MPA;
Suzanne E. Perumean-Chaney, MS;
Mary C. Gilbertson, PhD, RD;
Nanette L. McCall, RD;
Vicki Bovee, MS, RD
Arch Intern Med. 2001;161:1599-1604.
ABSTRACT
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Background Lifestyle changes involving diet, behavior, and physical activity are
the cornerstone of successful weight control. Incorporating meal replacements
(1-2 per day) into traditional lifestyle interventions may offer an additional
strategy for overweight patients in the primary care setting.
Methods One hundred thirteen overweight premenopausal women (mean ± SD
age, 40.4 ± 5.5 years; weight, 82 ± 10 kg; and body mass index,
30 ± 3 kg/m2) participated in a 1-year weight-reduction
study consisting of 26 sessions. The women were randomly assigned to 3 different
traditional lifestyle-based groups: (1) dietitian-led group intervention (1
hour per session), (2) dietitian-led group intervention incorporating meal
replacements (1 hour per session), or (3) primary care office intervention
incorporating meal replacements with individual physician and nurse visits
(10-15 minutes per visit).
Results For the 74 subjects (65%) completing 1 year, the primary care office
intervention using meal replacements was as effective as the traditional dietitian-led
group intervention not using meal replacements (mean ± SD weight loss,
4.3% ± 6.5% vs 4.1% ± 6.4%, respectively). Comparison of the
dietitian-led groups showed that women using meal replacements maintained
a significantly greater weight loss (9.1% ± 8.9% vs 4.1% ± 6.4%)
(P = .03). Analysis across groups showed that weight
loss of 5% to 10% was associated with significant (P
= .01) reduction in percentage of body fat, body mass index, waist circumference,
resting energy expenditure, insulin level, total cholesterol level, and low-density
lipoprotein cholesterol level. Weight loss of 10% or greater was associated
with additional significant (P = .05) improvements
in blood pressure and triglyceride level.
Conclusions A traditional lifestyle intervention using meal replacements can be
effective for weight control and reduction in risk of chronic disease in the
physician's office setting as well as in the dietitian-led group setting.
INTRODUCTION
RECENT SURVEYS have shown that Americans are getting heavier, with an
estimated 97 million adults classified as overweight or obese.1
Obesity fulfills the criteria of a chronic disease and is associated with
considerable increases in morbidity and mortality. It is lifelong or lasts
many years, is progressive and relapsing, and is associated with a wide range
of comorbid conditions, including coronary heart disease, type 2 diabetes,
hypertension, and dyslipidemia.1 The direct
cost of obesity is estimated to be almost 6% of our national health expenditure,
but the relative costs and benefits of various approaches to control obesity
are not available.2
The vast majority of the excess burden of overweight and obesity is
in those subjects with a moderately high body mass index (BMI).3
The traditional goal of therapy has been the reduction of a subject to "an
ideal weight," a difficult task for those faced with this condition. However,
new guidelines based on more recent evidence suggest that small weight losses
(5%-10% of initial body weight) can improve obesity-related health complications.1, 3-8
In addition, the maintenance of modest reductions, even with partial weight
regain, is frequently sufficient to sustain improvements in health,9-10 particularly if healthy diets and
increases in physical activity are maintained.
Physician recommendations have consistently been shown to exert a powerful
influence on patient behavior.11-12
Unfortunately, the health care community as a whole is not as active as it
might be in the treatment of obesity as a chronic disease.13-14
In a recent national survey, nearly 40% of women and 25% of men who were overweight
or obese reported having ever received medical counseling about the adverse
health consequences of increased weight.15
To encourage health providers to increase their involvement in obesity management,
effective and practical lifestyle intervention options that can be delivered
in a busy clinical setting are needed.14, 16
Recent reports indicate that meal replacements coupled with a low-calorie
diet can offer an effective option for long-term compliance or improvements
in metabolic risk factors in clinic patients.17-20
These studies examined a meal-replacement intervention in a university-based
clinic, in a community-based intervention program, or with minimal clinic
intervention. The present study is the first randomized trial to compare the
use of meal replacements in an established university-based weight loss clinic
and a primary care physician practice.
This 1-year study was designed to address 2 main questions regarding
diet and weight loss in moderately overweight and obese subjects. First, can
a primary care physician implement a successful long-term lifestyle change
using meal replacements within the time constraints existing in the general
office practice of medicine? Second, can a traditional lifestyle-modification
program administered by a registered dietitian using a meal-replacement strategy
be as effective as the same program using a standard food plan exchange strategy?
A further aim of this study was to evaluate the potential health benefits
of sustained weight loss for specific chronic disease risk factors associated
with the moderately overweight and obese.
SUBJECTS AND METHODS
SUBJECTS
Overweight or obese premenopausal women aged 25 to 50 years with a BMI
(calculated as weight in kilograms divided by the square of height in meters)
between 25 and 35 were selected from a larger sample responding to media announcements
and flyers distributed in the local community. After being screened by a telephone
questionnaire, interested women attended a group orientation meeting, at which
the objectives and protocols of the study were explained before written consent
was obtained. Exclusion criteria included current chronic or psychological
disease, abnormal serum laboratory values of clinical significance, or current
hormone-replacement therapies. In addition, women were excluded who were pregnant,
planning to become pregnant, lactating, or planning to move out of the area
within the following year. Eligible women were scheduled for a 1-hour clinic
assessment to determine their fasting serum chemistry, lipid, insulin, and
glucose values; weight; height; BMI; waist circumference; body fat percentage,
resting energy expenditure (kilocalories per 24 hours); blood pressure; dieting
history; eating and activity habits; and psychosocial status. Only those subjects
who obtained a medical release form signed by their physician were admitted
to the study. There were no costs to subjects for assessment measures, lifestyle-modification
materials, consultations (whether provided in the physician's office or in
groups), or meal-replacement products. The University of Nevada Human Subjects
Committee approved all procedures used in this study.
LIFESTYLE INTERVENTION
Subjects were randomly assigned to 1 of 3 interventions, as described
below. All subjects attended a total of 26 sessions during the 1-year study
and received instruction manuals that included lessons based on the Lifestyle,
Exercise, Attitude, Relationships, and Nutrition (LEARN) Program for Weight
Control.21 At each session, 1 of 26 intervention
lessons of the treatment manuals was distributed to subjects. Diet instruction
included a low-calorie diet of approximately 1200 kcal/d (with no more than
30% of calories from fat) using the US Department of Agriculture food guide
pyramid food groups and portion sizes to ensure adequate nutrients and a variety
of foods. Activity instruction as a method of self-motivation included increasing
energy expenditure by walking up to 10 000 steps a day as measured by
a pedometer (Yamax Digi-Walker; Yamax Inc, Tokyo, Japan) that was supplied
to each participant. Subjects completed homework assignments that recommended
recording food intake and activity levels. There were 3 traditional lifestyle-based
intervention groups:
Group 1: Traditional Dietitian-Led Intervention Group
Subjects in group 1 (n = 37) attended small classes (8-10 subjects per
class) led by a registered dietitian. A total of 26 one-hour sessions were
held weekly for the first 3 months (introduction and 12 sessions), biweekly
for the second 3 months (6 sessions), and monthly for the final 6 months (6
sessions and a 1-year session). The diet consisted of all meals and snacks
prepared from self-selected conventional foods following 1200 kcal/d using
the US Department of Agriculture food guide pyramid.
Group 2: Traditional Dietitian-Led Intervention Group Incorporating
Meal Replacements
Similar to group 1, subjects in this intervention group (n = 38) also
attended small classes led by a registered dietitian, including the 26 sessions
held on the same weekly, biweekly, and monthly schedule. This group followed
similar self-selected diets; however, 2 of the 3 main meals (breakfast, lunch,
or dinner) were replaced with meal-replacement shakes or meal-replacement
bars (Slim · Fast; Slim · Fast Foods Co, West Palm Beach, Fla).
Each liquid meal-replacement shake contained 220 kcal, 7 to 10 g of protein,
40 to 46 g of carbohydrates (of which 5 g was dietary fiber), and 1.5 to 3
g of fat, and was supplemented with 15% to 100% of the percentage of daily
value for essential vitamins and minerals. Each meal-replacement bar contained
220 kcal, 8 g of protein, 33 to 36 g of carbohydrates, 5 g of fat, and 2 g
of dietary fiber, and was supplemented with 25% to 35% of the percentage of
daily value for essential vitamins and minerals.
Meal-replacement shakes were supplied through coupons that the subjects
redeemed at local stores, while meal-replacement bars were distributed at
scheduled group sessions.
Group 3: Primary Care Office Intervention Incorporating Meal Replacements
With Individual Physician and Nurse Visits
Subjects in this intervention group (n = 38) met with a primary care
physician or a registered nurse at intervals similar to those routinely prescribed
for other types of long-term medical care. The focus of these brief visits
was to help the patients achieve their weight goal, although related medical
problems were also addressed. During the study, the patients were seen by
the same physician (for two thirds of the visits) and the same registered
nurse (for one third of the visits), both of whom were practitioners in our
university outpatient practice. Biweekly visits (26 sessions) lasted 10 to
15 minutes (approximately equal time with each subject) for a year, so that
the total number of sessions was the same as for groups 1 and 2. The diet
prescription in this group was identical to that for group 2, using self-selected
diets with meal-replacement shakes and bars. During the structured physician
or nurse visits, each subject's progress was reviewed, including diet, behavior
modification, and physical activity habits. Any brief questions about the
LEARN-based instruction manual lessons were addressed. These subjects received
no further counseling during the year.
Subjects in groups 2 and 3 who reached their goal weight (a loss of
10% of initial body weight) were instructed to replace 1 of 3 main meals each
day with a meal-replacement shake or bar. If a subject regained weight, she
was instructed to reinitiate the 2-mealreplacement plan until she lost
the regained weight.
DEPENDENT MEASURES
Milestone measures were taken at baseline and 1 year and included weight,
height, waist circumference, skinfolds, resting energy expenditure, and blood
pressure. Certified technicians took blood pressure and body measurements.
Fasting blood was taken to measure serum lipid levels (total cholesterol,
low-density lipoprotein cholesterol, high-density lipoprotein cholesterol,
triglyceride levels) and glucose and insulin levels. Blood values were analyzed
by standard methods at a statewide certified clinical laboratory (Laboratory
Corporation of America, Reno, Nev). Weight measurements (to the nearest 0.1
kg) were taken using the study's calibrated balance beam scale with patients
dressed in light clothing without shoes; height measurements (to the nearest
0.10 cm) were taken using a mounted wall stadiometer; and BMI was calculated.
Waist circumference was measured at the narrowest point of the torso (to the
nearest 0.5 cm) using a nonstretchable tape measure. Skinfolds (triceps, thigh,
and superior iliac crest) were measured (to the nearest 0.1 mm) with a Lange
caliper (Cambridge Scientific Industries, Cambridge, Md) and used to calculate
percentage of body fat.22 Twenty-fourhour
resting energy expenditure (kilocalories) was estimated from a 20-minute respiratory
sample in fasting subjects using a ventilated canopy hood by indirect calorimetry
as previously reported23 (Sensor Medics, Anaheim,
Calif). Blood pressure was measured on the right arm using a mercury-column
manometer to the nearest millimeter of mercury after the fasting subject had
been seated quietly for 5 minutes.
STATISTICS
All data are presented as mean ± SD. The primary dependent variable,
weight change, was examined by 1-way analysis of variance with subsequent
a priori analyses using contrasts for completers and for all subjects by intent
to treat (last observation carried forward). Secondary dependent variables,
percentage of weight loss from initial body weight, total cholesterol level
of 220 mg/dL or greater ( 5.7 mmol/L), and systolic/diastolic blood pressure
of 140/90 mm Hg or greater were recoded into dichotomous variables (collapsing
across the 3 intervention conditions). The mean differences for these variables
were assessed with independent t tests. The SPSS
statistical package (version 7; SPSS Inc, Chicago, Ill) was used to analyze
the data for statistical significance.
RESULTS
WEIGHT AND RISK FACTOR COMPARISONS BY INTERVENTION GROUP
The body weight results were evaluated for those subjects who completed
the 1-year study (74/113 [65%]), as well as for all 113 subjects enrolled.
This second evaluation followed the standard approach of intent to treat with
the last observation carried forward and provides an analysis of the programs,
taking into account those individuals who were not successful in completing
the program.
Subjects Completing the 1-Year Study
Of the 113 initial female subjects who met the inclusion criteria and
agreed to be randomly assigned to study groups, 74 (65%) completed the 1-year
study. Baseline characteristics of the 3 treatment groups are shown in Table 1. There were no significant differences
among the baseline parameters by treatment group. Retention rates among the
3 treatment groups were similar: ie, group 1, n = 23; group 2, n = 26; group
3, n = 25. Older subjects were more likely to remain in the study (t = 2.425; P = .02), as were those with a
higher initial percentage of body fat (t = 3.652; P<.001). Other baseline characteristics did not differ
between those subjects who chose to remain in the study and those who chose
to leave.
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Table 1. Baseline Characteristics*
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Weight change and the percentage of weight lost for the subjects who
completed the 1-year study are shown in Table 2. Subjects in group 2 (n = 26) had lost significantly more
weight than those in either group 1 (n = 23; P =
.03) or group 3 (n = 25; P = .03) at 1 year. Subjects
in group 2 showed a mean ± SD loss of 7.7 ± 7.8 kg (9.1% ±
8.9% of initial body weight), whereas subjects in group 1 and group 3 lost
3.4 ± 5.4 kg (4.1% ± 6.4% of initial body weight) and 3.5 ±
5.5 kg (4.3% ± 6.5% of initial body weight), respectively. Table 2 also shows that there was a significant
decrease in BMI in group 2 compared with group 1 (P
= .02).
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Table 2. Year-End Changes in Weight and Anthropometrics*
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All Subjects Enrolled in the Study (Intent to Treat)
Year-end changes in weight were also examined in the intent-to-treat
model. This analysis included all subjects (n = 113) enrolled in the study,
whether or not they completed the 1-year intervention. Results calculated
with the last weight value carried forward are shown in Figure 1. In this analysis, there was a significant difference in
weight loss and percentage weight loss between group 1 and group 2 (P = .008). Subjects in the groups using meal replacements
tended to have lost more weight at 1 year, with those in group 2 losing the
most weight. Those in group 2 lost, on average, 3.7 kg more than those in
group 1 (P = .008) and 3.0 kg more than those in
group 3 (P = .04). Thus, we drew similar conclusions
from this intent-to-treat analysis, although they were not of the same magnitude
as for the patients who completed the 1-year study.
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Changes in initial body weight over time (N = 113).
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PERCENTAGE WEIGHT LOSS AND RISK FACTOR IMPROVEMENT
Percentage Weight Loss Groups
To evaluate the reduction in chronic disease risk within levels of weight
loss, a secondary variable analysis was done using subgroups of subjects who
had lost weight in selected ranges after the 1-year study (59/74), regardless
of intervention group assignment. The first variable included those subjects
who had lost 5% or less of their initial body weight (n = 20); the second
variable included those who had lost 5% to 10% of their weight (n = 22); and
the third variable included those who had lost 10% or more of their weight
(n = 17) (Table 3). A loss in
initial body weight of more than 5% was associated with significant decreases
in body fat, BMI, waist circumference, resting energy expenditure, plasma
insulin level, total cholesterol level, and low-density lipoprotein cholesterol
level (P .05). In addition, subjects with weight
loss of more than 10% had significantly greater decreases in systolic and
diastolic blood pressure and plasma triglyceride level (P .05).
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Table 3. Change in Associated Risks Between Baseline and Year 1 by
Percentage Weight Loss*
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Cholesterol and Blood Pressure Changes
The data from subgroups of subjects at high risk for cardiovascular
disease based on baseline total cholesterol level or blood pressure were also
analyzed to determine the associations between 1-year changes and weight loss,
regardless of intervention group assignment. For the 25 subjects who had a
baseline total cholesterol level of 220 mg/dL or greater ( 5.7 mmol/L),
the difference between baseline and 1 year was significant (P = .001), with a mean reduction of 24.7 ± 30.9 mg/dL (0.64
± 0.80 mmol/L). For these higher-risk subjects, the improvements in
risk factors corresponded to a mean ± SD percentage weight loss of
4.1% ± 7.3%. For the 9 subjects who had a baseline systolic blood pressure
of 140 mm Hg or greater (only 1 subject had a baseline diastolic blood pressure 90
mm Hg), the difference between baseline and 1 year was significant (P = .02), with a mean ± SD reduction of 13.0 ±
16.4 mm Hg. For these higher-risk subjects, this difference corresponded to
a mean percentage weight loss of 11.0% ± 9.8%.
COMMENT
The brief primary care physician intervention incorporating meal replacements
achieved the same result as the dietitian-directed traditional group intervention
without meal replacements. In the 2 dietitian-led traditional groups, the
women using meal replacements maintained a greater weight loss. Thus, the
incorporation of a meal replacement into a traditional lifestyle intervention
was an independent contributor to the outcomes.
It has been shown previously that meal replacements are an effective
strategy for the long-term maintenance of weight loss as well as the promotion
of greater short-term weight loss compared with a traditional reduced-calorie
diet regimen.17-18 Using a pharmacotherapeutic
combination of fenfluramine and phentermine in a group of patients treated
with traditional group behavior modification or brief structured physician
visits, Wadden et al24 demonstrated significant
and equivalent weight loss in both groups. These findings indicate that physicians
can promote successful weight loss using pharmacological interventions. The
present study is the first attempt that incorporates long-term use of meal
replacements with a lifestyle intervention in a primary care practice and
in a traditional dietitian-led group weight control program.
The main finding in our study was that the primary care physician can
lead a successful lifestyle intervention for weight control with the appropriate
tools, ie, meal-replacement strategies and the LEARN manual. This study extends
the medical literature by suggesting that physicians can address overweight
and obese subjects in primary care in a way similar to that used for other
chronic disease risk factors. The Institute of Medicine of the National Academy
of Sciences has proposed that successful weight loss be defined as the reduction
in initial body weight of 5% or more and the maintenance of this loss for
at least 1 year.9 Subjects in the traditional
behavioral weight control program lost 3.4 ± 5.4 kg (4.1% ±
6.4% of body weight) over 52 weeks, whereas subjects provided with meal replacements
in addition to the traditional lifestyle program further improved their outcome,
with an average weight loss of 7.7 ± 7.8 kg (9.1% ± 8.9% weight
loss), meeting the established Institute of Medicine guidelines. However,
although the main findings of this study are both statistically and clinically
significant, the conclusions drawn may overstate the results since they are
based on completers, 65% of the initial group. Our second analysis using the
intent-to-treat model may also overestimate the degree of success, because
it is commonly assumed that individuals who drop out of a weight-control program
do so because they regain the weight. While this may be true in many instances,
a recent study using meal replacements reported that 22 (47%) of 47 subjects
who had dropped out of a 4-year study between 6 months and 27 months were
reweighed and found not to have regained the weight.18
Physicians often have the first opportunity to encourage weight control
and primary prevention. Their clinical offices are the mainstay for treatment
of obesity-related comorbid conditions.12, 15, 25-26
However, there remains considerable resistance on the part of many practitioners
to become actively involved with overweight and obese patients despite the
rapid increase in prevalence.13, 27
The reasons for this reluctance are varied, but include perceptions of the
causes of obesity, lack of training, insufficient office time to deal with
the difficulties patients face, limited staff support, difficulty with insurance
coverage, and the perceived poor long-term success rate.13, 25, 27
In our study, with intensive lifestyle modification and group support,
subjects in the physician-led group and the traditional behavior modification
group lost similar amounts of weight (3.4 ± 5.4 vs 3.5 ± 5.5
kg, respectively). This finding is particularly encouraging, since the markers
for disease risk were improved in many patients. The time required for weight
management by the physician was minimal and was patterned after the usual
clinic visit. Patients were able to educate themselves with written materials
at their own pace but were also able to discuss key concerns with the physician.
This personal advice provided by the physician has been shown to provide a
priming effect to help the patient make appropriate lifestyle changes.26
The significance of maintaining a healthy weight has been well established.1, 8, 10 Being overweight or
obese is associated with the development of a myriad of chronic diseases1 that, with the attainment and maintenance of a modest
weight loss, can be significantly improved.1, 8, 17-18
An extensive review1 of the causes of obesity
led a National Institutes of Health expert panel to conclude that significant
improvements in disease risk could be attained with moderate weight loss (5%-10%
reduction in initial weight). Abnormal metabolic changes are not uniformly
present in overweight individuals, and small numbers of moderately overweight
women, as a group, may not show a significant mean change in the biomarkers
measured. However, stratifying the patients in this study into specific weight
loss categories clearly demonstrated an improving health profile with increasing
weight loss regardless of treatment modality. Furthermore, the stratification
of subjects into groups with abnormally high initial biomarkers showed the
value of weight loss in improving the markers. Significant improvements in
lipid and lipoprotein levels were most apparent in those patients with cholesterol
blood levels of 220 mg/dL or greater ( 5.7 mmol/L) and in those experiencing
a weight loss greater than 5%. Blood pressure improvement in this population
was more sensitive and was significantly improved with a weight loss of 10%
or more of initial body weight.
In conclusion, effective approaches are needed for changes in weight
loss to reduce the risks of morbidity and mortality. This study demonstrates
that weight loss can be achieved using lifestyle counseling incorporating
meal-replacement strategies. For the physician, lifestyle counseling with
meal replacement provides a useful tool that allows easy explanation and has
demonstrated efficacy with patients. Although carried out in a university
outpatient setting, this study was designed to evaluate a meal-replacement
paradigm in the typical busy physician's office practice. Family practitioners
should undertake a similar program to deal with overweight and obese patients
in their practice. In addition, meal replacements can improve the magnitude
of weight loss in a traditional dietitian-led group intervention that includes
multiple sessions to promote changes in food selection, suggestions for increasing
physical activity, and appropriate behavior changes.
AUTHOR INFORMATION
Accepted for publication December 5, 2000.
Slim · Fast Nutrition Institute, West Palm Beach, Fla, provided
funding for the conduct of this study.
Corresponding author and reprints: Judith M. Ashley, PhD, RD, University
of Nevada School of Medicine, Nutrition Education and Research Program, Redfield
Building MS 153, Reno, NV 89557 (e-mail: jashley{at}scs.unr.edu).
From the Nutrition Education and Research Program (Drs Ashley, St Jeor,
Gilbertson, and Bovee and Mss Perumean-Chaney and McCall) and Department of
Internal Medicine (Dr Schrage), University of Nevada School of Medicine, Reno.
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Am. J. Clin. Nutr. 2007;85:651-661.
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Cardiovascular Risk Reduction: We Have the Will, But Do We Have the Way?
Terre
AMERICAN JOURNAL OF LIFESTYLE MEDICINE 2007;1:34-37.
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Meal Replacements Are as Effective as Structured Weight-Loss Diets for Treating Obesity in Adults with Features of Metabolic Syndrome
Noakes et al.
J. Nutr. 2004;134:1894-1899.
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Diabetes Diagnosis and Weight Loss in Middle-Aged Adults
Wray et al.
Research on Aging 2004;26:62-81.
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Screening and Interventions for Obesity in Adults: Summary of the Evidence for the U.S. Preventive Services Task Force
McTigue et al.
ANN INTERN MED 2003;139:933-949.
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Importance of Weight Management in Type 2 Diabetes: Review with Meta-analysis of Clinical Studies
Anderson et al.
J. Am. Coll. Nutr. 2003;22:331-339.
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One-Year Outcome of a Combination of Weight Loss Therapies for Subjects With Type 2 Diabetes: A randomized trial
Redmon et al.
Diabetes Care 2003;26:2505-2511.
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Treatment of Obesity: An Overview
Fabricatore and Wadden
Clin. Diabetes 2003;21:67-72.
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REAP and WAVE: New Tools to Rapidly Assess/Discuss Nutrition with Patients
Gans et al.
J. Nutr. 2003;133:556S-562.
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Evidence-Based Trends for Achieving Weight Loss and Increased Physical Activity: Applications for Diabetes Prevention and Treatment
Delahanty
Diabetes Spectr. 2002;15:183-189.
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Evidence-Based Nutrition Principles and Recommendations for the Treatment and Prevention of Diabetes and Related Complications
Franz et al.
Diabetes Care 2002;25:148-198.
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