Randomized Trial of Lifestyle Modification and Pharmacotherapy for Obesity
Open accessAbstract
BACKGROUND: Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This practice is likely to limit therapeutic benefits. METHODS: In this one-year trial, we randomly assigned 224 obese adults to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in eight visits of 10 to 15 minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestyle-modification counseling (i.e., combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen. RESULTS: At one year, subjects who received combined therapy lost a mean (+/-SD) of 12.1+/-9.8 kg, whereas those receiving sibutramine alone lost 5.0+/-7.4 kg, those treated by lifestyle modification alone lost 6.7+/-7.9 kg, and those receiving sibutramine plus brief therapy lost 7.5+/-8.0 kg (P<0.001). Those in the combined-therapy group who frequently recorded their food intake lost more weight than those who did so infrequently (18.1+/-9.8 kg vs. 7.7+/-7.5 kg, P=0.04). CONCLUSIONS: The combination of medication and group lifestyle modification resulted in more weight loss than either medication or lifestyle modification alone. The results underscore the importance of prescribing weight-loss medications in combination with, rather than in lieu of, lifestyle modification.
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The decline in self-monitoring over time has been a consistent finding in several studies.
“This decline in self-monitoring over time has been a consistent finding in several studies (12, 22).”
From The Effect of Electronic Self‐Monitoring on Weight Loss and Dietary Intake: A Randomized Behavioral Weight Loss Trial (2011) · cites this paper as [22]
More consistent self-monitoring is significantly correlated with weekly weight loss.
“Early cross-sectional studies found that more consistent self-monitoring correlated significantly with weekly weight loss [21–23]. More recent studies have confirmed these earlier findings [24,25].”
From SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings (2009) · cites this paper as [25]
The design used in the trial is the current state of the science for standard behavioral treatment for weight loss.
“The design used in this trial is the current state of the science for standard behavioral treatment for weight loss”
From SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings (2009) · cites this paper as [53]
The 2-year duration of the trial is longer than most studies.
“the 2-year duration is longer than most studies [15,51–54].”
From SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings (2009) · cites this paper as [53]
Both observational data and clinical trial evidence demonstrate the importance of self-monitoring in achieving behavior change.
“Both observational data60–64 and evidence from clinical trials26–28,30,36,38,50,52 demonstrate the importance of self-monitoring in achieving behavior change.”
In a weight-loss study, individuals in a combined therapy group who frequently recorded their weight achieved more than twice the weight loss of those who recorded infrequently.
“In a study testing interventions to promote weight loss, individuals in a combined therapy group who frequently recorded their weight achieved more than twice the weight loss than those who recorded their weight infrequently.28”
Programs that incorporate scheduled follow-up sessions as a core component are generally more effective than single-session interventions.
“Compared with single-session interventions, the evidence suggests that programs that incorporate scheduled follow-up sessions as a core component are generally more effective.25,26,28,41,43,47,52,55,66–69”
Group-based interventions have been successful in both white and minority populations.
“Group-based interventions have been successful in both white28 and minority populations.76”
Group-based approaches are commonly used in randomized clinical trials employing standard behavioral interventions for weight loss, as well as in other trials using diet and physical activity changes to target cardiovascular risk factors such as blood pressure or blood cholesterol.
“Group-based approaches are commonly used in randomized clinical trials employing standard behavioral interventions for weight loss,24,25,28,29,66,72,109 as well as in other trials using diet and PA changes to target CVD risk factors such as BP or blood cholesterol.23,26,27,56,66,67,113”
The STEP 3 study did not suggest fully additive weight loss when intensive behavioral therapy was combined with semaglutide, unlike when intensive behavioral therapy was combined with anti-obesity medications producing 5-6% weight reduction.
“Thus, the study did not suggest the occurrence of fully additive weight loss, which had been observed when IBT was combined with AOM that produced a mean reduction of only 5%−6% of initial weight.(43)”
From Semaglutide for the treatment of obesity (2023) · cites this paper as [43]
The combination of pharmacotherapy and lifestyle modification results in more weight loss than either approach used alone.
“even though several studies have suggested that the combination of pharmacotherapy and lifestyle modification results in more weight loss than either approach used alone [1, 12, 13].”
There are no approved weight management drugs for use in patients who had BS.
“Thus, there are no approved weight management drugs for use in patients who had BS, even though several studies have suggested that the combination of pharmacotherapy and lifestyle modification results in more weight loss than either approach used alone [1, 12, 13].”
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- Authors
- Wadden, T. A., Berkowitz, R. I., Womble, L. G., Sarwer, D. B., Phelan, S., Cato, R. K., Hesson, L. A., Osei, S. Y., Kaplan, R., & Stunkard, A. J.
- Affiliations
- University of Pennsylvania (US)
- Children's Hospital of Philadelphia (US)
- Brown University (US)
- GlaxoSmithKline (United States) (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2005-11-17
- Volume
- 353
- Issue
- 20
- Pages
- 2111-2120
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2133783450
- Cited by
- 794
- References
- 27
- Citations by year
- 2026: 12 · 2025: 14 · 2024: 18 · 2023: 17 · 2022: 23 · 2021: 18 · 2020: 18 · 2019: 25 · 2018: 18 · 2017: 28 · 2016: 37 · 2015: 33 · 2014: 38 · 2013: 51 · 2012: 53
- FWCI
- 46.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5k24dk065018-10)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK056124, DK-56124, DK065018)
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
- Health Sciences › Health Professions › Pharmacy › Obesity and Health Practices
- Keywords
- obesity, anti-obesity drugs, sibutramine, lifestyle modification, group counseling, combination therapy, weight loss, primary care, diet and exercise
- MeSH terms
- Adult, Appetite Depressants, Cardiovascular Diseases, Combined Modality Therapy, Counseling, Cyclobutanes, Female, Humans, Life Style, Male, Middle Aged, Obesity, Psychotherapy, Group, Risk Factors, Weight Loss, Exercise, Selective Serotonin Reuptake Inhibitors
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