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Open Access 01-12-2008 | Research article

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

Authors: Kristin L Schneider, Jamie S Bodenlos, Yunsheng Ma, Barbara Olendzki, Jessica Oleski, Philip Merriam, Sybil Crawford, Ira S Ockene, Sherry L Pagoto

Published in: BMC Psychiatry | Issue 1/2008

Abstract

Background

Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial.

Methods and design

This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined.

Discussion

Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes.

Trial registration

NCT00572520

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-244X/8/77/prepub

Title: Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder
Authors: Kristin L Schneider
Jamie S Bodenlos
Yunsheng Ma
Barbara Olendzki
Jessica Oleski
Philip Merriam
Sybil Crawford
Ira S Ockene
Sherry L Pagoto
Publication date: 01-12-2008
Publisher: BioMed Central
Published in: BMC Psychiatry / Issue 1/2008
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/1471-244X-8-77

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

Abstract

Background

Methods and design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods and design

Discussion

Trial registration

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