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


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


BACKGROUND
NCT00572520.
Schneider
Kristin L
KL
Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA, USA. kristin.schneider@umassmed.edu
Bodenlos
Jamie S
JS
Ma
Yunsheng
Y
Olendzki
Barbara
B
Oleski
Jessica
J
Merriam
Philip
P
Crawford
Sybil
S
Ockene
Ira S
IS
Pagoto
Sherry L
SL
D000328:Adult; D000368:Aged; D001521:Behavior Therapy; D015897:Comorbidity; D003865:Major Depressive Disorder / Q000453:epidemiology* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology* / Q000628:therapy*; D012107:Research Design; D055815:Young Adult
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