At a glance
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Use of Pharmacotherapy to Improve Weight Loss in Early Non-responders to Behavioral Treatment
In Brief
A Phase 4 clinical trial evaluating Behavioral Treatment, Placebo, and 1 other intervention for Obesity. Completed, enrolled 147 participants across 1 site.
Detailed Summary
This is a two-phase study. Phase 1 will evaluate obesity-related behavioral and biological characteristics as potential predictors of response to behavioral treatment (BT) for weight loss. Phase 2 is a double-blind, placebo-controlled, RCT to test whether adding weight loss medication to BT improves 24-week weight loss, as compared to BT with placebo, in subjects identified as having suboptimal early weight loss after 4 weeks of individual behavioral weight control. All participants, regardless of their early weight loss, will receive the same BT program of diet, physical activity, and behavior therapy for weight loss for an additional 24 weeks (28 total weeks of treatment).
Study Details
Timeline
Interventions
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.