N/A
N=191
Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
Obesity · Binge Eating
Bottom Line
View on ClinicalTrials.gov: NCT00829283 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Subjects Who Reached Binge Eating Remission — 16; 65 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Weight Loss (Behavioral); Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy (Behavioral); Placebo (Drug); Sibutramine/Orlistat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Reached Binge Eating Remission |
16; 65 | — |
| SECONDARY BMI |
35.9; 37.1 | — |
Summary
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
Eligibility Criteria
Inclusion criteria
- Obese (BMI>=30)
Exclusion criteria
- Medication regimen that represents medical contraindication to sibutramine
- Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00829283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.