Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons

NCT00516919

Obesity Binge Eating

COMPLETED PHASE4

Testing Intervention Strategies for Addressing Obesity and Binge Eating

NCT04771455

Obesity Binge Eating

COMPLETED NA

Bariatric Scalable Internet Treatments

NCT03680703

Bariatric Surgery Weight Loss

COMPLETED NA

Adaptive Responses to Overfeeding and Weight

NCT03857048

Obesity

UNKNOWN NA

Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms

NCT01854320

Acceptance-based Treatment Standard Behavioral Treatment

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Binge Eating

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Standard Care

Group Type ACTIVE_COMPARATOR

Behavioral Weight Loss

Intervention Type BEHAVIORAL

weekly individual sessions for 6 months

2

Stepped-care

Group Type EXPERIMENTAL

Behavioral Weight Loss

Intervention Type BEHAVIORAL

weekly individual sessions for 6 months

Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy

Intervention Type BEHAVIORAL

weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months

Placebo

Intervention Type DRUG

One pill daily

Sibutramine/Orlistat

Intervention Type DRUG

Sibutramine 15 mg daily or Orlistat 120mg TID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Weight Loss

weekly individual sessions for 6 months

Intervention Type BEHAVIORAL

Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy

weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months

Intervention Type BEHAVIORAL

Placebo

One pill daily

Intervention Type DRUG

Sibutramine/Orlistat

Sibutramine 15 mg daily or Orlistat 120mg TID

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes