Behavioral & Pharmacologic Therapy of Adolescent Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)0 sites120 target enrollmentSeptember 21, 2005

ConditionsProtocol #1:Behavioral Therapy + Placebo or Sibutramine Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food

DrugsSibutramine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Protocol #1:Behavioral Therapy + Placebo or Sibutramine
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment: 120
Primary Endpoint: Weight
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Protocol #1:The goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program.

Protocol #2: This study aims to improve the behavioral treatment of obesity during adolescence. A behavioral program using regular foods will be compared to a behavioral program using a structured meal plan (a portion-controlled approach with liquid-meal replacements [nutritional supplements]). This structured approach may be better for the promotion of weight loss compared to a diet of regular foods.

Registry

clinicaltrials.gov

Start Date

September 21, 2005

End Date

August 2007

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria

Inclusion Criteria

•Body Mass Index (BMI) between 28-50 kg/m2

Exclusion Criteria

•Severe cardiovascular problems; arrhythmias
•Hypertension, uncontrolled (blood pressure \>140/90 mm Hg)
•Diabetes mellitus (Fasting glucose \> 126)
•Other serious medical disorders that would complicate dieting such as: Ulcer disease, cancer, thrombophlebitis, liver or kidney disease
•Current use of weight loss medications, amphetamines, steroids, or aspirin; medications affecting body weight
•Mental retardation or genetic syndromes associated with obesity
•Currently pregnant or planning a pregnancy or engaging in sexual activity without using contraceptives. All females will have a serum pregnancy test at baseline and all must agree to use contraception if they are sexually active during the study.
•History of major depression, bipolar disorder, or psychosis
•History of anorexia or bulimia
•Alcoholism and other substance abuse