Adolescent Weight Management Study

Study Overview
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Brief Summary
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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.

Official Title
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Behavioral & Pharmacologic Therapy of Adolescent Obesity

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

Intervention / Treatment
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* Drug: Sibutramine
* Dietary Supplement: Slim Fast


Participation Criteria
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Eligibility Criteria
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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. Glaucoma History of major depression, bipolar disorder, or psychosis History of anorexia or bulimia Alcoholism and other substance abuse Use of anti-psychotic or anti-depressant medications in the last 6 months Highly dysfunctional family system or parental psychopathology Weight loss in the preceding 6 months of 5% or more and/or participation in another weight loss program Cigarette smoking or recent cessation If taking medication for hypertension or hypercholesterolemia condition must be stable for at least 3 months prior to enrollment in the study Chronic use of decongestants Intolerance of SlimFast

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sibutramine|nan|
|Dietary Supplement: Slim Fast|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  |  | 
| BMI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  |  | 
| Lipids |  |  | 
| Glucose |  |  | 
| Insulin |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Weight Management, Obesity Treatment, Behavioral Treatment