Official Title: “Behavioral & Pharmacologic Therapy of Adolescent Obesity”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Behavioral: #1 sibutramine #2 Slim-Fast

Primary Measures

• Weight
• BMI

Secondary Measures

• Blood Pressure
• Lipids
• Glucose
• Insulin

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

Robert I Berkowitz, MD Principal Investigator Children's Hospital of Philadelphia  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00212173

Study ID Number: DK54713

ClinicalTrials.gov Identifier: NCT00212173

Health Authority: United States: Food and Drug Administration