Adolescent Weight Management Study

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

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.

• 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