Adolescent Weight Management Study

National Institutes of Health (NIH)

Status

Completed

Conditions

Protocol #1:Behavioral Therapy + Placebo or Sibutramine

Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food

Treatments

Dietary Supplement: Slim Fast

Drug: Sibutramine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00212173

DK54713 (completed 2007)

Details and patient eligibility

About

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.

Sex

All

Ages

13 to 17 years old

Volunteers

Accepts Healthy Volunteers

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