Adolescent Weight Management Study

Condition(s) targeted: Protocol #1:Behavioral Therapy + Placebo or Sibutramine; Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food

Intervention: #1 sibutramine #2 Slim-Fast (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Robert I Berkowitz, MD, Principal Investigator, Affiliation: Children's Hospital of Philadelphia

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: Behavioral & Pharmacologic Therapy of Adolescent Obesity

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

Primary outcome:

Weight

BMI

Secondary outcome:

Blood Pressure

Lipids

Glucose

Insulin

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

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

Last updated: October 26, 2006