Adolescent Weight Management Study

This study has been completed.

First Received: September 13, 2005 Last Updated: October 26, 2006 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00212173

Purpose

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.

Condition	Intervention
Protocol #1:Behavioral Therapy + Placebo or Sibutramine Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food	Behavioral: #1 sibutramine #2 Slim-Fast

MedlinePlus related topics: Obesity Obesity in Children

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Behavioral & Pharmacologic Therapy of Adolescent Obesity

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Weight
BMI

Secondary Outcome Measures:

Blood Pressure
Lipids
Glucose
Insulin

Estimated Enrollment:

120

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212173

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Robert I Berkowitz, MD

Children's Hospital of Philadelphia

More Information

No publications provided

Study ID Numbers:	DK54713
Study First Received:	September 13, 2005
Last Updated:	October 26, 2006
ClinicalTrials.gov Identifier:	NCT00212173 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Adolescent
Weight Management
Obesity Treatment
Behavioral Treatment

Study placed in the following topic categories:

Sibutramine
Body Weight
Anti-Obesity Agents
Obesity

Psychotropic Drugs
Appetite Depressants
Antidepressive Agents

Additional relevant MeSH terms:

Sibutramine
Anti-Obesity Agents
Therapeutic Uses
Psychotropic Drugs

Appetite Depressants
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009