Adolescent Weight Management Study

This study has been completed.

First Received on September 13, 2005. Last Updated on April 18, 2011 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Behavioral & Pharmacologic Therapy of Adolescent Obesity

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

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
Study Completion Date:	August 2007

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

Publications:

Berkowitz RI, Wadden TA, Gehrman CA, Bishop-Gilyard CT, Moore RH, Womble LG, Cronquist JL, Trumpikas NL, Levitt Katz LE, Xanthopoulos MS. Meal Replacements in the Treatment of Adolescent Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2010 Dec 9; [Epub ahead of print]

Bishop-Gilyard CT, Berkowitz RI, Wadden TA, Gehrman CA, Cronquist JL, Moore RH. Weight Reduction in Obese Adolescents With and Without Binge Eating. Obesity (Silver Spring). 2010 Oct 14; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00212173 History of Changes
Other Study ID Numbers:	DK54713 (completed 2007)
Study First Received:	September 13, 2005
Last Updated:	April 18, 2011
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

Additional relevant MeSH terms:

Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012