Adolescent Weight Management Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 26, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Weight
BMI

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00212173 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood Pressure
Lipids
Glucose
Insulin

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Adolescent Weight Management Study

Official Title ^ICMJE

Behavioral & Pharmacologic Therapy of Adolescent Obesity

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Protocol #1:Behavioral Therapy + Placebo or Sibutramine
Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food

Intervention ^ICMJE

Behavioral: #1 sibutramine #2 Slim-Fast

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

13 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00212173

Responsible Party

Study ID Numbers ^ICMJE

DK54713

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Robert I Berkowitz, MD

Children's Hospital of Philadelphia

Information Provided By

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

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP