Adolescent Weight Management Study

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00212173
First received: September 13, 2005
Last updated: April 18, 2011
Last verified: April 2011
  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:


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
Investigators
Principal Investigator: Robert I Berkowitz, MD Children's Hospital of Philadelphia
  More Information

Publications:
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 April 23, 2014