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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014