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Adolescent Weight Management Study

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ClinicalTrials.gov Identifier: NCT00212173
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 17, 2015
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Protocol #1:Behavioral Therapy + Placebo or Sibutramine Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food Drug: Sibutramine Dietary Supplement: Slim Fast

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Behavioral & Pharmacologic Therapy of Adolescent Obesity
Study Completion Date : August 2007
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Weight
  2. BMI

Secondary Outcome Measures :
  1. Blood Pressure
  2. Lipids
  3. Glucose
  4. Insulin

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00212173     History of Changes
Other Study ID Numbers: DK54713 (completed 2007)
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

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
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents