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OpenTrials
Completed

NCT Number: NCT00212173

Adolescent Weight Management Study

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.

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Key information

Conditions

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

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sibutramine

Drug

Slim Fast

Dietary Supplement

Primary outcomes

  1. Weight

  2. BMI

Secondary outcomes

  1. Blood Pressure

  2. Lipids

  3. Glucose

  4. Insulin

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

Behavioral & Pharmacologic Therapy of Adolescent Obesity

Important dates

Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.