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
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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):
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 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 May 21, 2013