Protocol #1:Behavioral Therapy + Placebo or Sibutramine Clinical Trial
Official title:
Behavioral & Pharmacologic Therapy of Adolescent Obesity
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 13 Years to 17 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Berkowitz RI, Wadden TA, Gehrman CA, Bishop-Gilyard CT, Moore RH, Womble LG, Cronquist JL, Trumpikas NL, Levitt Katz LE, Xanthopoulos MS. Meal replacements in the treatment of adolescent obesity: a randomized controlled trial. Obesity (Silver Spring). 201 — View Citation
Bishop-Gilyard CT, Berkowitz RI, Wadden TA, Gehrman CA, Cronquist JL, Moore RH. Weight reduction in obese adolescents with and without binge eating. Obesity (Silver Spring). 2011 May;19(5):982-7. doi: 10.1038/oby.2010.249. Epub 2010 Oct 14. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight | |||
| Primary | BMI | |||
| Secondary | Blood Pressure | |||
| Secondary | Lipids | |||
| Secondary | Glucose | |||
| Secondary | Insulin |