Adolescent Weight Management Study

Not Applicable

Completed

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

• Registration Number: NCT00212173
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2007-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Weight
BMI

Secondary Outcome Measures

Name	Time	Method
Lipids
Glucose
Insulin
Blood Pressure