Status:
COMPLETED
Adolescent Weight Management Study
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Protocol #1:Behavioral Therapy + Placebo or Sibutramine
Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food
Eligibility:
All Genders
13-17 years
Phase:
NA
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 weigh...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) between 28-50 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00212173
End Date
August 1 2007
Last Update
April 17 2015
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