Protocol #1:Behavioral Therapy + Placebo or Sibutramine, Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food
Conditions
Keywords
Adolescent, Weight Management, Obesity Treatment, Behavioral Treatment
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.
Interventions
DRUGSibutramine
DIETARY_SUPPLEMENTSlim Fast
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight | — |
| BMI | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Pressure | — |
| Lipids | — |
| Glucose | — |
| Insulin | — |
Outcome results
None listed