Clinical trial NCT00212173: Adolescent Weight Management Study
Official title: Behavioral & Pharmacologic Therapy of Adolescent Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protocol #1:Behavioral Therapy + Placebo or Sibutramine
Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food
Keywords: Adolescent
Weight Management
Obesity Treatment
Behavioral Treatment
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: 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.


Eligibility 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

Primary outcomes:
measure: Weight
measure: BMI
Secondary outcomes:
measure: Blood Pressure
measure: Lipids
measure: Glucose
measure: Insulin
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Robert I Berkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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). 2011 Jun;19(6):1193-9. doi: 10.1038/oby.2010.288. Epub 2010 Dec 9.
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.