Adolescent Weight Management Study

NCT00212173 | Completed

• 1 other identifier: DK54713 (completed 2007)
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Weight

• BMI

Secondary Outcomes (4)

• Blood Pressure

• Lipids

• Glucose

• Insulin

Interventions

Sibutramine DRUG

Slim Fast DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Body Mass Index (BMI) between 28-50 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Related Publications (2)

• 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.

  PMID: 21151016 RESULT

• 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.

  PMID: 20948512 RESULT

MeSH Terms

Interventions

sibutramine

Study Officials

• Robert I Berkowitz, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Completion: August 1, 2007
• Last Updated: April 17, 2015

Record last verified: 2015-04