Adolescent Weight Management Study | NCT00212173

Studies
Adolescent Weight Management Study

NCT00212173

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Status

Completed

Last Update Posted

Apr 17, 2015Estimated

Enrollment

120

Phase

Not Applicable

Conditions

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

Interventions

Sibutramine
Slim Fast

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2015

Last Update Posted Date

Apr 17, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert I Berkowitz, MD	Children's Hospital of Philadelphia	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21151016	Result	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.
20948512	Result

Measure	Description	Time Frame
Blood Pressure
Lipids
Glucose

Name	Type	Description	Arm Group Labels	Other Names
Sibutramine	Drug
Slim Fast	Dietary Supplement