Adolescent Weight Management Study

April 16, 2015 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Behavioral & Pharmacologic Therapy of Adolescent Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Weight
BMI

Secondary Outcome Measures

Outcome Measure
Blood Pressure
Insulin
Glucose
Lipids

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Robert I Berkowitz, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK54713 (completed 2007)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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