Adolescent Weight Management Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

NCT04007393

Adolescent Obesity

COMPLETED PHASE2

A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety.

NCT00261911

Obesity

COMPLETED PHASE3

"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"

NCT01023139

Obesity

UNKNOWN NA

Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity

NCT00330525

Obesity Overweight

COMPLETED PHASE2

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

NCT04102189

Overweight Obesity

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sibutramine

Intervention Type DRUG

Slim Fast

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes