The Role of Exercise and Diet in Weight Loss in Obese Children

April 17, 2007 updated by: Rabin Medical Center

The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children

A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.

The total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. The study recruited patients from 2 endocrine clinics.

Objectives:

  1. The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.

  2. Secondary goals were:

    1. To determine the effects of exercise and/or diet on body composition.
    2. To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
    3. To determine the effects of exercise and/or diet on metabolic profile, cardiovascular risk factors, and inflammatory markers as fasting glucose,insulin and lipid profile,homocysteine ,adiponectin levels,CRP,and IL-6.
    4. To determine the role of exercise and/or diet on psychological parameters of obese children.

Study Population

Inclusion Criteria

  1. Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
  2. A signed informed consent will be taken from patients and their parents.
  3. Agreement to a follow-up of one year.

Exclusion Criteria

  1. Cardiac problems (arrhythmia, Congestive heart disease)
  2. Uncontrolled hypertension
  3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
  4. Renal failure
  5. Genetic syndromes associated with obesity
  6. Presence of untreated hypothyroidism
  7. Participation in a clinical study during the last month methods Children fulfilling the inclusion and exclusion criteria were randomly allocated into one of three groups.

The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.

On the first visit of the study, at the end of the intervention (12 weeks) and at the end of the follow-up period (1 year) the following had been checked:

Weight, Height, Body impedance, Waist and hip circumferences, Skin-folds, Blood pressure, Basal Metabolic Rate (evaluated by a metabolic monitor), and blood samples for: Blood count, Liver function, Renal function, Fasting Lipid, glucose and insulin,CRP, IL-6, TSH, free T4, Homocysteine, Adiponectin, Leptin and Ghrelin. Also at these point of time every patient underwent a psychosocial evaluation with life style questioners.

Safety:There were no complications with these modes of treatment.

Study Type

Interventional

Enrollment

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel
        • Soroka Medical Center
      • Petah-Tikva, Israel, 49202
        • Schneider Children's Medical Center

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

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
  2. A signed informed consent will be taken from patients and their parents.
  3. Agreement to a follow-up of one year.

Exclusion Criteria:

  1. Cardiac problems (arrhythmia, Congestive heart disease)
  2. Uncontrolled hypertension
  3. Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
  4. Renal failure
  5. Genetic syndromes associated with obesity
  6. Presence of untreated hypothyroidism
  7. Participation in a clinical study during the last month

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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES

Secondary Outcome Measures

Outcome Measure
BLOOD METABOLIC PROFILE
BLOOD INFLAMATORY MARKERS
GHRELIN AND LEPTIN LEVELS
RESTING ENERGY EXPENDITURE
PSYCHOLOGICAL PARAMETERS

Collaborators and Investigators

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

Sponsor

Rabin Medical Center

Collaborators

Soroka University Medical Center
D-Cure, Israel

Investigators

  • Principal Investigator: Moshe Phillip, Prof, MD, Schneider Children Medical Center

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 Start

April 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 18, 2007

Last Update Submitted That Met QC Criteria

April 17, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rmc003189CTil

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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