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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
diet
exercise
diet and exercise
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring OBESITY, CHILDREN, METABOLIC PARAMETERS, DIET, EXERCISE

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Soroka Medical Center
  • Schneider Children's Medical Center

Outcomes

Primary Outcome Measures

BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2007
Last Updated
April 17, 2007
Sponsor
Rabin Medical Center
Collaborators
D-Cure, Israel, Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00461994
Brief Title
The Role of Exercise and Diet in Weight Loss in Obese Children
Official Title
The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center
Collaborators
D-Cure, Israel, Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children. Secondary goals were: To determine the effects of exercise and/or diet on body composition. To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance. 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. To determine the role of exercise and/or diet on psychological parameters of obese children. Study Population Inclusion Criteria Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. A signed informed consent will be taken from patients and their parents. Agreement to a follow-up of one year. Exclusion Criteria Cardiac problems (arrhythmia, Congestive heart disease) Uncontrolled hypertension Severe hepatic impairment (liver enzymes above 3 folds the upper normal values) Renal failure Genetic syndromes associated with obesity Presence of untreated hypothyroidism 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
OBESITY, CHILDREN, METABOLIC PARAMETERS, DIET, EXERCISE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
diet
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Type
Behavioral
Intervention Name(s)
diet and exercise
Primary Outcome Measure Information:
Title
BMI
Title
BMI-SDS
Title
BODY FAT PERCENTAGE
Title
WAIST AND HIP CIRCUMFERENCES
Secondary Outcome Measure Information:
Title
BLOOD METABOLIC PROFILE
Title
BLOOD INFLAMATORY MARKERS
Title
GHRELIN AND LEPTIN LEVELS
Title
RESTING ENERGY EXPENDITURE
Title
PSYCHOLOGICAL PARAMETERS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. A signed informed consent will be taken from patients and their parents. Agreement to a follow-up of one year. Exclusion Criteria: Cardiac problems (arrhythmia, Congestive heart disease) Uncontrolled hypertension Severe hepatic impairment (liver enzymes above 3 folds the upper normal values) Renal failure Genetic syndromes associated with obesity Presence of untreated hypothyroidism Participation in a clinical study during the last month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof, MD
Organizational Affiliation
Schneider Children Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer-Sheva
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petah-Tikva
ZIP/Postal Code
49202
Country
Israel

12. IPD Sharing Statement

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

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