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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461994
• Other study ID #: rmc003189CTil
• Status: Completed
• Phase: N/A
• First received: April 17, 2007
• Last updated: April 17, 2007
• Start date: April 2004
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• diet

• exercise

• diet and exercise

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer-Sheva
Israel	Schneider Children's Medical Center	Petah-Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Rabin Medical Center	D-Cure, Israel, Pediatric Endocrine unit, Soroka medical center.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI
Primary	BMI-SDS
Primary	BODY FAT PERCENTAGE
Primary	WAIST AND HIP CIRCUMFERENCES
Secondary	BLOOD METABOLIC PROFILE
Secondary	BLOOD INFLAMATORY MARKERS
Secondary	GHRELIN AND LEPTIN LEVELS
Secondary	RESTING ENERGY EXPENDITURE
Secondary	PSYCHOLOGICAL PARAMETERS