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

NCT00461994 | Completed

• 1 other identifier: rmc003189CTil
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Obesity

Keywords

OBESITY; CHILDREN; METABOLIC PARAMETERS; DIET; EXERCISE

Outcome Measures

Primary Outcomes (4)

• BMI

• BMI-SDS

• BODY FAT PERCENTAGE

• WAIST AND HIP CIRCUMFERENCES

Secondary Outcomes (5)

• BLOOD METABOLIC PROFILE

• BLOOD INFLAMATORY MARKERS

• GHRELIN AND LEPTIN LEVELS

• RESTING ENERGY EXPENDITURE

• PSYCHOLOGICAL PARAMETERS

Interventions

diet BEHAVIORAL

exercise BEHAVIORAL

diet and exercise BEHAVIORAL

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• D-Cure, Israel: collaborator
• Soroka University Medical Center: collaborator

Study Sites (2)

Soroka Medical Center

Beersheba, Israel

Location

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Moshe Phillip, Prof, MD

  Schneider Children Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: April 1, 2004
• Study Completion: December 1, 2006
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

IL (2)