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Clinical Trials/NCT02024399
NCT02024399
Completed
N/A

Pilot Study of 10 Week Exercise and Nutrition Program for Children Who Are Overweight / Obese.

Stony Brook University1 site in 1 country48 target enrollmentAugust 2004

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Obesity
Sponsor
Stony Brook University
Enrollment
48
Locations
1
Primary Endpoint
Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXA
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This project will address the important area of childhood obesity and the risk of cardiovascular disease associated with obesity. This is a serious health concern since children who are overweight or obese are prone to other medical conditions including high blood pressure, abnormal lipid profiles,and type 2 diabetes. Although exercise and nutrition programs are recommended, evidence for the efficacy of these programs in improving cardiovascular health is lacking.

Specific Aims: a) improve cardiovascular risk factors, b) increase physical fitness levels, c) improve lean body mass, d) enhance QOL of the child e) influence adherence rates to exercise and a healthy lifestyle change both during and beyond the conclusion of the program.

Hypothesis 1a: Compared to baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and nutrition program will show significant improved levels of cardiovascular risk factors.

Specific Aim 2: To determine if a multidisciplinary fitness and nutrition program, when compared with a matched, WLC group will show a change in whole body assessment including a decrease in fat mass, an increase in percent lean body mass, and a decrease in percent body fat, as measured utilizing dual-energy X-ray absorptiometry Hypothesis 2a: Compared to baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and nutrition program will show improved whole body assessments including.

Specific Aim 3:To determine if a multidisciplinary fitness and nutrition program, when compared with a WLC group will show improved levels of fitness. Hypothesis 3a: Compared to baseline and matched controls, children randomized to a 10 week multidisciplinary fitness and nutrition program will show significant improvements in fitness including.

Registry
clinicaltrials.gov
Start Date
August 2004
End Date
August 2005
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • : a) in the 85th percentile Body Mass Index(BMI), standardized for age and gender; b) have hypercholesterolemia as defined as total cholesterol \> 170 mg/dl or LDL \> 110 mg/dl; and / or c) hypertension as defined as \>116/76 for 8-10 year olds, \> 120/80 for 10-13 year olds, and \>125/890 for 14-17 year olds.

Exclusion Criteria

  • age \< 8 or \> 17 years; 2) the determination of significant abnormalities on an initial graded exercise test performed by a pediatric cardiologist; 3) past history of chemotherapy or whole-body radiation therapy

Outcomes

Primary Outcomes

Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXA

Time Frame: Baseline, after 10 weeks and after 20 weeks (3 time points)

Dual energy x-ray absorptiometry - used to assess body composition.

Secondary Outcomes

  • Improved levels of fitness using ACSM guidelines / assessments to measure such constructs of fitness as flexibility, muscle strength, cardiovascular endurance and agility.(Measured at baseline, after 10 week sand again after 20 weeks.)

Study Sites (1)

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