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Cardiovascular Risk Factors, Body Composition, Fitness Levels And Quality Of Life In Overweight And Obese 8-17 Year Olds

NCT ID: NCT02024399

Last Updated: 2013-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Obesity Type 2 Diabetes Hypercholesterolemia Hypertension

Keywords

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Pediatric Overweight/Obesity, DEXA, Fitness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise

Strength training x 20 sessions (10 weeks) Aerobic exercise core strengthening Running

Group Type OTHER

Exercise

Intervention Type OTHER

Strength training, aerobic exercise and core strengthening, running

Interventions

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Exercise

Strength training, aerobic exercise and core strengthening, running

Intervention Type OTHER

Eligibility Criteria

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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

* 1\) 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon A Martino, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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87468

Identifier Type: -

Identifier Source: org_study_id