- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02024399
Cardiovascular Risk Factors, Body Composition, Fitness Levels And Quality Of Life In Overweight And Obese 8-17 Year Olds
Pilot Study of 10 Week Exercise and Nutrition Program for Children Who Are Overweight / Obese.
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Stony Brook, New York, 미국, 11790
- Stony Brook University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Exercise
Strength training x 20 sessions (10 weeks) Aerobic exercise core strengthening Running
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Strength training, aerobic exercise and core strengthening, running
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improved body compositon (decrease in % fat; increase in % lean tissue) using DEXA
기간: Baseline, after 10 weeks and after 20 weeks (3 time points)
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Dual energy x-ray absorptiometry - used to assess body composition.
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Baseline, after 10 weeks and after 20 weeks (3 time points)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improved levels of fitness using ACSM guidelines / assessments to measure such constructs of fitness as flexibility, muscle strength, cardiovascular endurance and agility.
기간: Measured at baseline, after 10 week sand again after 20 weeks.
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ACSM guidelines and measurement were used to assess strength, agility, flexibility, muscle endurance and cardiovascular endurance
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Measured at baseline, after 10 week sand again after 20 weeks.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life as perceived by the children and the parents.
기간: Baseline and after 10 weeks and 20 weeks.
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The impact of weight on quality of life was utilized.
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Baseline and after 10 weeks and 20 weeks.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sharon A Martino, PhD, Stony Brook University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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