Exercise and Behavioral Therapy in Obese Children
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
연구 개요
상세 설명
Introduction: The prevalence of childhood obesity is increasing rapidly in developing countries. The aim of this study is to determine the effects of exercise training and family-based behavioral treatment (FBBT), either in individual or in group setting,in pre-pubertal children and their mother.
Methods: This is a 6-month randomized controlled trial (RCT) including 75 pre-pubertal obese children (age 8-11 years) randomly assigned to an Intervention (I, n=50) or a Control group (C, n=25). The intervention consists of a family-based behavioural therapy in group (1 session/week with a dietician and a psychologist) or in individual setting (paediatrician or dietician 1x/month). The intervention includes exercise training sessions twice a week (60 minutes each).
Measures include: body mass index (BMI), waist and hip circumferences; whole body and abdominal fat mass by DXA; resting and ambulatory blood pressure; arterial intima-media thickness and vascular reactivity (flow-mediated dilation)using high resolution ultrasound; arterial stiffness by tonometry of applanation; cardiorespiratory fitness by a treadmill test; physical activity; fasting lipids, glucose, insulin, and C-reactive protein levels; health-related quality of life and psychological health using standardized questionnaires and a semi-structured interview. Measures are completed in children and their mother at baseline and 6 months post-randomization.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Geneva, 스위스, 1205
- University Hospital of Geneva
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Childhood obesity (>97 percentile WHO references)
Exclusion Criteria:
- being involved in any weight control, physical activity, behavior therapy, or gastric surgery program;
- familial history of dyslipidemia or essential hypertension;
- medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism in the preceding 6 months;
- orthopaedic affection limiting physical activity;
- genetic disorder or another chronic disease;
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
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실험적: Family-based behavioral therapy
Family-based behavioural therapy either in group or in individual setting.
Parents can choose between the 2 types of therapy.
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The intervention consist of a 6-month family-based behavioural therapy either in group (1 session/week, with a dietician and a psychologist) or in individual setting (with a paediatrician or a dietician in alternance 1x/month).
Both therapies include exercise training twice per week (60 minutes each).
Parents, or at at least the mother, must participate to the behavioral treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in Body Mass Index at 6 months
기간: 6 months
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Body Mass Index (weight/height 2) expressed in Standard Deviation Score
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from baseline in total body and abdominal fat at 6 months
기간: 6 months
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Body fat mass and percentage assessed using DXA
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6 months
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Change from baseline in waist circumference at 6 months
기간: 6 months
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6 months
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Change from baseline in blood pressure at 6 months
기간: 6 months
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Resting and ambulatory (24 hours) systolic and diastolic blood pressure
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6 months
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Change from baseline in arterial intima-media thickness at 6 months
기간: 6 months
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Measure of the arterial intima-media thickness using high-resolution ultrasound
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6 months
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Change from baseline in arterial flow-mediated dilation at 6 months
기간: 6 months
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Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
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6 months
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Change from baseline in arterial stiffness at 6 months
기간: 6 months
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Measure of mechanical indices using tonometry of applanation
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6 months
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Change from baseline in cardiorespiratory fitness at 6 months
기간: 6 months
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6 months
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Change from baseline in physical activity at 6 months
기간: 6 months
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Physical activity pattern using accelerometer
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6 months
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Change from baseline in biological markers at 6 months
기간: 6 months
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Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
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6 months
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Change from baseline in quality of life at 6 months
기간: 6 months
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Quality of life assessed using the Kidsscreen 52 questionnaire
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6 months
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Change from baseline in child's behavior at 6 months
기간: 6 months
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Child Behavior Checklist filled by parents
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6 months
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Change from baseline in parental psychological health at 6 months
기간: 6 months
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Global Health Questionnaire filled by parents
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nathalie Farpour-Lambert, MD, University of Geneva
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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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