- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02049788
Effects of a Low Glycemic Index in Obese Children
Effects of a Low Glycemic Index Diet on Body Composition and Metabolic Syndrome Risks in Obese Thai Children: A Randomized Controlled Trial
연구 개요
상세 설명
Obese children aged 9-16 years from King Chulalongkorn Memorial Hospital were randomized to receive instruction either for a low-GI diet (intervention group) or a low-calorie, low-fat diet (control group). Both groups were followed-up every month for six months. The primary outcomes were body composition changes during the six-month period, measured by dual X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). Secondary outcomes were metabolic syndrome risk changes measured by fasting plasma glucose, insulin, and lipid profiles.
The adherence to the nutritional education and physical activity recommendation was evaluated by using three-day dietary records (two weekdays and one weekend day) and a physical activity questionnaire at each visit. All participants were examined and counseled about physical activity and life style modification strategies by a pediatrician at every visit.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bangkok
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Patumwan, Bangkok, 태국, 10330
- Chulalongkorn University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children aged between nine to sixteen years old
- BMI higher than the International Obesity Task Force cut-off
Exclusion Criteria:
- psychological problems
- underlying diseases that might affect a weight management program
- used drugs associated with weight increment or reduction
- attended other weight management programs
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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활성 비교기: low calorie/fat diet
The low calorie/fat diet group, obese children aged 9-16, received conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).
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Conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).
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실험적: Low glycaemic index diet
Low glycaemic index diet group, obese children of both sexes aged 9-16, received experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).
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Experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from baseline in body composition measured by BIA and DEXA at month 6
기간: 6 months
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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 metabolic syndrome risks at month 6
기간: 6 months
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Metabolic syndrome risks are fasting blood sugar, insulin and lipid profiles.
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6 months
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from baseline in body weight, BMI z-score and waist circumference at month 6
기간: 6 months
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sirinuch Chomtho, M.D., PhD., Chulalongkorn 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 연구와 관련된 용어
기타 연구 ID 번호
- LGI-01
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