- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00554294
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial (trinkfit)
연구 개요
상세 설명
Soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. The intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. The environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. These lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. For the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. Body weight and height to calculate BMI as primary outcome were assessed at baseline and after the intervention period of 1 school year. As secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. The water flow of the dispenser was measured at regular intervals. In addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting.
To analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All children in 2nd and 3rd grade of selected elementary schools
Exclusion Criteria:
- parental consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control group
Control schools had school curriculum as usual and did not receive environmental intervention.
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|
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실험적: Intervention group
Intervention schools received water dispensers, drinking bottles and lessons as intervention.
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In intervention schools a water dispenser was installed and children received water bottles as environmental intervention.
Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overweight
기간: one school year
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Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
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one school year
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Intake of Drinks
기간: one school year
|
one school year
|
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Physical Activity and Inactivity
기간: one school year
|
one school year
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Water Flow of the Water Dispensers
기간: one school year
|
one school year
|
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Parameters of Process Evaluation (Acceptance, Feasibility)
기간: 1,5 years
|
1,5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mathilde Kersting, PhD, Research Insitute of Child Nutrition
간행물 및 유용한 링크
일반 간행물
- Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics. 2009 Apr;123(4):e661-7. doi: 10.1542/peds.2008-2186.
- Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Immigrational background affects the effectiveness of a school-based overweight prevention program promoting water consumption. Obesity (Silver Spring). 2010 Mar;18(3):528-34. doi: 10.1038/oby.2009.270. Epub 2009 Aug 27.
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
키워드
기타 연구 ID 번호
- 05HS026
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