- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01070251
Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial
연구 개요
상세 설명
In the last 25 years, obesity in children has increased dramatically in Germany (Lampert et al. 2007, Stolzenberg et al., 2007) and other western societies. Lack of physical activity (PA) is one important factor contributing to obesity development. However, healthy behaviors are established early in life (adiposity rebound: Reilly 2008), which underlines the importance of early interventions. Preschools therefore might be an ideal setting for interventions to promote physical activity. While previous preschool interventions were directly aimed at the children's physical activity behaviors (e.g. promoting activity by sports lessons), parents as influential caregivers were mainly involved in educational ways and by information (e.g. newsletters, physical activity homework).
The current intervention takes a participatory approach to involve parents as active agents of behavioral change. The study aim is to evaluate the effects of the participatory preference-based parental intervention on preschoolers' objectively measured physical activity behaviour and Body Mass Index (BMI). The intervention can easily be added as a parent module to existing children-focused physical activity programmes.
In several workshops, parents are presented a set of possible project ideas for improving everyday physical activity in the preschools. After forming teams, they either select project ideas from the preexisting menu or develop ideas de novo and then implement them into the local preschool environment.
The intervention is implemented in the frame of an existing state-sponsored physical activity (PA) program offering twice weekly sports lessons by external gym trainers to preschoolers over a period of 6 months. Preschools in the control arm get the state-sponsored PA program only. Preschools in the intervention arm get the participatory parent-focused PA intervention in addition to the existing state-sponsored PA program.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Baden-Württemberg
-
Mannheim, Baden-Württemberg, 독일, 68167
- Mannheim Institute of Public Health, University of Heidelberg
-
Mannheim, Baden-Württemberg, 독일, 68167
- Mannheim Institute of Public Health
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy children
- Participation in the standard physical activity lesson twice weekly
Exclusion Criteria:
- Age under 3 years or above 6 years
- Serious atopic dermatitis
- Genetic conditions
- Metabolic diseases
- Acute infectious diseases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Existing state-sponsored PA program
standard children-focused gym lessons approach
|
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
다른 이름들:
|
활성 비교기: Participatory intervention plus state-sponsored PA program
Participatory parent-focused intervention over nine months in addition to state-sponsored PA program
|
Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
다른 이름들:
Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in physical activity as measured by accelerometry and heart rate
기간: 0,6 and 12 months
|
before intervention (0 months), 6 and 12 months later
|
0,6 and 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Body Mass Index, percent fat mass (based on skin folds), waist-to-height ratio and waist circumference Change in blood pressure, sympathetic/parasympathetic tone. Sleep quantity by accelerometry.
기간: 0, 6 and 12 months
|
before intervention (0 months), 6 and 12 months later
|
0, 6 and 12 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in quality of life and subjective wellbeing
기간: 0, 6 and 12 months
|
before intervention (0 months), 6 and 12 months later
|
0, 6 and 12 months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Joachim E Fischer, Prof MD MSc, Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
간행물 및 유용한 링크
일반 간행물
- Reilly JJ, Kelly L, Montgomery C, Williamson A, Fisher A, McColl JH, Lo Conte R, Paton JY, Grant S. Physical activity to prevent obesity in young children: cluster randomised controlled trial. BMJ. 2006 Nov 18;333(7577):1041. doi: 10.1136/bmj.38979.623773.55. Epub 2006 Oct 6.
- Taylor RW, Mcauley KA, Williams SM, Barbezat W, Nielsen G, Mann JI. Reducing weight gain in children through enhancing physical activity and nutrition: the APPLE project. Int J Pediatr Obes. 2006;1(3):146-52. doi: 10.1080/17477160600881247.
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
- CRTLasti_PA_kiga
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. .