- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04628897
Physical Activity and the Home Environment in Preschool-aged Children in Urban Bangladesh
Risk Factors for Low Physical Activity Levels in Preschool-aged Children in a Densely Populated Urban Community in Bangladesh
연구 개요
상세 설명
Study Rationale
As the double burden of nutrition emerges in Bangladesh and other low- to middle-income countries, it is imperative to develop strategies to mitigate the adverse effects associated with both undernutrition and obesity. Identifying levels of physical activity among children is a requisite step to developing and targeting interventions to promote physical activity among young populations. Furthermore, exploring the risk factors associated with physical activity levels in young children can help better inform policy makers surrounding a public health intervention.
Goals The overall goal of the research is to generate new knowledge regarding the nutritional and environmental determinants of physical activity in young children living in a densely populated urban community in Bangladesh.
Primary Objectives
The specific objectives of this study are to:
- Describe physical activity levels in a sample of preschool-aged children in an inner-city community in Dhaka, Bangladesh,
- Estimate the associations between characteristics of the physical environment of the home (total area of available floor space inside of the home, number and presence of physical hazards, and the number of gross motor activity-oriented items present) and the physical activity levels of preschoolers in Dhaka, and
- Estimate the associations between hemoglobin concentration (Hb) and preschooler physical activity level.
- Describe sleep quantity and quality in the sample of preschool-aged children in urban Bangladesh
The investigators conducted a cross-sectional observational study of preschool-aged children between 34-38 months of age (n=60) selected from the ongoing Maternal Vitamin D for Infant Growth (MDIG) trial cohort (NCT01924013) in Dhaka, Bangladesh. The investigators planned to enrol a minimum of 60 participants with complete data sets, with recruitment up to 90 participants until this enrolment target was reached.
Study Procedures
- Accelerometry
- Home built environment audit
- Anthropometry
- hemoglobin concentration
- Maternal perception of the home environment and household food security
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
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Ontario
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Toronto, Ontario, 캐나다, M5G 1X8
- The Hospital for Sick Children
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Child is 34-38 months of age;
- Child and primary caregiver reside in Dhaka or urban environs;
- Parent/guardian provides written informed consent for study procedures.
Exclusion Criteria:
- Child requires mobility assistance and/or has been diagnosed with a major neurological or orthopedic condition or disorder affecting physical activity (e.g., cerebral palsy, club foot, etc.).
- Major physician-diagnosed chronic respiratory or cardiac disease that limits physical activity (e.g., severe asthma, currently taking medication for symptomatic congenital heart disease, etc.).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Moderate-to-Vigorous Physical Activity
기간: 3-14 days
|
Objectively measured accelerometry data, a continuous variable reflecting mean daily PA during the study period, expressed as mean counts per 15 seconds (cp15s).
This summary measure was generated by first calculating mean daily PA, then averaging the daily means across collection days, including data between the time the child woke up until the time the child went to sleep, as reported by the caregiver on all days that met criteria for inclusion (i.e., at least 10 hours of wear time)
|
3-14 days
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 1000057061
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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