- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02144519
Physical Activity and Nutrition Intervention in Afterschool Programs
2020년 11월 12일 업데이트: Michael Beets, University of South Carolina
Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
The investigators long-term goal is to advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide.
The investigators objective here is two fold.
First, the investigators will test the effectiveness of two promising strategies designed to 1) increase the amount of PA children accumulate while attending an ASP and 2) promote changes in the nutritional quality of the snacks served.
This represents a fundamental step in establishing practice-based guidelines (best practices) for the uptake and achievement of public health policy goals (CA and Harvard).
Second, the investigators will examine the barriers and facilitators to implementing these strategies.
The expected outcome of this study is evidence supporting best practices for ASPs to employ to meet policy goals.
연구 개요
상세 설명
The investigators will use a 3-year delayed treatment, cluster randomized controlled trial design with 20 ASPs that serve mostly low-income and minority children (approximately 1300 children ages 6-12yrs) in Columbia, SC and address the following specific aims: Aim 1. Evaluate the impact of a staff-level intervention, a professional development training program focused on core competencies to promote physical activity, on children's physical activity levels; Aim 2. Evaluate the impact of a site-level intervention, a snack modification program that includes a discount buying program, on the quality of snacks served and consumed; and Aim 3. Evaluate the implementation of the staff-level and site-level interventions and identify organizational, staff, and setting characteristics that influence the process of implementing these strategies.
연구 유형
중재적
등록 (실제)
2635
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Programs that:
- Operate immediately after the school day
- Operate every day of the school year for a minimum of 2 hours
- Serve a minimum of 30 children of elementary age (6-12 years)
- Operate in a school, community or faith Setting
- Provide a snack
- Provide homework assistance/completion time
- Provide enrichment
- Provide opportunities for physical activity
- All children enrolled, staff, and afterschool program (ASP) leaders in the ASPs were eligible to participate in the study.
Exclusion Criteria:
- Programs that:
- Were singularly focused
- Programs that were physical activity focused
Children that:
- Have any physical and/or orthopedic impairment that would limit a child's ability to participate in regular physical activity.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Immediate Intervention
Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
|
Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
다른 이름들:
|
|
실험적: Delayed Intervention
Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
|
Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Percentage of Children Meeting Physical Activity Policy
기간: Spring of Year 1, Year 2, and Year 3
|
We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity.
The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry.
All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+.
The accelerometers were distilled using 5-second epochs.
When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on).
Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off).
Children wore the monitors for their entire attendance at the ASPs.
Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior.
Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.
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Spring of Year 1, Year 2, and Year 3
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Nutritional Quality of Snacks
기간: Spring of Year 1, Year 2, and Year 3
|
We will assess quality of snacks served at the ASPs in terms of number of fruits and vegetables served per week.
These analyses were performed at the ASP level with a sample size of 20 (10 per arm)
|
Spring of Year 1, Year 2, and Year 3
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael W Beets, PhD, University of South Carolina
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Bottai M, Chandler J, Brazendale K, Beighle A. Physical activity outcomes in afterschool programs: A group randomized controlled trial. Prev Med. 2016 Sep;90:207-15. doi: 10.1016/j.ypmed.2016.07.002. Epub 2016 Jul 7.
- Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Freedman D, Hutto B, Moore JB, Beighle A. Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs. Am J Health Promot. 2016 Sep;30(7):521-31. doi: 10.4278/ajhp.141001-QUAN-486. Epub 2016 Jun 17.
- Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Beighle A. Making policy practice in afterschool programs: a randomized controlled trial on physical activity changes. Am J Prev Med. 2015 Jun;48(6):694-706. doi: 10.1016/j.amepre.2015.01.012.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 8월 1일
기본 완료 (실제)
2015년 4월 1일
연구 완료 (실제)
2016년 5월 1일
연구 등록 날짜
최초 제출
2014년 5월 13일
QC 기준을 충족하는 최초 제출
2014년 5월 21일
처음 게시됨 (추정)
2014년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 11월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 11월 12일
마지막으로 확인됨
2020년 11월 1일
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. .