- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03111264
Building Blocks for Healthy Preschoolers
Building Blocks for Healthy Preschoolers: Child Care and Family Models
Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.
Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.
연구 개요
상세 설명
The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are:
- to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children
- to examine the sustainability of the interventions
- to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory).
Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Maryland
-
Baltimore, Maryland, 미국, 21201
- University of Maryland Growth and Nutrition Division
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Preschooler 30-54 months
- Caregiver and childcare staff must be at least 18 years old
- Childcare center staff members willing to participate
- Licensed childcare centers serving low-income communities
- Children attending participating childcare centers (at least 3 days per week)
Exclusion Criteria:
- Caregivers and staff who do not speak or read English
- Childcare staff and preschoolers with health problems that would interfere with participation in physical activities
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: CHAMP group
Childcare centers randomly assigned the CHAMP group will receive an intervention that promotes physical activity in the classroom by developing gross motor skills through movement and enhances the nutritional environment in the centers by exposing preschoolers to new foods.
|
The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
|
실험적: CHAMP+ group
These childcare centers, also randomly assigned, will have the same intervention as the CHAMP group in addition to a parenting intervention that promotes wellness and healthy behaviors within families.
|
The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
The CHAMP+ component is comprised of a curriculum of parenting, wellness, physical activity, and feeding in the home environment.
The CHAMP+ intervention will span over the course of the CHAMP intervention.
|
간섭 없음: Control
This group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change of BMI Z-score for preschoolers
기간: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
|
Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score
|
Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change of Physical Activity for preschoolers and childcare center staff
기간: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
|
Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics
|
Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
|
Change in Gross Motor Skills
기간: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
Measured by Test of Gross Motor Development-2
|
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
Change in Preschoolers to try new foods
기간: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
Measured by Food Neophobia Scale (Caregiver report)
|
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
Change in Preschoolers to try new foods
기간: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
Measured by Fruit & Vegetable Knowledge & Preference Test
|
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
Change in Preschoolers to try new foods
기간: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
Measured by Food Tasting Assessment
|
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Maureen M Black, PhD, University of Maryland, Baltimore
간행물 및 유용한 링크
일반 간행물
- Rahmaty Z, Johantgen ME, Storr CL, Wang Y, Black MM. Preschoolers BMI: Associations with Patterns of Caregivers' Feeding Practices Using Structural Equation Models. Child Obes. 2022 Jun 1. doi: 10.1089/chi.2022.0026. Online ahead of print.
- Armstrong B, Trude ACB, Johnson C, Castelo RJ, Zemanick A, Haber-Sage S, Arbaiza R, Black MM. CHAMP: A cluster randomized-control trial to prevent obesity in child care centers. Contemp Clin Trials. 2019 Nov;86:105849. doi: 10.1016/j.cct.2019.105849. Epub 2019 Sep 13.
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 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. .
CHAMP에 대한 임상 시험
-
Children's Mercy Hospital Kansas CityThe Gerber Foundation초대로 등록
-
Indiana UniversityNational Institute on Aging (NIA)완전한