Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognitive Variables in Preschool-age Children From Low Socioeconomic Backgrounds.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Implementation - Study fidelity
研究概览
简要总结
The goal of this study will be to examine the implementation and preliminary efficacy of a teacher taught gross motor skill-based physical activity (PA) intervention on cognitive variables in low low socio-economic (SES) preschoolers. The movement and cognition intervention will be implemented for 4 days per week for 6 months. Primary outcome variables will be processed evaluation data. Secondary outcome variables will be changes in children's cognitive function (executive functions and memory), gross motor skills, and PA levels at baseline, 3- and 6-month.
详细描述
The goal of this study will be to examine the implementation and preliminary efficacy of a teacher taught gross motor skill-based physical activity (PA) intervention on cognition in low low socio-economic (SES) preschoolers. Low SES preschool centers (n=4) will be recruited and randomly assigned to either a Movement and Cognition (MAC) or a control group. From each preschool center, preschool-age children will be recruited to participate in their assigned center intervention. The MAC intervention will be implemented for 4 days per week for 6 months. The research team will train the preschool providers to implement the intervention. The control centers will be asked to maintain their usual preschool schedule. Primary outcome variables will be processed evaluation data [study fidelity (adherence, compliance, and integrity of study design), intervention dosage, acceptability, quality, adaptation], and will be assessed throughout the 6-month study. Secondary outcome variables will be changes in children's cognitive function (executive functions and memory), gross motor skills, and PA levels at baseline, 3- and 6-month. Aim 1 will examine the implementation of a 6-month teacher taught gross motor skill-based movement intervention in low SES preschoolers. Aim 2 will examine the preliminary efficacy of the MAC intervention on cognition, gross motor skills, and PA in preschoolers. For aim 2, the study will compare the outcome variables of interest between the MAC and the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data collectors (outcome assessors) collecting cognition outcome variables will be masked.
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Implementation - Study fidelity
时间窗: Through out the 6 months intervention
Process evaluation data, specifically the study fidelity of the intervention, will be assessed. On 2 randomly selected days per week within the treatment preschool center classrooms, research staff members will directly observe the intervention and use a semi-structured questionnaire (created by research PI) to collect information on intervention study fidelity (are the intervention activities being implemented as designed). In addition, 1 day per week, research staff members will directly observe the control center and use a semi-structured questionnaire to assessment of control (CON) school activities.
Implementation - Quality
时间窗: Through out the 6 months intervention
This will be assessed how well intervention training was delivered to providers \& research staff. On 2 randomly selected days per week within the treatment preschool center classrooms, research staff members will directly observe the intervention and use a semi-structured questionnaire (created by research PI) to collect information on intervention study fidelity (quality of the intervention implementation by classroom providers).
Implementation - Adaptation
时间窗: Through out the 6 months intervention
Weekly survey with researchers and providers during 6-month program at both Movement and Cognition (MAC) and control (CON) centers to determine if there was any modification to either the MAC or the CON program.
Implementation - Acceptability
时间窗: Completion of 6 months intervention
A semi-structured questionnaire with providers at the completion of 6-month intervention in the Movement and Cognition (MAC) group. This will address the acceptability and satisfaction of the overall program and the individual intervention components.
Implementation - Intervention intensity
时间窗: Through out the 6 months intervention
Process evaluation data on the intervention intensity. Children in both the Movement and Cognition (MAC) and control (CON) centers will be asked to wear the activity accelerometer on one random day per week to assess the intervention intensity.
Implementation - Dose delivered
时间窗: Through out the 6 months intervention
Process evaluation data on how much of the intervention was delivered. This will be assessed using the weekly log of Movement and Cognition (MAC) implementation by research staff and childcare providers.
次要结局
- Change in preschoolers cognition(Baseline, 3-month and 6-month)
- Change in preschoolers' behavioral outcome(Baseline, 3-month and 6-month)
- Change in preschoolers' gross motor skills(Baseline, 3-month and 6-month)
- Change in preschoolers moderate-to-vigorous physical activity(Baseline, 3-month and 6-month)
研究者
Sofiya Alhassan
Professor
University of Massachusetts, Amherst