Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Acceptability of the HSRC program
研究概览
简要总结
Healthy School Recognized Campus is a Texas A&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs for diverse youth across Texas. The purpose of this study is to conduct a type 2 hybrid implementation-effectiveness, cluster dual randomized controlled trial (DRCT) to assess both Healthy School Recognized Campus (HSRC) and the mentoring program.
详细描述
This study uses a type 2 hybrid implementation-effectiveness, cluster dual randomized controlled trial (DRCT). DRCTs include two randomized controlled trials within the same study: one testing an intervention (i.e., HSRC) and one testing an implementation strategy (i.e., the mentoring program).
Schools in Central and East Texas (n=20) of similar socio-economic status will be randomized at baseline to either the HSRC condition or the Waitlist Control condition. In the HSRC condition, schools will attempt to deliver youth and adult physical activity or nutrition programs. In the Waitlist Control condition, schools will not add or remove any current physical activity and/or healthy eating programs, and will receive HSRC the next school year. Schools will also be randomized to receive the mentoring program or standard implementation immediately or after being a waitlist control.
Aim 1: Determine the effectiveness of the HSRC initiative compared to a control group on BMI-Z score, physical activity, and skin carotenoids (i.e., fruit and vegetable intake).
For Aim 1, the investigators will compare outcomes in 10 Texas schools that receive HSRC with 10 Waitlist Control communities.
Aim 2: Determine the impact of the mentoring program compared to standard implementation on short-term (acceptability, appropriateness, feasibility) and long-term (number of students reached, total dosage delivered) implementation outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •School Inclusion Criteria:
- •located in Central and East Texas
- •Public school
- •Student Inclusion Criteria
- •enrolled in the 4th, 5th, 6th, 7th, 8th, or 9th grade
- •able to read, speak, and write in English
排除标准
- •any motor or cognitive impairments or other health conditions that would prevent them from completing a physical assessment
研究组 & 干预措施
HSRC + Standard Implementation
Participants in this group will receive HSRC in the first year of enrollment with standard implementation. [schools (n=5), participants (n=225)]
HSRC + Mentoring Program
Participants in this group will receive HSRC in the first year of enrollment with the mentoring program. [schools (n=5), participants (n=225)]
干预措施: Mentoring program (Behavioral)
Waitlist Control + HSRC + Standard Implementation
Participants in this group will receive HSRC with standard implementation one year after enrollment. [schools (n=5), participants (n=225)]
干预措施: Waitlist (Behavioral)
Waitlist Control + HSRC + Mentoring Program
Participants in this group will receive HSRC with the mentoring program one year after enrollment. [schools (n=5), participants (n=225)]
干预措施: Mentoring program (Behavioral)
Waitlist Control + HSRC + Mentoring Program
Participants in this group will receive HSRC with the mentoring program one year after enrollment. [schools (n=5), participants (n=225)]
干预措施: Waitlist (Behavioral)
结局指标
主要结局
Acceptability of the HSRC program
时间窗: Baseline, 9 months
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) 4-item survey. The survey will be used to assess program implementers' perceived acceptability of the program (i.e., This program seems fine.)
Appropriateness of the HSRC program
时间窗: Baseline, 9 months
Appropriateness will be assessed with the Intervention Appropriateness Measure (IAM) 4-item survey. The survey will assess program implementers' perception of the appropriateness of the program (e.g., This program seems suitable.)
Feasibility of the HSRC program
时间窗: Baseline, 9 months
Feasibility will be assessed using the Feasibility of Intervention Measure (FIM) 4-item survey. The survey will assess program implementers' perception of the program's feasibility (e.g., This program seems doable.)
Body mass index (BMI)
时间窗: Baseline, 9 months
Weight will be measured with a scale (in pounds), and height will be measured using a stadiometer (in inches). Weight and height will be combined to report BMI as follows, BMI = (weight (lb)/height (inches)2) x 703.
次要结局
- Total program dosage delivered(Baseline, 9 months)
- Accelerometer-derived physical activity estimation(Baseline, 9 months)
- Concentration of subdermal carotenoids(Baseline, 9 months)
- Number of students reached(Baseline, 9 months)