Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT07079995
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial
Sponsor:
Texas A&M University
Organization:
Study Overview
Official Title:
Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
For Aim 2, the investigators will compare outcomes in 10 Texas schools that receive the mentoring program with 10 that receive standard implementation.
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.
For Aim 2, the investigators will compare outcomes in 10 Texas schools that receive the mentoring program with 10 that receive standard implementation.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: