Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526312
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Primary Care Evidence-based Approach for Improving Lifelong Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testing Technology-Based Implementation Strategies for a Family-Based Pediatric Health Behavior Intervention in Community-Based Primary Care A Cluster Randomized Factorial Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVAIL
Brief Summary:
This study investigates the implementation and effectiveness of the Family Check-Up 4 Health FCU4Health intervention in primary care settings for reducing cardiovascular disease risk in children Through a hybrid type 3 cluster randomized factorial trial and innovative technology-based strategies integrated with Electronic Health Records the study aims to enhance intervention fidelity and engagement Results will inform scalable approaches to promote child and family health behaviors improve parenting skills and potentially reduce child BMI contributing to significant public health impacts in addressing cardiovascular health disparities
Detailed Description:
The proposed implementation trial is a hybrid effectiveness-implementation type III design with a primary focus on implementation strategies and outcomes Eligible families include children aged 2-17 who are patients at Denova Integrated Healthcare All families n 900-1200 will receive FCU4Health services from a Denova staff member trained in the intervention and supervised by FCU4Health experts Following guidance from the ongoing Community Advisory Board investigators previous trials and Reach Effectiveness Adoption Implementation and Maintenance RE-AIM framework implementation barriers were identified to scale-up and implementation strategies adopted for the trial Lyssn fidelity support and Short Message Service SMS text messaging to promote program engagement
Randomization to these strategies will occur at the care team level n 11-12 using a factorial design Parentcaregivers and children at least 6 years of age will complete assessments at baseline 6 months 12 months and 18 months
Primary outcomes are fidelity and engagement Aim 1a and child health behaviors Aim 1b Investigators will also examine secondary outcomes including family health routines and parenting conduct economic analyses Aim 2 and examine the link between trajectories of improvement in health behaviors and improvements in BMI for subgroups related to baseline BMI child developmental age group raceethnicity language and gender Aim 3
Randomization to these strategies will occur at the care team level n 11-12 using a factorial design Parentcaregivers and children at least 6 years of age will complete assessments at baseline 6 months 12 months and 18 months
Primary outcomes are fidelity and engagement Aim 1a and child health behaviors Aim 1b Investigators will also examine secondary outcomes including family health routines and parenting conduct economic analyses Aim 2 and examine the link between trajectories of improvement in health behaviors and improvements in BMI for subgroups related to baseline BMI child developmental age group raceethnicity language and gender Aim 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None