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RECRUITING
NCT06526312
NA

Primary Care Evidence-based Approach for Improving Lifelong Health

Sponsor: Arizona State University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

840

Start Date

2025-06-09

Completion Date

2028-07

Last Updated

2025-08-06

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

SMS/Text (CAMPI)

Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.

BEHAVIORAL

Fidelity Monitoring (Lyssn and COACH)

Lyssn's HIPAA-compliant, cloud-based platform uses embedded speech-to-text transcription from audio recorded sessions for rapid assessment and easy session review for supervisors and interventionists. The COACH fidelity rating system assesses clinical skills in five domains considered essential for the effective provision of the FCU and the EDP intervention sessions. The COACH rating form is used to assess the extent to which the provider is: Conceptually accurate and adherent to the intervention model Observant and responsive to the family's needs Active in structuring the session Careful when teaching and providing feedback Helpful in building hope and motivation

BEHAVIORAL

Family Check-Up 4 Health (FCU4Health)

An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually.

Locations (1)

Denova Integrated Healthcare

Phoenix, Arizona, United States