Primary Care Evidence-based Approach for Improving Lifelong Health (PREVAIL)

Arizona State University (ASU)

Status: Enrolling

Conditions: Clinical Trial

Treatments: Behavioral: Family Check-Up 4 Health (FCU4Health); Behavioral: SMS/Text (CAMPI); Behavioral: Fidelity Monitoring (Lyssn and COACH)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06526312

R61HL166976 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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, investigator's 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. Parent/caregivers 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, race/ethnicity, language, and gender (Aim 3).

Enrollment: 840 estimated patients

Sex: All

Ages: 2 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI at or above 85 percentile for age and gender.

Exclusion criteria

• N/A

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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840 participants in 4 patient groups

SMS/Text (CAMPI)

Experimental group

Description:

Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.

Treatment:

Behavioral: SMS/Text (CAMPI)

Behavioral: Family Check-Up 4 Health (FCU4Health)

Fidelity Monitoring (Lyssn and COACH)

Experimental group

Description:

Standard Training Activities 1. asynchronous training in the program via an e-learning program 2. synchronous training led by a certified FCU4Health Trainer Standard Supervision Activities 3. use of the valid and reliable COACH observational fidelity rating system to provide individualized feedback from COACH ratings to BHCs 4. group supervision (typically for a period of a year provided by a certified Trainer and then taken over by the organization in a train-the-trainer type model) Enhanced Supervision Activities 5. use of the Lyssn system to provide individualized feedback to BHCs All BHCs will receive the standard training activities (a-b). For the experimental condition, half of the BHCs will be randomly assigned to full fidelity support strategy, which will include the standard and enhanced supervision activities (c-e).

Treatment:

Behavioral: Fidelity Monitoring (Lyssn and COACH)

Behavioral: Family Check-Up 4 Health (FCU4Health)

SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)

Experimental group

Description:

Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives fidelity monitoring via COACH and Lyssn.

Treatment:

Behavioral: Fidelity Monitoring (Lyssn and COACH)

Behavioral: SMS/Text (CAMPI)

Behavioral: Family Check-Up 4 Health (FCU4Health)

No CAMPI or Fidelity Monitoring

Experimental group

Description:

Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH).

Treatment:

Behavioral: Family Check-Up 4 Health (FCU4Health)