Primary Care Evidence-based Approach for Improving Lifelong Health

Conditions

• Clinical Trial

Eligibility Criteria

Sex

ALL

Age

2 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• SMS/Text (CAMPI) — BEHAVIORAL
  Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
• Fidelity Monitoring (Lyssn and COACH) — BEHAVIORAL
  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
• Family Check-Up 4 Health (FCU4Health) — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jun 9, 2025

Status verified

Aug 2025

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

840 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Arms

• Experimental: SMS/Text (CAMPI)
  Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
• Experimental: Fidelity Monitoring (Lyssn and COACH)
  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).
• Experimental: SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)
  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.
• Experimental: No CAMPI or Fidelity Monitoring
  Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH).

Primary Outcome Measure

Lyssn Fidelity Ratings [ Time Frame: Up to 36 months ]

Central Contacts

• Michele M Porter, Ph.D.
  4802037550
  [email protected]
• Cady Berkel, Ph.D.
  [email protected]

Locations (1)

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