Primary Care Evidence-based Approach for Improving Lifelong Health
NCT ID: NCT06526312
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
840 participants
INTERVENTIONAL
2025-06-09
2028-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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SMS/Text (CAMPI)
Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
SMS/Text (CAMPI)
Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
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.
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).
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
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.
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.
SMS/Text (CAMPI)
Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
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
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.
No CAMPI or Fidelity Monitoring
Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH).
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.
Interventions
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SMS/Text (CAMPI)
Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
99 Years
ALL
No
Sponsors
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Northwestern University
OTHER
University of Oregon
OTHER
University of Utah
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Arizona State University
OTHER
Responsible Party
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Principal Investigators
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Cady Berkel, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
Justin D Smith, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Denova Integrated Healthcare
Phoenix, Arizona, United States
Countries
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Central Contacts
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Other Identifiers
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