Primary Care Evidence-based Approach for Improving Lifelong Health

NCT06526312 | Recruiting DMC

• 1 other identifier: R61HL166976
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Trial

Keywords

implementation; cost-effectiveness; health behaviors; BMI

Outcome Measures

Primary Outcomes (5)

• Lyssn Fidelity Ratings

  Co-primary outcome of Aim 1: Fidelity to the motivational interviewing (MI) skills that are central to Family Check-Up 4 Health effects using the Lyssn automated coding platform. The system has been shown to be competitive with human coding using the Motivational Interviewing Skill Code (MISC) and the Motivational Interviewing Treatment Integrity Code (MITI 4). The Lyssn fidelity rating system consists of three dimensions: acceptance, empathy, and spirit, scored on a 7-point Likert scale. (1=low rating, 4=mid rating, 7=high rating). Lyssn scores are also convergent with human codings on the COACH observational rating system (see next measure).

  Up to 36 months

• Engagement in Family Check Up 4 Health (FCU4Health) (in-session caregiver engagement)

  Co-primary outcome of Aim 1: COACH rating system Parent In-Session Engagement Domain, 1-9 scale (1=low, 5=moderate, 9=high). Reliable and validly predictive of intervention outcomes.

  Up to 36 months

• Budget impact of implementation

  Co-Primary outcome of Aim 2: Cost capture survey based on time-driven activity-based costing methods and data from FCU4Health services provided.

  Up to 48 months

• Cost-effectiveness of FCU4Health

  Co-Primary outcome of Aim 2: Cost-effectiveness analysis using incremental cost-effectiveness ratios will be used to determine the value of each strategy as it relates to child BMI change and to implementation outcomes known to be related to intervention effects (e.g., fidelity). Data obtained via Cost capture survey based on time-driven activity-based costing methods and data from FCU4Health services provided.

  Up to 48 months

• Child Health Behaviors: Dietary Screener Questionnaire

  Primary outcome of Aim 1b and Aim 3: National Health and Nutrition Examination Survey's Dietary Screener Questionnaire: 6 questions collect intake frequency of food (fruits, vegetables, fast food) and beverage choices (regular soda, 100 percent fruit juice, or sweetened fruit drinks, sports drinks, or energy drinks) during the past month. (i.e. During the past month, how often did you drink regular soda that contains sugar? Frequency of choices within past 2 weeks). The Dietary Screener Questionnaire has been shown to be a low burden food recall screener for specific dietary factors. This scale was administered in investigator's Centers for Disease Control and Prevention (CDC) funded trial and had good psychometrics as demonstrated using confirmatory factor analysis. Values range from 0-8. Never=0, 5-6 times per week=4, 6+per day=8. For food items, higher scores indicate healthier behaviors. For the beverage choices, lower scores indicate healthier behaviors.

  Baseline, 6, 12, and 18 months

Secondary Outcomes (18)

• COACH Fidelity Rating System

  Up to 36 months

• Engagement (participation) in FCU4Health services

  From enrollment to end of intervention at 18 months

• Engagement in home practice

  From enrollment to end of intervention at 18 month

• Engagement with the SMS text messaging platform

  From enrollment to end of intervention at 18 month

• Child BMI - Percentage of the 95th percentile (BMIp95)

  Baseline and 18 months

Other Outcomes (2)

• Satisfaction with FCU4Health Parent Service

  Month 12 and Month 18 surveys to parents

• Satisfaction with FCU4Health Parent-Coordinator

  Month 12 and Month 18 surveys to parents

Study Arms (4)

SMS/Text (CAMPI)

EXPERIMENTAL

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

Behavioral: SMS/Text (CAMPI); Behavioral: Family Check-Up 4 Health (FCU4Health)

Fidelity Monitoring (Lyssn and COACH)

EXPERIMENTAL

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).

Behavioral: Fidelity Monitoring (Lyssn and COACH); Behavioral: Family Check-Up 4 Health (FCU4Health)

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

EXPERIMENTAL

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.

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

No CAMPI or Fidelity Monitoring

EXPERIMENTAL

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

Behavioral: Family Check-Up 4 Health (FCU4Health)

Interventions

SMS/Text (CAMPI) BEHAVIORAL

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

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

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

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

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.

Fidelity Monitoring (Lyssn and COACH); No CAMPI or Fidelity Monitoring; SMS/Text (CAMPI); SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Arizona State University: lead
• Northwestern University: collaborator
• University of Oregon: collaborator
• University of Utah: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Denova Integrated Healthcare

Phoenix, Arizona, 85012, United States

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Cady Berkel, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Justin D Smith, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele M Porter, Ph.D.

CONTACT

4802037550; michele.porter@asu.edu

Cady Berkel, Ph.D.

CONTACT

cady.berkel@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will test the hypotheses related to implementation strategies at α=.025 to control the family-wise type I error rate at 0.05: (1) mean difference in fidelity in favor of those randomized to the fidelity support condition (including Lyssn, COACH coding, and group supervision), (2) higher engagement for those randomized to SMS. Each hypothesis will be tested under the framework of a linear mixed-effects model to account for care team, FCU4Health Coordinator, and family-level clustering. In addition to the main, each model will include random effects for care team and Coordinator, and covariates used in the restricted randomization. Updated power analyses were performed by simulation assuming 80% complete data for Lyssn and COACH scores (fidelity strategy) and 95% data available on SMS text messaging (i.e., allowing for up to a very conservative 5% opt-out rate).

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 29, 2024
• Study Start: June 9, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)