Primary Care Evidence-based Approach for Improving Lifelong Health

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

Overview

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.

Detailed 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).

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 intervent
• 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

Primary outcome measures

• Lyssn Fidelity Ratings [Time frame: Up to 36 months]
• Engagement in Family Check Up 4 Health (FCU4Health) (in-session caregiver engagement) [Time frame: Up to 36 months]
• Budget impact of implementation [Time frame: Up to 48 months]
• Cost-effectiveness of FCU4Health [Time frame: Up to 48 months]
• Child Health Behaviors: Dietary Screener Questionnaire [Time frame: Baseline, 6, 12, and 18 months]

Secondary outcome measures (12)

• COACH Fidelity Rating System [Time frame: Up to 36 months]
• Engagement (participation) in FCU4Health services [Time frame: From enrollment to end of intervention at 18 months]
• Engagement in home practice [Time frame: From enrollment to end of intervention at 18 month]
• Engagement with the SMS text messaging platform [Time frame: From enrollment to end of intervention at 18 month]
• Child BMI - Percentage of the 95th percentile (BMIp95) [Time frame: Baseline and 18 months]
• Reach of the intervention [Time frame: Up to 36 months]
• Normalisation MeAsure Development questionnaire [Time frame: Month 6, Month 16, Month 24]
• Maintenance/Sustainability [Time frame: Month 6, Month 16, Month 24]
• Parenting Skills: Incentives and Encouragement [Time frame: Baseline, 6, 12, and 18 months]
• Parenting Skills: Proactive Parenting [Time frame: Baseline, 6, 12, and 18 months]
• Parenting Skills: Parenting Warmth [Time frame: Baseline, 6, 12, and 18 months]
• Parenting Skills: Parent-Child Conflict [Time frame: Baseline, 6, 12, and 18 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• N/A

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Denova Integrated Healthcare — Phoenix

Identifiers

NCT: NCT06526312 · R61HL166976

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗