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).