R33HL166976

Testing technology-based implementation strategies for a family-based pediatric health behavior intervention in community-based primary care: A cluster randomized factorial trial - Project summary/abstract

Decades of research support the effectiveness of family-centered preventive interventions (FCPIs) in limiting cardiovascular disease (CVD) risk for children.

Pediatric primary care offers the ideal delivery system in which to embed effective FCPIs for CVD risk given goal alignment, parents’ trust in and longitudinal contact with pediatricians, and reach into communities facing CVD disparities.

Despite endorsement from the United States Preventive Services Task Force, few FCPIs have been widely implemented in primary care, resulting in limited access for families and public health impact.

This application focuses on facilitating the widespread implementation of the evidence-based Family Check-Up 4 Health (FCU4HEALTH), a FCPI with demonstrated positive effects on family and child health behaviors.

To test the FCU4HEALTH, we conducted an RCT with 240 primarily Mexican American and low-income families in partnership with multiple primary care systems.

Children were ≥5.5 to <13 years old and had elevated BMI (≥85th percentile for age and gender) at their most recent primary care visit.

Compared to usual care, FCU4HEALTH significantly improved child and family health behaviors, child social-emotional health, and resulted in meaningful change in child BMI at a magnitude consistent with other interventions.

Given this positive evidence, integrated primary care organizations have become increasingly interested in its adoption.

Our universal prevention trial with 217 primarily Mexican American and low-income families with a 2- to 5-year-old child is currently underway in an integrated primary care system.

During these two trials, with guidance from the RE-AIM framework, and a community advisory board that has overseen FCU4HEALTH development and testing, several implementation barriers were identified affecting its reach, fidelity, and engagement.

Technology-based implementation strategies (a clinical decision support tool, automated fidelity monitoring, and an electronic health record (EHR)-integrated SMS text messaging platform) were developed to promote delivery at scale.

In the proposed biphasic study, the R61 phase involves integration of these strategies with the EHR and usability testing.

In the R33 phase, a hybrid type 3 cluster randomized factorial trial will be conducted with 150 coordinators and 1200 families to examine effects of the strategies on fidelity and engagement (primary implementation outcomes) and child health behaviors (primary clinical outcomes), family health routines, parenting skills, and child BMI.

Prospective implementation cost analyses will be performed to examine the economic impact and cost-effectiveness of each strategy.

Finally, we will model trajectories of child and family health behaviors and examine the associations with BMI at the 18-month follow-up.

The large sample size will allow us to examine these associations by baseline characteristics (BMI, developmental stage, race/ethnicity, and gender).

Results have the potential for a significant public health impact on CVD risk by facilitating the scale-up of effective interventions for families in primary care settings.

Arizona State University

NOT APPLICABLE

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Tempe, Arizona 852876011 United States

Single Zip Code

Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) (PAR-22-189)

Amendment Since initial award the total obligations have increased 159% from $1,851,680 to $4,801,290.