Testing Technology-Based Implementation Strategies for a Family-Based Pediatric Health Behavior Intervention in Community-Based Primary Care: A Cluster Randomized Factorial Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Clinical Trial
- Sponsor
- Arizona State University
- Enrollment
- 840
- Locations
- 1
- Primary Endpoint
- Child Health Behaviors: Dietary Screener Questionnaire
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI at or above 85 percentile for age and gender.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Child Health Behaviors: Dietary Screener Questionnaire
Time Frame: Baseline, 6, 12, and 18 months
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.
Lyssn Fidelity Ratings
Time Frame: Up to 36 months
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).
Engagement in Family Check Up 4 Health (FCU4Health) (in-session caregiver engagement)
Time Frame: Up to 36 months
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.
Budget impact of implementation
Time Frame: Up to 48 months
Co-Primary outcome of Aim 2: Cost capture survey based on time-driven activity-based costing methods and data from FCU4Health services provided.
Cost-effectiveness of FCU4Health
Time Frame: Up to 48 months
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.
Secondary Outcomes
- Reach of the intervention(Up to 36 months)
- Parenting Skills: Proactive Parenting(Baseline, 6, 12, and 18 months)
- Family Health Routines: Mealtime(Baseline, 6, 12, and 18 months)
- Family Health Routines: Sleep(Baseline, 6, 12, and 18 months)
- Normalisation MeAsure Development questionnaire(Month 6, Month 16, Month 24)
- Maintenance/Sustainability(Month 6, Month 16, Month 24)
- Parenting Skills: Parenting Warmth(Baseline, 6, 12, and 18 months)
- Parenting Skills: Quality Time(Baseline, 6, 12, and 18 months)
- 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)
- Family Health Routines: Media(Baseline, 6, 12, and 18 months)
- Engagement in home practice(From enrollment to end of intervention at 18 month)
- COACH Fidelity Rating System(Up to 36 months)
- Engagement (participation) in FCU4Health services(From enrollment to end of intervention at 18 months)
- Parenting Skills: Incentives and Encouragement(Baseline, 6, 12, and 18 months)
- Parenting Skills: Parent-Child Conflict(Baseline, 6, 12, and 18 months)
- Parenting Skills: Negative Parenting Behaviors(Baseline, 6, 12, and 18 months)
- Parenting Skills: Monitoring and Limit Setting(Baseline, 6, 12, and 18 months)