Clinical trial NCT06526312: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical Trial
Keywords: implementation
cost-effectiveness
health behaviors
BMI
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: University of Oregon
name: University of Utah
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-07-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This phase of the project consists of recruitment, enrollment, and execution of a cluster randomized factorial implementation trial using a hybrid type 3 effectiveness-implementation approach guided by the RE-AIM plan-ning and evaluation framework. In a type 3 hybrid trial, the primary focus is on implementation outcomes with a secondary focus on intervention effectiveness.
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Lyssn Fidelity Ratings
timeFrame: Up to 36 months
measure: Engagement in Family Check Up 4 Health (FCU4Health) (in-session caregiver engagement)
timeFrame: Up to 36 months
measure: Budget impact of implementation
timeFrame: Up to 48 months
measure: Cost-effectiveness of FCU4Health
timeFrame: Up to 48 months
measure: Child Health Behaviors: Dietary Screener Questionnaire
timeFrame: Baseline, 6, 12, and 18 months
Secondary outcomes:
measure: COACH Fidelity Rating System
timeFrame: Up to 36 months
measure: Engagement (participation) in FCU4Health services
timeFrame: From enrollment to end of intervention at 18 months
measure: Engagement in home practice
timeFrame: From enrollment to end of intervention at 18 month
measure: Engagement with the SMS text messaging platform
timeFrame: From enrollment to end of intervention at 18 month
measure: Child BMI - Percentage of the 95th percentile (BMIp95)
timeFrame: Baseline and 18 months
measure: Reach of the intervention
timeFrame: Up to 36 months
measure: Normalisation MeAsure Development questionnaire
timeFrame: Month 6, Month 16, Month 24
measure: Maintenance/Sustainability
timeFrame: Month 6, Month 16, Month 24
measure: Parenting Skills: Incentives and Encouragement
timeFrame: Baseline, 6, 12, and 18 months
measure: Parenting Skills: Proactive Parenting
timeFrame: Baseline, 6, 12, and 18 months
measure: Parenting Skills: Parenting Warmth
timeFrame: Baseline, 6, 12, and 18 months
measure: Parenting Skills: Parent-Child Conflict
timeFrame: Baseline, 6, 12, and 18 months
measure: Parenting Skills: Quality Time
timeFrame: Baseline, 6, 12, and 18 months
measure: Parenting Skills: Monitoring and Limit Setting
timeFrame: Baseline, 6, 12, and 18 months
measure: Parenting Skills: Negative Parenting Behaviors
timeFrame: Baseline, 6, 12, and 18 months
measure: Family Health Routines: Mealtime
timeFrame: Baseline, 6, 12, and 18 months
measure: Family Health Routines: Media
timeFrame: Baseline, 6, 12, and 18 months
measure: Family Health Routines: Sleep
timeFrame: Baseline, 6, 12, and 18 months
Other outcomes:
measure: Satisfaction with FCU4Health Parent Service
timeFrame: Month 12 and Month 18 surveys to parents
measure: Satisfaction with FCU4Health Parent-Coordinator
timeFrame: Month 12 and Month 18 surveys to parents
Locations:
city: Phoenix
country: United States
facility: Denova Integrated Healthcare
state: Arizona
Study officials:
affiliation: Arizona State University
name: Cady Berkel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Justin D Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: