Primary Care Evidence-based Approach for Improving Lifelong Health
- Conditions
- Clinical Trial
- Interventions
- Behavioral: SMS/Text (CAMPI)Behavioral: Fidelity Monitoring System (Lyssn)Behavioral: Family Check-Up 4 Health (FCU4Health)
- Registration Number
- NCT06526312
- Lead Sponsor
- Arizona State University
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- BMI at or above 85 percentile for age and gender.
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description SMS/Text (CAMPI) SMS/Text (CAMPI) Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention. SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn) Fidelity Monitoring System (Lyssn) Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention. Fidelity Monitoring System (Lyssn) Fidelity Monitoring System (Lyssn) Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention. SMS/Text (CAMPI) Family Check-Up 4 Health (FCU4Health) Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention. SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn) SMS/Text (CAMPI) Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention. Fidelity Monitoring System (Lyssn) Family Check-Up 4 Health (FCU4Health) Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention. SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn) Family Check-Up 4 Health (FCU4Health) Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention. No CAMPI or Lyssn Family Check-Up 4 Health (FCU4Health) Receives neither SMS/Text (CAMPI) or Fidelity Monitoring System (Lyssn). Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.
- Primary Outcome Measures
Name Time Method Child Health Behaviors: Dietary Screener Questionnaire 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 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) 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 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 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 Outcome Measures
Name Time Method Reach of the intervention Up to 36 months Secondary outcome of Aim 1: 1. Proportion of enrolled children/families (study participants) referred to FCU4Health / number eligible.
2. Proportion of referred children/families engaged in the intervention / number eligible.Parenting Skills: Proactive Parenting Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b:
The Positive Behavior Support: Proactive Parenting survey consists of 7 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better positive behavior supports in the domain of proactive parenting.
This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable.Family Health Routines: Mealtime Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b: Mealtime Parenting Scale: 5 items using a 5-point Likert scale (0=almost never, 2=sometimes, 4=nearly always). Scale was administered in investigator's CDC-funded trial and had good psychometrics as demonstrated using confirmatory factor analysis.
Family Health Routines: Sleep Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b: Sleep Parenting Scale 8 items from existing scales that have shown high validity and reliability (i.e., Children's Sleep Wake Scale, Children's Sleep Hygiene Scale, Parental Interactive Behaviour Scale, Brief Infant Sleep Questionnaire and the Sleep Environment Scale). Uses a 5-point Likert scale (0=almost never, 2=sometimes, 4=nearly always). Scale was administered in investigator's CDC-funded trial and had good psychometrics as demonstrated using confirmatory factor analysis.
Maintenance/Sustainability Month 6, Month 16, Month 24 Secondary outcome of Aim 1: Clinical Sustainability Assessment Tool: 21 items, 7 domains: Engaged Leadership and Staff; Engaged Stakeholders; Planning and Implementation; Workflow Integration; Monitoring and Evaluation; Organizational Context and Capacity; Outcomes and Effectiveness. A 7-point Likert scale is used for all domains (1=little or no extent, 4=some extent, 7=great extent). Reliable and valid.
Normalisation MeAsure Development questionnaire Month 6, Month 16, Month 24 Secondary outcome of Aim 1: Acceptability, appropriateness, and feasibility of the implementation strategies.
The Normalisation MeAsure Development questionnaire (NoMAD) comprises 23-items, concerned with: implementation (bringing a practice or practices into action); embedding (when a practice or practices may be routinely incorporated in everyday work); and integration (when a practice or practices are reproduced and sustained in the social matrices of an organization). A 5-point Likert scale is used for all responses (1=disagree, 3=neither agree nor disagree, 5=agree). Particularly relevant for evaluating implementation of technology in primary care.Parenting Skills: Parenting Warmth Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b:
The Relationship Quality: Parenting Warmth survey consists of 5 items and uses a 5-point Likert scale (1=not at all, 3=somewhat true, 4=very true). Higher scores indicating better ratings of relationship quality in the domain of parenting warmth.
This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable.Parenting Skills: Quality Time Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b:
The Relationship Quality: Quality Time survey consists of 6 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better ratings of relationship quality in the domain of parent-child quality time.
This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable.Engagement with the SMS text messaging platform From enrollment to end of intervention at 18 month SMS Text messaging interactions (parent read/ response percentage rates)in the Configurable Assessment Messaging Platform for Interventions (CAMPI) platform \*only for those in SMS study condition.
Child BMI - Percentage of the 95th percentile (BMIp95) Baseline and 18 months Secondary outcome of Aim 1b and Aim 3: Children will be weighed using a portable electronic dual frequency bioelectrical impedance scale (Tanita SC-331SU). A portable stadiometer will take two height measurements, which are then averaged.
A third measurement is taken if the first two differ by more than one-eighth of an inch. Child BMI will be standardized by age and gender according to the CDC growth reference data for children, and percentage of the 95th percentile (BMIp95) will be calculated, as this is a more robust metric for assessing pediatric BMI change over time.Family Health Routines: Media Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b: Media Parenting Scale: 3 items using a 5-point Likert scale (0=almost never, 2=sometimes, 4=nearly always). Scale was administered in investigator's CDC-funded trial and had good psychometrics as demonstrated using confirmatory factor analysis.
Engagement in home practice From enrollment to end of intervention at 18 month FCU4Health coordinator ratings of home practice using a rating scale found to be predictive of program outcomes, 1-9 scale. High Engagement (scores 7-9) Moderate Engagement (scores 4-6) Low Engagement (scores 1-3).
COACH Fidelity Rating System Up to 36 months Conceptually accurate and adherent to the intervention model, Observant and responsive to the family's needs, Active in structuring the session, Careful when teaching and providing feedback, Helpful in building hope and motivation (COACH) observational rating system for FCU4Health consists of 5 domains, 1-9 scale (1=needs work, 5=competent work, 9=excellent work). Ratings have been found to be reliable and validly predict engagement and effectiveness outcomes.
Engagement (participation) in FCU4Health services From enrollment to end of intervention at 18 months FCU4Health services received (attendance at intervention sessions, referrals completed)
Parenting Skills: Incentives and Encouragement Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b:
The Positive Behavior Support: Incentives and Encouragement survey consists of 4 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better positive behavior supports in the domain of parent incentives and encouragement.
This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable.Parenting Skills: Parent-Child Conflict Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b:
The Relationship Quality: Parent-Child Conflict survey consists of 10 items and uses a 5-point Likert scale (1=not at all, 3=somewhat true 4=very true). Lower scores indicating better ratings of relationship quality in the domain of parent-child conflict.
This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable.Parenting Skills: Negative Parenting Behaviors Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b:
The Negative Parent Behaviors survey consists of 5 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Lower scores indicating better ratings of parent behaviors.
This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable.Parenting Skills: Monitoring and Limit Setting Baseline, 6, 12, and 18 months Secondary outcome of Aim 1b:
The Monitoring and Limit Setting survey consists of 7 items and uses a 5-point Likert scale (0=never, 3=sometimes, 4=very often). Higher scores indicating better parent monitoring and limit setting.
This domain has minor age- appropriate variations for ages 2-5 years, 6-12 years, and 13+ years that are valid and reliable.
Trial Locations
- Locations (1)
Denova Integrated Healthcare
🇺🇸Phoenix, Arizona, United States