Testing Technology-Based Implementation Strategies for a Family-Based Pediatric Health Behavior Intervention in Community-Based Primary Care: A Cluster Randomized Factorial Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Child Health Behaviors: Dietary Screener Questionnaire
研究概览
简要总结
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.
详细描述
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 Collaborative Health, Valleywise Health, Terros Health, or Canyon Pediatrics. All families (n = 400) will receive FCU4Health services from a Denova Collaborative Health, Valleywise Health, Terros Health, or Canyon Pediatrics staff member trained in the intervention and supervised by FCU4Health experts. Following guidance from our ongoing Community Advisory Board, our previous trials, and RE-AIM, implementation barriers were identified to scale-up and implementation strategies adopted for the trial: enhanced fidelity support using LYSSN and SMS text messaging to promote program engagement. Randomization to these strategies will occur at the individual level. Parent/caregivers and children at least 11 years of age will complete assessments at baseline, 4 months, and 9 months. Primary outcomes are fidelity and engagement (Aim 1a) and child health behaviors (Aim 1b). We 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI at or above 85 percentile for age and gender.
排除标准
- 未提供
研究组 & 干预措施
Fidelity Monitoring (Lyssn and COACH)
Standard Training Activities
- asynchronous training in the program via an e-learning program
- synchronous training led by a certified FCU4Health Trainer Standard Supervision Activities
- use of the valid and reliable COACH observational fidelity rating system to provide individualized feedback from COACH ratings to BHCs
- group supervision (typically for a period of a year provided by a certified Trainer and then taken over by the organization in a train-the-trainer type model) Enhanced Supervision Activities
- use of the Lyssn system to provide individualized feedback to BHCs
All BHCs will receive the standard training activities (a-b). For the experimental condition, half of the BHCs will be randomly assigned to full fidelity support strategy, which will include the standard and enhanced supervision activities (c-e).
干预措施: Fidelity Monitoring (Lyssn and COACH) (Behavioral)
Fidelity Monitoring (Lyssn and COACH)
Standard Training Activities
- asynchronous training in the program via an e-learning program
- synchronous training led by a certified FCU4Health Trainer Standard Supervision Activities
- use of the valid and reliable COACH observational fidelity rating system to provide individualized feedback from COACH ratings to BHCs
- group supervision (typically for a period of a year provided by a certified Trainer and then taken over by the organization in a train-the-trainer type model) Enhanced Supervision Activities
- use of the Lyssn system to provide individualized feedback to BHCs
All BHCs will receive the standard training activities (a-b). For the experimental condition, half of the BHCs will be randomly assigned to full fidelity support strategy, which will include the standard and enhanced supervision activities (c-e).
干预措施: Family Check-Up 4 Health (FCU4Health) (Behavioral)
SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)
Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
Receives fidelity monitoring via COACH and Lyssn.
干预措施: Fidelity Monitoring (Lyssn and COACH) (Behavioral)
SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)
Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
Receives fidelity monitoring via COACH and Lyssn.
干预措施: Family Check-Up 4 Health (FCU4Health) (Behavioral)
SMS/Text (CAMPI)
Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
干预措施: SMS/Text (CAMPI) (Behavioral)
SMS/Text (CAMPI)
Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
干预措施: Family Check-Up 4 Health (FCU4Health) (Behavioral)
SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH)
Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.
Receives fidelity monitoring via COACH and Lyssn.
干预措施: SMS/Text (CAMPI) (Behavioral)
No CAMPI or Fidelity Monitoring
Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH).
干预措施: Family Check-Up 4 Health (FCU4Health) (Behavioral)
结局指标
主要结局
Child Health Behaviors: Dietary Screener Questionnaire
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
Child Health Behaviors: Dietary Screener Questionnaire
时间窗: Baseline, 4, and 9 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.
次要结局
- 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)
- Engagement (participation) in FCU4Health services(From enrollment to end of intervention at 9 months)
- Engagement in home practice(From enrollment to end of intervention at 9 month)
- Engagement with the SMS text messaging platform(From enrollment to end of intervention at 9 month)
- Child BMI - Percentage of the 95th percentile (BMIp95)(Baseline and 9 months)
- Normalisation MeAsure Development questionnaire(Month 9)
- Maintenance/Sustainability(Month 9)
- Parenting Skills: Incentives and Encouragement(Baseline, 4, and 9 months)
- Parenting Skills: Proactive Parenting(Baseline, 4, and 9 months)
- Parenting Skills: Parenting Warmth(Baseline, 4, and 9 months)
- Parenting Skills: Parent-Child Conflict(Baseline, 4, and 9 months)
- Parenting Skills: Quality Time(Baseline, 4, and 9 months)
- Parenting Skills: Monitoring and Limit Setting(Baseline, 4, and 9 months)
- Parenting Skills: Negative Parenting Behaviors(Baseline, 4, and 9 months)
- Family Health Routines: Mealtime(Baseline, 4, and 9 months)
- Family Health Routines: Media(Baseline, 4, and 9 months)
- Family Health Routines: Sleep(Baseline, 4, and 9 months)
