Clinical TrialPREVAILNCT06526312
Primary Care Evidence-based Approach for Improving Lifelong Health
A study testing SMS/Text (CAMPI), Fidelity Monitoring (Lyssn and COACH) and Family Check-Up 4 Health (FCU4Health) in people with Clinical Trial, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Clinical Trial
- What is being tested?
- SMS/Text (CAMPI), Fidelity Monitoring (Lyssn and COACH) and Family Check-Up 4 Health (FCU4Health)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI at or above 85 percentile for age and gender.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cady Berkel, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Denova Integrated Healthcare
Phoenix, Arizona, 85012
About this study
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
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.
Read the 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 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).
- Conditions
- Clinical Trial
- Being tested
- SMS/Text (CAMPI), Fidelity Monitoring (Lyssn and COACH), Family Check-Up 4 Health (FCU4Health)
- Keywords
- implementation, cost-effectiveness, health behaviors, BMI
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS/Text (CAMPI)Behavioural
Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice.
Fidelity Monitoring (Lyssn and COACH)Behavioural
Lyssn's HIPAA-compliant, cloud-based platform uses embedded speech-to-text transcription from audio recorded sessions for rapid assessment and easy session review for supervisors and interventionists.
The COACH fidelity rating system assesses clinical skills in five domains considered essential for the effective provision of the FCU and the EDP intervention sessions. The COACH rating form is used to assess the extent to which the provider is:
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
Family Check-Up 4 Health (FCU4Health)Behavioural
An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually.
| Study group | Role | What they receive |
|---|---|---|
| SMS/Text (CAMPI) | Experimental | Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform. Receives: Behavioral: SMS/Text (CAMPI); Behavioral: Family Check-Up 4 Health (FCU4Health) |
| Fidelity Monitoring (Lyssn and COACH) | Experimental | Standard Training Activities
1. asynchronous training in the program via an e-learning program
2. synchronous training led by a certified FCU4Health Trainer Standard Supervision Activities
3. use of the valid and reliable COACH observational fidelity rating system to provide individualized feedback from COACH ratings to BHCs
4. 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
5. 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). Receives: Behavioral: Fidelity Monitoring (Lyssn and COACH); Behavioral: Family Check-Up 4 Health (FCU4Health) |
| SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH) | Experimental | 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. Receives: Behavioral: SMS/Text (CAMPI); Behavioral: Fidelity Monitoring (Lyssn and COACH); Behavioral: Family Check-Up 4 Health (FCU4Health) |
| No CAMPI or Fidelity Monitoring | Experimental | Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH). Receives: Behavioral: Family Check-Up 4 Health (FCU4Health) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lyssn Fidelity Ratings
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).
Measured: Up to 36 months
Engagement in Family Check Up 4 Health (FCU4Health) (in-session caregiver engagement)
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.
Measured: Up to 36 months
Budget impact of implementation
Co-Primary outcome of Aim 2: Cost capture survey based on time-driven activity-based costing methods and data from FCU4Health services provided.
Measured: Up to 48 months
Cost-effectiveness of FCU4Health
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.
Measured: Up to 48 months
Child Health Behaviors: Dietary Screener Questionnaire
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.
Measured: Baseline, 4, and 9 months
Secondary outcomes (18)
COACH Fidelity Rating System
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.
Measured: Up to 36 months
Engagement (participation) in FCU4Health services
FCU4Health services received (attendance at intervention sessions, referrals completed)
Measured: From enrollment to end of intervention at 9 months
Engagement in home practice
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).
Measured: From enrollment to end of intervention at 9 month
Engagement with the SMS text messaging platform
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.
Measured: From enrollment to end of intervention at 9 month
Child BMI - Percentage of the 95th percentile (BMIp95)
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.
Measured: Baseline and 9 months
Reach of the intervention
Secondary outcome of Aim 1: 1. Proportion of enrolled children/families (study participants) referred to FCU4Health / number eligible.
- Proportion of referred children/families engaged in the intervention / number eligible.
Measured: Up to 36 months
Normalisation MeAsure Development questionnaire
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.
Measured: Month 9
Maintenance/Sustainability
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.
Measured: Month 9
Parenting Skills: Incentives and Encouragement
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.
Measured: Baseline, 4, and 9 months
Parenting Skills: Proactive Parenting
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.
Measured: Baseline, 4, and 9 months
Parenting Skills: Parenting Warmth
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.
Measured: Baseline, 4, and 9 months
Parenting Skills: Parent-Child Conflict
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.
Measured: Baseline, 4, and 9 months
Parenting Skills: Quality Time
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.
Measured: Baseline, 4, and 9 months
Parenting Skills: Monitoring and Limit Setting
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.
Measured: Baseline, 4, and 9 months
Parenting Skills: Negative Parenting Behaviors
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.
Measured: Baseline, 4, and 9 months
Family Health Routines: Mealtime
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.
Measured: Baseline, 4, and 9 months
Family Health Routines: Media
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.
Measured: Baseline, 4, and 9 months
Family Health Routines: Sleep
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.
Measured: Baseline, 4, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start5 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- We will test the hypotheses related to implementation strategies at α=.025 to control the family-wise type I error rate at 0.05: (1) mean difference in fidelity in favor of those randomized to the fidelity support condition (including Lyssn, COACH coding, and group supervision), (2) higher engagement for those randomized to SMS. Each hypothesis will be tested under the framework of a linear mixed-effects model to account for care team, FCU4Health Coordinator, and family-level clustering. In addition to the main, each model will include random effects for care team and Coordinator, and covariates used in the restricted randomization. Updated power analyses were performed by simulation assuming 80% complete data for Lyssn and COACH scores (fidelity strategy) and 95% data available on SMS text messaging (i.e., allowing for up to a very conservative 5% opt-out rate).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Oregon, University of Utah, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Cady Berkel, Ph.D., Principal investigator, Arizona State UniversityJustin D Smith, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526312
- Sponsor's protocol ID
- R33HL166976
- Acronym
- PREVAIL
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06526312
- Acronym / sponsor ID
- PREVAIL / R33HL166976
- Conditions
- Clinical Trial
- Keywords
- implementation, cost-effectiveness, health behaviors, BMI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, University of Oregon, University of Utah, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- We will test the hypotheses related to implementation strategies at α=.025 to control the family-wise type I error rate at 0.05: (1) mean difference in fidelity in favor of those randomized to the fidelity support condition (including Lyssn, COACH coding, and group supervision), (2) higher engagement for those randomized to SMS. Each hypothesis will be tested under the framework of a linear mixed-effects model to account for care team, FCU4Health Coordinator, and family-level clustering. In addition to the main, each model will include random effects for care team and Coordinator, and covariates used in the restricted randomization. Updated power analyses were performed by simulation assuming 80% complete data for Lyssn and COACH scores (fidelity strategy) and 95% data available on SMS text messaging (i.e., allowing for up to a very conservative 5% opt-out rate).
| Arm | Type | Receives |
|---|---|---|
| SMS/Text (CAMPI) | Experimental | Behavioral: SMS/Text (CAMPI), Behavioral: 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. |
| Fidelity Monitoring (Lyssn and COACH) | Experimental | Behavioral: Fidelity Monitoring (Lyssn and COACH), Behavioral: Family Check-Up 4 Health (FCU4Health)Standard Training Activities 1. asynchronous training in the program via an e-learning program 2. synchronous training led by a certified FCU4Health Trainer Standard Supervision Activities 3. use of the valid and reliable COACH observational fidelity rating system to provide individualized feedback from COACH ratings to BHCs 4. 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 5. 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). |
| SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH) | Experimental | Behavioral: SMS/Text (CAMPI), Behavioral: Fidelity Monitoring (Lyssn and COACH), Behavioral: 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 fidelity monitoring via COACH and Lyssn. |
| No CAMPI or Fidelity Monitoring | Experimental | Behavioral: Family Check-Up 4 Health (FCU4Health)Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- BMI at or above 85 percentile for age and gender.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS/Text (CAMPI)Configurable Assessment Messaging Platform for Interventions (CAMPI) is a SMS text messaging platform to promote motivation and home practice. | Behavioural | SMS/Text (CAMPI), SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH) |
| Fidelity Monitoring (Lyssn and COACH)Lyssn's HIPAA-compliant, cloud-based platform uses embedded speech-to-text transcription from audio recorded sessions for rapid assessment and easy session review for supervisors and interventionists. The COACH fidelity rating system assesses clinical skills in five domains considered essential for the effective provision of the FCU and the EDP intervention sessions. The COACH rating form is used to assess the extent to which the provider is: 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 | Behavioural | Fidelity Monitoring (Lyssn and COACH), SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH) |
| Family Check-Up 4 Health (FCU4Health)An evidence-based, data-driven, individually tailored parenting intervention with evidence of effectiveness on child and family health behaviors and psychosocial well-being. The program includes three components: 1) a comprehensive family assessment, 2) feedback and motivation session, and 3) individually tailored follow-up support (including parent training modules from the Everyday Parenting curriculum and connection with community resources). Dosage and content of these follow-up sessions are driven by the results of the assessment and family interest. The assessment, feedback and motivation session, and follow-up support are repeated annually. | Behavioural | Fidelity Monitoring (Lyssn and COACH), No CAMPI or Fidelity Monitoring, SMS/Text (CAMPI), SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH) |
Primary outcome
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.
Child Health Behaviors: Dietary Screener Questionnaire
Time frame: 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.
18 secondary outcomes
COACH Fidelity Rating System
Time frame: Up to 36 months
Engagement (participation) in FCU4Health services
Time frame: From enrollment to end of intervention at 9 months
Engagement in home practice
Time frame: From enrollment to end of intervention at 9 month
Engagement with the SMS text messaging platform
Time frame: From enrollment to end of intervention at 9 month
Child BMI - Percentage of the 95th percentile (BMIp95)
Time frame: Baseline and 9 months
Reach of the intervention
Time frame: Up to 36 months
Normalisation MeAsure Development questionnaire
Time frame: Month 9
Maintenance/Sustainability
Time frame: Month 9
Parenting Skills: Incentives and Encouragement
Time frame: Baseline, 4, and 9 months
Parenting Skills: Proactive Parenting
Time frame: Baseline, 4, and 9 months
Parenting Skills: Parenting Warmth
Time frame: Baseline, 4, and 9 months
Parenting Skills: Parent-Child Conflict
Time frame: Baseline, 4, and 9 months
Parenting Skills: Quality Time
Time frame: Baseline, 4, and 9 months
Parenting Skills: Monitoring and Limit Setting
Time frame: Baseline, 4, and 9 months
Parenting Skills: Negative Parenting Behaviors
Time frame: Baseline, 4, and 9 months
Family Health Routines: Mealtime
Time frame: Baseline, 4, and 9 months
Family Health Routines: Media
Time frame: Baseline, 4, and 9 months
Family Health Routines: Sleep
Time frame: Baseline, 4, and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cady Berkel, Ph.D. contact
Cady Berkel, Ph.D. principal investigator
Arizona State University
Justin D Smith, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS/Text (CAMPI), Fidelity Monitoring (Lyssn and COACH) and Family Check-Up 4 Health (FCU4Health) in people with Clinical Trial, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele M Porter, Ph.D. (4802037550, michele.porter@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lyssn Fidelity Ratings (time frame: Up to 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.