FCU4Health for Reducing Heart Disease Risk in Children

(PREVAIL Trial)

Overseen By Michele M Porter, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 18 months

840 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called Family Check-Up 4 Health, aimed at reducing heart disease risk in children. By using interactive text messages and monitoring systems, the researchers aim to improve family health habits, parenting skills, and children's weight management. The trial involves different groups: some receive text prompts, some get feedback from trainers, and others experience both or neither. Children who qualify have a BMI (a measure of body fat based on height and weight) at or above the 85th percentile for their age and gender. As an unphased trial, this study offers families the chance to contribute to innovative health solutions and enhance their well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Family Check-Up 4 Health (FCU4Health) intervention is safe for children?

Research has shown that family-based programs like Family Check-Up 4 Health (FCU4Health) are generally safe for children. These programs aim to boost health and improve family interactions without using medication or medical procedures, reducing the risk of side effects.

Studies have found that families in similar programs often experience better parenting skills and improvements in children's health and behavior. This suggests that the program is safe and does not cause harm. Although specific safety data for FCU4Health is limited, the program's design indicates it is unlikely to cause problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FCU4Health trial because it explores innovative ways to reduce heart disease risk in children by engaging families through interactive methods. Unlike traditional treatments that might focus solely on medication or lifestyle changes, this approach includes delivering health-promoting content via SMS/text messages using the CAMPI platform, making it easily accessible and engaging for families. Additionally, the trial uses fidelity monitoring systems like Lyssn and COACH to provide personalized feedback to behavioral health consultants, ensuring high-quality support and guidance. This combination of technology-driven engagement and personalized professional feedback could lead to more effective prevention strategies for heart disease risk in young populations.

What evidence suggests that this trial's treatments could be effective for reducing heart disease risk in children?

Research shows that the Family Check-Up 4 Health (FCU4Health) program can lower the risk of heart disease in children. Studies have found that this program, which involves the whole family, improves children's health habits and parenting skills. Specifically, past trials demonstrated that FCU4Health helps reduce children's body weight and encourages healthier lifestyle choices. These changes are crucial because they decrease the risk of heart disease in the long run. In this trial, participants will be assigned to different arms, including receiving interactive content via SMS (CAMPI), fidelity monitoring (Lyssn and COACH), both interventions, or neither. By focusing on family interactions and health habits, FCU4Health addresses the root causes of heart issues early. ^{1 4 6 7 8}

Who Is on the Research Team?

Justin D Smith, Ph.D.

Principal Investigator

University of Utah

Cady Berkel, Ph.D.

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

This trial is for children at risk of cardiovascular disease. It's being conducted in primary care settings and aims to help improve health behaviors, parenting skills, and potentially reduce child BMI.

Inclusion Criteria

My BMI is in the top 15% for my age and gender.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments are conducted for parent/caregivers and children at least 6 years of age

1-2 weeks

1 visit (in-person)

Treatment

Participants receive the Family Check-Up 4 Health (FCU4Health) intervention, with randomization to fidelity monitoring and/or SMS text messaging strategies

18 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6, 12, and 18 months

18 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Family Check-Up 4 Health (FCU4Health)

Trial Overview The study tests the FCU4Health intervention combined with tech strategies like a fidelity monitoring system (Lyssn) and text messages (CAMPI), all integrated with Electronic Health Records to see if they can lower heart disease risks in kids.

How Is the Trial Designed?

Group I: SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn and COACH) Experimental Treatment 3 Interventions

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.

Group II: SMS/Text (CAMPI) Experimental Treatment 2 Interventions

Receives interactive content with prompts via SMS (text) message to participant cellular phones developed within this project using the CAMPI platform.

Group III: No CAMPI or Fidelity Monitoring Experimental Treatment 1 Intervention

Receives neither SMS/Text (CAMPI) or Fidelity Monitoring (Lyssn and COACH).

Group IV: Fidelity Monitoring (Lyssn and COACH) Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The Family Matters study is a randomized controlled trial involving 525 children aged 5-10 at risk for cardiovascular disease, aiming to improve child cardiovascular health by increasing the frequency and quality of family meals through innovative methods like ecological momentary intervention and video feedback.

This study is unique as it combines multiple intervention strategies, including home visits by Community Health Workers, to evaluate their effectiveness in enhancing diet quality and overall health outcomes, potentially influencing future clinical practices in child cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Three-Arm Randomized Controlled Trial Using Ecological Momentary Intervention, Community Health Workers, and Video Feedback at Family Meals to Improve Child Cardiovascular Health: The Family Matters Study Design. Berge, JM., Trofholz, AC., Aqeel, M., et al.[2023]

The Prevention Education Program (PEP) is a long-term, home-based intervention aimed at improving cardiovascular health in children and their families, involving 1740 families across 37 schools over a 10-year period.

Baseline data revealed a high prevalence of cardiovascular risk factors among both adults and children, highlighting the urgent need for this type of intervention in Germany.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevention education program (PEP). A prospective study of the efficacy of family-oriented life style modification in the reduction of cardiovascular risk and disease: design and baseline data. Schwandt, P., Geiss, HC., Ritter, MM., et al.[2022]

The 12-week 'Be a Fit Kid' program successfully improved children's physical activity and nutrition, leading to significant enhancements in body composition, fitness, and dietary habits.

Children who participated in at least 75% of the program experienced notable reductions in total cholesterol and triglyceride levels, indicating potential long-term health benefits and a lower risk of lifestyle-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting healthy lifestyles in children: a pilot program of be a fit kid. Slawta, J., Bentley, J., Smith, J., et al.[2016]

Citations

1. reporter.nih.gov reporter.nih.gov/search/PBq_kmaVYkSw1rP1ys7_iw/project-details/10931971

Testing Technology-Based Implementation Strategies for a Family ... Two randomized effectiveness-implementation trials of the Family Check-Up 4 Health program conducted in several primary care systems have demonstrated ...

2. withpower.com withpower.com/trial/phase-clinical-trials-8-2024-fcbf5

FCU4Health for Reducing Heart Disease Risk in Children This study investigates the implementation and effectiveness of the Family Check-Up 4 Health (FCU4Health) intervention in primary care settings for reducing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214109X21003193

Efficacy of a family-based cardiovascular risk reduction ... We aimed to investigate the efficacy of a targeted family-based intervention for reduction of total cardiovascular risk in individuals with a family history of ...

4. researchgate.net researchgate.net/publication/350056517_Effects_of_the_Family_Check-Up_4_Health_on_Parenting_and_Child_Behavioral_Health_A_Randomized_Clinical_Trial_in_Primary_Care

Effects of the Family Check-Up 4 Health on Parenting and ... The primary effectiveness outcomes were child obesogenic health behaviors ... effectiveness is critical for improving patient health outcomes at a reduced cost.

5. reporter.nih.gov reporter.nih.gov/project-details/10931971

Testing Technology-Based Implementation Strategies for a Family ... Two randomized effectiveness-implementation trials of the Family Check-Up 4 Health program conducted in several primary care systems have demonstrated ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30374436/

The Family Check-Up 4 Health (FCU4Health) - PubMed - NIH In this paper, adaptation included shifting the frame of the intervention from one of risk reduction to health promotion; adding health-specific assessments in ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000618

Cardiovascular Risk Reduction in High-Risk Pediatric ... Children and adolescents may be at higher risk for cardiovascular disease because of significant atherosclerotic or arteriosclerotic risk ...

8. welcome.thefamilycheckup.com welcome.thefamilycheckup.com/resources

Resources This resource provides detailed information, reviews, data, links, and statistics about the Family Check-Up Model. ... Reduced Suicide Risk · Improved Peer ...