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

1200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Family Check-Up 4 Health (FCU4Health) for reducing heart disease risk in children?

Research shows that family-oriented lifestyle changes, like those in FCU4Health, can help reduce heart disease risk factors in children. Programs focusing on family meals and health education have been linked to better heart health in kids, suggesting that similar approaches in FCU4Health could be effective. ^{1 2 3 4 5}

Is FCU4Health safe for children?

The available research on family-based interventions, including those similar to FCU4Health, suggests they are generally safe for children. These interventions focus on improving diet and lifestyle habits, which are typically safe and beneficial for cardiovascular health. ^{1 3 6 7 8}

How is the FCU4Health treatment different from other treatments for reducing heart disease risk in children?

FCU4Health is unique because it focuses on family-oriented prevention and lifestyle changes, such as healthy eating and physical activity, rather than just medical interventions. This approach aims to reduce heart disease risk by addressing habits and risk factors early in childhood, involving the whole family in the process. ^{2 8 9 10 11}

What is the purpose of this 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.

Research Team

Cady Berkel, Ph.D.

Principal Investigator

Arizona State University

Justin D Smith, Ph.D.

Principal Investigator

University of Utah

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: SMS/Text (CAMPI) and Fidelity Monitoring System (Lyssn) 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 automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

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. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

Group III: No CAMPI or Lyssn Experimental Treatment 1 Intervention

Receives neither SMS/Text (CAMPI) or Fidelity Monitoring System (Lyssn). Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

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

Receives automated fidelity monitoring and interactive feedback reports. Receives Family Check-Up 4 Health (FCU4Health) parenting intervention.

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+

Findings from Research

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition intervention and health risk reduction in childhood: creating healthy adults. [2008]

3. United States 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. [2022]

4. Croatia pubmed.ncbi.nlm.nih.gov

[Familial cardiovascular risk factors]. [2009]

5. Ireland pubmed.ncbi.nlm.nih.gov

Cardiovascular risk screening in school children predicts risk in parents. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of family-based eHealth interventions in cardiovascular disease risk reduction: A systematic review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effects of a controlled family-based health education/counseling intervention. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of family-oriented risk-based prevention on serum cholesterol and blood pressure values of children and adolescents. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary intake of children at high risk for cardiovascular disease. [2022]

10. Finland pubmed.ncbi.nlm.nih.gov

[Prevention of cardiovascular diseases--the most recent recommendations from the United States]. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Promoting healthy lifestyles in children: a pilot program of be a fit kid. [2016]