Healthy Hearts Family Program for Cardiovascular Disease

Overseen By NaNet Jenkins, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Poudre Valley Health System

Disqualifiers: Unwilling to wear Fitbit, Language barrier, Follow-up noncompliance, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the feasibility of a 6-month family-based community intervention to mitigate cardiovascular disease risk factors in Hispanic families in northern Colorado as measured through biometric screenings, body composition, physical activity, and health knowledge.

Research Team

Victoria Bandera, MS

Principal Investigator

University of Colorado Health

Eligibility Criteria

This trial is for Hispanic families with members aged 13 or older, aiming to reduce cardiovascular disease risk. Participants must be able to read English or Spanish and commit to wearing a Fitbit device daily, except when charging or sleeping. They also need to attend baseline, 3-month, and 6-month follow-up screenings.

Inclusion Criteria

At least one person in the family says they are Hispanic.

I am 13 years old or older.

Exclusion Criteria

Unwilling to wear Fitbit devices daily for 6 months except when charging and sleeping

Cannot read or understand either English or Spanish

Cannot return to screening location to perform the minimum of the baseline, 3-month and 6-month follow-up screenings

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Class Series

Participants attend a 6-week interactive educational class series as part of the Healthy Hearts Family Program

6 weeks

Weekly classes

Treatment

Participants engage in a 6-month family-based community intervention to mitigate cardiovascular disease risk factors

6 months

Baseline, 3-month, and 6-month follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

Quarterly biometric screenings

Treatment Details

Interventions

• Healthy Hearts Family Program

Trial Overview The 'Healthy Hearts Family Program' is being tested over six months to see if it can lower the risk of heart disease in Hispanics. The program's success will be measured by changes in biometric data, body composition, physical activity levels, and health knowledge.

Participant Groups

Group I: Healthy Hearts Family Program Experimental Treatment 1 Intervention

Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program.

Who Is Running the Clinical Trial?

Poudre Valley Health System

Lead Sponsor

Trials

17

Recruited

780+

Fitbit LLC

Industry Sponsor

Trials

7

Recruited

452,000+

Fitbit Inc

Industry Sponsor

Trials

6

Recruited

452,000+

Small Steps Labs, LLC

Collaborator

Trials

3

Recruited

1,100+