Healthy Hearts Family Program for Cardiovascular Disease Risk in Hispanic Families

This study is testing a program called the Healthy Hearts Family Program to see if it can help reduce risk factors for heart and blood vessel diseases (cardiovascular diseases) and metabolic syndrome in Hispanic families in northern Colorado. The program involves a 6-week series of classes, along with health screenings at the beginning, 3 months, and 6 months. Researchers will look at changes in daily steps, physical activity levels, and blood pressure to see how well the program works. You can join if at least one family member identifies as Hispanic and is at least 13 years old. The study aims to enroll 80 participants.

Study design
This is an interventional study with a planned enrollment of 80 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will attend a baseline health screening, a 6-week series of weekly classes, and follow-up screenings at 3 and 6 months. You will also need to wear a Fitbit device daily for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will have follow-up health and knowledge screenings at 3 and 6 months after the program starts.

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NCT05322876

Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention

UNKNOWN
NAAges 13+InterventionalPrevention
Poudre Valley Health System
~80 participants
Updated 2024-04-03 on ClinicalTrials.gov
What's tested:Healthy Hearts Family Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of program through changes in physical health - Daily Steps
Measured over Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
+11 more outcomes measured
Cardiovascular Diseases
Metabolic Syndrome
1 sites across 1 states
Colorado1
  • Victoria Bandera, MS · PRINCIPAL_INVESTIGATOR · University of Colorado Health

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Eligibility criteria

Inclusion

At least one member of the family unit self-identifies as Hispanic
At least 13 years of age

Exclusion

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
Children or adolescents will be excluded from this project without a minimum of one accompanying parent or guardian
  • Efficacy of program through changes in physical health - Daily StepsBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Physical activity metrics (daily average steps per month) measured by Fitbit devices

  • Efficacy of program through changes in physical health - Physical ActivityBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Physical activity metrics (daily minutes of light, moderate and vigorous activity per month) measured by Fitbit devices

  • Efficacy of program through changes in physical health - Blood PressureBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Biometric variables (blood pressure in mmHg)

  • Efficacy of program through changes in physical health - Lab Value -Lipid ProfileBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Biometric variables - lab values (lipid profile in mg/dL) measured through finger stick blood sampling

  • Efficacy of program through changes in physical health - Lab Value - TriglyceridesBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Biometric variables - lab values ( triglycerides in mg/dL) measured through finger stick blood sampling

  • Efficacy of program through changes in physical health - Lab Value - Blood GlucoseBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Biometric variables - lab values (blood glucose all in mg/dL) measured through finger stick blood sampling

  • Efficacy of program through changes in physical health - Waist CircumferenceBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Body composition (waist circumference in inches)

  • Efficacy of program through changes in physical health - Body Composition - Muscle MassBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Body composition (muscle mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  • Efficacy of program through changes in physical health - Body Composition - Fat MassBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Body composition (fat-free mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  • Efficacy of program through changes in physical health - Body Fat PercentageBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Body composition (body fat percentage) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  • Efficacy of program through changes in physical health - Visceral Fat RatingBaseline, 3-month follow up and 6-month follow up data will be evaluated and compared

    Body composition (Tanita visceral fat rating) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.

  • Efficacy of program through changes in health knowledgeBaseline, post-6 week class series, 3- and 6-month follow-up appointments.

    Health knowledge gained and retained will be evaluated and compared at baseline, post-6 week class series, 3- and 6-month follow-ups utilizing previously developed and utilized Healthy Hearts knowledge survey. This outcome will be measured by correct responses on the Healthy Hearts knowledge survey.