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Healthy Hearts Family Program for Cardiovascular Disease

N/A
Recruiting
Led By Victoria Bandera, MS
Research Sponsored by Poudre Valley Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 13 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-6 week class series, 3- and 6-month follow-up appointments.
Awards & highlights

Summary

This trial will test a family-based intervention to help Hispanic families in northern Colorado reduce their risk of cardiovascular disease.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication, side effects are minimal but may include discomfort from regular wear of fitness tracking devices and potential stress related to lifestyle adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 13 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-6 week class series, 3- and 6-month follow-up appointments.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-6 week class series, 3- and 6-month follow-up appointments. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of program through changes in health knowledge
Efficacy of program through changes in physical health - Blood Pressure
Efficacy of program through changes in physical health - Body Composition - Fat Mass
+9 more
Secondary study objectives
Adherence to program and utilization of additional resources - Fitbit Utilization
Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended
Adherence to program and utilization of additional resources - Resource Utilization

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy Hearts Family ProgramExperimental Treatment1 Intervention
Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program.

Find a Location

Who is running the clinical trial?

Poudre Valley Health SystemLead Sponsor
16 Previous Clinical Trials
703 Total Patients Enrolled
Fitbit LLCIndustry Sponsor
6 Previous Clinical Trials
451,581 Total Patients Enrolled
Fitbit IncIndustry Sponsor
5 Previous Clinical Trials
451,431 Total Patients Enrolled

Media Library

Healthy Hearts Family Program Clinical Trial Eligibility Overview. Trial Name: NCT05322876 — N/A
Cardiovascular Disease Research Study Groups: Healthy Hearts Family Program
Cardiovascular Disease Clinical Trial 2023: Healthy Hearts Family Program Highlights & Side Effects. Trial Name: NCT05322876 — N/A
Healthy Hearts Family Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05322876 — N/A
~7 spots leftby Dec 2024
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