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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-6 week class series, 3- and 6-month follow-up appointments.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are involved in the current experimentation?

"Affirmative. Clinicaltrials.gov's records confirm that this clinical trial is presently seeking participants, which was originally posted on March 22nd 2022 and last updated on September 27th 2022. This research endeavour requires 80 people across one medical site to partake in the study."

Answered by AI

Are there any open slots for participation in this research project?

"Affirmative. The clinical trial is currently in a recruitment phase, according to the information hosted on clinicialtrials.gov. This research project was first posted on March 22nd 2022 and updated lastly on September 27th of that same year. 80 patients need to be sourced from 1 medical center for participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Gary J. Luckasen, MD 2022. "Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322876.

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