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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
No Placebo-Only Group
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 belowSelect...
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.
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 moreSecondary 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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
451,574 Total Patients Enrolled
Fitbit IncIndustry Sponsor
5 Previous Clinical Trials
451,431 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- At least one person in the family says they are Hispanic.I am 13 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Hearts Family Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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