80 Participants Needed

Healthy Hearts Family Program for Cardiovascular Disease

VM
NJ
Overseen ByNaNet Jenkins, MPH
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Poudre Valley Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Healthy Hearts Family Program, a 6-month family-based initiative, can reduce heart disease risk in Hispanic families in northern Colorado. The program emphasizes improving heart health through physical activity, health education, and monitoring bodily changes. Families with at least one Hispanic member who are willing to wear a Fitbit daily and participate in screenings are suitable for this study. As an unphased trial, it offers families the chance to contribute to important research that could improve heart health in their community.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What prior data suggests that the Healthy Hearts Family Program is safe?

Research shows that the Healthy Hearts Family Program aims to prevent heart disease through education and lifestyle changes. Studies have found that similar programs are generally easy for participants to follow, often leading to improvements in heart health indicators like body weight and physical activity levels.

Although specific safety data for this program is unavailable, similar programs have been used in different states with positive results. These community-based programs have not reported major safety issues. Since the program does not involve medication or medical procedures, it is less likely to cause side effects.

Overall, the Healthy Hearts Family Program appears to be a safe choice for those wanting to improve heart health through lifestyle changes.12345

Why are researchers excited about this trial?

The Healthy Hearts Family Program is unique because it focuses on involving the whole family in a prevention approach for cardiovascular disease, rather than just treating the individual. Standard treatments for cardiovascular disease often rely on medications, lifestyle changes, and sometimes surgical interventions, but this program emphasizes a family-based strategy to promote long-term heart health. Researchers are excited about this method because it could lead to more sustainable lifestyle changes and better health outcomes by engaging family support, which is often a key factor in maintaining healthy habits. This comprehensive approach aims to not only reduce risk factors like high blood pressure and cholesterol but also improve overall family dynamics and health literacy.

What evidence suggests that the Healthy Hearts Family Program is effective for cardiovascular disease prevention?

Research has shown that the Healthy Hearts Family Program, which participants in this trial will join, can improve heart health by promoting lifestyle changes. One study found that similar programs increased physical activity and improved dietary habits, both crucial for heart health. Another study reported that participants gained confidence in managing their health, resulting in more exercise and healthier eating. Although not all studies showed significant improvements, these programs aim to help families make healthier choices to reduce heart disease risk. The program emphasizes simple steps like increasing activity and improving diet, aiming for long-term health benefits.26789

Who Is on the Research Team?

VB

Victoria Bandera, MS

Principal Investigator

University of Colorado Health

Are You a Good Fit for This Trial?

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
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Healthy Hearts Family ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

The Healthy Hearts Project: Development and evaluation ...Development and evaluation of a website for cardiovascular risk assessment and visualisation and self-management through healthy lifestyle goal-setting.
Process evaluation findings from Strong Hearts, Healthy ...SHHC-2.0 was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical ...
Healthy Hearts for an Abundant Life: Feasibility of a ...This study tested the feasibility of implementing Healthy Hearts for an Abundant Life (HHAL), a cultural adaptation for African American (AA) women.
Results of the Healthy Heart Stepped-Wedge TrialOffering the Healthy Heart programme to high-cardiovascular-risk patients did not improve their lifestyle behaviour nor cardiovascular risk and was not cost- ...
The StrongWomen–Healthy Hearts Program: Reducing ...Our results suggest that a community-based program can improve self-efficacy, increase physical activity, and decrease energy intake, resulting ...
Healthy Hearts California - CDPH - CA.govHealthy Hearts California (HHC) aims to be a driving force behind reducing the risk and prevalence of heart disease and stroke in our state.
Healthy Hearts Project - Illinois Department of Public HealthMillion Hearts is a nationwide initiative to focus, coordinate, and enhance cardiovascular disease prevention activities across the public and private sectors.
Healthy Hearts and MindsThe program aims to prevent cardiovascular disease through education, social connections and sustainable lifestyle changes. Key areas of focus include:
StrongWomen- Healthy Hearts: A Community Based ...StrongWomen - Healthy Hearts is a 12-week, community-based program that has demonstrated effectiveness at improving CVD risk factors, including body weight, ...
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