Lifestyle Intervention for Cardiovascular Disease and Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how a family-focused lifestyle program, the Family Dyad Intervention, can help rural adults manage their risk of cardiovascular disease and type 2 diabetes. Participants with at least two risk factors, such as high blood pressure or being overweight, will join sessions to learn about healthy habits. Some will attend alone, while others may bring a family member for support. Ideal participants are rural Hispanic or non-Hispanic adults living in Kentucky with internet access, who are willing to engage for a year. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could benefit rural communities.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on lifestyle changes, so it's best to discuss your medications with the trial coordinators or your doctor.
What prior data suggests that this lifestyle intervention is safe for rural populations?
Research shows that when individuals with health risks collaborate with a family member in a program, it can aid in managing diabetes. Studies on these programs have found that participants generally tolerate them well, without major side effects. Family support appears to enhance diabetes management and improve daily health.
These programs aim to promote healthy lifestyle changes, such as better eating habits and regular exercise, which are unlikely to cause harm. Although the specific trial for rural areas in the U.S. lacks detailed safety information, past research on similar programs suggests they are safe and can help manage health risks related to heart disease and type 2 diabetes.12345Why are researchers excited about this trial?
Researchers are excited about the Family Dyad Intervention because it emphasizes a collaborative approach to managing cardiovascular disease and type 2 diabetes risk factors. Unlike standard individual-focused treatments, which often involve self-directed lifestyle changes and medications, this intervention involves both the patient and a family member participating in educational sessions together. This family-centered approach aims to boost motivation and adherence to healthier lifestyles by leveraging support from loved ones, potentially leading to more sustainable long-term health improvements.
What evidence suggests that this trial's treatments could be effective for cardiovascular disease and type 2 diabetes?
Research has shown that involving family in health care can help manage type 2 diabetes and heart disease. In this trial, participants in the Family Dyad Arm will attend sessions with a family member, focusing on self-management and healthy behaviors. Studies have found that when family members make lifestyle changes together, health outcomes improve. For instance, individuals with family support in managing diabetes often see improvements in blood sugar levels and overall well-being. Involving family encourages support, which is crucial for maintaining healthy habits. This method has proven effective in other groups and might help rural communities lower their health risks. Overall, family involvement in health management can significantly impact controlling these conditions.12346
Who Is on the Research Team?
Gia Mudd, RN, PhD
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
This trial is for adults over 18 living in rural Kentucky, with internet access and at risk for type 2 diabetes or cardiovascular disease. Participants must speak English or Spanish and may include a family member who lives nearby. Those with cognitive impairments, major psychiatric conditions, pregnancy, or known heart diseases are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive eight weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction
Follow-up
Community health workers follow up with participants once a month by phone to monitor long-term impact on type 2 diabetes and CVD risk factors
What Are the Treatments Tested in This Trial?
Interventions
- Active Control Intervention educational sessions
- Family Dyad Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gia Mudd
Lead Sponsor
National Institute of Nursing Research (NINR)
Collaborator