Lifestyle Intervention for Cardiovascular Disease and Type 2 Diabetes

GM
Overseen ByGia Mudd, RN, PhD
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 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.12345

Why 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?

GM

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

I have two or more risk factors for type 2 diabetes or heart disease.
I am a rural-dwelling adult at risk for type 2 diabetes or heart disease, and I have a family member who can join if needed.
Criterion: Lives in a rural area in the state of Kentucky.
See 4 more

Exclusion Criteria

I do not have heart or brain vessel disease, diabetes, and can safely do physical activities and lose weight.
Both the main participant and their family member cannot have trouble understanding information, answering questions, or taking part in the study. They also cannot have serious mental health conditions, be pregnant, nursing, or planning to get pregnant soon because their dietary needs will be different.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive eight weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction

8 weeks
8 visits (virtual)

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

12 months
12 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Active Control Intervention educational sessions
  • Family Dyad Intervention
Trial Overview The study tests a culturally tailored lifestyle intervention aimed at reducing the risk of cardiovascular disease and type 2 diabetes among rural Hispanic and non-Hispanic families. It involves educational sessions comparing individual versus family dyad participation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Family Dyad ArmExperimental Treatment1 Intervention
Group II: Active Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gia Mudd

Lead Sponsor

Trials
3
Recruited
1,100+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Published Research Related to This Trial

A family-based self-management support intervention for adults with type 2 diabetes significantly improved various aspects of diabetes self-management, including diet and exercise, over a 6-month period with 157 participants involved.
The intervention not only led to immediate improvements in diabetes self-efficacy and reduced distress but also showed sustained benefits, highlighting the importance of culturally relevant and intensive support for effective diabetes management.
Effects of a Family-based Diabetes Intervention on Behavioral and Biological Outcomes for Mexican American Adults.McEwen, MM., Pasvogel, A., Murdaugh, C., et al.[2023]
The 'Lifestyle Africa' intervention, adapted for a South African community, showed a significant reduction in hemoglobin A1c levels compared to usual care, indicating potential benefits for managing diabetes despite no significant weight loss differences.
The program was successfully delivered by community health workers using video-based sessions, demonstrating feasibility for scaling lifestyle interventions in low- and middle-income countries, with no serious adverse events reported.
Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa.Catley, D., Puoane, T., Tsolekile, L., et al.[2023]
The Juntos program, a culturally sensitive diabetes intervention for older Latino adults with type 2 diabetes, was found to be acceptable and feasible, with participants expressing a desire for its expansion after completing the 6-week program.
Improvements were observed in A1C levels, health status, and dyadic communication from baseline to 6 months post-intervention, suggesting that the program may effectively support glycemic control, although the study was not powered to definitively assess these outcomes.
The Juntos Pilot Study: A Diabetes Management Intervention for Latino Caregiving Dyads.Mendez-Luck, CA., Miranda, J., Mangione, CM., et al.[2020]

Citations

Family dyad-focused diabetes self-management ...Secondary outcomes will provide preliminary data on A1c, HRQOL, and blood pressure in participants with T2D. Secondary outcomes will explore the ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40706841/
Family dyad-focused diabetes self-management intervention ...Objective: We will examine a family-dyad-focused intervention to facilitate family support to promote diabetes self-management among middle-aged ...
Lifestyle Intervention for Cardiovascular Disease and Type ...Trial Overview The study tests a culturally tailored lifestyle intervention aimed at reducing the risk of cardiovascular disease and type 2 diabetes among rural ...
NCT05905575 | A Family Dyad-focused Diabetes Self ...A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the ...
(PDF) Family dyad-focused diabetes self-management ...Conceptual framework of family dyad-focused intervention for African American adults with Type 2 diabetes. J. Hu et al.
Culturally tailored lifestyle interventions for the prevention ...Conclusion: This evidence supports the effectiveness of culturally tailored lifestyle interventions for T2D management in populations of Black African ancestry, ...
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