Lifestyle Intervention for Cardiovascular Disease and Type 2 Diabetes

Overseen By Gia Mudd, RN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gia Mudd

Disqualifiers: Cognitive impairment, Major psychiatric, Pregnancy, Coronary artery, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

540 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for cardiovascular disease and type 2 diabetes?

Research shows that family-based interventions, especially those culturally tailored, can improve self-management and reduce distress in individuals with type 2 diabetes. These interventions have shown sustained improvements in diet and exercise management, which are crucial for managing diabetes and potentially beneficial for cardiovascular health. ^{1 2 3 4 5}

Is the lifestyle intervention for cardiovascular disease and type 2 diabetes safe for humans?

The studies on family-based lifestyle interventions for diabetes, particularly among Latino families, suggest that these interventions are generally safe. They focus on education, social support, and self-management, which are non-invasive and promote healthy behaviors. ^{1 2 3 4 6}

How is the Family Dyad Intervention treatment different from other treatments for cardiovascular disease and type 2 diabetes?

The Family Dyad Intervention is unique because it involves the patient's family in the treatment process, focusing on family engagement, empowerment, and support to improve lifestyle habits and manage health conditions. This approach is culturally tailored and emphasizes the role of family dynamics in promoting health, which is different from traditional individual-focused treatments. ^{1 2 3 7 8}

What is the purpose of this trial?

Rural populations in the U.S. are disproportionately burdened by cardiovascular disease and type 2 diabetes. Lifestyle modification interventions are needed that support long-term engagement in risk-reducing health behaviors. This trial will study the effects of a family-focused, lifestyle intervention that is culturally tailored for use with rural Hispanic and non-Hispanic adults. If successful, this community-based intervention has significant potential for broad dissemination to reduce cardiovascular disease and type 2 diabetes health disparities in rural U.S. communities.

Research Team

Gia Mudd, RN, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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.

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

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)

Treatment Details

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.

Participant Groups

Group I: Family Dyad Arm Experimental Treatment 1 Intervention

An index participant with 2 or more risk factors for cardiovascular disease or type 2 diabetes and a co-participating family member will together attend 8 weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction. The dyadic intervention sessions also incorporate family-focused throughout each session to encourage dyadic support.

Group II: Active Control Arm Active Control 1 Intervention

An index participant with 2 or more risk factors for cardiovascular disease or type 2 diabetes who is randomized to this arm will attend 8 weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction. The index participant will attend the sessions as an individual and will receive standard individual-focused lifestyle modification education.

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+

Findings from Research

The study aims to evaluate a culturally-grounded lifestyle intervention for Latino families, involving 132 participants, to improve glucose tolerance and quality of life over 12 months.

The intervention includes 16 weeks of nutrition and wellness classes led by bilingual professionals and supervised physical activities, which may enhance family engagement and empowerment in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing diabetes in Latino families: A protocol for a randomized control trial. Braxton, ME., Nwabichie, E., Diaz, M., et al.[2023]

The study involved 12 Mexican American adults with type 2 diabetes and their family members, who participated in focus groups to identify barriers and strategies for diabetes management, highlighting the importance of family support.

The findings suggest that effective diabetes management can be enhanced by fostering a shared commitment within families, moving away from individual-focused approaches to a more collaborative model that values family knowledge and skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnering With Families to Refine and Expand a Diabetes Intervention for Mexican Americans. McEwen, MM., Murdaugh, C.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Juntos Pilot Study: A Diabetes Management Intervention for Latino Caregiving Dyads. Mendez-Luck, CA., Miranda, J., Mangione, CM., et al.[2020]

A study involving 350 couples, where one partner has poorly controlled type 2 diabetes, is exploring the effectiveness of a couples-focused intervention compared to individual interventions and enhanced usual care, with outcomes including glycemic control and psychosocial well-being.

The research highlights the importance of specific skills for interventionists to effectively promote communal coping among couples, which may enhance the success of diabetes management interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Lessons Learned in the Development and Implementation of a Couples-Focused Telephone Intervention for Adults with Type 2 Diabetes: The Diabetes Support Project. Trief, PM.[2021]

The Unidas por la Vida program, a 16-week lifestyle intervention for high-risk Mexican American mothers with Type 2 diabetes and their overweight/obese daughters, resulted in significantly greater weight loss and improved dietary habits compared to a control group.

Participants in the Unidas program not only lost more weight but also reported eating foods with lower glycemic loads and less saturated fat, highlighting the program's effectiveness in promoting healthier eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic collaboration in shared health behavior change: the effects of a randomized trial to test a lifestyle intervention for high-risk Latinas. Sorkin, DH., Mavandadi, S., Rook, KS., et al.[2022]

The interdisciplinary family intervention (FI) significantly improved glucose metabolism and insulin sensitivity in patients with prediabetes over 12 months, while the individual intervention (II) did not maintain these benefits after 6 months.

Family members of the FI group also showed sustained improvements in metabolic risk, whereas the II group experienced an increase in metabolic risk, highlighting the importance of family involvement in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial. Vargas-Ortiz, K., Lira-Mendiola, G., Gómez-Navarro, CM., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preventing diabetes in Latino families: A protocol for a randomized control trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Partnering With Families to Refine and Expand a Diabetes Intervention for Mexican Americans. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of a Family-based Diabetes Intervention on Behavioral and Biological Outcomes for Mexican American Adults. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Juntos Pilot Study: A Diabetes Management Intervention for Latino Caregiving Dyads. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Challenges and Lessons Learned in the Development and Implementation of a Couples-Focused Telephone Intervention for Adults with Type 2 Diabetes: The Diabetes Support Project. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Dyadic collaboration in shared health behavior change: the effects of a randomized trial to test a lifestyle intervention for high-risk Latinas. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

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. [2023]