NCT04891575

Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Gia Mudd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The Heart of the Family study is a randomized controlled trial conducted to examine if a virtual lifestyle modification intervention is more effective in reducing risk for type 2 diabetes (T2D) and cardiovascular disease (CVD) when it is delivered to family dyads or to individuals and to compare intervention effects in Hispanic and non-Hispanic rural-dwelling adults at-risk for T2D or CVD. The Heart of the Family study will enroll 360 participants - 180 Hispanics and 180 non-Hispanics - from rural communities who have two or more risk factors for T2D or CVD. Participants will be randomized to participate as an individual or with a family member who may or may not be at risk for T2D or CVD or may or may not have diagnosed T2D or CVD for a total of 540 participants. The interventions for both groups will be provided by community health workers using a virtual platform. Both groups will receive eight educational sessions about healthy lifestyle behaviors and support to address personal and environmental barriers to engaging in healthy behaviors. After the eight sessions, the community health workers will follow up with participants once a month by phone over the next 12 months. Primary outcomes include short-term and long-term impact of the family-focused active intervention compared to the individual-focused control condition on type 2 diabetes and CVD biological risk factors (for example, blood pressure and weight) and behavioral risk factors (for example, physical activity and tobacco use). Outcomes are measured at baseline, immediately post-intervention, and at the end of the 12 month period of the study for both groups.

Conditions

• Diabetes Mellitus, Type 2
• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Active Control Intervention educational sessions	The participant will attend 8 sessions that provide type 2 diabetes (T2D) and cardiovascular (CVD) risk reduction and lifestyle modification education focused on CVD and T2D risk factor reduction through promotion of participant self-management. Education will concentrate on healthy eating, physical activity, stress reduction, and other lifestyle risk reduction recommendations.
BEHAVIORAL	Family Dyad Intervention	The participant and a co-participating family member will attend 8 sessions that provide type 2 diabetes (T2D) and cardiovascular (CVD) risk reduction and lifestyle modification education focused on CVD and T2D risk factor reduction through promotion of participant self-management. Education will concentrate on healthy eating, physical activity, stress reduction, and other lifestyle risk reduction recommendations.

Timeline

• Start date: 2021-09-11
• Primary completion: 2026-01-09
• Completion: 2026-01-09
• First posted: 2021-05-18
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States