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

NCT ID: NCT04891575

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-11
• Study Completion Date: 2026-02-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Active Control Arm

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.

Group Type: ACTIVE_COMPARATOR

Active Control Intervention educational sessions

Intervention Type: BEHAVIORAL

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.

Family Dyad Arm

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 Type: EXPERIMENTAL

Family Dyad Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Primary participants are rural-dwelling Hispanic and non-Hispanic adults who are at-risk for type 2 diabetes or cardiovascular disease and have a family member who is willing to participate if the primary participant is randomly selected to participate with a family member.

• Is Hispanic or non-Hispanic adult
• Is 18 years of age and older
• Is a primary Spanish or English speaker
• Has internet access
• Has two or more risk factors for type 2 diabetes or cardiovascular disease including:

1. clinical diagnosis of hypertension;

2. clinical diagnosis of hyperlipidemia;

3. clinical diagnosis of prediabetes;

4. overweight or obese (body mass index ≥ 25 kg/m2);

5. is a current cigarette smoker;

6. male 45 years of age or older or female 55 years of age or older;

7. family history in first degree relative of type 2 diabetes or cardiovascular disease; or

8. is a female with a history of gestational diabetes mellitus or polycystic ovary syndrome.

• Lives in rural Kentucky
• Is willing to participate in the study for the next 12 months

• Is 18 years of age and older
• Is a primary Spanish or English speaker
• Lives in the same household or in close proximity (no further than 25 miles distance) to the primary participant
• Has internet access
• Is willing to participate in the study for the next 12 months

Exclusion Criteria

Primary participant and family member participant will be excluded if they:

• Have cognitive impairment that preclude them from understanding the consent process, answering questionnaires, or participating in the intervention;
• Have a major psychiatric (e.g., schizophrenia) condition;
• Are pregnant or nursing or plan on becoming pregnant within the next year since dietary needs will be different.

• Have known coronary artery or cerebrovascular disease;
• Have a diagnosis of type 1 or type 2 diabetes;
• Have medical contraindications to participate in a lifestyle intervention that includes unsupervised physical activity and weight loss

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Gia Mudd

OTHER

Sponsor Role: lead

Responsible Party

Gia Mudd

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gia Mudd, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

2201 Regency Rd.

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

1R01NR019456-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

60980

Identifier Type: -

Identifier Source: org_study_id