NCT04891575Completed
Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 504 (actual)
- First submitted
- 13 May 2021
- Start date
- 11 Sept 2021
- Primary completion date
- 9 Jan 2026
- Lead sponsor
- Gia Mudd
- Diseases
- Type 2 diabetes
- NCT number
- NCT04891575
What you commit to
- Study type: Interventional
- Participants enrolled: 504
- From 11 Sept 2021 to the primary completion date, 9 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Have known coronary artery or cerebrovascular disease;
- Have a diagnosis of type 1 or type 2 diabetes;
Other
- Primary participant and family member participant will be excluded if they:
- Are pregnant or nursing or plan on becoming pregnant within the next year since dietary needs will be different.
- Have medical contraindications to participate in a lifestyle intervention that includes unsupervised physical activity and weight loss
Who the study is looking for
- 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:
- clinical diagnosis of hypertension;
- clinical diagnosis of hyperlipidemia;
- clinical diagnosis of prediabetes;
- overweight or obese (body mass index ≥ 25 kg/m2);
- is a current cigarette smoker;
- male 45 years of age or older or female 55 years of age or older;
- family history in first degree relative of type 2 diabetes or cardiovascular disease; or
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2201 Regency Rd. Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.