Family-focused lifestyle intervention for reducing diabetes and heart disease risk in rural communities
Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
This study is testing a virtual program that helps rural Hispanic and non-Hispanic adults and their families make healthier lifestyle choices to lower their risk of type 2 diabetes and heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04891575 on ClinicalTrials.gov |
What this trial studies
This trial investigates a virtual lifestyle modification intervention aimed at reducing the risk of type 2 diabetes and cardiovascular disease among rural Hispanic and non-Hispanic adults. It involves a randomized controlled design where participants are either enrolled individually or with a family member. The intervention includes eight educational sessions focused on healthy lifestyle behaviors, followed by monthly follow-ups from community health workers over a year. The study aims to assess both biological and behavioral risk factors for these conditions.
Who should consider this trial
Good fit: Ideal candidates are rural-dwelling Hispanic and non-Hispanic adults aged 18 and older with two or more risk factors for type 2 diabetes or cardiovascular disease.
Not a fit: Patients without internet access or those who do not have a family member willing to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of type 2 diabetes and cardiovascular disease in high-risk rural populations.
How similar studies have performed: Other studies have shown success with family-based lifestyle interventions, indicating potential for this culturally tailored approach.
Eligibility criteria
Show full inclusion / exclusion 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. Inclusion criteria for the primary participant: * 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 Inclusion criteria for the co-participating family member if primary participant is randomly selected to participate with a family member * 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: Exclusion criteria for family dyads: 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. Exclusion criteria that apply only to the primary participant: * 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
Where this trial is running
Lexington, Kentucky
- 2201 Regency Rd. — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Gia Mudd, RN, PhD — University of Kentucky
- Study coordinator: Gia Mudd, RN, PhD
- Email: gia.mudd@uky.edu
- Phone: 8592574204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.