Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2, Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT04891575
- Run by
- Gia Mudd
- People needed
- 504
- Starts
- 2021-09-11
- Expected to finish
- 2026-01-09
- Last updated by the study team
- 2026-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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:
- 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
- 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
You may not qualify if…
- 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 it is running
- 2201 Regency Rd. — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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