Rural families fight heart disease and diabetes together in new study
NCT ID NCT04891575
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a family-focused lifestyle program designed to help rural Hispanic and non-Hispanic adults lower their risk for heart disease and type 2 diabetes. Over 500 participants took part in a culturally tailored program that encouraged healthy eating, physical activity, and other heart-healthy habits. The goal was to see if this approach could help families make lasting changes to prevent these serious conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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504 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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2201 Regency Rd.
Lexington, Kentucky, 40503, United States
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