Status:
ACTIVE_NOT_RECRUITING
Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
Lead Sponsor:
Gia Mudd
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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-r...
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 11 2026
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT04891575
Start Date
September 11 2021
End Date
February 11 2026
Last Update
July 14 2025
Active Locations (1)
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1
2201 Regency Rd.
Lexington, Kentucky, United States, 40503