ACTIVE_NOT_RECRUITING

Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases lifestyle modification rural Hispanic non-Hispanic dyad family risk reduction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families

Quick Facts

Study Start:2021-09-11

Study Completion:2026-05-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04891575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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	* 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. * 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

Inclusion Criteria

Exclusion Criteria

* 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
* 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

* 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.
* 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

Contacts and Locations

Principal Investigator

Gia Mudd, RN, PhD

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

2201 Regency Rd.

Lexington, Kentucky, 40503

United States

Collaborators and Investigators

Sponsor: Gia Mudd

Gia Mudd, RN, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-11

Study Completion Date2026-05-11

Study Record Updates

Study Start Date2021-09-11

Study Completion Date2026-05-11

Terms related to this study

Keywords Provided by Researchers

lifestyle modification
rural
Hispanic
non-Hispanic
dyad
family
risk reduction

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2
Cardiovascular Diseases