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

NCT04891575 | Completed

• 2 other identifiers: 609801R01NR019456-01
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

lifestyle modification; rural; Hispanic; non-Hispanic; dyad; family; risk reduction

Outcome Measures

Primary Outcomes (7)

• Change in body mass index (BMI)

  BMI based on measurements of weight and height and calculated as kg/m2.

  1 year (baseline, 3 months and 12 months)

• Change in blood pressure

  Blood pressure assessed using calibrated sphygmomanometry.

  1 year (baseline, 3 months and 12 months)

• Change in lipid profile

  Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.

  1 year (at baseline, 3 months and 12 months)

• Change in hemoglobin A1c (HbA1c)

  HbA1c will be measured using point-of-care testing obtained by fingerstick.

  1 year (at baseline, 3 months and 12 months)

• Change in physical activity level

  Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ) to assess the number of days in the last 7 days that the participant engaged in vigorous or moderate physical activity and confirmed by comparing responses to activity levels as determine through actigraphy.

  1 year (at baseline, 3 months and 12 months)

• Change in dietary intake patterns

  Dietary intake patterns will be assessed using the Vioscreen food frequency questionnaire.

  1 year (at baseline, 3 months and 12 months)

• Change in tobacco use

  Tobacco use will be confirmed by collection of a saliva sample to determine cotinine levels.

  1 year (at baseline, 3 months and 12 months)

Study Arms (2)

Active Control Arm

ACTIVE COMPARATOR

An index participant with 2 or more risk factors for cardiovascular disease or type 2 diabetes who is randomized to this arm will attend 8 weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction. The index participant will attend the sessions as an individual and will receive standard individual-focused lifestyle modification education.

Behavioral: Active Control Intervention educational sessions

Family Dyad Arm

EXPERIMENTAL

An index participant with 2 or more risk factors for cardiovascular disease or type 2 diabetes and a co-participating family member will together attend 8 weekly educational sessions focused on self-management of risk factors and engagement in healthy behaviors for risk reduction. The dyadic intervention sessions also incorporate family-focused throughout each session to encourage dyadic support.

Behavioral: Family Dyad Intervention

Interventions

Family Dyad Intervention BEHAVIORAL

The participant and a co-participating family member will attend 8 sessions that provide type 2 diabetes (T2D) and cardiovascular (CVD) risk reduction and lifestyle modification education focused on CVD and T2D risk factor reduction through promotion of participant self-management. Education will concentrate on healthy eating, physical activity, stress reduction, and other lifestyle risk reduction recommendations.

Family Dyad Arm

Active Control Intervention educational sessions BEHAVIORAL

The participant will attend 8 sessions that provide type 2 diabetes (T2D) and cardiovascular (CVD) risk reduction and lifestyle modification education focused on CVD and T2D risk factor reduction through promotion of participant self-management. Education will concentrate on healthy eating, physical activity, stress reduction, and other lifestyle risk reduction recommendations.

Active Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Gia Mudd: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

2201 Regency Rd.

Lexington, Kentucky, 40503, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Gia Mudd, RN, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, intervention providers and assessors are blinded to which arm is the active intervention and which is the active comparator and are blinded to hypotheses regarding group differences.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: September 11, 2021
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)