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

Primary Purpose

Diabetes Mellitus, Type 2, Cardiovascular Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Control Intervention educational sessions

Family Dyad Intervention

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring lifestyle modification, rural, Hispanic, non-Hispanic, dyad, family, risk reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

2201 Regency Rd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active Control Arm

Family Dyad Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in body mass index (BMI)

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

Change in blood pressure

Blood pressure assessed using calibrated sphygmomanometry.

Change in lipid profile

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

Change in hemoglobin A1c (HbA1c)

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

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.

Change in dietary intake patterns

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

Change in tobacco use

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04891575

First Posted

May 13, 2021

Last Updated

June 12, 2023

Sponsor

Gia Mudd

Collaborators

National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT04891575

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 11, 2021 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gia Mudd

Collaborators

National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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 cardiovascular disease (CVD) when it is delivered to family dyads or to individuals and to compare intervention effects in Hispanic and non-Hispanic rural-dwelling adults at-risk for T2D or CVD. The Heart of the Family study will enroll 360 participants - 180 Hispanics and 180 non-Hispanics - from rural communities who have two or more risk factors for T2D or CVD. Participants will be randomized to participate as an individual or with a family member who may or may not be at risk for T2D or CVD or may or may not have diagnosed T2D or CVD for a total of 540 participants. The interventions for both groups will be provided by community health workers using a virtual platform. Both groups will receive eight educational sessions about healthy lifestyle behaviors and support to address personal and environmental barriers to engaging in healthy behaviors. After the eight sessions, the community health workers will follow up with participants once a month by phone over the next 12 months. Primary outcomes include short-term and long-term impact of the family-focused active intervention compared to the individual-focused control condition on type 2 diabetes and CVD biological risk factors (for example, blood pressure and weight) and behavioral risk factors (for example, physical activity and tobacco use). Outcomes are measured at baseline, immediately post-intervention, and at the end of the 12 month period of the study for both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Cardiovascular Diseases

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Control Arm

Arm Type

Active Comparator

Arm Description

Arm Title

Family Dyad Arm

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Active Control Intervention educational sessions

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Family Dyad Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in body mass index (BMI)

Description

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

Time Frame

1 year (baseline, 3 months and 12 months)

Title

Change in blood pressure

Description

Blood pressure assessed using calibrated sphygmomanometry.

Time Frame

1 year (baseline, 3 months and 12 months)

Title

Change in lipid profile

Description

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

Time Frame