Diabetes Mellitus, Type 2NCT04891575
Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
A study testing Family Dyad Intervention in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Gia Mudd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Family Dyad Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2021to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Being tested
- Active Control Intervention educational sessions, Family Dyad Intervention
- Keywords
- lifestyle modification, rural, Hispanic, non-Hispanic, dyad, family, risk reduction
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Control Intervention educational sessionsBehavioural
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.
Family Dyad InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Family Dyad Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI)
BMI based on measurements of weight and height and calculated as kg/m2.
Measured: 1 year (baseline, 3 months and 12 months)
Change in blood pressure
Blood pressure assessed using calibrated sphygmomanometry.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year (at baseline, 3 months and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start11 Sep 2021
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gia Mudd
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Gia Mudd, University of Kentucky
- Investigators
- Gia Mudd, RN, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891575
- Sponsor's protocol ID
- 60980
- Other IDs
- 1R01NR019456-01
- Status last verified
- Mar 2026
- First submitted
- 13 May 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
- ClinicalTrials.gov ID
- NCT04891575
- Acronym / sponsor ID
- 60980
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Keywords
- lifestyle modification, rural, Hispanic, non-Hispanic, dyad, family, risk reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Gia MuddUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control Arm | Active comparator | Behavioral: Active Control Intervention educational sessionsAn 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. |
| Family Dyad Arm | Experimental | Behavioral: Family Dyad InterventionAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Control Intervention educational sessionsThe 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. | Behavioural | Active Control Arm |
| Family Dyad InterventionThe 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. | Behavioural | Family Dyad Arm |
Primary outcome
Change in body mass index (BMI)
Time frame: 1 year (baseline, 3 months and 12 months)
BMI based on measurements of weight and height and calculated as kg/m2.
Change in blood pressure
Time frame: 1 year (baseline, 3 months and 12 months)
Blood pressure assessed using calibrated sphygmomanometry.
Change in lipid profile
Time frame: 1 year (at baseline, 3 months and 12 months)
Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.
Change in hemoglobin A1c (HbA1c)
Time frame: 1 year (at baseline, 3 months and 12 months)
HbA1c will be measured using point-of-care testing obtained by fingerstick.
Change in physical activity level
Time frame: 1 year (at baseline, 3 months and 12 months)
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
Time frame: 1 year (at baseline, 3 months and 12 months)
Dietary intake patterns will be assessed using the Vioscreen food frequency questionnaire.
Change in tobacco use
Time frame: 1 year (at baseline, 3 months and 12 months)
Tobacco use will be confirmed by collection of a saliva sample to determine cotinine levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gia Mudd, RN, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Dyad Intervention in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Gia Mudd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) (time frame: 1 year (baseline, 3 months and 12 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.