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Lifestyle Intervention for Cardiovascular Disease and Type 2 Diabetes

N/A
Recruiting
Led By Gia Mudd, RN, PhD
Research Sponsored by Gia Mudd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year (baseline, 3 months and 12 months)
Awards & highlights

Study Summary

This trial will study the effects of a 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 reducing cardiovascular disease and type 2 diabetes health disparities in rural U.S. communities.

Who is the study for?
This trial is for adults over 18 living in rural Kentucky, with internet access and at risk for type 2 diabetes or cardiovascular disease. Participants must speak English or Spanish and may include a family member who lives nearby. Those with cognitive impairments, major psychiatric conditions, pregnancy, or known heart diseases are excluded.Check my eligibility
What is being tested?
The study tests a culturally tailored lifestyle intervention aimed at reducing the risk of cardiovascular disease and type 2 diabetes among rural Hispanic and non-Hispanic families. It involves educational sessions comparing individual versus family dyad participation.See study design
What are the potential side effects?
Since this is a lifestyle modification study involving education sessions without medical drugs, typical drug side effects are not expected. However, changes in diet and exercise might cause temporary discomfort like muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have two or more risk factors for type 2 diabetes or heart disease.
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I am a rural-dwelling adult at risk for type 2 diabetes or heart disease, and I have a family member who can join if needed.
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I am 18 years old or older.
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I primarily speak Spanish or English.
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I am an adult and identify as either Hispanic or non-Hispanic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year (baseline, 3 months and 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year (baseline, 3 months and 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in blood pressure
Change in body mass index (BMI)
Change in dietary intake patterns
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Family Dyad ArmExperimental Treatment1 Intervention
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.
Group II: Active Control ArmActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Gia MuddLead Sponsor
2 Previous Clinical Trials
568 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
576 Previous Clinical Trials
10,374,593 Total Patients Enrolled
Gia Mudd, RN, PhDPrincipal InvestigatorUniversity of Kentucky

Media Library

Family Dyad Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04891575 — N/A
Type 2 Diabetes Research Study Groups: Active Control Arm, Family Dyad Arm
Type 2 Diabetes Clinical Trial 2023: Family Dyad Intervention Highlights & Side Effects. Trial Name: NCT04891575 — N/A
Family Dyad Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04891575 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to engage in this clinical investigation?

"Affirmative. The clinical trial database shows that this medical research project, initially posted on September 11th 2021, is still recruiting participants. To fulfil the requirements of the study, 540 patients must be enrolled from one particular site."

Answered by AI

What is the maximum size of the participant pool for this experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this research study is still recruiting patients. It was initially posted on September 11th 2021 and last edited on May 11th 2022; 540 participants are needed across a single site."

Answered by AI
~180 spots leftby Jun 2025