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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
Is 18 years of age and older
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year (baseline, 3 months and 12 months)
Awards & highlights
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.
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.
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 belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have heart or brain vessel disease, diabetes, and can safely do physical activities and lose weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year (baseline, 3 months and 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year (baseline, 3 months and 12 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in blood pressure
Change in body mass index (BMI)
Change in dietary intake patterns
+4 moreTrial 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.
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Who is running the clinical trial?
Gia MuddLead Sponsor
2 Previous Clinical Trials
568 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
598 Previous Clinical Trials
10,377,622 Total Patients Enrolled
Gia Mudd, RN, PhDPrincipal InvestigatorUniversity of Kentucky
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have two or more risk factors for type 2 diabetes or heart disease.I do not have heart or brain vessel disease, diabetes, and can safely do physical activities and lose weight.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.Both the main participant and their family member cannot have trouble understanding information, answering questions, or taking part in the study. They also cannot have serious mental health conditions, be pregnant, nursing, or planning to get pregnant soon because their dietary needs will be different.Criterion: Lives in a rural area in the state of Kentucky.I am 18 years old or older.I primarily speak Spanish or English.I am an adult and identify as either Hispanic or non-Hispanic.
Research Study Groups:
This trial has the following groups:- Group 1: Active Control Arm
- Group 2: Family Dyad Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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