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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

No Placebo-Only Group

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 below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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)

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

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met