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Family-focused Lifestyle Intervention for Diabetes and Cardiovascular Risk Reduction
N/A
Waitlist Available
Led By Gia Mudd-Martin, PhD, RN
Research Sponsored by Gia Mudd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, and 12 months
Awards & highlights
Study Summary
This trial is examining the effects of a lifestyle modification intervention that is focused on families, rather than individuals. The goal is to reduce the risk for type 2 diabetes and cardiovascular disease among Hispanics/Latinos.
Who is the study for?
This trial is for Hispanic/Latino families where one member has a high risk of type 2 diabetes or cardiovascular disease. Both participants must be over 18, speak Spanish, and live close to each other in Kentucky. They should commit to the study for a year but can't join if they have cognitive impairments, major psychiatric conditions, are pregnant/nursing, or have existing heart diseases or diabetes.Check my eligibility
What is being tested?
The 'Corazon de la Familia' study tests whether involving family members improves lifestyle changes that reduce the risk of type 2 diabetes and cardiovascular disease among Hispanics/Latinos. It compares an educational program's impact on health when done with family versus individually.See study design
What are the potential side effects?
Since this trial focuses on lifestyle modifications rather than medication, side effects may include typical responses to changes in diet and exercise such as muscle soreness, fatigue, or dietary adjustment issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, and 12 months
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 diet quality
+4 moreSecondary outcome measures
Support for healthy behaviors
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Family-focused intervention armExperimental Treatment1 Intervention
Family-focused intervention arm: Educational sessions will be provided to family pairs that include participants who are at-risk for type 2 diabetes or CVD and their co-participating family member.
Group II: Individual-focused intervention armActive Control1 Intervention
Individual-focused intervention arm: Educational sessions will be provided to the individual members of the family pairs who are at-risk for type 2 diabetes or CVD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family-focused intervention arm
2017
N/A
~530
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,375,856 Total Patients Enrolled
Gia MuddLead Sponsor
2 Previous Clinical Trials
582 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,062 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have heart or blood vessel disease, type 1 or type 2 diabetes, or medical reasons that make it unsafe for you to take part in a program involving exercise and weight loss without supervision.You are Hispanic or Latino, speak Spanish as your main language, have two or more risk factors for diabetes or heart disease, plan to be in Kentucky, and are willing to join the study for the next 12 months.We are looking for pairs of family members, where one member is at risk for type 2 diabetes or heart disease, and the other member can be at risk or not at risk for these conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Individual-focused intervention arm
- Group 2: Family-focused intervention 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this particular medical trial actively seeking participants?
"According to the information found on clinicaltrials.gov, this medical trial is enrolling participants at present time. The initial posting was made on October 5th 2017 and the study's details have been kept up-to-date since then, with its last update being March 8th 2022."
Answered by AI
How many participants were recruited for this trial?
"Affirmative. Clinicaltrials.gov data affirms that this research project, which was first publicized on the 5th of October 2017, is presently enrolling subjects. 440 participants are required from a single medical centre to complete the trial."
Answered by AI
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