CompletedNot Applicable

Corazon de la Familia (Heart of the Family)

United States526 participantsStarted 2017-10-05

Plain-language summary

The Corazón de la Familia study is a randomized controlled trial to examine the effects of a novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health workers, the family-focused intervention engages two members of a family in an educational program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a randomized controlled trial using a 2-group design and compare the short-term and long-term impact of the family-focused active intervention to an individual-focused control condition on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will examine outcomes of participants in the family-focused intervention to determine how each family member's engagement in healthy lifestyle behaviors and level of support for the other family member's engagement in healthy lifestyle behaviors affects their own and their partner's outcomes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in body mass index (BMI)

Timeframe: Baseline, 3 months, and 12 months

Change in blood pressure

Timeframe: Baseline, 3 months, and 12 months

Change in lipid profile

Timeframe: Baseline, 3 months, and 12 months

Change in hemoglobin A1c (HbA1c)

Timeframe: Baseline, 3 months, and 12 months

Change in level of physical activity

Timeframe: Baseline, 3 months, and 12 months

Change in diet quality

Timeframe: Baseline, 3 months, and 12 months

Change in tobacco use

Timeframe: Baseline, 3 months, and 12 months

Trial details

NCT IDNCT03196024

SponsorGia Mudd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-23

View on ClinicalTrials.gov More Risk Reduction Behavior trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

What they're measuring

Change in body mass index (BMI)

Timeframe: Baseline, 3 months, and 12 months

Change in blood pressure

Timeframe: Baseline, 3 months, and 12 months

Change in lipid profile

Timeframe: Baseline, 3 months, and 12 months

Change in hemoglobin A1c (HbA1c)

Timeframe: Baseline, 3 months, and 12 months

Change in level of physical activity

Timeframe: Baseline, 3 months, and 12 months

Change in diet quality

Timeframe: Baseline, 3 months, and 12 months

Change in tobacco use

Timeframe: Baseline, 3 months, and 12 months