NCT03196024Completed
Corazon de la Familia (Heart of the Family)
A Randomized Controlled Trial to Examine a Healthy Lifestyle Intervention With Families to Prevent Cardiovascular Disease and Type 2 Diabetes in Hispanics/Latinos
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 526 (actual)
- First submitted
- 20 Jun 2017
- Start date
- 5 Oct 2017
- Primary completion date
- 23 Dec 2023
- Lead sponsor
- Gia Mudd
- Diseases
- Type 2 diabetes
- NCT number
- NCT03196024
What you commit to
- Study type: Interventional
- Participants enrolled: 526
- From 5 Oct 2017 to the primary completion date, 23 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have cognitive impairment that preclude them from understanding the consent process, answering questionnaires, or participating in the intervention;
- Have a major psychiatric (e.g., schizophrenia) condition;
- Have known coronary artery or cerebrovascular disease;
- Have a diagnosis of type 1 or type 2 diabetes;
Other
- Dyads will be excluded if one or both dyad members have any of the following:
- Are pregnant or nursing or plan on becoming pregnant within the next year since dietary needs will be different.
- Have medical contraindications to participate in a lifestyle intervention that includes unsupervised physical activity and weight loss
Who the study is looking for
- We are enrolling family dyads, or 2 family members, one of whom is at-risk for type 2 diabetes or cardiovascular disease and the second of whom is a co-participating family member who may or may not be at risk for type 2 diabetes or cardiovascular disease.
- Is Hispanic or Latino
- Is 18 years of age and older
- Is a primary Spanish speaker
- 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.
- Plan to be in Kentucky and Is willing to participate in the study for the next 12 months
- Is 18 years of age and older
- At a minimum, understands Spanish
- Lives in the same household or in close proximity (no further than 25 miles distance) to the at-risk member of the dyad
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.