Corazon de la Familia (Heart of the Family)

Gia Mudd

Status: Completed

Conditions: Risk Reduction Behavior; Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Behavioral: Individual-focused intervention arm; Behavioral: Family-focused intervention arm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03196024

1R01NR016262-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The Corazón de la Familia study is a randomized controlled trial conducted to examine if a novel family-focused lifestyle modification intervention is more effective in reducing risk for type 2 diabetes and cardiovascular disease (CVD) than an individual-focused lifestyle modification intervention. We will enroll 220 Hispanic family pairs or dyads, of whom one member has two or more risk factors for type 2 diabetes or CVD but does not have type 2 diabetes or CVD. The second member of the family dyad may or may not have type 2 diabetes or CVD or may or may not be at risk for type 2 diabetes or CVD. Of the 220 family dyads, 110 will be randomly selected to participate in the family-focused intervention and 110 will be randomly selected to participate in the individual-focused intervention. The interventions for both groups will be provided by community health workers. Both groups will receive eight educational sessions about healthy lifestyle behaviors and support to address personal and environmental barriers to engaging in healthy behaviors. After the eight sessions, the community health workers will follow up with participants once a month by phone over the next 12 months. Primary outcomes include short-term and long-term impact of the family-focused active intervention compared to the individual-focused control condition on type 2 diabetes and CVD biological risk factors (for example, blood pressure and weight) and behavioral risk factors (for example, physical activity and tobacco use). Outcomes are measured at baseline, immediately post-intervention, and at the end of the 12 month period of the study for both groups.

Enrollment: 526 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Inclusion criteria for the at-risk member of the dyad:

• 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:

  1. clinical diagnosis of hypertension;
  2. clinical diagnosis of hyperlipidemia;
  3. clinical diagnosis of prediabetes;
  4. overweight or obese (body mass index ≥ 25 kg/m2);
  5. is a current cigarette smoker;
  6. male 45 years of age or older or female 55 years of age or older;
  7. family history in first degree relative of type 2 diabetes or cardiovascular disease; or
  8. 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

Inclusion criteria for the co-participating member of the dyad

• 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

Exclusion criteria

Exclusion criteria for family dyads:

• Dyads will be excluded if one or both dyad members have any of the following:
• 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;
• Are pregnant or nursing or plan on becoming pregnant within the next year since dietary needs will be different.

Exclusion criteria that apply only to the at-risk member of the dyad:

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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526 participants in 2 patient groups

Family-focused intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: Family-focused intervention arm

Individual-focused intervention arm

Active Comparator group

Description:

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:

Behavioral: Individual-focused intervention arm