Corazon de la Familia (Heart of the Family)

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.

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