Clinical trial NCT03196024: Corazon de la Familia (Heart of the Family)
Official title: A Randomized Controlled Trial to Examine a Healthy Lifestyle Intervention With Families to Prevent Cardiovascular Disease and Type 2 Diabetes in Hispanics/Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction Behavior
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Keywords: Diabetes; CVD; Lifestyle; Hispanic; Promotora
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Risk Reduction Behavior
Hispanic Americans; Latinos
Community Health Workers
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Institutes of Health (NIH)
First posted: 2017-06-22
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a randomized controlled trial with Hispanic family dyads using a 2-group design (Corazón de la Familia active intervention versus control condition) to test effects of a type 2 diabetes and CVD risk reduction intervention at 3 (short-term) and 12 (long-term) months. For dyads randomized to the active intervention, the participant with 2 or more CVD or type 2 diabetes risk factors (index participant) and their co-participating family member will attend 8 sessions that provide type 2 diabetes and CVD risk reduction and lifestyle modification education. For dyads randomized to the control condition, only the index participant will attend 8 educational lifestyle modification sessions. Participants in both groups will receive monthly follow up phone calls up through 12 months post-baseline. The sessions for both the intervention and the control group and the monthly post-intervention phone calls will be provided by community health workers.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass index (BMI)
timeFrame: Baseline, 3 months, and 12 months
measure: Change in blood pressure
timeFrame: Baseline, 3 months, and 12 months
measure: Change in lipid profile
timeFrame: Baseline, 3 months, and 12 months
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Baseline, 3 months, and 12 months
measure: Change in level of physical activity
timeFrame: Baseline, 3 months, and 12 months
measure: Change in diet quality
timeFrame: Baseline, 3 months, and 12 months
measure: Change in tobacco use
timeFrame: Baseline, 3 months, and 12 months
Secondary outcomes:
measure: Support for healthy behaviors
timeFrame: Baseline, 3 months, and 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gia Mudd-Martin, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Rosa Martin
role: STUDY_DIRECTOR
References: