Clinical trial NCT04891575: Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
Official title: Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Keywords: lifestyle modification
rural
Hispanic
non-Hispanic
dyad
family
risk reduction
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-05-18
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rural populations in the U.S. are disproportionately burdened by cardiovascular disease and type 2 diabetes. Lifestyle modification interventions are needed that support long-term engagement in risk-reducing health behaviors. This trial will study the effects of a family-focused, lifestyle intervention that is culturally tailored for use with rural Hispanic and non-Hispanic adults. If successful, this community-based intervention has significant potential for broad dissemination to reduce cardiovascular disease and type 2 diabetes health disparities in rural U.S. communities.

Detailed description: The Heart of the Family study is a randomized controlled trial conducted to examine if a virtual lifestyle modification intervention is more effective in reducing risk for type 2 diabetes (T2D) and cardiovascular disease (CVD) when it is delivered to family dyads or to individuals and to compare intervention effects in Hispanic and non-Hispanic rural-dwelling adults at-risk for T2D or CVD. The Heart of the Family study will enroll 360 participants - 180 Hispanics and 180 non-Hispanics - from rural communities who have two or more risk factors for T2D or CVD. Participants will be randomized to participate as an individual or with a family member who may or may not be at risk for T2D or CVD or may or may not have diagnosed T2D or CVD for a total of 540 participants. The interventions for both groups will be provided by community health workers using a virtual platform. 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:

Primary participants are rural-dwelling Hispanic and non-Hispanic adults who are at-risk for type 2 diabetes or cardiovascular disease and have a family member who is willing to participate if the primary participant is randomly selected to participate with a family member.

Inclusion criteria for the primary participant:

* Is Hispanic or non-Hispanic adult
* Is 18 years of age and older
* Is a primary Spanish or English speaker
* Has internet access
* 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.
* Lives in rural Kentucky
* Is willing to participate in the study for the next 12 months

Inclusion criteria for the co-participating family member if primary participant is randomly selected to participate with a family member

* Is 18 years of age and older
* Is a primary Spanish or English speaker
* Lives in the same household or in close proximity (no further than 25 miles distance) to the primary participant
* Has internet access
* Is willing to participate in the study for the next 12 months

Exclusion Criteria:

Exclusion criteria for family dyads:

Primary participant and family member participant will be excluded if they:

* 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 primary participant:

* 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: 1 year (baseline, 3 months and 12 months)
measure: Change in blood pressure
timeFrame: 1 year (baseline, 3 months and 12 months)
measure: Change in lipid profile
timeFrame: 1 year (at baseline, 3 months and 12 months)
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: 1 year (at baseline, 3 months and 12 months)
measure: Change in physical activity level
timeFrame: 1 year (at baseline, 3 months and 12 months)
measure: Change in dietary intake patterns
timeFrame: 1 year (at baseline, 3 months and 12 months)
measure: Change in tobacco use
timeFrame: 1 year (at baseline, 3 months and 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: 2201 Regency Rd.
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gia Mudd, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: