Heart of the Family: A Cardiovascular Disease and Type 2 Diabetes Risk Reduction Intervention in High-Risk Rural Families

Cardiovascular disease (CVD) is the leading cause of death in the U.S. and type 2 diabetes (T2D) the seventh. Of U.S. adults, nearly half have CVD, 10% have diabetes (95% of which is type 2 diabetes), and more than 30% have prediabetes. Certain geographic and racial/ethnic groups are disproportionately affected by these diseases with the highest prevalence among Hispanics and non-Hispanic whites (NHWs) in rural settings. As aggregates, Hispanics compared to non-Hispanic whites (NHWs) in the general U.S. population have an almost 2 times higher rate of type 2 diabetes (T2D) and are 1.5 times more likely to die from the disease. Diabetes significantly increases the risk for cardiovascular disease (CVD) the leading cause of death among U.S. Hispanic adults. However NHWs living in rural counties fare far worse than those in urban counties, having disproportionately higher rates of CVD and T2D than non-urban dwelling NHWs. Among the highest CVD and T2D rates in the nation are in rural Kentucky where heart disease mortality rates (254 per 100,000) are significantly higher than in the U.S. (175 per 100,000). Rural counties in the state are located in the center of both the Diabetes and the Heart and Stroke Belts. Reflecting these disparities, from 1980 to 2014 only 13 U.S. counties experienced a decrease in life expectancy; 8 of these were rural Kentucky counties. Risk profiles in both cultural groups are similarly dismal. Hispanics and rural NHWs in Kentucky have higher prevalence of hypertension, hypercholesterolemia, obesity, physical inactivity, and poor dietary patterns than almost any other ethnic/racial or geographic group in the nation. To reduce CVD and T2D disparities, risk self-management strategies that promote engagement in healthy lifestyle behaviors and support culturally appropriate approaches responsive to social and environmental contexts are critical. Working with at-risk Hispanic and rural NHW communities and guided by principles of community-based participatory research (CBPR), we developed CVD and T2D risk reduction interventions: Corazones Saludables in partnership with Kentucky Hispanic communities and HeartHealth in partnership with NHW rural Kentucky communities. Developed collaboratively with each cultural group, the interventions are based on self-care principles and address multiple factors critical to reducing CVD and T2D risk (e.g., healthy diet, physical activity, weight management, and management of comorbid conditions) using strategies that reflect cultural values. Given that many values are shared by rural Kentucky Hispanic and NHW communities (for example, cultural value placed on food, help-seeking behaviors, prioritizing of families over individuals), we recognized the potential to develop an intervention responsive to disparities in both communities using strategies culturally appropriate for both. We have integrated components of each intervention into a single intervention, Corazon de la Familia/Heart of the Family, while retaining cultural relevance and acceptability. Reflective of feedback from our Hispanic and NHW rural community partners that in both cultures family well-being is prioritized over that of the individual, we have redesigned the intervention from an individual focus to one that is family focused. A family-focused approach is supported by associations of family support with positive health outcomes and protection against engagement in unhealthy behaviors in cultures with high family values. The purpose of the proposed randomized, controlled trial is to test the effectiveness of a family dyad-focused T2D and CVD risk reduction intervention, Corazón de la Familia/Heart of the Family, in Hispanic and NHW communities of rural Kentucky. This study will be conducted in collaboration with our community partners (Kentucky Area Health Education Center; Kentucky Agricultural Extension; and the Foundation for Latin American Culture and Arts). The study design will include two randomized group assignments (Corazón de la Familia/Heart of the Family active intervention versus active control condition) to test the 8-week intervention effects at 3 (short-term) and 12 (long-term) months. For dyads randomized to the intervention group, index participants (participants with 2 or more CVD or T2D risk factors) and co-participants (family members) will attend 8 sessions that provide T2D and CVD risk reduction and lifestyle modification education complemented by dyadic social support strategies. For dyads randomized to the active control condition, only index participants will participate in 8 educational sessions on T2D and CVD risk reduction and lifestyle modification. The intervention effects will be tested among index participants in both groups using logistic or linear regressions, or repeated measures mixed modeling, as appropriate, on primary and secondary outcome measures. We will also conduct innovative analyses of interdependence within active intervention family dyads (index participant and co-participant) using the Actor-Partner Interdependence Regression model to determine if degree of engagement in health behaviors by one dyad member influences the outcomes of the other dyad member. This will clarify the potential for boosting the intervention effect through the participation of a family member. Specific Aim 1: Compare the short-term and long-term impact of the Corazón de la Familia/Heart of the Family active intervention and active control on biological (body mass index [BMI], blood pressure, lipid profile, and hemoglobin A1c [HgA1c]) and behavioral (physical activity level, nutritional patterns, and tobacco use) T2D and CVD risk factors of index participants. Hypothesis 1: There will be a greater decline in biological and behavioral risk at 3 and 12 months in index participants receiving the Corazón de la Familia intervention compared to index participants randomized to the active control condition. Aim 1a: Evaluate whether cultural background is a moderator of the relationship between the Corazón de la Familia active intervention and the biological and behavioral outcomes as described above. This analysis will determine if the effect of the intervention varies between Hispanic and NHWs included in the study Specific Aim 2: Using the Actor-Partner Interdependence Regression Model, determine how each active intervention dyad member’s engagement in healthy lifestyle behaviors and level of support for their partner’s engagement in healthy lifestyle behaviors affects their own and their partner’s outcomes. Hypothesis 2: Among dyads in the active intervention, index participants’ and family member co-participants’ biological and behavioral outcomes will be influenced by their own (actor effect) and their partners’ (partner effect) level of engagement in healthy lifestyle behaviors and support for partner engagement in healthy lifestyle behaviors.