Background and design of the empowering cardiovascular health in grandfamilies (ECHG) study: A mixed methods study...

A steady increase in the number of grandparent caregivers - accelerated by recent trends such as children orphaned by the COVID-19 pandemic or the opioid crisis - magnifies the importance of addressing cardiovascular disease (CVD) risk in that already at high-risk group. However, few efforts have directly addressed the specific cardiac health needs of grandparent primary caregivers (or custodial grandparents). In this paper, we describe the research protocol for the Rural Caregiver Heart Health Education (RICHH) intervention for implementation with grandparent caregivers (RICHH-GP) study funded by the National Institute of Heart, Lung, and Blood. This study will tailor an existing CVD risk reduction intervention (RICHH) for implementation with grandparent primary caregivers and then test the modified design for feasibility, acceptability, and preliminary efficacy. The expected outcome of RICHH-GP is to establish the groundwork for an expanded future clinical trial in which we will test effectiveness with a longer follow-up and with increased inclusivity of participants from marginalized populations. The specific aims are: 1) modify the RICHH intervention to target custodial grandparents from a variety of backgrounds; 2) employ the tailored intervention and assess its feasibility and acceptability via a 2-arm randomized controlled trial; 3) test the preliminary efficacy of RICHH-GP based on measures of CVD risk (physical activity, dietary intake, nicotine exposure, sleep, body mass index, lipids, blood pressure, and HbA1c), self-management behaviors, and depressive symptoms at 4- and 6-months compared to baseline and; 4) (exploratory) examine the proximal impact of the RICHH-GP intervention on CVD risk and depressive symptoms on a subsample of grandchildren of the grandparent participants. The ultimate objectives of this work are to prevent CVD-related morbidity and mortality and overall physical decline, improve psychological well-being among grandparent caregivers, and foster a more heart-healthy environment in grandfamilies.