R01MD017961

Delivering Food Resources & Kitchen Skills (FORKS) to Adults with Food Insecurity and Hypertension: An RCT - Abstract

Food insecurity, defined by the United Nations as inconsistent access to a sufficient quantity of affordable, nutritious food, is a prevalent social determinant of health among safety-net primary care patients. Among adults with food insecurity, conditions like hypertension (HTN) and type 2 diabetes (DM2) are as much as two times more prevalent. Widely available chronic disease self-management education and support (SMES) programs place much emphasis on nutrition education but do not significantly address access to affordable, nutritious food or meals. Notably, simulations have shown that medically-tailored meals for food-insecure adults could be as cost-effective as some commonly prescribed medications.

Drawing upon our knowledge of systems engineering and user-centered design, our team created and successfully piloted a novel, dietitian-led sociotechnical intervention called FORKS: Food Resources & Kitchen Skills. Safety-net primary care patient-participants (N=20 across two pilots) received essential home cooking tools, home-delivered lower sodium, lower-carbohydrate Mediterranean-style meals and ingredients, and twice-weekly hands-on home cooking classes. Mean attendance was 87% and mean satisfaction was 4.7/5.0 for delivered foods and 4.9/5.0 for hands-on cooking class. Webex videoconference classes allowed participants to learn and cook together in a socially supportive "space" from their own home kitchen.

We here propose a randomized controlled trial to evaluate FORKS versus enhanced usual care (EUC). Safety-net primary care patients aged 35 years or over with food insecurity and systolic blood pressure ≥120 mm Hg (~40% will also have DM2) will be invited, consented, assessed, and randomized. EUC consists of social determinants of health (SDOH) screening, referrals to food pantries, and assistance enrolling in food programs (e.g., SNAP). EUC also consists of our CDC-approved 5-week SMES program. Those randomized to FORKS will, in addition to EUC, receive home-delivered meals and ingredient kits, and twice-weekly Webex cooking classes to week 16. In week 17, participants will transition from FORKS-delivered foods to shopping for affordable, nutritious foods. FORKS classes will continue in order to maintain learning and social support that may be critical to longer-term engagement and self-efficacy for obtaining and preparing nutritious food.

The primary hypothesis is that, relative to EUC, FORKS participants will experience lower mean systolic blood pressure immediately post-intervention (16 weeks post-baseline). Maintenance to 24-weeks post-baseline will also be assessed. Food security, nutrition, and HbA1c will also be evaluated, as will cost-effectiveness and behavioral mechanisms such as learning engagement, self-efficacy, and food resource management skills.

Trustees Of Indiana University

NOT APPLICABLE

93.307 - Minority Health and Health Disparities Research

National Institute for Minority Health and Health Disparities (NIMHD) [HHS - NIH]

Indianapolis, Indiana 462025187 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-20-183)

Amendment Since initial award the total obligations have increased 396% from $610,490 to $3,027,022.