nutrition to optimize, understand, and restore insulin sensitivity in hiv for oklahoma

Conditions: HIV; Insulin Resistance; Food Insecurity

Summary: the nourish-ok study will identify how food insecurity contributes to insulin resistance, an important surrogate marker of many co-morbidities in hiv disease, using an integrated framework to identify key leverage points for insulin resistance. drawing from these pathways, this study will adapt and evaluate a community-driven, science-informed "food as medicine" intervention designed to lower insulin resistance through healthy food access, food utilization skills, and other self-care behaviors. knowledge gained from this study can benefit those living with hiv through the prevention and more effective management of pre-diabetes, diabetes, obesity, and non-alcoholic fatty liver disease.

the community-based participatory research study will be conducted in oklahoma, and include hiv-positive individuals living in urban and rural communities. the first two aims are observational, the third aim will test an intervention. aim 1: test and refine a conceptual integrated framework of food insecurity and insulin resistance to identify significant structural, social, behavioral, and biological pathways as candidate intervention points. this aim will be accomplished using a cross-sectional survey (n=410 final sample size) and a one-month observational sub-study from the main study sample (n=89 final sample size) to collect intensive measures of dietary intake and gut microbiome samples. aim 2: adapt a home-delivered grocery and cooking self-care nourish-ok intervention to address key nutrition disparities and other health risk behaviors identified as significant path contributors to insulin resistance among people living with hiv. this aim will be achieved through a series of interviews and focus groups with people living with hiv who are food insecure (n=45 qualitative study subjects, including interviews and focus groups). aim 3: implement the 12-week nourish-ok intervention and assess it for feasibility, acceptability, and preliminary impact using a randomized wait-list control design (n=234). this study will use a simple randomized wait-list control trial design. additionally, the investigators will invite a random selection from the main study sample (n=80) to participate in more intensive data collection, including multiple 24-hr food recalls and stool samples during the intervention period to assess for food insecurity, dietary, and gut microbiome changes throughout the intervention periods.

Eligibility criteria:
inclusion criteria: * hiv-positive with income \<400% federal poverty level * at least 1 risk factor for insulin resistance per the national institute of diabetes and digestive and kidney diseases (niddk) (i.e., overweight/obesity, age 45 yrs or older, immediate family member with diabetes, non-white race, physical inactivity, history of gestational diabetes, history of heart disease or stroke, diagnosis of polycystic ovarian syndrome, high blood pressure, high cholesterol, or hepatitis c virus antibody positivity * using antiretroviral therapy for at least 6 months * english-speaking exclusion criteria: * participating in another health-related research study * receiving treatment for a terminal or other serious illness, such as cancer or end-stage renal failure * plan to move outside of oklahoma during the study period * does not have an address that can accept home-delivered groceries

Keywords: food as medicine nutrition