Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma (NOURISH-OK)
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About
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.
Full description
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.
Enrollment
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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
Trial design
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675 participants in 2 patient groups
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Central trial contact
Lacey Caywood, MPH
Data sourced from clinicaltrials.gov
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