Food Insecurity, HIV, Insulin Resistance
Conditions
Keywords
food as medicine, nutrition
Brief 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.
Detailed 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.
Interventions
OTHERNOURISH Food Box
Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum
Sponsors
University of Oklahoma
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline insulin sensitivity at 12-weeks | Baseline; 12-weeks | Quantitative Insulin-Sensitivity Check Index (QUICKI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks | Baseline; 6-weeks; 12-weeks; 16-weeks | 10-item US Adult Food Security Module (0-10 point range; higher score reflects lower food security) |
| Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks | Baseline; 6-weeks; 12-weeks; 16-weeks | Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential) |
| Change from baseline skin carotenoid at 12-weeks | Baseline; 12-weeks | reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status) |
| Change from baseline chronic inflammation at 12-weeks | Baseline; 12-weeks | C-reactive protein (blood measure) (higher score reflects higher chronic inflammation) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarianna S Wetherill, PhD, MPH, RD
University of Oklahoma
Outcome results
None listed