Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma

Study Overview
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Brief Summary
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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
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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=500) and a one-month observational sub-study from the main study sample (n=100) 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=56 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=270). This study will use a simple randomized wait-list control trial design with stratification by geography (urban/rural) and further stratification in the urban group by low and very low food security status.

Official Title
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Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma

Conditions
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HIV, Insulin Resistance, Food Insecurity

Intervention / Treatment
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* Other: NOURISH Food Box


Participation Criteria
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Eligibility Criteria
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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 have low or very low household food security in the past month 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOURISH Food Box<br>12-week food assistance with low Dietary Inflammatory Index (DII) foods | Other: NOURISH Food Box<br>* Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum<br>|
| No Intervention: Wait-list Control<br>Wait-list control group eligible to receive NOURISH box after study period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline insulin sensitivity at 12-weeks | Quantitative Insulin-Sensitivity Check Index (QUICKI) | Baseline; 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks | 10-item US Adult Food Security Module (0-10 point range; higher score reflects lower food security) | Baseline; 6-weeks; 12-weeks; 16-weeks | 
| Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks | Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential) | Baseline; 6-weeks; 12-weeks; 16-weeks | 
| Change from baseline skin carotenoid at 12-weeks | reflection spectroscopy using Veggie Meter device (higher score reflects higher carotenoid status) | Baseline; 12-weeks | 
| Change from baseline chronic inflammation at 12-weeks | C-reactive protein (blood measure) (higher score reflects higher chronic inflammation) | Baseline; 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food as medicine, nutrition