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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK127464 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOURISH Food Box | Experimental | 12-week food assistance with low Dietary Inflammatory Index (DII) foods |
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| Wait-list Control | No Intervention | Wait-list control group eligible to receive NOURISH box after study period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOURISH Food Box | Other | Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline insulin sensitivity at 12-weeks | Quantitative Insulin-Sensitivity Check Index (QUICKI) | Baseline; 12-weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline gut microbiome composition at 12-weeks | Microbiome composition (diversity) - subsample only | Baseline; 12-weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianna S Wetherill, PhD, MPH, RD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Integrative Immunology Center | Tulsa | Oklahoma | 74135 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36225538 | Derived | Wetherill MS, Bakhsh C, Caywood L, Williams MB, Hartwell ML, Wheeler DL, Hubach RD, Teague TK, Kohler G, Hebert JR, Weiser SD. Unpacking determinants and consequences of food insecurity for insulin resistance among people living with HIV: Conceptual framework and protocol for the NOURISH-OK study. Front Clin Diabetes Healthc. 2022;3:947552. doi: 10.3389/fcdhc.2022.947552. Epub 2022 Aug 16. |
| Label | URL |
|---|---|
| NOURISH-OK Study Information Webpage | View source |
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Made available within 12 months of study end.
Written request to PI.
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |