Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma (NOURISH-OK)

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; HIV; Food Insecurity
• Intervention / Treatment: Other: NOURISH Food Box

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.

• Study Type: Interventional
• Enrollment (Actual): 675
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • OU Integrative Immunology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline gut microbiome composition at 12-weeks	Microbiome composition (diversity) - subsample only	Baseline; 12-weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Marianna S Wetherill, PhD, MPH, RD, University of Oklahoma

Publications and helpful links

General Publications

• 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.

Helpful Links

• NOURISH-OK Study Information Webpage

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): November 17, 2025

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: food as medicine; nutrition
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Nutritional and Metabolic Diseases; Insulin Resistance
• Other Study ID Numbers: 12509; 5R01DK127464 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Made available within 12 months of study end.
• IPD Sharing Access Criteria: Written request to PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No