Skip to main content
OpenTrials
Completed

NCT Number: NCT05208671

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OU Integrative Immunology Center

Tulsa, Oklahoma, 74135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOURISH Food Box

Other

Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum

Primary outcomes

  1. Change from baseline insulin sensitivity at 12-weeks

    Time frame: Baseline; 12-weeks

    Quantitative Insulin-Sensitivity Check Index (QUICKI)

Secondary outcomes

  1. Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks

    Time frame: Baseline; 6-weeks; 12-weeks; 16-weeks

    10-item US Adult Food Security Module (0-10 point range; higher score reflects lower food security)

  2. Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks

    Time frame: Baseline; 6-weeks; 12-weeks; 16-weeks

    Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential)

  3. Change from baseline skin carotenoid at 12-weeks

    Time frame: Baseline; 12-weeks

    reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status)

  4. Change from baseline chronic inflammation at 12-weeks

    Time frame: Baseline; 12-weeks

    C-reactive protein (blood measure) (higher score reflects higher chronic inflammation)

Other outcomes

  1. Change from baseline gut microbiome composition at 12-weeks

    Time frame: Baseline; 12-weeks

    Microbiome composition (diversity) - subsample only

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: NOURISH-OK

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.