HIVNOURISH-OKNCT05208671
Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
A study testing NOURISH Food Box in people with HIV and Insulin Resistance, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Insulin Resistance, Food Insecurity
- What is being tested?
- NOURISH Food Box
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2020to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OU Integrative Immunology Center
Tulsa, Oklahoma, 74135
About this study
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.
Read the 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.
- Conditions
- HIV, Insulin Resistance, Food Insecurity
- Being tested
- NOURISH Food Box
- Keywords
- food as medicine, nutrition
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOURISH Food BoxOther
Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum
| Study group | Role | What they receive |
|---|---|---|
| NOURISH Food Box | Experimental | 12-week food assistance with low Dietary Inflammatory Index (DII) foods Receives: Other: NOURISH Food Box |
| Wait-list Control | No intervention | Wait-list control group eligible to receive NOURISH box after study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline insulin sensitivity at 12-weeks
Quantitative Insulin-Sensitivity Check Index (QUICKI)
Measured: Baseline; 12-weeks
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: Baseline; 12-weeks
Change from baseline chronic inflammation at 12-weeks
C-reactive protein (blood measure) (higher score reflects higher chronic inflammation)
Measured: Baseline; 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start9 Oct 2020
- Primary completion30 Oct 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianna S Wetherill, PhD, MPH, RD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208671
- Sponsor's protocol ID
- 12509
- Other IDs
- 5R01DK127464
- Acronym
- NOURISH-OK
- Status last verified
- May 2026
- First submitted
- 11 Jan 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 36225538
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
- ClinicalTrials.gov ID
- NCT05208671
- Acronym / sponsor ID
- NOURISH-OK / 12509
- Conditions
- HIV, Insulin Resistance, Food Insecurity
- Keywords
- food as medicine, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOURISH Food Box | Experimental | Other: NOURISH Food Box12-week food assistance with low Dietary Inflammatory Index (DII) foods |
| Wait-list Control | No intervention | –Wait-list control group eligible to receive NOURISH box after study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOURISH Food BoxSelection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum | Other | NOURISH Food Box |
Primary outcome
Change from baseline insulin sensitivity at 12-weeks
Time frame: Baseline; 12-weeks
Quantitative Insulin-Sensitivity Check Index (QUICKI)
4 secondary outcomes
Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks
Time frame: Baseline; 6-weeks; 12-weeks; 16-weeks
Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks
Time frame: Baseline; 6-weeks; 12-weeks; 16-weeks
Change from baseline skin carotenoid at 12-weeks
Time frame: Baseline; 12-weeks
Change from baseline chronic inflammation at 12-weeks
Time frame: Baseline; 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 36225538Wetherill 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.
- NOURISH-OK Study Information WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianna S Wetherill, PhD, MPH, RD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOURISH Food Box in people with HIV and Insulin Resistance, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline insulin sensitivity at 12-weeks (time frame: Baseline; 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.