Clinical trial NCT05208671: Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
Official title: Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Insulin Resistance
Food Insecurity
Keywords: food as medicine
nutrition
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-01-26
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline insulin sensitivity at 12-weeks
timeFrame: Baseline; 12-weeks
Secondary outcomes:
measure: Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks
timeFrame: Baseline; 6-weeks; 12-weeks; 16-weeks
measure: Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks
timeFrame: Baseline; 6-weeks; 12-weeks; 16-weeks
measure: Change from baseline skin carotenoid at 12-weeks
timeFrame: Baseline; 12-weeks
measure: Change from baseline chronic inflammation at 12-weeks
timeFrame: Baseline; 12-weeks
Other outcomes:
measure: Change from baseline gut microbiome composition at 12-weeks
timeFrame: Baseline; 12-weeks
Locations:
city: Tulsa
country: United States
facility: OU Integrative Immunology Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Marianna S Wetherill, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.