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

Not Applicable

Recruiting

• Conditions: Insulin Resistance; HIV; Food Insecurity

• Registration Number: NCT05208671
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2020-10-09
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 234

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline insulin sensitivity at 12-weeks	Baseline; 12-weeks	Quantitative Insulin-Sensitivity Check Index (QUICKI)

Secondary Outcome Measures

Name	Time	Method
Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks	Baseline; 6-weeks; 12-weeks; 16-weeks	Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential)
Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks	Baseline; 6-weeks; 12-weeks; 16-weeks	10-item US Adult Food Security Module (0-10 point range; higher score reflects lower food security)
Change from baseline skin carotenoid at 12-weeks	Baseline; 12-weeks	reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status)
Change from baseline chronic inflammation at 12-weeks	Baseline; 12-weeks	C-reactive protein (blood measure) (higher score reflects higher chronic inflammation)

Trial Locations

Locations (1)

OU Integrative Immunology Center; 🇺🇸 Tulsa, Oklahoma, United States