OU Integrative Immunology Center
Tulsa, Oklahoma, 74135, United States
NCT Number: NCT05208671
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tulsa, Oklahoma, 74135, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum
Time frame: Baseline; 12-weeks
Quantitative Insulin-Sensitivity Check Index (QUICKI)
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)
Time frame: Baseline; 6-weeks; 12-weeks; 16-weeks
Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential)
Time frame: Baseline; 12-weeks
reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status)
Time frame: Baseline; 12-weeks
C-reactive protein (blood measure) (higher score reflects higher chronic inflammation)
Time frame: Baseline; 12-weeks
Microbiome composition (diversity) - subsample only
University of Oklahoma
Other
Acronym: NOURISH-OK
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.
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