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

Studies

Study First Submitted Date 2022-01-11
Study First Posted Date 2022-01-26
Last Update Posted Date 2023-05-10
Start Month Year March 1, 2024
Primary Completion Month Year August 28, 2025
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-10

Detailed Descriptions

Sequence: 20841894
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=500) and a one-month observational sub-study from the main study sample (n=100) 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=56 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=270). This study will use a simple randomized wait-list control trial design with stratification by geography (urban/rural) and further stratification in the urban group by low and very low food security status.

Conditions

Sequence: 52479330 Sequence: 52479331 Sequence: 52479332
Name HIV Name Insulin Resistance Name Food Insecurity
Downcase Name hiv Downcase Name insulin resistance Downcase Name food insecurity

Id Information

Sequence: 40379239 Sequence: 40379240
Id Source org_study_id Id Source secondary_id
Id Value 5R01DK127464 Id Value 5R01DK127464
Id Type U.S. NIH Grant/Contract Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/5R01DK127464 Id Link https://reporter.nih.gov/quickSearch/5R01DK127464

Design Groups

Sequence: 55935394 Sequence: 55935395
Group Type Experimental Group Type No Intervention
Title NOURISH Food Box Title Wait-list Control
Description 12-week food assistance with low Dietary Inflammatory Index (DII) foods Description Wait-list control group eligible to receive NOURISH box after study period

Interventions

Sequence: 52789118
Intervention Type Other
Name NOURISH Food Box
Description Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum

Keywords

Sequence: 80287102 Sequence: 80287103
Name food as medicine Name nutrition
Downcase Name food as medicine Downcase Name nutrition

Design Outcomes

Sequence: 178534908 Sequence: 178534909 Sequence: 178534910 Sequence: 178534911 Sequence: 178534912 Sequence: 178534913
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other
Measure Change from baseline insulin sensitivity at 12-weeks Measure Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks Measure Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks Measure Change from baseline skin carotenoid at 12-weeks Measure Change from baseline chronic inflammation at 12-weeks Measure Change from baseline gut microbiome composition at 12-weeks
Time Frame Baseline; 12-weeks Time Frame Baseline; 6-weeks; 12-weeks; 16-weeks Time Frame Baseline; 6-weeks; 12-weeks; 16-weeks Time Frame Baseline; 12-weeks Time Frame Baseline; 12-weeks Time Frame Baseline; 12-weeks
Description Quantitative Insulin-Sensitivity Check Index (QUICKI) Description 10-item US Adult Food Security Module (0-10 point range; higher score reflects lower food security) Description Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential) Description reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status) Description C-reactive protein (blood measure) (higher score reflects higher chronic inflammation) Description Microbiome composition (diversity) – subsample only

Browse Conditions

Sequence: 194664007 Sequence: 194664008 Sequence: 194664009 Sequence: 194664010
Mesh Term Insulin Resistance Mesh Term Hyperinsulinism Mesh Term Glucose Metabolism Disorders Mesh Term Metabolic Diseases
Downcase Mesh Term insulin resistance Downcase Mesh Term hyperinsulinism Downcase Mesh Term glucose metabolism disorders Downcase Mesh Term metabolic diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48605643 Sequence: 48605644
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Oklahoma Name National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Officials

Sequence: 29446892
Role Principal Investigator
Name Marianna S Wetherill, PhD, MPH, RD
Affiliation University of Oklahoma

Central Contacts

Sequence: 12087923
Contact Type primary
Name Lacey Caywood, MPH
Phone 918-834-4194
Email nourish@tulsacares.org
Role Contact

Design Group Interventions

Sequence: 68571226
Design Group Id 55935394
Intervention Id 52789118

Eligibilities

Sequence: 30942140
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
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 have low or very low household food security in the past month 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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254282636
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 4
Number Of Other Outcomes To Measure 1

Designs

Sequence: 30687750
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Links

Sequence: 4411455
Url http://www.tulsacares.org/nourish/
Description NOURISH-OK Study Information Webpage

Responsible Parties

Sequence: 29054487
Responsible Party Type Principal Investigator
Name Marianna Wetherill, PhD
Title Associate Professor
Affiliation University of Oklahoma

Study References

Sequence: 52388699
Pmid 36225538
Reference Type derived
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.

Ipd Information Types

Sequence: 3359402 Sequence: 3359403
Name Study Protocol Name Informed Consent Form (ICF)