Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma (NOURISH-OK)
Primary Purpose
HIV, Insulin Resistance, Food Insecurity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NOURISH Food Box
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring food as medicine, nutrition
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NOURISH Food Box
Wait-list Control
Arm Description
12-week food assistance with low Dietary Inflammatory Index (DII) foods
Wait-list control group eligible to receive NOURISH box after study period
Outcomes
Primary Outcome Measures
Change from baseline insulin sensitivity at 12-weeks
Quantitative Insulin-Sensitivity Check Index (QUICKI)
Secondary Outcome Measures
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)
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)
Change from baseline skin carotenoid at 12-weeks
reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status)
Change from baseline chronic inflammation at 12-weeks
C-reactive protein (blood measure) (higher score reflects higher chronic inflammation)
Full Information
NCT ID
NCT05208671
First Posted
January 11, 2022
Last Updated
May 8, 2023
Sponsor
University of Oklahoma
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05208671
Brief Title
Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
Acronym
NOURISH-OK
Official Title
Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2024 (Anticipated)
Primary Completion Date
August 28, 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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=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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Insulin Resistance, Food Insecurity
Keywords
food as medicine, nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NOURISH Food Box
Arm Type
Experimental
Arm Description
12-week food assistance with low Dietary Inflammatory Index (DII) foods
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
Wait-list control group eligible to receive NOURISH box after study period
Intervention Type
Other
Intervention Name(s)
NOURISH Food Box
Intervention Description
Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum
Primary Outcome Measure Information:
Title
Change from baseline insulin sensitivity at 12-weeks
Description
Quantitative Insulin-Sensitivity Check Index (QUICKI)
Time Frame
Baseline; 12-weeks
Secondary Outcome Measure Information:
Title
Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks
Description
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
Title
Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks
Description
Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential)
Time Frame
Baseline; 6-weeks; 12-weeks; 16-weeks
Title
Change from baseline skin carotenoid at 12-weeks
Description
reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status)
Time Frame
Baseline; 12-weeks
Title
Change from baseline chronic inflammation at 12-weeks
Description
C-reactive protein (blood measure) (higher score reflects higher chronic inflammation)
Time Frame
Baseline; 12-weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline gut microbiome composition at 12-weeks
Description
Microbiome composition (diversity) - subsample only
Time Frame
Baseline; 12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lacey Caywood, MPH
Phone
918-834-4194
Email
nourish@tulsacares.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianna S Wetherill, PhD, MPH, RD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Made available within 12 months of study end.
IPD Sharing Access Criteria
Written request to PI.
Citations:
PubMed Identifier
36225538
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.
Results Reference
derived
Links:
URL
http://www.tulsacares.org/nourish/
Description
NOURISH-OK Study Information Webpage
Learn more about this trial
Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
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