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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
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring food as medicine, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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)
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    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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