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NOURISH Food Box for HIV/AIDS (NOURISH-OK Trial)

N/A

Recruiting

Led By Marianna S Wetherill, PhD, MPH, RD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; 6-weeks; 12-weeks; 16-weeks

Awards & highlights

NOURISH-OK Trial Summary

"This trial aims to understand how lack of access to food contributes to insulin resistance in HIV patients. The study will develop a community-based intervention focused on providing healthy food options and promoting self-care behaviors to improve

Who is the study for?

This trial is for HIV-positive individuals with an income below 400% of the federal poverty level who are at risk for insulin resistance due to factors like being overweight, aged 45 or older, having a family history of diabetes, or leading a physically inactive lifestyle. Participants must have experienced food insecurity recently and been on antiretroviral therapy for at least six months.Check my eligibility

What is being tested?

The NOURISH-OK Study is testing whether providing healthy food boxes can improve insulin sensitivity in people living with HIV. The study will give participants these special food boxes designed to promote better self-care behaviors and teach them how to use the foods effectively.See study design

What are the potential side effects?

Since this intervention involves nutrition rather than medication, side effects may be minimal but could include potential dietary intolerance or allergies related to new foods introduced through the NOURISH Food Box.

NOURISH-OK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 6-weeks; 12-weeks; 16-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; 6-weeks; 12-weeks; 16-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 6-weeks; 12-weeks; 16-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline insulin sensitivity at 12-weeks

Secondary outcome measures

Change from baseline chronic inflammation at 12-weeks

Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks

Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks

+1 more

Other outcome measures

Change from baseline gut microbiome composition at 12-weeks

NOURISH-OK Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NOURISH Food BoxExperimental Treatment1 Intervention

12-week food assistance with low Dietary Inflammatory Index (DII) foods

Group II: Wait-list ControlActive Control1 Intervention

Wait-list control group eligible to receive NOURISH box after study period

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,597 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,360 Previous Clinical Trials

4,314,618 Total Patients Enrolled

Marianna S Wetherill, PhD, MPH, RDPrincipal InvestigatorUniversity of Oklahoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals actively involved in this clinical investigation?

"Indeed, the details on clinicaltrials.gov affirm that this medical investigation is actively seeking eligible participants. Originally posted on October 9th, 2020 and last revised on April 1st, 2024, the study aims to enroll a total of 234 individuals from one designated site."

Answered by AI

Is the enrollment for this research study still ongoing?

"Indeed, the details on clinicaltrials.gov reveal that this research initiative is currently in search of suitable participants. Initially shared on October 9th, 2020, the latest update was made on April 1st, 2024. The study aims to enroll a total of 234 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Marianna Wetherill, PhD 2020. "Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208671.