Improving insulin sensitivity in HIV patients through nutrition in Oklahoma
Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma
NA · University of Oklahoma · NCT05208671
This study is trying to see if improving access to healthy food can help people with HIV in Oklahoma manage their insulin resistance better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Locations | 1 site (Tulsa, Oklahoma) |
| Trial ID | NCT05208671 on ClinicalTrials.gov |
What this trial studies
The NOURISH-OK Study aims to explore the relationship between food insecurity and insulin resistance among HIV-positive individuals in Oklahoma. It employs a community-based participatory research approach, starting with observational studies to identify key factors contributing to insulin resistance. Following this, a tailored 'food as medicine' intervention will be developed and tested to improve access to healthy food and enhance self-care behaviors. The study will involve surveys, interviews, and a randomized wait-list control trial to assess the intervention's feasibility and impact.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals with income below 400% of the federal poverty level and at least one risk factor for insulin resistance.
Not a fit: Patients who are not HIV-positive or those with serious terminal illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of insulin resistance and related health issues for individuals living with HIV.
How similar studies have performed: Other studies have shown promise in using nutrition-based interventions to address health disparities, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Tulsa, Oklahoma
- OU Integrative Immunology Center — Tulsa, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Marianna S Wetherill, PhD, MPH, RD — University of Oklahoma
- Study coordinator: Lacey Caywood, MPH
- Email: nourish@tulsacares.org
- Phone: 918-834-4194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV, Insulin Resistance, Food Insecurity, food as medicine, nutrition