Purpose

Diabetes prevalence is increasing among people living with HIV (PLWH), yet blood glucose control is less successful in this population who are also often food insecure. Food assistance programs often provide nutrient-poor foods. This proposal asses the feasibility of monitoring diabetes-related health outcomes among food insecure PLWH who are receiving food boxes higher in dietary protein and fiber and lower in simple carbohydrates.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • CNICS participants aged 18 and over
  • Currently prescribed antiretroviral therapy
  • Have a diagnosis of diabetes, or documented hemoglobin A1c >7.0%, or glucose >125gm/dL

Exclusion Criteria

  • Not diagnosed with HIV
  • PLWH who are not patients at 1917 Clinic
  • Under age 18
  • Pregnant women
  • Recent cancer diagnosis Current serious illness or trauma Persons with an active secondary infection including tuberculosis or untreated Hepatitis C.

Study Design

Phase
Study Type
Observational
Observational Model
Ecologic or Community
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
B-FED Clients of the Birmingham AIDS Outreach Food and Education Delivery (B-FED) program who are also patients at the 1917 Clinic.
  • Other: Food assistance
    This is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program.
    Other names:
    • no food assistance
non B-FED Patients at the 1917 Clinic who have chosen not to participate in B-FED at this time.

Recruiting Locations

UAB
Birmingham, Alabama 35294
Contact:
Amanda Willig, PhD, RD
205-975-5464
awillig@uabmc.edu

More Details

NCT ID
NCT04045184
Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Detailed Description

The objective of this investigation is to develop and assess a study protocol to evaluate the impact of food assistance on diabetes-related health outcomes in food insecure people living with HIV (PLWH). Compared to the general population, PLWH have increased risk for type 2 diabetes and worse glycemic control when using similar pharmaceutical treatments. Interventions to improve diet quality could thus have a clinically meaningful impact on diabetes treatment in this population. However, many PLWH are food insecure and rely on food assistance to meet basic nutrition needs. This proposal will determine the feasibility of a protocol to evaluate diabetes-related health outcomes in food insecure PLWH and diabetes who receive high protein, high dietary fiber food boxes from Birmingham AIDS Outreach. The study will consist of retrospective analysis of electronic medical record data and stored specimens, and prospective cross-sectional analysis of food security and diet quality in PLWH who do versus those who do not receive the food boxes.

Specific Aim 1: To determine the feasibility of recruiting, enrolling, and collecting dietary intake data from people living with HIV who are food insecure.

Specific Aim 2: To compare changes over twelve months in glycemic control, food security, and diet quality in B-FED participants compared to non-participating 1917 clinic patients.

This proposal aligns with the UAB Diabetes Research Center's goal to facilitate development of new methods to treat diabetes and its complications. The investigators will determine the effect size for scale-up of larger, longer-term assessment through an NIDDK-R18 grant to evaluate the real-world impact of B-FED on glycemic control and food security.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.