Clinical trial NCT04045184: Food Assistance, Diabetes, and HIV
Official title: Improving the Quality of Food Assistance for People Living With HIV and Diabetes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
HIV/AIDS
FOOD SECURITY
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients at the UAB 1917 Clinic who are diagnosed with HIV and type 2 diabetes.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the feasibility of recruiting, enrolling from people living with HIV who are food insecure.
timeFrame: 1 year
measure: Change in diabetes-related health outcomes as measured by hemoglobin A1c.
timeFrame: 1 year
measure: Compare food security among groups using the Food Security Questionnaire.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References: