Food Assistance, Diabetes, and HIV

Diabetes Clinical Trial

— BFED  

Official title:

Improving the Quality of Food Assistance for People Living With HIV and Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045184
• Other study ID #: IRB-300001424
• Secondary ID: P30DK079626
• Status: Recruiting
• Start date: October 20, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• FOOD SECURITY
• HIV/AIDS

Intervention

Other:
• Food assistance
This is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of recruiting, enrolling from people living with HIV who are food insecure.	We will track the ability to recruit and enroll eligible participants in the study.	1 year
Primary	To determine the feasibility of collecting dietary intake data from people living with HIV who are food insecure.	We will track the percentage of enrolled participants who complete 3 24-hour diet recalls	1 year
Primary	Change in diabetes-related health outcomes as measured by hemoglobin A1c.	Six months after program enrollment, B-FED participants will have improved glycemic control (lower hemoglobin A1c). Value will be measured using stored blood samples.	1 year
Primary	Change in diabetes-related health outcomes as measured by body weight.	Six months after program enrollment, B-FED participants will have improved body mass index (calculated using height and weight from electronic medical record) versus PLWH with insulin resistance and type 2 diabetes who do not participate in the program. Body weight will be measured to the nearest 0.1 kg using a Medtronic scale. Height will be measured to the nearest 0.1 cm using a stadiometer. The values will be used to compute the body mass index (weight[kg]/height[m2]).	1 year
Primary	Change in diabetes-related health outcomes as measured by waist circumference	Six months after program enrollment, B-FED participants will have lower waist circumference versus PLWH with insulin resistance and type 2 diabetes who do not participate in the program. Waist circumference will be measured to the nearest 0.1 cm using a flexible measuring tape.	1 year
Primary	Compare food security among groups using the Food Security Questionnaire.	B-FED participants will report a higher prevalence of food security compared to clinic patients who do not participate in the program. This will be assessed at 1 time point using the validated 2-item Food Security Questionnaire to classify participants as food secure, low food security, or very low food security.	1 year
Primary	Compare hemoglobin A1c levels between groups with high versus low dietary fiber intake	B-FED participants in the highest tertile of dietary fiber intake will experience greater reductions in hemoglobin A1c levels compared to participants in the lowest fiber tertile. Hemoglobin A1c will be measured using stored blood samples. Dietary fiber intake will be assessed as the average daily fiber intake in grams from three 24-hour diet recalls.	1 year