Food Assistance, Diabetes, and HIV (BFED)
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|ClinicalTrials.gov Identifier: NCT04045184|
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment|
|Diabetes HIV/AIDS FOOD SECURITY||Other: Food assistance|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Improving the Quality of Food Assistance for People Living With HIV and Diabetes|
|Actual Study Start Date :||October 20, 2018|
|Estimated Primary Completion Date :||October 19, 2019|
|Estimated Study Completion Date :||October 19, 2019|
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 Name: no food assistance
Patients at the 1917 Clinic who have chosen not to participate in B-FED at this time.
- To determine the feasibility of recruiting, enrolling from people living with HIV who are food insecure. [ Time Frame: 1 year ]We will track the ability to recruit and enroll eligible participants in the study.
- To determine the feasibility of collecting dietary intake data from people living with HIV who are food insecure. [ Time Frame: 1 year ]We will track the percentage of enrolled participants who complete 3 24-hour diet recalls
- Change in diabetes-related health outcomes as measured by hemoglobin A1c. [ Time Frame: 1 year ]Six months after program enrollment, B-FED participants will have improved glycemic control (lower hemoglobin A1c). Value will be measured using stored blood samples.
- Change in diabetes-related health outcomes as measured by body weight. [ Time Frame: 1 year ]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]).
- Change in diabetes-related health outcomes as measured by waist circumference [ Time Frame: 1 year ]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.
- Compare food security among groups using the Food Security Questionnaire. [ Time Frame: 1 year ]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.
- Compare hemoglobin A1c levels between groups with high versus low dietary fiber intake [ Time Frame: 1 year ]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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045184
|United States, Alabama|
|Birmingham, Alabama, United States, 35294|
|Contact: Amanda Willig, PhD, RD 205-975-5464 firstname.lastname@example.org|