DiabetesBFEDNCT04045184
Food Assistance, Diabetes, and HIV
An observational study of Diabetes and HIV/AIDS, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, HIV/AIDS, FOOD SECURITY
- What is being tested?
- Food assistance
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be patients at the UAB 1917 Clinic who are diagnosed with HIV and type 2 diabetes.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Quality of Food Assistance for People Living With HIV and Diabetes
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.
Read the 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.
- Conditions
- Diabetes, HIV/AIDS, FOOD SECURITY
- Being tested
- Food assistance
- Medical subject headings
- Diabetes Mellitus, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food assistanceOther
Also called no food assistance
This is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program.
| Study group | Role | What they receive |
|---|---|---|
| B-FED | Clients of the Birmingham AIDS Outreach Food and Education Delivery (B-FED) program who are also patients at the 1917 Clinic. Receives: Other: Food assistance | |
| non B-FED | Patients at the 1917 Clinic who have chosen not to participate in B-FED at this time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start20 Oct 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Stored specimens unavailable due to being depleted for COVID-19 research. Study converted to retrospective observational study of clinic patients diabetes trends using EMR data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Amanda Willig, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045184
- Sponsor's protocol ID
- IRB-300001424
- Other IDs
- P30DK079626
- Acronym
- BFED
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2019
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be available to the study PI and research coordinator. Only deidentified data will be shared with other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Food Assistance for People Living With HIV and Diabetes
- ClinicalTrials.gov ID
- NCT04045184
- Acronym / sponsor ID
- BFED / IRB-300001424
- Conditions
- Diabetes, HIV/AIDS, FOOD SECURITY
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Stored specimens unavailable due to being depleted for COVID-19 research. Study converted to retrospective observational study of clinic patients diabetes trends using EMR data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-FED | – | Other: Food assistanceClients of the Birmingham AIDS Outreach Food and Education Delivery (B-FED) program who are also patients at the 1917 Clinic. |
| non B-FED | – | –Patients at the 1917 Clinic who have chosen not to participate in B-FED at this time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients at the UAB 1917 Clinic who are diagnosed with HIV and type 2 diabetes.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food assistanceAlso: no food assistanceThis is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program. | Other | B-FED |
Primary outcome
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. IPD will only be available to the study PI and research coordinator. Only deidentified data will be shared with other investigators.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and HIV/AIDS, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility of recruiting, enrolling from people living with HIV who are food insecure. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.