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Trial record 33 of 88 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Amanda Willig, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment
Diabetes HIV/AIDS FOOD SECURITY Other: Food assistance

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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 Name: no food assistance

non B-FED
Patients at the 1917 Clinic who have chosen not to participate in B-FED at this time.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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]).

  5. 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.

  6. 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.

  7. 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
Stored serum will be analyzed for markers of glycemic control: glucose, insulin, glycosylated hemoglobin, and fructosamine.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Locations
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United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35294
Contact: Amanda Willig, PhD, RD    205-975-5464    awillig@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Study Documents (Full-Text)

Documents provided by Amanda Willig, University of Alabama at Birmingham:
Statistical Analysis Plan  [PDF] April 10, 2019


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Responsible Party: Amanda Willig, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04045184     History of Changes
Other Study ID Numbers: IRB-300001424
P30DK079626 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will only be available to the study PI and research coordinator. Only deidentified data will be shared with other investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases