Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)
LIFT-DM
1 other identifier
interventional
300
1 country
1
Brief Summary
The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Dec 2019
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2019
CompletedFirst Posted
Study publicly available on registry
November 29, 2019
CompletedStudy Start
First participant enrolled
December 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 6, 2025
August 1, 2025
6.5 years
November 26, 2019
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Glycemic control (HbA1c)
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
12-months post randomization
Secondary Outcomes (3)
Quality of Life as measured by the SF-12
12-months post randomization
LDL-Cholesterol
12-months post randomization
Blood Pressure
12-months post randomization
Study Arms (4)
Group 1- Diabetes Education Only
ACTIVE COMPARATORIndividuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.
Group 2 - Diabetes Education Plus Monthly Food Vouchers
EXPERIMENTALIndividuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.
Group 3 - Diabetes Education Plus Monthly Stock Boxes
EXPERIMENTALIndividuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.
Group 4 -- Diabetes Education Plus Combination of Monthly Food
EXPERIMENTALIndividuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.
Interventions
Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.
Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.
Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.
Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State University of New York at Buffalo
Buffalo, New York, 14203, United States
Related Publications (1)
Walker RJ, Knapp RG, Dismuke-Greer CE, Walker RE, Ozieh MN, Egede LE. Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) - Study protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Dec;99:106206. doi: 10.1016/j.cct.2020.106206. Epub 2020 Nov 7.
PMID: 33166622BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard E Egede, MD
State University of New York at Buffalo
- PRINCIPAL INVESTIGATOR
Rebekah J Walker, PhD
State University of New York at Buffalo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Chair, Department of Medicine
Study Record Dates
First Submitted
November 26, 2019
First Posted
November 29, 2019
Study Start
December 15, 2019
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
August 6, 2025
Record last verified: 2025-08