Lowering Food Insecurity and Improving Diabetes With Financial Incentives
NCT ID: NCT05352022
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2022-05-01
2026-12-31
Brief Summary
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Detailed Description
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Patient Randomization. A permuted block randomization method will be used to assign subjects to control or intervention. The research assistant will collect eligibility information and enter it into the study database via the secured RedCap study website. Once eligibility is confirmed, the computer will generate the intervention assignment based on the pre-programmed randomization scheme. All subjects who are randomized will be entered into the study database and analyzed according to CONSORT guidelines .
Description of the LIFT-FINANCE Intervention. LIFT FINANCE is comprised of education and a structured financial incentive. All participants will receive a diabetes education booklet and monthly diabetes education modules mailed to their home, that will include healthy menu recommendations, meal planning resources, and healthy recipes that are affordable and easy to make. In addition, participants will receive one of three structured incentives:
Group 1: Monthly Unconditional Financial Incentive - this group will receive monthly unconditional incentive of $100 per month for 6 months to supplement income and enhance ability to purchase healthy food options. No requirements will be placed on how or where funds will be spent.
Group 2: Monthly Unconditional Plus Healthy Food Purchasing Financial Incentive - this group will receive monthly unconditional incentive of $100 per month for 6 months to supplement income and enhance ability to purchase healthy food options. In addition, participants will receive an additional $25 incentive per week if receipt for purchase of healthy food items from a grocery store is provided.
Group 3: Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive - this group will receive monthly unconditional incentive of $100 per month for 6 months to supplement income and enhance ability to purchase healthy food options. In addition, participants will receive an additional $25 incentive per week if receipt for purchase of healthy food items from a grocery store is provided. Finally, participants will receive incentives for absolute drop in hemoglobin A1c at 6 months as follows: If HbA1c has dropped 2% or more from baseline, or absolute HbA1c is less than 7%, the additional incentive will be $150. If HbA1c has dropped between 1% to 1.9% from baseline the additional incentive will be $100. If HbA1c has dropped between 0.5% to 0.9% from baseline the additional incentive will be $50.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Monthly Unconditional Financial Incentive
Individuals assigned to this group will receive diabetes education and a monthly incentive to supplement income and enhance ability to purchase healthy food options.
Monthly Unconditional Financial Incentive
No requirements will be placed on how or where funds will be spent.
Diabetes Education
mailed education information
Monthly Unconditional Plus Healthy Food Purchasing Financial Incentive
Individuals assigned to this group will receive diabetes education, a monthly incentive to supplement income and enhance ability to purchase healthy food options, and an additional weekly incentive if receipt for purchase of healthy food items from a grocery store is provided.
Monthly Unconditional Financial Incentive
No requirements will be placed on how or where funds will be spent.
Weekly Food Purchasing Financial Incentive
Incentive for healthy food purchases
Diabetes Education
mailed education information
Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive
Individuals assigned to this group will receive diabetes education, a monthly incentive to supplement income and enhance ability to purchase healthy food options, an additional weekly incentive if receipt for purchase of healthy food items from a grocery store is provided, and an incentive at the end of the study based on absolute drop in HbA1c.
Monthly Unconditional Financial Incentive
No requirements will be placed on how or where funds will be spent.
Weekly Food Purchasing Financial Incentive
Incentive for healthy food purchases
Glycemic Control Financial Incentive
Incentive for absolute drop in HbA1c
Diabetes Education
mailed education information
Interventions
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Monthly Unconditional Financial Incentive
No requirements will be placed on how or where funds will be spent.
Weekly Food Purchasing Financial Incentive
Incentive for healthy food purchases
Glycemic Control Financial Incentive
Incentive for absolute drop in HbA1c
Diabetes Education
mailed education information
Eligibility Criteria
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Inclusion Criteria
* clinical diagnosis of type 2 diabetes
* HbA1c of 9 or higher at screening visit
* screen positive for food insecurity using food insecurity risk tool
* ability to communicate in English
Exclusion Criteria
* participation in other diabetes clinical trial
* alcohol or drug abuse/dependency based on CAGE screening tool
* active psychosis or acute mental disorder
* life expectancy of less than 6 months
21 Years
ALL
No
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Rebekah Jo Walker
Associate Professor
Principal Investigators
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Rebekah J Walker, PhD
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
Locations
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University at Buffalo
Buffalo, New York, United States
Countries
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References
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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.
Other Identifiers
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PRO41475
Identifier Type: -
Identifier Source: org_study_id
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