Lowering Food Insecurity and Improving Diabetes With Financial Incentives

NCT ID: NCT05352022

Last Updated: 2025-06-26

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2026-12-31

Brief Summary

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The overarching aim of this proposal is to test the efficacy of financial incentives in improving HbA1c, blood pressure, and quality of life in food insecure adults with poorly controlled type 2 diabetes. Using a clinical trial design, the investigators will randomize food insecure adults with type 2 diabetes to one of three financial incentive structures in combination with monthly mailings that will include diabetes education, healthy recipes, and meal planning resources.

Detailed Description

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Study Overview: The overarching aim of this proposal is to test the efficacy of financial incentives in improving HbA1c, blood pressure, and quality of life in food insecure adults with poorly controlled type 2 diabetes. Using a clinical trial design, the investigators will randomize 150 (50 per arm) food insecure adults with type 2 diabetes to one of three financial incentive structures in combination with monthly mailings that will include diabetes education, healthy recipes, and meal planning resources. Each individual will be followed for 6 months, with study visits at baseline, post-intervention (3-months), and 6 months. The primary outcome will be glycemic control (HbA1c) measured at 6 months post-randomization, while the secondary outcomes will include blood pressure and quality of life at 6 months post-randomization. Each outcome will be investigated for within group change and between group change. Finally, a cost and cost effectiveness analysis will be conducted to inform implementation in a broader population.

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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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Monthly Unconditional Financial Incentive

Intervention Type BEHAVIORAL

No requirements will be placed on how or where funds will be spent.

Diabetes Education

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Monthly Unconditional Financial Incentive

Intervention Type BEHAVIORAL

No requirements will be placed on how or where funds will be spent.

Weekly Food Purchasing Financial Incentive

Intervention Type BEHAVIORAL

Incentive for healthy food purchases

Diabetes Education

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Monthly Unconditional Financial Incentive

Intervention Type BEHAVIORAL

No requirements will be placed on how or where funds will be spent.

Weekly Food Purchasing Financial Incentive

Intervention Type BEHAVIORAL

Incentive for healthy food purchases

Glycemic Control Financial Incentive

Intervention Type BEHAVIORAL

Incentive for absolute drop in HbA1c

Diabetes Education

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Weekly Food Purchasing Financial Incentive

Incentive for healthy food purchases

Intervention Type BEHAVIORAL

Glycemic Control Financial Incentive

Incentive for absolute drop in HbA1c

Intervention Type BEHAVIORAL

Diabetes Education

mailed education information

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 21 years or older
* 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

* mental confusion on interview suggesting significant dementia
* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Rebekah Jo Walker

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 33166622 (View on PubMed)

Other Identifiers

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PRO41475

Identifier Type: -

Identifier Source: org_study_id

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