Lowering Food Insecurity and Improving Diabetes With Financial Incentives

NCT05352022 | Active Not Recruiting

• 1 other identifier: PRO41475
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycemic control (HbA1c)

  Point of care A1c machine will be used to obtain HbA1c

  6-months post randomization

Secondary Outcomes (2)

• Blood pressure (both systolic and diastolic)

  6-months post randomization

• Quality of life as measured by the Short Form Health Survey (SF-12)

  6-months post randomization

Study Arms (3)

Monthly Unconditional Financial Incentive

EXPERIMENTAL

Individuals assigned to this group will receive diabetes education and a monthly incentive to supplement income and enhance ability to purchase healthy food options.

Behavioral: Monthly Unconditional Financial Incentive; Behavioral: Diabetes Education

Monthly Unconditional Plus Healthy Food Purchasing Financial Incentive

EXPERIMENTAL

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.

Behavioral: Monthly Unconditional Financial Incentive; Behavioral: Weekly Food Purchasing Financial Incentive; Behavioral: Diabetes Education

Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive

EXPERIMENTAL

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.

Behavioral: Monthly Unconditional Financial Incentive; Behavioral: Weekly Food Purchasing Financial Incentive; Behavioral: Glycemic Control Financial Incentive; Behavioral: Diabetes Education

Interventions

Monthly Unconditional Financial Incentive BEHAVIORAL

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

Monthly Unconditional Financial Incentive; Monthly Unconditional Plus Healthy Food Purchasing Financial Incentive; Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive

Weekly Food Purchasing Financial Incentive BEHAVIORAL

Incentive for healthy food purchases

Monthly Unconditional Plus Healthy Food Purchasing Financial Incentive; Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive

Glycemic Control Financial Incentive BEHAVIORAL

Incentive for absolute drop in HbA1c

Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive

Diabetes Education BEHAVIORAL

mailed education information

Monthly Unconditional Financial Incentive; Monthly Unconditional Plus Healthy Food Purchasing Financial Incentive; Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14203, United States

Location

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: 33166622 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rebekah J Walker, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)