Skip to main content
Clinical Trials/NCT05352022
NCT05352022Active, not recruitingNot Applicable

Lowering Food Insecurity and Improving Diabetes With Financial Incentives (LIFT-FINANCE)

State University of New York at Buffalo2 sites in 1 country150 target enrollmentStarted: May 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
150
Locations
2
Primary Endpoint
Glycemic control (HbA1c)

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Monthly Unconditional Financial Incentive (Behavioral)

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.

Intervention: Weekly Food Purchasing Financial Incentive (Behavioral)

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.

Intervention: Diabetes Education (Behavioral)

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.

Intervention: Monthly Unconditional Financial Incentive (Behavioral)

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.

Intervention: Weekly Food Purchasing Financial Incentive (Behavioral)

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.

Intervention: Glycemic Control Financial Incentive (Behavioral)

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.

Intervention: Diabetes Education (Behavioral)

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.

Intervention: Monthly Unconditional Financial Incentive (Behavioral)

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.

Intervention: Diabetes Education (Behavioral)

Outcomes

Primary Outcomes

Glycemic control (HbA1c)

Time Frame: 6-months post randomization

Point of care A1c machine will be used to obtain HbA1c

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rebekah Jo Walker

Associate Professor

State University of New York at Buffalo

Study Sites (2)

Loading locations...

Similar Trials