Lowering Food Insecurity and Improving Diabetes With Financial Incentives

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Monthly Unconditional Financial Incentive
* Behavioral: Weekly Food Purchasing Financial Incentive
* Behavioral: Glycemic Control Financial Incentive
* Behavioral: Diabetes Education


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monthly Unconditional Financial Incentive<br>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<br>* No requirements will be placed on how or where funds will be spent.<br>Behavioral: Diabetes Education<br>* mailed education information<br>|
| Experimental: Monthly Unconditional Plus Healthy Food Purchasing Financial Incentive<br>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<br>* No requirements will be placed on how or where funds will be spent.<br>Behavioral: Weekly Food Purchasing Financial Incentive<br>* Incentive for healthy food purchases<br>Behavioral: Diabetes Education<br>* mailed education information<br>|
| Experimental: Monthly Unconditional Plus Healthy Food Purchasing Plus Glycemic Control Financial Incentive<br>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<br>* No requirements will be placed on how or where funds will be spent.<br>Behavioral: Weekly Food Purchasing Financial Incentive<br>* Incentive for healthy food purchases<br>Behavioral: Glycemic Control Financial Incentive<br>* Incentive for absolute drop in HbA1c<br>Behavioral: Diabetes Education<br>* mailed education information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control (HbA1c) | Point of care A1c machine will be used to obtain HbA1c | 6-months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure (both systolic and diastolic) | Blood pressure readings (both systolic and diastolic) will be obtained using automated BP monitors programmed to take 3 readings at 2 minute intervals and give average of the 3 readings | 6-months post randomization | 
| Quality of life as measured by the Short Form Health Survey (SF-12) | The Short Form Health Survey (SF-12) version 1, developed by Ware et al. in 1996 is a valid and reliable instrument that will be used to measure quality of life. Scores will be reported in physical health related (PCS) and mental health related (MCS). Scores range from 0 to 100 with higher scores indicating better quality of life. | 6-months post randomization |