Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05352022 |
| Other study ID # |
PRO41475 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
December 31, 2027 |
Study information
| Verified date |
March 2024 |
| Source |
Medical College of Wisconsin |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
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.
