Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)

Type 2 Diabetes Clinical Trial

— LIFT-DM  

Official title:

Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04181424
• Other study ID #: 5R01MD013826
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.

Description:

The overarching aim of this proposal is to conduct a 4-arm RCT to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with T2DM using a 2x2 factorial design. 300 patients will be randomly assigned to four groups of 75 patients each: 1) diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus mailed stock boxes; and 4) diabetes education plus combined food vouchers and mailed stock boxes. Each patient will be followed for 12 months, with study assessments at baseline, 3, 6, and 12 months. Primary aim is efficacy of separate and combined interventions on HbA1c at 12 months post-randomization. Secondary aims are efficacy of separate and combined interventions on BP, LDL and QOL as well as cost-effectiveness at 12 months post-randomization.

Description of the LIFT-DM Intervention Group 1 - Diabetes Education Only: Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. Twelve 30-minute weekly sessions will be delivered via the telephone, with two 30-minute booster sessions at months 6 and 9.

Group 2 - Diabetes Education Plus Monthly Food Vouchers: Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local farmer's markets mailed to their home. Vouchers for $50 will be mailed monthly for 12 months.

Group 3 - Diabetes Education Plus Monthly Stock Boxes: Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home. Stock boxes with foods valued at $50 will be mailed monthly for 12 months.

Group 4 - Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes:

Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home. Vouchers for $25 and stock boxes with food valued at $25 will be mailed monthly for 12 months. In essence, the combined group will still receive $50 worth of food supplementation monthly as combination of $25 vouchers and $25 mailed stock boxes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria: 1) age >=21 years; 2) self-report as African American/non-Hispanic Black; 3) screen positive for food insecurity over past 12-months using screening questionnaire; 4) clinical diagnosis of type 2 diabetes and HbA1c >=8% at the screening visit; 5) income <=133% of federal poverty level based on household income and size of household or Medicaid eligible; 6) able to communicate in English.

Exclusion Criteria: 1) Mental confusion on interview suggesting significant dementia; 2) Participation in other diabetes clinical trials; 3) Alcohol or drug abuse/dependency; 4) Active psychosis or acute mental disorder; and 5) Life expectancy <12 months.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Diabetes Education Plus Monthly Food Vouchers
Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.
• Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes
Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.
• Diabetes Education Only
Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.
• Diabetes Education Plus Monthly Stock Boxes
Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control (HbA1c)	Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.	12-months post randomization
Secondary	Quality of Life as measured by the SF-12	The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.	12-months post randomization
Secondary	LDL-Cholesterol	About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.	12-months post randomization
Secondary	Blood Pressure	Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.	12-months post randomization

External Links

•   Protocol paper