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

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ClinicalTrials.gov Identifier: NCT04181424
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Egede, Leonard E, Medical College of Wisconsin

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Diabetes Education Plus Monthly Food Vouchers Behavioral: Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes Behavioral: Diabetes Education Only Behavioral: Diabetes Education Plus Monthly Stock Boxes Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1- Diabetes Education Only
Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.
Behavioral: Diabetes Education Only
Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.

Experimental: 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.
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.

Experimental: 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.
Behavioral: 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.

Experimental: Group 4 -- Diabetes Education Plus Combination of Monthly Food
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.
Behavioral: 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.




Primary Outcome Measures :
  1. Glycemic control (HbA1c) [ Time Frame: 12-months post randomization ]
    Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.


Secondary Outcome Measures :
  1. Quality of Life as measured by the SF-12 [ Time Frame: 12-months post randomization ]
    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.

  2. LDL-Cholesterol [ Time Frame: 12-months post randomization ]
    About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.

  3. Blood Pressure [ Time Frame: 12-months post randomization ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181424


Contacts
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Contact: Elise Mosley-Johnson, MPH 414-955-8810 emosley@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jennifer A Campbell, MPH    414-955-8829    jacampbell@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Leonard E Egede, MD Medical College of Wisconsin
Principal Investigator: Rebekah J Walker, PhD Medical College of Wisconsin
Additional Information:
Publications:
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Responsible Party: Egede, Leonard E, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04181424    
Other Study ID Numbers: 5R01MD013826 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases