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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 28, 2019
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

AIM 1: 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 (HbA1c) in low income, food insecure, African Americans with T2DM using a 2x2 factorial design.

Hypothesis 1: Individuals randomized to diabetes education plus food supplementation interventions (food vouchers alone, mailed stock boxes alone or the combined intervention) will have significantly greater reduction in HbA1c at 12 months compared to the diabetes education only control group.

Hypothesis 2: Individuals randomized to the diabetes education plus combined food vouchers and mailed stock boxes intervention will have significantly greater reduction in HbA1c at 12 months compared to either diabetes education plus food vouchers alone or diabetes education plus mailed stock boxes alone.

AIM 2: 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 blood pressure (BP), lipids (LDL) and quality of life (QOL) in low income, food insecure, AAs with poorly controlled T2DM using a 2x2 factorial design.

Hypothesis 1: Individuals randomized to diabetes education plus food supplementation interventions (food vouchers alone, mailed stock boxes alone or the combined intervention) will have significantly greater reduction in BP, LDL and QOL at 12 months compared to the diabetes education only control group.

Hypothesis 2: Individuals randomized to the diabetes education plus combined food vouchers and mailed stock boxes intervention will have significantly greater reduction in BP, LDL and QOL at 12 months compared to either diabetes education plus food vouchers alone or diabetes education mailed stock boxes alone.

AIM 3: To test the cost-effectiveness of the separate and combined food supplementation interventions.

Hypothesis: The diabetes education plus combined food vouchers and mailed stock boxes intervention will be more cost-effective in improving HbA1c levels at 12 months, compared to diabetes education plus each separate intervention alone, and diabetes education only control group, as measured by differences in program costs, utilization and quality of life.

Exploratory analyses will evaluate intervention effects on self-care behaviors and diabetes empowerment, self-efficacy and dietary intake as mediators of intervention effects on HbA1c, BP, LDL and QOL.


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

  Show Detailed Description

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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)
Estimated Study Start Date : December 1, 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: baseline, 3-months, 6-months, and 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: baseline, 3-months, 6-months, and 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: baseline, 3-months, 6-months, and 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: baseline, 3-months, 6-months, and 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.


Other Outcome Measures:
  1. Resource Utilization and Cost [ Time Frame: baseline, 3-months, 6-months, and 12-months post randomization ]
    Previously validated questions on resource utilization will be administered. The questionnaires capture information on hospitalizations, physician/professional visits, and medications.



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 2 question food insecurity 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: Jennifer A Campbell, MPH 414-955-8829 jacampbell@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

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Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04181424     History of Changes
Other Study ID Numbers: 5R01MD013826 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2019    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019

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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