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

Clinical Trial ID: NCT04181424

Description

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.

Study Overview. 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. Exploratory analyses will evaluate intervention effects on self-care behaviors and the role of diabetes empowerment and self-efficacy as mediators of intervention effects on HbA1c, BP, LDL and QOL. Patient Randomization. A permuted block randomization method will be used to assign subjects to one of the four intervention groups (cells within the 2x2 factorial design): Group 1 (Diabetes Education Only); Group 2 (Diabetes Education Plus Monthly Food Vouchers); Group 3 (Diabetes Education Plus Monthly Stock Boxes); and Group 4 (Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes). Block size will be varied to protect blinding. The randomization will be stratified by baseline HbA1c levels (8-10% vs. >10%). Using REDCap, RAs will collect eligibility information and enter the information into the study database via the secured study website. Once eligibility is confirmed, intervention assignment will be made by a pre-programmed randomization scheme. Description of the LIFT-DM Intervention After enrollment and completing the baseline assessment, each subject will have a face-to-face meeting with the study nurse. The primary purpose of the face-to-face visit is to randomize subjects to one of the four (4) treatment groups outlined below. In addition, during this visit the nurses will go over the study in detail, obtain contact information, primary and alternate telephone numbers, and establish guidelines for the study group that the subject has been assigned to. Group 1 - Diabetes Education Only: Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. 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. 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. 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. Diabetes Education: The diabetes education portion of the intervention will use materials developed by our group and that has been tested in prior R01 studies in African Americans with T2DM (R01DK081121; R01DK098529). It consists of culturally tailored diabetes education and skills training modules delivered by telephone. Modules were developed based on American Diabetes Association guidelines for diabetes education. Content was developed based on the principles of adult learning theory and was designed to be relevant, person centered, and using language at or below a seventh-grade level. Education modules were reviewed by an endocrinologist, primary care physician, diabetes educator, and nurse practitioner and revised based on feedback. Weekly sessions cover: 1) Overview of ABC's of diabetes; 2) Self Blood Glucose Monitoring; 3) Medications; 4) Basics of Eating; 5) Meal Planning; 6) Carbohydrate Counting; 7) Exercise; 8) Blood Pressure; 9) Cholesterol; 10) Foot and Skin Care; and 11) Stress. The twelfth session provides a summary of prior session materials. Behavioral skills are addressed through individualized problem-solving and self-monitoring strategies. Sessions will stress four behaviors ??? physical activity, diet, medication adherence, and glucose self-monitoring. Using the participant???s current barriers and preferences, target behavior goals will be set and each of the behaviors will be covered in 3 sessions over the course of the intervention. Twelve 30-minute weekly sessions will be delivered via the telephone, with two 30-minute booster sessions at months 6 and 9. Monthly Food Vouchers to Local Farmer???s Markets: Monthly food vouchers are intended to provide additional access to healthy food beyond that which participants currently have. Individuals will not be prevented from obtaining food from other programs such as WIC, SNAP, or food pantries, but the supplementation from the intervention will not be increased to cover family size. Vouchers will be limited to purchasing food at local farmer???s markets. Specifying use of vouchers for purchase of food at farmer???s markets is intended to support increasing purchase of fruits and vegetables. Farmer???s markets are available in the Milwaukee area year-round, with winter farmer???s markets located indoors rather than outside. However, given the limited access, during winter months vouchers will also be redeemable at local grocery stores for the purchase of fresh fruits and vegetables. Kroger grocery stores currently work with Hunger Task Force to provide access to fruits and vegetables through vouchers, and focus group participants were familiar with WIC programs that use vouchers to farmer???s markets during summer months. Vouchers for $50 will be mailed monthly for 12 months. Monthly Stock Boxes: Monthly shipments of pre-packaged food boxes are intended to provide additional access to healthy food beyond that which participants currently have. Individuals will not be prevented from obtaining food from other programs such as WIC, SNAP, or food pantries, but the supplementation from the intervention will not be increased to cover family size. Stock boxes will have foods selected based on ADA diet guidelines to include fresh produce, whole and unrefined grain products, low sodium canned vegetables, sauces, and soups, low-fat dairy, lean meats, and beans. Items such as spices, cooking oil, and utensils for cooking will also be included in boxes to facilitate individuals introducing new products into their diet. The research team has established a collaborative relationship with Feeding America of Southeastern Wisconsin who has previously created stock boxes for diabetes specific diets. In addition, we have partnered with local pantries that have piloted small studies to test feasibility of creating stock boxes. Stock boxes with foods valued at $50 will be mailed monthly for 12 months. Combined Monthly Food Vouchers and Stock Boxes: Monthly food vouchers and stock boxes are intended to provide additional access to healthy food beyond that which participants currently have. Individuals will not be prevented from obtaining food from other programs such as WIC, SNAP, or food pantries, but the supplementation from the intervention will not be increased to cover family size. Vouchers will be limited to purchasing food at local farmer???s markets to support increasing purchase of fruits and vegetables. During winter months vouchers will also be redeemable at local grocery stores for the purchase of fresh fruits and vegetables. Stock boxes will have foods selected based on ADA diet guidelines to include fresh produce, whole and unrefined grain products, low sodium canned vegetables, sauces, and soups, low-fat dairy, lean meats, and beans. Items such as spices, cooking oil, and utensils for cooking will also be included in boxes to facilitate individuals introducing new products into their diet. 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.


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.

  • Start Date

    2019-12-15

  • Last Updated

    2019-12-16

  • Sponsor

    Medical College of Wisconsin

  • Condition Name

    Type 2 Diabetes

Learn about this trial.

Check the eligibility requirements, study details, and more.

Related Trials

Different trials target different symptoms, condition types, and patients. Learn more about other emergeing treatments being investigated now.