Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (… (NCT04181424) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)
United States300 participantsStarted 2019-12-15
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically focused on African American adults with Type 2 Diabetes and seems to be looking at how food insecurity affects blood sugar control — is addressing food access something my doctor thinks could make a real difference in managing my HbA1c levels?
2Since this study is 'active but not recruiting,' it sounds like I can't join right now — are there similar programs or interventions that target food insecurity and diabetes management that I could access today through my care team or community resources?
3The trial is measuring glycemic control through HbA1c as its main outcome — based on where my own HbA1c numbers currently stand, does my doctor think food security and nutrition access are significant factors in why my blood sugar might be hard to control?
4Since this is listed as Phase NA, which often means it's a behavioral or lifestyle study rather than a drug trial, does my doctor know of any findings or early results from this kind of research that might already be shaping how they approach diabetes care for patients facing food insecurity?
5If food insecurity is a real barrier for me or someone I care for, what resources — like meal programs, diabetes-focused food pantries, or community health workers — can my doctor's practice connect us with right now, without waiting for a clinical trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.