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Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.
- Source :
-
Contemporary Clinical Trials . Jan2023, Vol. 124, pN.PAG-N.PAG. 1p. - Publication Year :
- 2023
-
Abstract
- Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear. To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity. The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results. Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions. ClinicalTrials.gov : NCT04828785 [ABSTRACT FROM AUTHOR]
- Subjects :
- *TYPE 2 diabetes
*FOOD security
*MEDICAL protocols
*QUALITY of life
*DIABETES
Subjects
Details
- Language :
- English
- ISSN :
- 15517144
- Volume :
- 124
- Database :
- Academic Search Index
- Journal :
- Contemporary Clinical Trials
- Publication Type :
- Academic Journal
- Accession number :
- 161232882
- Full Text :
- https://doi.org/10.1016/j.cct.2022.107039