Introduction and Objective: Food insecurity leads to worse type 2 diabetes (T2D) outcomes, but which food insecurity intervention best improves T2D outcomes is unclear. Our objective was to compare the effectiveness of two food insecurity interventions: medically tailored meals (MTM) and food subsidies.Methods: Randomized comparative effectiveness trial (NCT04828785). Adults with T2D and food insecurity received either MTM (home delivery of 10 meals/week tailored to T2D diet guidelines by a registered dietitian-nutritionist + telephone lifestyle intervention adapted from Look AHEAD) or a food subsidy ($40/month for healthy groceries) for 6 months. Lifestyle intervention (6 main sessions + 6 brief ‘check-ins’) focused on skills for healthy eating, increased activity, and behavior change with or without a weight loss goal (per participant preference). The primary outcome was hemoglobin A1c (HbA1c). Other outcomes were systolic and diastolic blood pressure (SBP and DBP), and weight. The primary timepoint was 6 months from randomization.Results: 194 participants were randomized. 178 (92%) had 6-month follow-up measurements. Mean age was 56 (SD: 12) years, 117 (60%) were women, 55 (28%) self-identified as Black, and 35 (18%) self-identified as Hispanic. Mean HbA1c at baseline was 8.4 (SD:1.7)%, SBP was 132.7 (SD:19.6) mmHg, DBP was 80.1 (SD:11.7) mmHg, and weight was 103.5 (SD: 24.5) kg. At 6 months, HbA1c was significantly lower for MTM, compared with food subsidy (7.74 vs. 8.17, mean difference -0.42%, 95% CI -0.82 to -0.03, p=0.037). SBP was also lower (124.3 vs. 130.8 mmHg, mean difference -6.5, 95% CI -12.0 to -1.1, p=0.02). Differences for DBP (76.1 vs. 78.8 mmHg, mean difference -2.7, 95% CI -5.9 to 0.5, p=0.10) and weight (101.6 vs. 102.5 kg, mean difference -1.0, 95% CI -2.9 to 0.9, p=0.31) were not statistically significant.Conclusion: For adults with T2D and food insecurity, 6 months of MTM lowered HbA1c and SBP, compared with a food subsidy. Medically tailored meals can help improve health outcomes for people with food insecurity and T2D.
S. Berkowitz: Research Support; Current; Blue Cross Blue Shield North Carolina. K.A. Ricks: None. J. Terranova: Employee; Current; Community Servings. Research Support; Current; American Heart Association, National Institutes of Health. C. Dagley: None. B. Steiner: None. G. Kruse: Research Support; Current; AstraZeneca, Edwards Lifesciences Corporation. Stock/Shareholder; Current; Dimagi, Inc. T.C. Keyserling: None. J.B. Buse: Consultant; Current; Aardvark Therapeutics, Altimmune, Alveus Therapeutics, Amgen Inc., Antag Therapeutics, Aqua Medical, AstraZeneca, Boehringer Ingelheim International GmbH. Other – Consultant and clinical trial support; Current; Corcept Therapeutics. Consultant; Ended; Dexcom, Inc. Consultant; Current; Eli Lilly and Company. Consultant; Ended; embecta. Consultant; Current; General Medicines Inc. Other – Consultant and clinical trial support; Current; GentiBio. Consultant; Ended; Insulet Corporation. Consultant; Current; Kayothera. Other – Consultant and stock options; Current; Metsera. Other – Expert witness; Ended; Medtronic. Other – Consultant and investigator; Current; Novo Nordisk. Consultant; Current; Recordati S.p.A, Sparrow Pharmaceuticals. Consultant; Ended; Tandem Diabetes Care, Inc. Consultant; Current; Vertex Pharmaceuticals Incorporated, vTv Therapeutics, Zealand Pharma A/S. D. Wexler: Other – Data Monitoring Committee; Ended; Novo Nordisk. Other – Data Monitoring Committee; Current; Amgen Inc. L.M. Delahanty: Stock/Shareholder; Current; Omada Health, Inc. Stock/Shareholder; Ended; Jana Care Inc. Consultant; Current; ZOE Limited. Stock/Shareholder; Current; ZOE Limited.
NIH/NIDDK (R01DK125831)
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