TY - JOUR
T1 - Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia
AU - Law, K. K.
AU - Coyle, D. H.
AU - Neal, B.
AU - Huang, L.
AU - Barrett, E. M.
AU - Arnott, C.
AU - Chow, C. K.
AU - Di Tanna, G. L.
AU - Lung, T.
AU - Mozaffarian, D.
AU - Berkowitz, S. A.
AU - Wong, J.
AU - Wu, T.
AU - Twigg, S.
AU - Gauld, A.
AU - Simmons, David
AU - Piya, Milan K.
AU - MacMillan, Freya
AU - Khoo, Chee L.
AU - Tian, M.
AU - Trieu, K.
AU - Wu, J. H. Y.
PY - 2023/9
Y1 - 2023/9
N2 - Background: ‘Food is medicine’ strategies aim to integrate food-based nutrition interventions into healthcare systems and are of growing interest to healthcare providers and policy makers. ‘Medically Tailored Meals’ (MTM) is one such intervention, which involves the ‘prescription’ by healthcare providers of subsidized, pre-prepared meals for individuals to prevent or manage chronic conditions, combined with nutrition education. Objective: This study will test the efficacy of an MTM program in Australia among participants with type 2 diabetes (T2D) and hyperglycemia, who experience difficulties accessing and eating nutritious food. Methods: This study will be a two-arm parallel trial (goal n = 212) with individuals randomized in a 1:1 ratio to a MTM intervention group or a control group (106 per arm). Over 26 weeks, the intervention group will be prescribed 20 MTM per fortnight and up to 3 sessions with an accredited dietitian. Controls will continue with their usual care. The primary outcome is glycated hemoglobin (HbA1c, %) and secondary outcomes include differences in blood pressure, blood lipids and weight, all measured at 26 weeks. Process and economic data will be analyzed to assess the feasibility, acceptability, scalability, and cost-effectiveness of the intervention. Recruitment commenced in the first quarter of 2023, with analyses and results anticipated to be available by March 2025. Discussion: Few randomized controlled trials have assessed the impact of MTM on clinical outcomes. This Australian-first trial will generate robust data to inform the case for sustained, large-scale implementation of MTM to improve the management of T2D among vulnerable populations. ANZCTR: ACTRN12622000852752. Protocol version: Version 1.1, July 2023.
AB - Background: ‘Food is medicine’ strategies aim to integrate food-based nutrition interventions into healthcare systems and are of growing interest to healthcare providers and policy makers. ‘Medically Tailored Meals’ (MTM) is one such intervention, which involves the ‘prescription’ by healthcare providers of subsidized, pre-prepared meals for individuals to prevent or manage chronic conditions, combined with nutrition education. Objective: This study will test the efficacy of an MTM program in Australia among participants with type 2 diabetes (T2D) and hyperglycemia, who experience difficulties accessing and eating nutritious food. Methods: This study will be a two-arm parallel trial (goal n = 212) with individuals randomized in a 1:1 ratio to a MTM intervention group or a control group (106 per arm). Over 26 weeks, the intervention group will be prescribed 20 MTM per fortnight and up to 3 sessions with an accredited dietitian. Controls will continue with their usual care. The primary outcome is glycated hemoglobin (HbA1c, %) and secondary outcomes include differences in blood pressure, blood lipids and weight, all measured at 26 weeks. Process and economic data will be analyzed to assess the feasibility, acceptability, scalability, and cost-effectiveness of the intervention. Recruitment commenced in the first quarter of 2023, with analyses and results anticipated to be available by March 2025. Discussion: Few randomized controlled trials have assessed the impact of MTM on clinical outcomes. This Australian-first trial will generate robust data to inform the case for sustained, large-scale implementation of MTM to improve the management of T2D among vulnerable populations. ANZCTR: ACTRN12622000852752. Protocol version: Version 1.1, July 2023.
UR - https://hdl.handle.net/1959.7/uws:73298
U2 - 10.1016/j.cct.2023.107307
DO - 10.1016/j.cct.2023.107307
M3 - Article
SN - 0197-2456
VL - 132
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107307
ER -
