Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia

Kristy K Law; Daisy H Coyle; Bruce Neal; Liping Huang; Eden M Barrett; Clare Arnott; Clara K Chow; Gian Luca Di Tanna; Thomas Lung; Dariush Mozaffarian; Seth A Berkowitz; Jencia Wong; Ted Wu; Stephen Twigg; Amanda Gauld; David Simmons; Milan K Piya; Freya MacMillan; Chee L Khoo; Maoyi Tian; Kathy Trieu; Jason H Y Wu

doi:10.1016/j.cct.2023.107307

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia

Contemp Clin Trials. 2023 Sep:132:107307. doi: 10.1016/j.cct.2023.107307. Epub 2023 Jul 28.

Authors

Kristy K Law¹, Daisy H Coyle², Bruce Neal³, Liping Huang², Eden M Barrett², Clare Arnott⁴, Clara K Chow⁵, Gian Luca Di Tanna⁶, Thomas Lung⁷, Dariush Mozaffarian⁸, Seth A Berkowitz⁹, Jencia Wong¹⁰, Ted Wu¹¹, Stephen Twigg¹⁰, Amanda Gauld¹¹, David Simmons¹², Milan K Piya¹², Freya MacMillan¹³, Chee L Khoo¹⁴, Maoyi Tian¹⁵, Kathy Trieu², Jason H Y Wu¹⁶

Affiliations

¹ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia. Electronic address: klaw@georgeinstitute.org.au.
² The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
³ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; Department of Epidemiology and Biostatistics, Imperial College London, London, United Kingdom.
⁴ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
⁵ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; Department of Cardiology, Westmead Hospital, Westmead, NSW, Australia.
⁶ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland, Lugano, Switzerland.
⁷ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
⁸ Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States of America.
⁹ Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
¹⁰ Diabetes Centre, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Faculty of Medicine and Health, Sydney Medical School, Central Clinical School, Central Sydney (Patyegarang) Precinct, University of Sydney, NSW, Australia.
¹¹ Diabetes Centre, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
¹² School of Medicine, Western Sydney University, Campbelltown, NSW, Australia; Macarthur Diabetes Endocrinology and Metabolism Service, Camden and Campbelltown Hospitals, Campbelltown, NSW, Australia.
¹³ Macarthur Diabetes Endocrinology and Metabolism Service, Camden and Campbelltown Hospitals, Campbelltown, NSW, Australia.; School of Health Sciences, Western Sydney University, Campbelltown, NSW, Australia.
¹⁴ Healthfocus Family Practice, Sydney, NSW, Australia.
¹⁵ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; School of Public Health, Harbin Medical University, Harbin, China.
¹⁶ The George Institute for Global Health, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; School of Population Health, University of New South Wales, Sydney, NSW, Australia.

PMID: 37516164
DOI: 10.1016/j.cct.2023.107307

Abstract

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.

Keywords: Food insecurity; Food prescription; Glycemic control; Medically tailored meals; Nutrition; Type 2 diabetes mellitus.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Australia
Counseling
Diabetes Mellitus, Type 2* / therapy
Glycated Hemoglobin
Humans
Meals
Randomized Controlled Trials as Topic

Substances

Glycated Hemoglobin