TY - JOUR
T1 - Produce prescription to improve health among adults with type 2 diabetes in Australia
T2 - protocol for a randomised controlled trial
AU - Glover, Kimberly
AU - Gow, Megan
AU - Trieu, Kathy
AU - Huang, Liping
AU - Law, Kristy K.
AU - Neal, Bruce
AU - Wong, Jencia
AU - Wu, Ted
AU - Twigg, Stephen
AU - Gauld, Amanda
AU - Constantino, Maria
AU - McGill, Margaret
AU - Noonan, Stephanie
AU - Simmons, David
AU - Caterson, Ian D.
AU - Mozaffarian, Dariush
AU - Nau, Claudia
AU - Li, Jing
AU - Di Tanna, Gian Luca
AU - Wong, Vincent
AU - Speight, Jane
AU - Lung, Thomas
AU - Wu, Jason H.Y.
PY - 2025/6
Y1 - 2025/6
N2 - Background: ‘Food is medicine’ programs such as Produce Prescription (PRx) aim to integrate food-based nutrition programs into healthcare, for the prevention, management and treatment of diet-related diseases, typically for those experiencing food insecurity. However, the impact of PRx on health indicators in Australia has never been tested in a randomised trial. Objectives: To determine the effect of PRx on blood glucose control and other health indicators in adults with type 2 diabetes experiencing hyperglycaemia and food insecurity and/or financial hardship in Australia. Methods: Using a parallel design randomised controlled trial, n = 224 participants will be randomised (1:1) to PRx or usual care. Over 26 weeks, the intervention group will receive a weekly delivery of fruits, vegetables, wholegrains and nuts, and up to 3 sessions with an accredited dietitian. Controls will receive usual care. The primary outcome is change in mean HbA1c over 26 weeks, comparing the intervention and control group. Secondary outcomes include between-group differences at 26 weeks in change in blood pressure, body weight, blood lipids, food and nutrition insecurity, person-reported outcome measures, medication use, and diet quality. Implementation outcomes assessed will include feasibility, acceptability, scalability and cost effectiveness. Discussion: This Australia-first PRx trial will provide novel and rigorous data for an intervention that may be feasible to improve health and health equity as part of the Australian healthcare system. We anticipate PRx will lead to a clinically meaningful reduction in HbA1c, contribute to improved health equity and long-term health benefits for adults with type 2 diabetes and food insecurity.
AB - Background: ‘Food is medicine’ programs such as Produce Prescription (PRx) aim to integrate food-based nutrition programs into healthcare, for the prevention, management and treatment of diet-related diseases, typically for those experiencing food insecurity. However, the impact of PRx on health indicators in Australia has never been tested in a randomised trial. Objectives: To determine the effect of PRx on blood glucose control and other health indicators in adults with type 2 diabetes experiencing hyperglycaemia and food insecurity and/or financial hardship in Australia. Methods: Using a parallel design randomised controlled trial, n = 224 participants will be randomised (1:1) to PRx or usual care. Over 26 weeks, the intervention group will receive a weekly delivery of fruits, vegetables, wholegrains and nuts, and up to 3 sessions with an accredited dietitian. Controls will receive usual care. The primary outcome is change in mean HbA1c over 26 weeks, comparing the intervention and control group. Secondary outcomes include between-group differences at 26 weeks in change in blood pressure, body weight, blood lipids, food and nutrition insecurity, person-reported outcome measures, medication use, and diet quality. Implementation outcomes assessed will include feasibility, acceptability, scalability and cost effectiveness. Discussion: This Australia-first PRx trial will provide novel and rigorous data for an intervention that may be feasible to improve health and health equity as part of the Australian healthcare system. We anticipate PRx will lead to a clinically meaningful reduction in HbA1c, contribute to improved health equity and long-term health benefits for adults with type 2 diabetes and food insecurity.
UR - http://www.scopus.com/inward/record.url?scp=105002787082&partnerID=8YFLogxK
UR - https://go.openathens.net/redirector/westernsydney.edu.au?url=https://doi.org/10.1016/j.cct.2025.107915
U2 - 10.1016/j.cct.2025.107915
DO - 10.1016/j.cct.2025.107915
M3 - Article
AN - SCOPUS:105002787082
SN - 1551-7144
VL - 153
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107915
ER -
