Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000680561
Ethics application status
Approved
Date submitted
24/04/2024
Date registered
28/05/2024
Date last updated
31/07/2024
Date data sharing statement initially provided
28/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Produce Prescription on health among adults with type 2 diabetes – a randomised controlled trial
Scientific title
Evaluating the impact of the provision of healthy food on glycated haemoglobin of adults with type 2 diabetes.
Secondary ID [1] 311635 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 333530 0
Condition category
Condition code
Diet and Nutrition 330212 330212 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 330213 330213 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over 26 weeks, each intervention participant will receive a weekly healthy food box which will include plant-based core food groups (fruit, vegetables, nuts and seeds, and whole grains) as recommended by the Australian Dietary Guidelines while taking into account participants’ preferences, cost and seasonality of products. The amount (‘dose’) of healthy foods provided will cover ~50% of daily recommended intake for fruit, vegetables, whole grains, and nuts and seeds, for 5 days every week. Participants will also receive a booklet which contains healthy recipe ideas that use the foods for breakfast, lunch and dinner. The healthy food boxes will be purchased from existing home-grocery delivery companies.

Intervention participants will also receive 3 phone consults (up to 30 minutes) with dietitians at week 2, 8 and 16, to encourage uptake of healthy food boxes and improvements in diet quality overall. Intervention participants will also receive a $50 voucher each at baseline, week 13 and week 26 (after completion of pathology data collection).

Any changes to diabetes medication requirements will be at the discretion of their treating clinician and documented. All participants will also be advised to follow up with their own doctors closely throughout the study, and that they should contact their treating doctors if they experience hypoglycaemia (self-monitored blood glucose <3mmol/L) or hypoglycaemic symptoms. A hot line for the participants to call an accredited diabetes educator will also be made available to answer any urgent questions.

To monitor adherence to the intervention, study staff who conduct the diet consultations will log the number of dietary counselling sessions with each participant and collect the responses to three routine questions related to healthy food box acceptability and uptake at week 2, 4 and 16. Participants will also be asked to complete a self-administered Process Evaluation questionnaire at week 13 and week 26 of the intervention which includes questions about the uptake of the healthy food boxes.
Intervention code [1] 328398 0
Treatment: Other
Comparator / control treatment
Over the 26 weeks, participants in the control group will continue their usual medications and self-blood glucose monitoring practices as recommended by their doctors. All participants will also be advised to follow up with their own doctors closely throughout the study, and that they should contact their treating doctors if they experience hypoglycaemia (self-monitored blood glucose <3mmol/L) or hypoglycaemic symptoms. Each participant will receive a $100 voucher at baseline, week 13 and week 26 (after completion of data collection). The vouchers can be used to purchase groceries at a local food retailer. There will be no specific recommendations about how the vouchers are to be spent.
Control group
Active

Outcomes
Primary outcome [1] 338084 0
Evaluate HbA1c, comparing intervention to control.
Timepoint [1] 338084 0
Baseline, 13 weeks and 26 weeks (primary timepoint) post-baseline.
Secondary outcome [1] 434436 0
Blood pressure.
Timepoint [1] 434436 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [2] 434474 0
Body weight
Timepoint [2] 434474 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [3] 434476 0
Blood lipids.
Timepoint [3] 434476 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [4] 434478 0
Glucose.
Timepoint [4] 434478 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [5] 434479 0
C reactive protein.
Timepoint [5] 434479 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [6] 434480 0
Liver function.
Timepoint [6] 434480 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [7] 434481 0
Food insecurity.
Timepoint [7] 434481 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [8] 434482 0
Generic health status.
Timepoint [8] 434482 0
Baseline and 26 weeks post-baseline.
Secondary outcome [9] 434483 0
Medication use.
Timepoint [9] 434483 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [10] 434484 0
Diet quality.
Timepoint [10] 434484 0
Baseline, 13 weeks and 26 weeks post-baseline.
Secondary outcome [11] 435165 0
General emotional well-being.
Timepoint [11] 435165 0
Baseline and 26 weeks post-baseline.
Secondary outcome [12] 435166 0
Diabetes distress.
Timepoint [12] 435166 0
Baseline and 26 weeks post-baseline.
Secondary outcome [13] 435167 0
Diabetes self-management.
Timepoint [13] 435167 0
Baseline and 26 weeks post-baseline.
Secondary outcome [14] 435168 0
Medication adherence.
Timepoint [14] 435168 0
Baseline and 26 weeks post-baseline.
Secondary outcome [15] 435169 0
Food/ medicine purchasing trade-offs.
Timepoint [15] 435169 0
Baseline and 26 weeks post-baseline.
Secondary outcome [16] 435171 0
Financial hardship.
Timepoint [16] 435171 0
Baseline and 26 weeks post-baseline.

Eligibility
Key inclusion criteria
- Adults (greater than or equal to 18 years of age).
- Clinically diagnosed type 2 diabetes (T2D) for at least 12 months.
- Persistently high blood glucose levels, defined as self-reported or observed difficulty maintaining ideal blood sugar control AND at least one measured HbA1c greater than or equal to 7.5% within the past 6 months.
- Experiencing food insecurity as ascertained by a 6-item questionnaire or experiencing financial hardship ascertained by a 4-item questionnaire.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable or unwilling to provide informed consent.
- Not living within the distribution zone of the study food supplier
- Planning to move away from the Greater Sydney area in the next 7 months.
- Living in a hospice or receiving palliative care
- Living in a facility that provides meals.
- Unable to receive food deliveries.
- lacking sufficient equipment (i.e., a refrigerator and hot plate/oven or stove or microwave) for food storage and preparation.
- Lacking anyone in the household (including the participant) able to prepare meals.
- Existing medical conditions such as severe food allergies that strictly limits dietary intake or requires individualised diets. (but those with gluten or dairy intolerances can participate)
- Those with active cancer or severe chronic kidney disease (need for dialysis).
- Pregnant people
- People participating in any other lifestyle modification research projects
- Self-identify as not being able to read and speak English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done using an online computerised system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation for each individual will be undertaken once all their baseline data are available using an online computerised system in a 1:1 ratio with stratification by HbA1c (=<9%, >9%), sex and study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of 190 participants (with a 1:1 allocation ratio) will provide 80% (at alpha 0.05) power to detect a 0.6% or greater difference in HbA1c between randomised groups. A 0.6% difference is deemed a plausible effect size from the intervention and a clinically meaningful effect on HbA1c. This power estimate is based on a standard deviation of HbA1c assumed to be 1.54% and on a mixed model to fit HbA1c measures retrieved at baseline, 13 weeks and 26 weeks. Allowing for a 15% drop-out rate we aim to recruit a total of 224 participants.

Primary efficacy analyses will be performed on all available HbA1c measurements. Analyses will be based on a mixed model which will include – as a covariate set –the intervention, the time of study visit, their interaction, and baseline value. An intention to treat principle will be followed but we will also run exploratory per-protocol analyses.
Complete case analyses will be performed but we will carefully evaluate the presence and patterns of missing data in outcomes and covariates and - if appropriate - multiple imputation will be used as sensitivity analyses to assess the robustness of the base case analyses.
We will explore for potential different effects of the intervention in subsets of participants including by age, sex, body mass index, baseline HbA1c and baseline anti-hyperglycaemic drug use. We do not plan to perform any formal adjustment for multiplicity and subgroup findings will be interpreted in light of the main results.

We will combine data on the process indicators from administrative data, routine monitoring data, and the process evaluation questionnaire to understand the reach, dose, fidelity, adoption and maintenance of the intervention, and the barriers and facilitators of adhering to the intervention and achieving lower HbA1c levels.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2024
Actual
Date of last participant enrolment
Anticipated
27/03/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
224
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315958 0
Charities/Societies/Foundations
Name [1] 315958 0
Ian Potter Foundation
Country [1] 315958 0
Australia
Funding source category [2] 316394 0
Other Collaborative groups
Name [2] 316394 0
Future Food Systems Cooperative Research Centre.
Country [2] 316394 0
Australia
Funding source category [3] 316395 0
Commercial sector/Industry
Name [3] 316395 0
Costa
Country [3] 316395 0
Australia
Funding source category [4] 316396 0
Commercial sector/Industry
Name [4] 316396 0
Fresh Produce Group
Country [4] 316396 0
Australia
Funding source category [5] 316397 0
Charities/Societies/Foundations
Name [5] 316397 0
International Fresh Produce Association
Country [5] 316397 0
Australia
Funding source category [6] 316398 0
Commercial sector/Industry
Name [6] 316398 0
One Harvest
Country [6] 316398 0
Australia
Funding source category [7] 316399 0
Commercial sector/Industry
Name [7] 316399 0
Perfection fresh
Country [7] 316399 0
Australia
Funding source category [8] 316400 0
Commercial sector/Industry
Name [8] 316400 0
Pinata Farms
Country [8] 316400 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Country
Australia
Secondary sponsor category [1] 318096 0
None
Name [1] 318096 0
Address [1] 318096 0
Country [1] 318096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314785 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 314785 0
Ethics committee country [1] 314785 0
Australia
Date submitted for ethics approval [1] 314785 0
22/03/2024
Approval date [1] 314785 0
04/06/2024
Ethics approval number [1] 314785 0
X24-0085 & 2024/ETH00599

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132722 0
Prof Jason Wu
Address 132722 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 132722 0
Australia
Phone 132722 0
+61 2 8052 4648
Fax 132722 0
Email 132722 0
[email protected]
Contact person for public queries
Name 132723 0
Jason Wu
Address 132723 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 132723 0
Australia
Phone 132723 0
+61 2 8052 4648
Fax 132723 0
Email 132723 0
[email protected]
Contact person for scientific queries
Name 132724 0
Jason Wu
Address 132724 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 132724 0
Australia
Phone 132724 0
+61 2 8052 4648
Fax 132724 0
Email 132724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22283Ethical approval  [email protected] Request can be made to the Chief Investigator.



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.