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Trial registered on ANZCTR


Registration number
ACTRN12622000852752
Ethics application status
Approved
Date submitted
7/06/2022
Date registered
16/06/2022
Date last updated
24/03/2024
Date data sharing statement initially provided
16/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Food is Medicine: an Australian trial of a medically tailored meals intervention on type 2 diabetes and heart disease outcomes in adults
Scientific title
Medically Tailored Meals for diabetes and heart disease: an Australian trial of a 'Food is Medicine' intervention
Secondary ID [1] 306987 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 326102 0
Heart disease 326103 0
Condition category
Condition code
Metabolic and Endocrine 323416 323416 0 0
Diabetes
Diet and Nutrition 323417 323417 0 0
Other diet and nutrition disorders
Cardiovascular 323873 323873 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over 26 weeks, each intervention participant will receive 20 pre-prepared meals a fortnight (i.e. lunch and dinner each day for 5 days per week) and a bag of mixed nuts (approximately 300g to provide 10 serves per fortnight). Meals will be purchased from three existing home-meal delivery companies, which have been screened to meet current evidence-based nutritional recommendations for people with type 2 diabetes. Meals will typically contain on average 1500kJ per meal, with 37% carbohydrate, 33% fat and 30% protein.

Different sets of meals will be available to enable flexibility and cater to dietary preferences, and participants will be provided with a booklet of the meal set options to choose from. Participants will receive the same meal set until they request for a different meal set. Individual meals will come with specific information about recommended storage, preparation, and heating instructions. Intervention participants will also receive 3 consults (up to 30 minutes) with dietitians at week 2, 4 and 8, to encourage uptake of meals and improvements in diet quality overall. Participants will also receive a $50 voucher each at baseline, week 13 and week 26 (after completion of pathology data collection).

Intervention participants that are on insulin or other glucose lowering medication will be advised to check their blood sugar levels premeal when commencing the provided meals to ensure safety, or as otherwise specifically advised by their treating physician. 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 meal acceptability and uptake at week 2, 4 and 8. 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 average number of meals consumed each week.

At end of the study, key informant interviews (up to 40 minutes in duration) will be conducted by phone (i.e. Microsoft Teams or Zoom audio function) with one to two purposively selected representatives each from the food supplier (Managing Directors/Chief Executive Officers and other staff engaged in the intervention), clinical staff, and study staff as well as 12 purposively selected intervention participants (with a range of characteristics). For current participants of the study, they will be asked by study staff at their final visit if they are interested in partaking in the interview (they have already indicated their consent to the interview as part of the broader trial consent). We will initially select 4 participants to take part in these interviews, and then seek maximum variability sampling (in terms of age, sex, severity of diabetes based on their baseline HbA1c (=<9% vs >9%), and income) to recruit additional participants with the goal of achieving thematic saturation. We anticipate 12 participants will be involved in the qualitative data collection.

For the meal supplier interviews, study staff are in contact with them as part of running the study and will ask who may be willing to be interviewed. For clinicians, relationships exist (some are collaborators on this study) and these contact details will be used to ask who may be willing to be interviewed and provide the Information Statement to them. For study staff, willing interviewees will self-nominate and access the Information Statement and use our usual means of contacting each other.

The interviews will seek to obtain an in-depth understanding of what worked (or not), for whom and how, challenges and facilitators, and any adaptations throughout the implementation process. For all key informant interviews (except among trial participants), verbal consent will be obtained at the start of the interviews as per the verbal consent script and consent will be audio-recorded.
Intervention code [1] 323429 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 of their choice. There will be no specific recommendations about how the vouchers are to be spent.
Control group
Active

Outcomes
Primary outcome [1] 331623 0
Changes in glycated haemoglobin (HbA1c, %) between week 26 and baseline
Timepoint [1] 331623 0
Baseline, 13 weeks and 26 weeks (primary timepoint) after intervention commencement via pathology lab blood test
Secondary outcome [1] 410563 0
Changes in blood pressure between week 26 and baseline
Timepoint [1] 410563 0
Baseline, 13 weeks and 26 weeks after intervention commencement using a validated blood pressure monitor
Secondary outcome [2] 410564 0
Changes in body weight between week 26 and baseline
Timepoint [2] 410564 0
Baseline, 13 weeks and 26 weeks after intervention commencement using a validated body weight scale
Secondary outcome [3] 410567 0
Changes in fasting glucose between week 26 and baseline
Timepoint [3] 410567 0
Baseline, 13 weeks and 26 weeks after intervention commencement via pathology lab blood sample
Secondary outcome [4] 410568 0
Changes in medication between week 26 and baseline
Timepoint [4] 410568 0
Baseline, 13 weeks and 26 weeks after intervention commencement via data collection form designed specifically for this study.
Secondary outcome [5] 410569 0
Changes in dietary intake between week 26 and baseline
Timepoint [5] 410569 0
Baseline and 26 weeks after intervention commencement via 24-hour recalls
Secondary outcome [6] 410570 0
Feasibility will be assessed as a composite of attrition rates, dietary counselling participation rates, adoption of the medically tailored meals. These outcomes will be measured by audit of study database.

Feasibility will also be assessed and measured through routine monitoring data (questions asked by the dietitian at dietary consultations), self-administered process evaluation questionnaire and semi-structured interviews (up to 40 minutes in duration). The interviews will be conducted one-on-one over the phone with a member of the research team.
Timepoint [6] 410570 0
Routine questions and process evaluation questionnaire: 13 weeks and 26 weeks after commencement of intervention.

Semi-structured interviews: 26 weeks after commencement of intervention.

All questions, self-administered questionnaires and interviews are designed specifically for this study.
Secondary outcome [7] 410571 0
Acceptability of the intervention will be assessed and measured through routine monitoring data (questions asked by the dietitian at dietary consultations), self-administered process evaluation questionnaire and semi-structured interviews (up to 40 minutes in duration). The interviews will be conducted one-on-one over the phone with a member of the research team..
Timepoint [7] 410571 0
Routine questions and process evaluation questionnaire: 13 weeks and 26 weeks after commencement of intervention.

Semi-structured interviews: 26 weeks after commencement of intervention.

All questions, self-administered questionnaires and interviews are designed specifically for this study.
Secondary outcome [8] 410812 0
Changes in lipid levels between week 26 and baseline
Timepoint [8] 410812 0
Baseline, 13 weeks and 26 weeks after intervention commencement via pathology lab blood sample
Secondary outcome [9] 410813 0
Changes in liver function between week 26 and baseline
Timepoint [9] 410813 0
Baseline, 13 weeks and 26 weeks after intervention commencement via pathology lab blood sample
Secondary outcome [10] 410814 0
Changes in c-reactive protein between week 26 and baseline
Timepoint [10] 410814 0
Baseline, 13 weeks and 26 weeks after intervention commencement via pathology lab blood sample

Eligibility
Key inclusion criteria
* Adults (greater than or equal to 18 years of age)
* Clinically diagnosed T2D for at least 12 months
* Persistently high blood glucose levels, defined as:
- For those referred by clinics: measured HbA1c greater than or equal to 7.5% at their most recent clinical assessment AND at least one more clinically measured HbA1c greater than or equal to 7.5% within the past 12 months.
- For those referred by Trial Facts or meal delivery companies: self-reported difficulty maintaining ideal blood sugar control AND measured HbA1c greater than or equal to 7.5% at their most recent clinical assessment within the past six months.
* Have difficulty getting and eating nutritious foods, assessed based judgement of the healthcare provider or a short 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 planning to stay within their home in Greater Sydney area in the next 7 months.
* Individuals who have had an episode of severe hypoglycaemia defined as having received glucagon, or required ambulance or emergency department visit for hypoglycaemia, or requiring assistance from another individual / third party for hypoglycaemia within the last 6 months.
* In hospice or palliative care
* Living in a facility that provides most or all their meals.
* Does not have freezers at home for storing study meals.
* Does not have a microwave for heating meals at home
* Existing medical conditions that severely limits dietary intake, requires individualised diets
* Those with active cancer, severe chronic kidney disease (stage 4 or worse), or heart failure
* Those with severe food allergies (but those with gluten or dairy intolerances can participate)
* Pregnant women
* People participating in any other lifestyle modification research trials
* For individuals referred from meal delivery companies: have not placed an order with the meal companies in the past 12 months.

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
All data collection procedures for this study will be undertaken remotely.

The baseline procedure will involve a self-reported demographic survey, physical activity survey (using the International Physical Activity Questionnaire), patient-reported outcome measures (PROMs) questionnaire with questions selected with input from consumer advisors, questions about the use of health care services in the last 12 months, current medication use, a 6-item food insecurity questionnaire, and two 24-hour diet recalls, undertaken by dietitians, to assess dietary intake (on one weekday and one weekend day). Participants will be asked to self-report their height (baseline only), and will be sent a blood pressure monitor and a body weight scale with clear written instructions to be completed during data collection over the phone. Participants will also be sent pathology request forms and asked to attend a pathology service provider to have their blood glycated haemoglobin, fasting glucose, lipid panel, liver function and C reactive protein measured. For this study, one pathology service provider will be used (Australian Clinical Labs).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our aim is to be able to detect a greater than or equal to 0.6% difference (conservative yet considered clinically worthwhile) in HbA1c between intervention and control. Assuming a standard deviation of 1.54% we would have a power of 80% (at alpha 0.05) to detect the 0.6% difference recruiting a total sample of 190 participants. This is based on an ANalysis Of COVAriance (ANCOVA) procedure with a conservative scenario of being able to explain with a mixed model 10% (R^2) of the variability in HbA1c measures. Allowing for a 10% drop out rate we plan to randomize a total of 212 participants (with a 1:1 allocation ratio is 106 in each arm).

Primary efficacy analyses will be performed on all available HbA1c measurements with a specific focus on the 26-week contrast. Analyses will be based on a mixed model which will include – as covariates set – the intervention, the time visit, their interaction and the baseline values. An intention to treat principle will be followed but we will also run 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 proposed as sensitivity analyses to assess the robustness of the base case analyses.
We will explore for potential different effects of the intervention in different 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 adjustment for multiplicity and p-values will be critically assessed.
We will triangulate quantitative and qualitative data from three sources (routine monitoring data, self-administered process evaluation questionnaire and the semi-structured interviews) to gain an in-depth understanding of the implementation process, the feasibility and acceptability of the intervention, and the barriers and facilitators of implementing the intervention and achieving lower HbA1c levels.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/01/2023
Actual
3/03/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
212
Accrual to date
108
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22506 0
Westmead Hospital - Westmead
Recruitment hospital [2] 22507 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 22508 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 24276 0
Healthfocus Family Practice - Ingleburn
Recruitment hospital [5] 26310 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 37743 0
2145 - Westmead
Recruitment postcode(s) [2] 37744 0
2050 - Camperdown
Recruitment postcode(s) [3] 37745 0
2560 - Campbelltown
Recruitment postcode(s) [4] 39818 0
2565 - Ingleburn
Recruitment postcode(s) [5] 42282 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 311299 0
Government body
Name [1] 311299 0
NHMRC
Country [1] 311299 0
Australia
Funding source category [2] 311593 0
Government body
Name [2] 311593 0
NSW Health
Country [2] 311593 0
Australia
Funding source category [3] 311594 0
Other
Name [3] 311594 0
Estate of Faye Williams (philanthropic donation)
Country [3] 311594 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country
Australia
Secondary sponsor category [1] 312661 0
None
Name [1] 312661 0
Address [1] 312661 0
Country [1] 312661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310801 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310801 0
Ethics committee country [1] 310801 0
Australia
Date submitted for ethics approval [1] 310801 0
Approval date [1] 310801 0
06/06/2022
Ethics approval number [1] 310801 0
Protocol no. X22-0087 & 2022/ETH00227

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

Contacts
Principal investigator
Name 118918 0
A/Prof Jason Wu
Address 118918 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 118918 0
Australia
Phone 118918 0
+61 2 8052 4648
Fax 118918 0
Email 118918 0
[email protected]
Contact person for public queries
Name 118919 0
Jason Wu
Address 118919 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 118919 0
Australia
Phone 118919 0
+61 2 8052 4648
Fax 118919 0
Email 118919 0
[email protected]
Contact person for scientific queries
Name 118920 0
Jason Wu
Address 118920 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000 Australia
Country 118920 0
Australia
Phone 118920 0
+61 2 8052 4648
Fax 118920 0
Email 118920 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
16328Ethical approval  [email protected] Request can be made to Chief Investigator



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia.2023https://dx.doi.org/10.1016/j.cct.2023.107307
N.B. These documents automatically identified may not have been verified by the study sponsor.