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Trial registered on ANZCTR
Registration number
ACTRN12625000893404
Ethics application status
Approved
Date submitted
18/06/2025
Date registered
18/08/2025
Date last updated
18/08/2025
Date data sharing statement initially provided
18/08/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
FareShare Medically Tailored Meals Pilot Program for Type 2 Diabetes
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Scientific title
FareShare Medically Tailored Meals Pilot Program for Type 2 Diabetes: A pilot feasibility study
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Secondary ID [1]
314661
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Nil
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Universal Trial Number (UTN)
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Trial acronym
FareShareMTM Pilot
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
337836
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Condition category
Condition code
Metabolic and Endocrine
334169
334169
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Within the scope of this jointly led community-based, non-randomised clinical pilot feasibility study, the 12-week medically tailored meals intervention comprises weekly direct delivery of ready-made meals prepared by chefs at FareShare—the meal provider and research partner in this pilot. Meals are prepared and cooked onsite and stored, and delivered to recipients frozen, ready to be heated by recipients. Meals are prepared according to recipes developed jointly by FareShare chefs and study dietitians in line with evidence-based nutritional recommendations for the management of type 2 diabetes. FareShare will use donated and purchased ingredients and produce grown in their kitchen gardens. The intervention will provide participants—adults living in inner and parts of Greater Melbourne with diagnosed, undermanaged type 2 diabetes and who have trouble accessing nutritious foods with two main meals (lunch and dinner) and two snacks daily, five days a week. Our referral partner site dietitians from community health organisations—cohealth and Holstep Health will identify, pre-screen and refer clients within their networks diagnosed with type 2 diabetes and ongoing hyperglycaemia who face challenges accessing or preparing nutritious food, according to their clinical judgement and will administer the Hunger Vital Signs screening tool. With their client’s verbal permission, the study team will contact the referred client to explain the study requirements, provide the Participant Information and Consent Form, obtain informed consent and complete eligibility screening.
Enrolled participants will then be contacted by a member of the FareShare operational project team to provide information about meal ordering and delivery processes. Participants will self-order weekly boxes by calling FareShare via a dedicated phone line coordinated and monitored by FareShare, which will oversee and facilitate meal ordering and coordinate delivery logistics. Participants can order meals weekly or up to two weeks ahead by phone by selecting meals from a menu of four meal set options comprising meals aligned with the Australian Dietary Guidelines and prepared using additional guidelines from the National Diabetes Service and Diabetes Australia - Carbohydrate counting and diabetes 2016. A meal box of 10 frozen meals and 10 snacks (5x30g portions of mixed nuts and 5 pieces of seasonal fruit) will be delivered directly to the participant's home address weekly for 12 weeks in consultation with the participant to ensure they are available within the delivery days and windows to receive the meal box.
As part of the intervention, participants will be contacted by phone at Weeks 1 and 4 by the meal provider to review meal satisfaction via three short routine monitoring questions, taking up to 15 minutes. Moreover, participants will be contacted at Weeks 2, 6 and 8 by the study team to review their consumption of meals and provide their feedback regarding meal satisfaction. Calls to participants at Weeks 2 and 8 will be conducted by a study dietitian providing auxiliary dietary support, including an individually tailored dietary consultation as part of the intervention and also to encourage meal uptake and support healthier food choices. The dietary consults aim to ask participants three routine monitoring questions related to consumption and satisfaction with the delivered MTMs. That is, 1) Can you tell me what you thought about the healthy meals provided in the last few weeks (briefly note response, i.e, satisfied or not satisfied); 2) In the last week, of the 10 meals provided, how many healthy meals did you eat? (Write down the number and reason if provided.) If a reason is not provided, participants will be asked a third question, i.e., 3) Can you tell me more about why you did not eat (X number) of meals in the last week? Reasons will be noted by the dietitian, e.g., bad taste or was in hospital for a few days or not delivered, etc. Study dietitians will also consult with participants and provide healthy eating advice and resources as required around their topics of interest or queries. For example, regarding meal timing, other meals, snacks and fluids consumed alongside the MTMs, including on the two non-prescribed meal days as directed by the participant's queries. Examples of available resources include (but are not limited to) Baker Institute Factsheets regarding 'Dietary Fibre', 'Healthy Snacks', as well as an 'Eating Out Guide' by Diabetes Australia, 'Breakfast Ideas' and 'Healthy Snacks and Meal Ideas' developed by the National Diabetes Services Scheme. The duration of this call will be up to 30 minutes. If resources are provided in response to the participant's queries, the relevant information will be either posted or emailed, depending on the needs of the participant. In Weeks 6 and 13, participants will complete a short process evaluation questionnaire, which will take up to 15 minutes.
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Intervention code [1]
331287
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Lifestyle
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Comparator / control treatment
NIL
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Acceptability of the 12-week intervention.
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Assessment method [1]
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This outcome will be assessed by the data captured using the following methods: 1) Three routine monitoring questions (related to meal satisfaction) and auxiliary dietary support; 2) The process evaluation questionnaire at Week 6; 3) The in-depth semi-structured process evaluation interview respectively. Routine monitoring questions relate to participant satisfaction with meals and meal delivery. The number of calls with participants will be logged and their responses recorded. Questions include consumption and the number of meals consumed since commencing the intervention. The process evaluation questionnaire will include questions related to meal delivery, consumption, satisfaction with delivery, taste and variety of meal options. The process evaluation interview will capture in-depth participant perspectives of the acceptability of the intervention and its implementation.
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Timepoint [1]
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Routine monitoring questions will be completed at Weeks 1, 2, 4 and 8. Dietary consultations take place during the Week 2 and 8 call for routine monitoring questions. A process evaluation questionnaire will be completed at Week 6. A process evaluation interview will be completed at Week 13 i.e., 12 weeks post-commencement of the intervention with participants and key informants including program implementers, healthcare providers and kitchen and delivery staff.
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Primary outcome [2]
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Accessibility of the 12-week intervention
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Assessment method [2]
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This outcome will be assessed by the data captured using the following methods: 1) Three routine monitoring questions and auxiliary dietary support; 2) The process evaluation questionnaire at Week 6; 3) The in-depth semi-structured process evaluation interview. Routine monitoring questions to assess accessibility relate to participant satisfaction with meal onboarding, ordering and delivery procedures, and the number of calls by participants to the FareShare MTM dedicated line will be logged and responses recorded. Similarly, the number of dietary consults completed by participants will be recorded. The process evaluation questionnaire includes questions related to meal delivery processes, such as the suitability of the one-to-one delivery method and whether the days and times were suitable for participant access to MTMs. The process evaluation interview will capture in-depth participant perspectives of the accessibility of the intervention related to meal onboarding, ordering and delivery procedures.
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Timepoint [2]
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Routine monitoring questions will be completed at Weeks 1, 2, 4 and 8. Dietary consultations take place during the Week 2 and 8 call for completion of the routine monitoring questions. A process evaluation questionnaire will be completed at Week 6. A process evaluation interview will be completed at Week 13 i.e., 12 weeks post-commencement of the intervention with participants and a key informants including program implementers, healthcare providers and kitchen and delivery staff.
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Primary outcome [3]
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Change in diet quality.
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Assessment method [3]
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Assessed according to the validated Alternate Healthy Eating Index (AHEI, score range 0-11), calculated from 24-hour diet recalls
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Timepoint [3]
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At baseline and week 13 i.e, 12 weeks post commencement of the intervention
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Secondary outcome [1]
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Food security
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Assessment method [1]
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Assessed using the USDA 6-item Household Food Security questionnaire.
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Timepoint [1]
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At baseline and week 13 i.e, 12 weeks post commencement of the intervention
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Secondary outcome [2]
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Nutrition security
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Assessment method [2]
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2-item Nutrition Security Screener
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Timepoint [2]
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At baseline and week 13 i.e, 12 weeks post commencement of the intervention
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Secondary outcome [3]
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Changes in clinical indicators, a composite of all clinical indicators - HbA1c, lipid panel, blood pressure and body weight
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Assessment method [3]
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Non-fasting blood test and participant self report. Scales and blood pressure monitor provided.
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Timepoint [3]
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At baseline and week 13 i.e, 12 weeks post commencement of the intervention
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Secondary outcome [4]
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Changes in patient-reported outcome measure related to generic health status.
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Assessment method [4]
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EQ-5D-5L questionnaire
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Timepoint [4]
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At baseline and week 13 i.e, 12 weeks post commencement of the intervention
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Secondary outcome [5]
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Changes in patient-reported outcome measure related to general emotional well-being
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Assessment method [5]
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WHO-5 questionnaire
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Timepoint [5]
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At baseline and week 13 i.e, 12 weeks post commencement of the intervention
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Secondary outcome [6]
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Changes in patient-reported outcome measure related to diabetes distress
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Assessment method [6]
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PAID-20 questionnaire
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Timepoint [6]
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At baseline and week 13 i.e, 12 weeks post commencement of the intervention
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Eligibility
Key inclusion criteria
1. Individuals aged 18 years or older.
2. Lives in a suburb within FareShare’s meal delivery zone.
3. Able to communicate in English at a conversational level that does not require an interpreter or translation support (based on the healthcare provider’s judgment).
4. Clinically diagnosed with type 2 diabetes for at least 12 months
5. Persistently high blood glucose defined as HbA1c of 7.0% or higher at their most recent
clinical assessment within the past 6 months.
6. Have difficulties accessing and eating nutritious food based on the following:
-Healthcare provider’s clinical judgement and, a food insecurity screener (Hunger Vital Signs) – administered by the clinician, e.g., site dietitian.
7. Lives alone (or with a household carer or partner).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Are unable or unwilling to provide informed consent.
2. Will require an interpreter and translation support.
3. Not planning to stay within their home in inner Melbourne for the next 6 months.
4. Are in hospice or palliative care.
5. Live in a facility that provides most or all of their meals.
6. Does not have a freezer for storing study meals.
7. Pregnant women (or lactating).
8. Are caring for dependents/children.
9. Have existing medical condition(s) that limit dietary intake or require an individualised diet(s).
10. Have active cancer, severe chronic kidney disease (stage 4 or worse) or heart
failure.
11. Have severe food allergies
12. Are participating in other lifestyle modification trials.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Primary analyses will assess the feasibility and acceptability of the intervention by describing referral rates, time to meet the target sample, attrition rates, dietary counselling participation rates, number of adverse events, and the acceptability of the MTMs as measured by routine monitoring data, a process evaluation questionnaire, and in-depth semi-structured interviews with a subset of key informants. Primary analyses will be performed on the AHEI and food insecurity score to assess the change in these outcomes from baseline to week 13, assessed using paired t-tests.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
23/05/2025
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Date of last participant enrolment
Anticipated
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Actual
28/07/2025
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Date of last data collection
Anticipated
7/11/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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FareShare
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Address [1]
319224
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Country [1]
319224
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
The George Institute of Global Health
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Address
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Country
Australia
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Secondary sponsor category [1]
321716
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None
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Name [1]
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None
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Address [1]
321716
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Country [1]
321716
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317803
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
317803
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
317803
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Australia
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Date submitted for ethics approval [1]
317803
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17/02/2025
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Approval date [1]
317803
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24/04/2025
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Ethics approval number [1]
317803
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Summary
Brief summary
Healthy and nutritious foods and meals can help to manage or improve diet-related conditions like type 2 diabetes (T2D), but access to healthy food can be challenging. FareShare is a large food relief organisation in Abbotsford, Melbourne, that cooks and freezes meals ready to be delivered to organisations to distribute to the community for free. FareShare and The George Institute for Global Health (TGI) are conducting the FareShare Medically Tailored Meals Pilot Program (or, FareShare MTM) with two community health organisations in Melbourne—cohealth and Holstep Health. You are invited to participate in this pilot study, which will test the feasibility of delivering ‘diabetes-friendly’ meals for free to individuals in the community to help improve diet and T2D. This information will help develop and expand future MTM programs for T2D in Australia. We aim to enrol 40 participants.
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Trial website
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Trial related presentations / publications
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Public notes
Unhealthy dietary patterns, including high intakes of sodium, refined carbohydrates, processed and red meat, and low intakes of fruits, vegetables, whole grains, nuts and legumes, and fibre, are leading risk factors for noncommunicable diet-related diseases such as type 2 diabetes. Eating a healthy diet is fundamental to managing type 2 diabetes. However, this can be challenging for those who struggle with activities of daily living or cannot access and prepare nutritious meals. Current clinical practice, based on providing dietary counselling alone, is inadequate if individuals cannot access and prepare the recommended foods and meals. ‘Food is Medicine' programs aim to integrate nutrition interventions into the health care system to help improve the clinical population’s diets and complement the pharmacologic treatment of diseases. [1] Medically tailored meals are one approach whereby pre-prepared meals are tailored to the management of a condition such as type 2 diabetes. Designed by nutritionists, medically tailored meals could be prescribed by healthcare providers to improve participants’ health outcomes. Initial evidence about such programs, mostly from the United States, is promising [2]. Existing literature indicates that providing 10 medically tailored meals per week has health benefits and reduced healthcare utilisation, including among people with undermanaged type 2 diabetes. For recipients of medically tailored meals, these include improved diet quality, reduced food insecurity, reduced risk of hypoglycemia [3], fewer days where mental health interfered with quality of life, improved ability to manage diabetes, stress reduction [4], fewer inpatient admissions, fewer skilled nursing facility admissions and less overall medical spending [5]. It is unclear whether these could be similarly acceptable and beneficial in Australia. Local and adequately powered trials are needed to generate robust effect estimates in the Australian context. References 1. Mozaffarian, D., Blanck, H. M., Garfield, K. M., Wassung, A., & Petersen, R. (2022). A Food is Medicine approach to achieve nutrition security and improve health. Nature Medicine, 28(12), 2476–2486. https://doi.org/10.1038/s41591-022-02180-z 2. Mozaffarian, D., Aspry, K. E., Garfield, K., et al. (2024). "Food Is Medicine" strategies for nutrition security and cardiometabolic health equity: JACC state-of-the-art review. Journal of the American College of Cardiology, 83(8), 843–864. https://doi.org/10.1016/j.jacc.2023.12.033 3. Berkowitz, S. A., Delahanty, L. M., Terranova, J., et al. (2019). Medically tailored meal delivery for diabetes patients with food insecurity: A randomized cross-over trial. Journal of General Internal Medicine, 34(3), 396–404. https://doi.org/10.1007/s11606-018-4716-z 4. Berkowitz, S. A., Shahid, N. N., Terranova, J., et al. (2020). “I was able to eat what I am supposed to eat”—Patient reflections on a medically-tailored meal intervention: A qualitative analysis. BMC Endocrine Disorders, 20(1), 1–11. https://doi.org/10.1186/s12902-020-00586-0 5. Berkowitz, S. A., Terranova, J., Randall, L., Cranston, K., Waters, D. B., & Hsu, J. (2019). Association between receipt of a medically tailored meal program and health care use. JAMA Internal Medicine, 179(6), 786–793. https://doi.org/10.1001/jamainternmed.2019.0196"
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Contacts
Principal investigator
Name
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Dr Antonia Thodis
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Address
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The George Institute for Global Health, Level 8, 55 Botany Street, Randwick, New South Wales 2031, Australia
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Country
142206
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Australia
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Phone
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+61 2 8052 4358
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Fax
142206
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Email
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[email protected]
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Contact person for public queries
Name
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Antonia Thodis
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Address
142207
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The George Institute for Global Health, Level 8, 55 Botany Street, Randwick, New South Wales 2031, Australia
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Country
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Australia
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Phone
142207
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+61 2 8052 4358
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Fax
142207
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Email
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[email protected]
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Contact person for scientific queries
Name
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Antonia Thodis
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Address
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The George Institute for Global Health, Level 8, 55 Botany Street, Randwick, New South Wales 2031, Australia
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Country
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Australia
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Phone
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+61 2 8052 4358
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Fax
142208
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF