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Trial registered on ANZCTR


Registration number
ACTRN12621000404820
Ethics application status
Approved
Date submitted
1/02/2021
Date registered
14/04/2021
Date last updated
5/04/2022
Date data sharing statement initially provided
14/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Food is medicine: pilot testing a ‘Food Farmacy’ program in food-insecure adults with poorly controlled type 2 diabetes in Australia
Scientific title
Food is medicine: the effect of a pilot ‘Food Farmacy’ program on dietary quality in food-insecure adults with poorly controlled type 2 diabetes in Australia
Secondary ID [1] 303211 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 320360 0
Food insecurity 320926 0
Condition category
Condition code
Diet and Nutrition 318266 318266 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 318734 318734 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will receive a ‘prescription’ for healthy food boxes which meet Australian Dietary Guidelines and were developed specifically for this study. The participants will have healthy food boxes delivered to them weekly by the study food supplier for a period of 12 weeks. Orders will be placed by study staff at a delivery time convenient for the participant
and each participant will receive the same content. The prescription will also contain simple recipes using foods available in the healthy food boxes. In addition, the prescription will allow the participants to have fortnightly telephone appointments (up to 30-minutes) with trained accredited dietitian capable of offering behaviour change support, who will provide dietary advice, including a specific focus on how to store and cook the healthy foods provided to the participants.
Intervention code [1] 319526 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326249 0
Changes in dietary quality of the participants, as assessed by the Alternate Healthy Eating Index (AHEI).
Timepoint [1] 326249 0
3 months post-commencement of intervention
Secondary outcome [1] 390738 0
Feasibility will be assessed as a composite of attrition rates, dietary counselling participation rates, adoption of healthy food boxes. These outcomes will be measured by audit of study database.
Timepoint [1] 390738 0
3 months post-commencement of intervention
Secondary outcome [2] 392737 0
Acceptability of the content in the healthy food boxes will be measured by routine monitoring data (questions asked by the dietician at fortnightly dietary consultations), self-administered questionnaire and the semi-structured interviews. All questions, self-administered questionnaires and interviews are deigned specifically for this study.
Timepoint [2] 392737 0
3 months post-commencement of intervention

Eligibility
Key inclusion criteria
- Adults (greater than or equal to 18 years of age) who have had clinically diagnosed type 2 diabetes for at least 6 months, which is poorly controlled (defined as measured HbA1c greater than or equal to 8% at their most recent clinical assessment).
- Food insecure based on a two-item questionnaire. This two-item questionnaire is based on Questions 1 & 2 of the U.S. Household Food Security Survey and has been validated for use as a screening tool in the health care setting.
- Live within the distribution zone of the study food supplier.
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.
- Anyone not planning to stay within their home in Sydney area in the next 4 months.
- On hospice or palliative care.
- Living in a facility that provides meals.
- Does not have refrigerators at home for storing study foods.
- Existing medical conditions that may preclude participants from being able to complete data collection, or result in limited diets, including for example: active cancer, chronic kidney disease (stages 4-5), and coeliac disease.
- Pregnant women, and if sexually active, not using regular contraception.
- People participating in any other lifestyle modification research projects (for example, the Pasifika Preventing Diabetes Programme, a concurrent trial underway in the western Sydney area).
- Another household member already participating in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline subject demographic characteristics will be summarized as mean ±SD or median (inter-quartile range) for continuous variables and frequency (n and %) for categorical variables. Self-reported dietary intake of major food groups (fruits, vegetables, nuts, fish or seafood, meat or meat products, dairy products, alcohol, cereal) and macronutrient intake (protein, carbohydrate, major-groups of dietary fat) at baseline and end of trial will be summarized as servings per day and percentage of total daily energy, respectively.
Exploratory outcomes will include HbA1c, lipid levels, micronutrient status (as measured by blood test), blood pressure (as measured by sphygmomanometer), body weight (as measured by weighing scales) and waist circumference (as measured by tape measure) measured at baseline and 3 months. These are considered exploratory outcomes as the study is not powered to detect treatment effect in these outcomes.
Differences in post- and pre-intervention mean AHEI score (the primary outcome) and the exploratory outcomes (HbA1c and blood pressure etc) will be assessed by paired t-test or Mann-Whitney test as appropriate depending on data distribution.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/12/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
30/07/2021
Date of last data collection
Anticipated
30/11/2021
Actual
31/10/2021
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18465 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 32574 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 307615 0
Government body
Name [1] 307615 0
NHMRC
Country [1] 307615 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Heath
Address
Level 5, 1 King St
Newtown
NSW 2042
Country
Australia
Secondary sponsor category [1] 308322 0
None
Name [1] 308322 0
Address [1] 308322 0
Country [1] 308322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307666 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 307666 0
Ethics committee country [1] 307666 0
Australia
Date submitted for ethics approval [1] 307666 0
24/08/2020
Approval date [1] 307666 0
09/10/2020
Ethics approval number [1] 307666 0

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

Contacts
Principal investigator
Name 108062 0
A/Prof Jason Wu
Address 108062 0
The George Institute for Global Health
Level 5, 1 King St
Newtown
NSW 2042
Country 108062 0
Australia
Phone 108062 0
+61 2 8052 4648
Fax 108062 0
Email 108062 0
jwu1@georgeinstitute.org.au
Contact person for public queries
Name 108063 0
Jason Wu
Address 108063 0
The George Institute for Global Health
Level 5, 1 King St
Newtown
NSW 2042
Country 108063 0
Australia
Phone 108063 0
+61 2 8052 4648
Fax 108063 0
Email 108063 0
jwu1@georgeinstitute.org.au
Contact person for scientific queries
Name 108064 0
Jason Wu
Address 108064 0
The George Institute for Global Health
Level 5, 1 King St
Newtown
NSW 2042
Country 108064 0
Australia
Phone 108064 0
+61 2 8052 4648
Fax 108064 0
Email 108064 0
jwu1@georgeinstitute.org.au

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
10301Ethical approval  jwu1@georgeinstitute.org.au Request 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
EmbaseTesting the Feasibility and Dietary Impact of a "Produce Prescription" Program for Adults with Undermanaged Type 2 Diabetes and Food Insecurity in Australia.2022https://dx.doi.org/10.1093/jn/nxac152
N.B. These documents automatically identified may not have been verified by the study sponsor.