Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000640808
Ethics application status
Approved
Date submitted
27/04/2021
Date registered
28/05/2021
Date last updated
25/05/2022
Date data sharing statement initially provided
28/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of a healthy food discount on diet quality and healthy food affordability among Aboriginal and Torres Strait Islander women and children in remote Australia.
Scientific title
Giving Aboriginal and Torres Strait Islander children the best start in life: investigating the impact of a healthy food discount on diet quality, diet cost, diet affordability and food security in remote Australia.
Secondary ID [1] 304073 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 321724 0
Anaemia 321725 0
Intrauterine growth restriction 321726 0
Underweight 321727 0
Stunting 321728 0
Overweight 321729 0
Obesity 322082 0
Risk of cardiovascular disease 322083 0
Risk of type 2 diabetes 322084 0
Condition category
Condition code
Public Health 319469 319469 0 0
Other public health
Diet and Nutrition 319470 319470 0 0
Other diet and nutrition disorders
Diet and Nutrition 319471 319471 0 0
Obesity
Blood 319472 319472 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Healthy food discount.

The intervention will provide eligible participants with a loyalty card which will give access to a 30% discount on a range of healthy food and drinks, in the community store. All discounted food and drinks will fit within the five food groups and healthy fat group and will exclude infant formula.

Materials: Participants will be provided with a loyalty card and informed of discounted products through promotional material.

Procedures: Participants will be allocated to one of three capped fortnightly discount levels each: level 1 will provide $80 discount value for a family with one eligible person; level 2, $100 discount value for a family with two eligible people; and level 3, $120 discount value for a family with three or more eligible people. The loyalty card, once scanned, will unlock the discount as the product’s barcode or price look-up (PLU) is scanned. Once the discount level is reached, no further discounts will be applied for that period.

Who: The research team will provide loyalty cards to eligible participants. The healthy food and drink price discount will be implemented through participating stores.
Mode of delivery: face to face.

Duration: 3-6 months depending on time of study start. All stores will cease the discount after 6 months, or in December, whichever comes first. Stores beginning the discount later in the year will have a shorter period of discount, however no store shall have a discount period shorter than 3 months.

Location: community store.

Adherence: loyalty card data will be collected to monitor adherence to the intervention. Research staff will also conduct monthly visits to discuss adherence with store managers and community leaders, and review and refresh in-store promotional material as required.
Intervention code [1] 320402 0
Behaviour
Intervention code [2] 320403 0
Lifestyle
Intervention code [3] 320679 0
Prevention
Comparator / control treatment
Usual store practice. Usual store practice may and can include discounts on healthy foods as per usual store operating business. This usual practice may and can occur in intervention and control stores. The study intervention applied in treatment communities only, is a discount on range of healthy foods only eligible to loyalty card holders that meet the study’s criteria and delivered through the loyalty card.
Control group
Active

Outcomes
Primary outcome [1] 327344 0
Diet quality as assessed by dietary guideline index score (DGI-CA/DGI, 0-90 for <2 years, 0-100 for >2years) derived using the Menzies Short-Item Dietary Assessment Tool (MRSDAT).
Timepoint [1] 327344 0
On a single occasion at baseline and again during the final month of intervention.
Secondary outcome [1] 394660 0
Food insecurity category, derived using a modified version of the USDA Household Food Security Survey (18-item) delivered through a supportive interview structure.
Timepoint [1] 394660 0
On a single occasion at baseline and again during the final month of intervention
Secondary outcome [2] 394661 0
Diet cost assessed using the Aboriginal and Torres Strait Islander Healthy Diets ASAP.
Timepoint [2] 394661 0
On a single occasion at baseline and again during the final month of intervention
Secondary outcome [3] 394662 0
Diet affordability assessed using the Aboriginal and Torres Strait Islander Healthy Diets ASAP.
Timepoint [3] 394662 0
On a single occasion at baseline and again during the final month of intervention
Secondary outcome [4] 394663 0
Minimum meal frequency for children <2 years assessed using the WHO Indicators for assessing infant and young child feeding practices collated into a study-specific questionnaire.
Timepoint [4] 394663 0
On a single occasion at baseline and again during the final month of intervention
Secondary outcome [5] 394664 0
Dietary iron intake score derived using the Menzies Short-Item Dietary Assessment Tool (MRSDAT)
Timepoint [5] 394664 0
On a single occasion at baseline and again during the final month of intervention
Secondary outcome [6] 396145 0
Anaemia incidence and prevalence assessed by data linkage to medical records of routinely collected haemoglobin levels.
Timepoint [6] 396145 0
All haemoglobin levels routinely collected within the two months prior to baseline and during the final month of intervention will be included.

Eligibility
Key inclusion criteria
Community eligibility: Stores operating within remote Aboriginal and Torres Strait Islander communities in Australia which have: i) previous or expressed commitment from councils, health boards or health action teams or other local governing bodies to support food and nutrition projects; ii) existence of strong community groups; and iii) the store operates a point-of-sale system to support the delivery of the healthy food and drink price discount.

Inclusion criteria for participants within eligible communities: Aboriginal and/or Torres Strait Islander pregnant women, women breastfeeding children aged up to 5 years, and parents/primary carers of children aged six months to five years who identify as a resident and plan to reside in the community until the end of the intervention.
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We expect to have 240 participants in each of the intervention and control groups, 480 in total with allowance for non-consent/drop-out. With this number, we will have 80% power to detect an improvement of four (SD = 12) DGI-CA/DGI points between intervention and control communities.

Descriptive analysis will be used to report the DGI-CA/DGI scores, minimum meal frequency, dietary iron scores, anaemia incidence and prevalence, and food security status for participants in intervention and control communities. The difference in the change from baseline between participants in intervention and control communities will be calculated. Mixed models will be used to assess difference in DGI-CA/DGI scores and food security status. The models will include random effects for community. Secondary analyses will explore comparisons of change in individual DGI-CA/DGI indicator scores and food group servings, to determine which areas of the diet were influenced by the intervention, if any. We will report effect sizes (and 95% CI) together with the associated p-values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2021
Actual
8/06/2021
Date of last participant enrolment
Anticipated
26/08/2021
Actual
24/09/2021
Date of last data collection
Anticipated
26/11/2021
Actual
15/12/2021
Sample size
Target
480
Accrual to date
Final
477
Recruitment in Australia
Recruitment state(s)
NT,QLD

Funding & Sponsors
Funding source category [1] 308457 0
Government body
Name [1] 308457 0
National Health and Medical Research Council
Country [1] 308457 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Public Health
Level 4, Public Health Building,
288 Herston Road
Herston Qld 4006
Country
Australia
Secondary sponsor category [1] 309294 0
None
Name [1] 309294 0
Address [1] 309294 0
Country [1] 309294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308412 0
University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 308412 0
Ethics committee country [1] 308412 0
Australia
Date submitted for ethics approval [1] 308412 0
25/03/2020
Approval date [1] 308412 0
24/07/2020
Ethics approval number [1] 308412 0
2020000636
Ethics committee name [2] 308413 0
Central Australian Human Research Ethics Committee
Ethics committee address [2] 308413 0
Ethics committee country [2] 308413 0
Australia
Date submitted for ethics approval [2] 308413 0
25/03/2020
Approval date [2] 308413 0
22/06/2020
Ethics approval number [2] 308413 0
CA-20-3701

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

Contacts
Principal investigator
Name 110626 0
Dr Megan Ferguson
Address 110626 0
School of Public Health
Level 4, Public Health Building,
288 Herston Road
Herston Qld 4006
Country 110626 0
Australia
Phone 110626 0
+61 7 3365 5546
Fax 110626 0
Email 110626 0
[email protected]
Contact person for public queries
Name 110627 0
Megan Ferguson
Address 110627 0
School of Public Health
Level 4, Public Health Building,
288 Herston Road
Herston Qld 4006
Country 110627 0
Australia
Phone 110627 0
+61 7 3365 5546
Fax 110627 0
Email 110627 0
[email protected]
Contact person for scientific queries
Name 110628 0
Megan Ferguson
Address 110628 0
School of Public Health
Level 4, Public Health Building,
288 Herston Road
Herston Qld 4006
Country 110628 0
Australia
Phone 110628 0
+61 7 3365 5546
Fax 110628 0
Email 110628 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?

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.