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Trial registered on ANZCTR


Registration number
ACTRN12617001200370p
Ethics application status
Not yet submitted
Date submitted
1/08/2017
Date registered
16/08/2017
Date last updated
16/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
He Pataka Marohi: will provision of cheap or free food increase vegetable and fruit consumption for Maori households
Scientific title
a 2x2 randomized trial intervention to investigate the difference in vegetable and fruit consumption between ad libitum (at cost) and ad libitum (free), with or without education in Maori households
Secondary ID [1] 292564 0
Nil known
Universal Trial Number (UTN)
U1111-1200-1047
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nutrition deficiency 304233 0
Condition category
Condition code
Public Health 303581 303581 0 0
Health promotion/education
Diet and Nutrition 303606 303606 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design follows a four-arm, randomised trial, superiority approach. There are 2 main components:
• Food packages: all groups will be offered weekly fruit (3 serves) and vegetable (6 serves) packages up to the recommended number of servings for the composition of the household. For example:
o For a family of 2 adults and 3 children, up to 15 serves of fruit and 30 serves of vegetables can be ordered
• Wananga: eight interactive wananga (seminar) will be held, including topics such as, how to cook and prepare provided foods, how to grow foods, sources of cheap or free foods. The wananga will be on average 3 hours long

The food packages will be ordered and delivered every week over 26 weeks. Eight wananga will be held during that 26 weeks, as suitable.

• Forty households will be randomly assigned to one of four groups.
• Group 1 will receive the Food Package free;
• Group 2 will receive the Food package free and wananga;
• Group 3 can order weekly packs of NZ$5 worth of fruit and vegetables up to the maximum number of packages based on the size of the family.
• Group 4 can order weekly packs of NZ$5 worth of fruit and vegetables up to the maximum number of packages based on the size of the family and wananga.

Each week, all participants will be contacted to order food, which will be recorded in a spreadsheet. Each week, a group reminder will be sent each week, in addition to follow up as preferred by the participants. If participants are not responding to contact attempts, a NC (not contactable) will be recorded in the spreadsheet. Every participant will be contacted every week, irrespective of if they responded the previous week.

A co-ordinator, currently working with Te Wakahuia o Manawatu Trust (TWMT), will be employed to support research work and organise the intervention. The job will include:
• Contacting food providers, sourcing weekly foods, organising pick up, packing and delivery.
• Organise recruitment
• Provide support with designing research material
• Organise data collection
• Organise wananga
In addition, up to 2 people will be employed to pick up, package, deliver and return weekly foods.

Food supply
All groups will receive a package of fruit and vegetables over a period of six-months. Each week households will be contacted to order fruit and vegetables. The order will be delivered to the door of each participating household and at the same time food not consumed from the preceding week will be retrieved.
Wananga
In addition to the supply of food, eight wananga (group education) will be held to provide the following to groups 2 and 4:
- Recipes for cooking foods
- Methods for preparing and cooking ‘uncommon, inexpensive foods’ such as legumes
- Assistance with setting up a vegetable garden
The wananga will be facilitated by enlisted local experts and will be held in a facility local to participants.
Intervention code [1] 298771 0
Prevention
Intervention code [2] 298789 0
Lifestyle
Comparator / control treatment
Group 3 can order weekly packs of NZ$5 worth of fruit and vegetables up to the maximum number of packages based on the size of the family
Control group
Active

Outcomes
Primary outcome [1] 302939 0
Number of vegetable servings consumed.
Each week participants will order fruit and vegetables, which will be delivered to them in a food container. At the delivery of the order, any fruit or vegetables left over from the previous week, will be collected.
The servings consumed each week will be calculated:
Number of servings consumed = number of vegetable servings delivered – number of vegetable servings returned.
Timepoint [1] 302939 0
Weekly, for the duration of the intervention (that is 26 weeks), and analysed after the completion of the intervention
Primary outcome [2] 302959 0
Number of fruit servings consumed.
Each week participants will order fruit and vegetables, which will be delivered to them in a food container. At the delivery of the order, any fruit or vegetables left over from the previous week, will be collected.
The servings consumed each week will be calculated:
Number of servings consumed = number of fruit servings delivered – number of fruit servings returned.
Timepoint [2] 302959 0
Weekly, for the duration of the intervention (that is 26 weeks), and analysed after the completion of the intervention
Secondary outcome [1] 337507 0
Cost of food provision
Each week, the following data will be collected in order to assess the weekly cost of providing foods:
• Hours worked on sourcing, collecting, packaging and delivering foods
• Hours worked on collecting orders
• Cost of communicating to obtain orders
• Number of kilometres driven
• Cost of purchasing foods
Timepoint [1] 337507 0
Collected weekly, and analysed after the completion of the intervention
Secondary outcome [2] 337508 0
Semi-structured face-to-face Interviews will be conducted by an independent contracted person, with a subsample of household, to conduct Intervention evaluation, which encompasses:
o Suitability of intervention
o Potential improvements to intervention
o decisions about consuming fruit and vegetables, in the household
o interest in future interventions
o perspectives of the barriers and facilitators of fruit and vegetable consumption
Timepoint [2] 337508 0
Post-intervention

Eligibility
Key inclusion criteria
The inclusion criteria includes:
- Households identifying as Maori
- the main participant being minimum 18 years old and have at least one child (less than 18 years of age), living in their household
- In Highbury area in Palmerston North, Manawatu, NZ
- Likely to be able to remain in the study for 6 months
- If allocated to the “at-cost” condition, likely to be able to pay for a $5 pack of food most weeks
- In high need
o “high need” will be established through motivational interviewing technique conducted by recruiter.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Food secure

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to condition will be concealed from participants at the time they agree to participate. Once a participant has agreed to participate, they will be given a sealed opaque envelop with their allocation. The allocation will be concealed to researchers and intervention staff until the participant opens the envelop.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of this study will be the product of:
SerDel (servings delivered) – SerRet (servings retrieved) = SerCon (Servings consumed)

This outcome variable will be adjusted by number of household members and number of children.
The primary outcome will be analysed using generalised linear mixed models analysis as the repeated measures design of the study works well within this model. Randomised and fixed effects will be enacted for this analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2017
Actual
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 9116 0
New Zealand
State/province [1] 9116 0
Manawatu

Funding & Sponsors
Funding source category [1] 297144 0
Government body
Name [1] 297144 0
Health Research Council of New Zealand
Country [1] 297144 0
New Zealand
Primary sponsor type
Individual
Name
Geoff Kira
Address
School of Public Health
Massey University
Massey Wellington Campus
Block 4, Level E
Wallace St
Mt Cook
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 296159 0
None
Name [1] 296159 0
Address [1] 296159 0
Country [1] 296159 0
Other collaborator category [1] 279663 0
Other Collaborative groups
Name [1] 279663 0
Te Waka Huia a Manawatu Trust
Address [1] 279663 0
56 Pembroke Street
Palmerston North 4412
Country [1] 279663 0
New Zealand
Other collaborator category [2] 279664 0
Individual
Name [2] 279664 0
Anette Kira
Address [2] 279664 0
Pohangina
Manawatu
C/O School of Public Health
Massey University
Massey Wellington Campus
Block 4, Level E
Wallace St
Mt Cook
Wellington 6021
Country [2] 279664 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298313 0
Health and Disability Ethics Committees
Ethics committee address [1] 298313 0
Ethics committee country [1] 298313 0
New Zealand
Date submitted for ethics approval [1] 298313 0
18/09/2017
Approval date [1] 298313 0
Ethics approval number [1] 298313 0

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

Contacts
Principal investigator
Name 76678 0
Dr Geoff Kira
Address 76678 0
School of Public Health
Massey University
Massey Wellington Campus
Block 4, Level E
Wallace St
Mt Cook
Wellington 6021
Country 76678 0
New Zealand
Phone 76678 0
+64 4 979 3974
Fax 76678 0
Email 76678 0
g.kira@massey.ac.nz
Contact person for public queries
Name 76679 0
Geoff Kira
Address 76679 0
School of Public Health
Massey University
Massey Wellington Campus
Block 4, Level E
Wallace St
Mt Cook
Wellington 6021
Country 76679 0
New Zealand
Phone 76679 0
+64 4 979 3974
Fax 76679 0
Email 76679 0
g.kira@massey.ac.nz
Contact person for scientific queries
Name 76680 0
Geoff Kira
Address 76680 0
School of Public Health
Massey University
Massey Wellington Campus
Block 4, Level E
Wallace St
Mt Cook
Wellington 6021
Country 76680 0
New Zealand
Phone 76680 0
+64 4 979 3974
Fax 76680 0
Email 76680 0
g.kira@massey.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Plain language summaryNo To be completed.

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