Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001090707
Ethics application status
Approved
Date submitted
22/09/2013
Date registered
30/09/2013
Date last updated
28/06/2019
Date data sharing statement initially provided
28/06/2019
Date results information initially provided
28/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing children’s vegetable acceptance and consumption
Scientific title
The effect of multiple target versus single target repeated exposure to increase vegetable acceptance and intake in children.
Secondary ID [1] 283224 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low vegetable intake in children 290097 0
Condition category
Condition code
Diet and Nutrition 290474 290474 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will be repeatedly exposed to a small amount of vegetables in the home environment. Two intervention conditions are tested: 1) single target vegetable, and 2) multiple target vegetable. Trial staff will tell parents what vegetables to use. Both interventions will be conducted over a 5 week period, with exposure three times a week, providing a total of 15 exposure days. Exposure to vegetables means that the parent will present a small piece of vegetable to the child, and encourages their child to taste the vegetable. The vegetable will be presented at a time when the child is hungry (before a snack or dinner) which remains constant throughout the intervention. Children in the single vegetable exposure group will be exposed to the same (single) vegetable every time. Children in the multiple vegetable exposure group will be presented three vegetables in total, in a rotating schedule (provided by trial staff) whereby the child receives 2 of the 3 vegetables on every exposure day. The parent will deliver the intervention to the child, and they will receive the information on how to do this in a booklet, which will be explained by a trial staff member in a face to face session (approximate duration 15-20 min) with the parent also. The intervention information will include practical advice on how and when to prepare and present the vegetables for their child to eat, and information how they can effectively address negative reactions from their child when tasting vegetables. This information includes a flowchart with suggestions how to respond to a child who refuses to taste (specifically by 1) modelling tasting the vegetable, and 2) cut the vegetable in smaller pieces, and 3) stop after that). A follow up phone call (estimated duration 15 min) will be made to parents mid trial to discuss any queries they may have, and parents will also be provided with a phone number they can ring if they have questions or concerns. Parents will use a diary to record the outcome of every exposure day (i.e. child consumed vegetable wholly/partially/refused etc..). Stickers are provided as a small reward to the child for tasting the vegetable.
Intervention code [1] 287955 0
Behaviour
Comparator / control treatment
The control group will not be exposed to any vegetables during the intervention phase, and parents will be instructed to keep using the same techniques /strategies they are currently using at home to encourage their child to consume vegetables.
Control group
Active

Outcomes
Primary outcome [1] 290501 0
Change (from pre to post test) in intake (g) of tasted and non-tasted vegetables in an experimental setting. Children’s will be provided with a meal in the research facilities before and after the intervention (weeks 0,6). The meal will consist of three vegetables, a non-vegetable staple and a protein component. Intake will be calculated by subtracting the leftover weight from the weight served for each food component. Intake in the post-session will be subtracted from intake in the pre-session for each vegetable separately, and for the total intake of vegetables.
Timepoint [1] 290501 0
Weeks 0 and 6
Primary outcome [2] 290522 0
Change (from pre to post test, to 3 month follow up) in vegetable intake of child at home. Children’s intake of vegetables at home will be measured using multiple (3 day) weighed food records on 3 occasions (weeks 0, 6 and 18). Parents will record food intake for their child. Average vegetable intake in pre-test, post-test and three month follow up will be compared.
Timepoint [2] 290522 0
Weeks 0,6 and 18
Primary outcome [3] 290523 0
Change (from pre to post test, to 3 month follow up) in the child’s vegetable acceptance. The child’s acceptance for a range of vegetables will be provided by the parent using a nine-point hedonic scale (weeks 0, 6 and 18). Acceptance for vegetables will be compared in pre-test, post-test and three month follow up.
Timepoint [3] 290523 0
Weeks 0, 6 and 18
Secondary outcome [1] 304643 0
Change (from pre to post test, to 3 month follow up) in vegetable offering by the parent to the child at home. Parent will provide information on type and quantity of vegetable offered to the child in the past month, and which and how much have been consumed by the child.
Timepoint [1] 304643 0
Weeks 0, 6 and 18
Secondary outcome [2] 304712 0
Change (from pre test to 3 month follow up) in usual vegetable consumption of the child as reported by the parent
Timepoint [2] 304712 0
Week 0 and 18
Secondary outcome [3] 304713 0
Development of acceptance (as reported by the parent) for the vegetables the children are exposed to during the intervention. Nine-point scale will be used to measure the child's acceptance
Timepoint [3] 304713 0
Week 1-5

Eligibility
Key inclusion criteria
Children aged between 4 and 6 years.
Children who consume 2 serves of vegetables or less per day
Parent needs to be legal parent or guardian of the child
Parent would like their child to consume more vegetables
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child with any known food allergies or food intolerances.
Other family members within household with any allergies or intolerances to any vegetables
Children on regular medication that may affect taste and appetite

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited by public advertisements and flyers in daycare centres, school newsletters etc. Participants may also be recruited from Commonwealth Scientific and Industrial Research Organization (CSIRO) staff in proximity to the research facilities, and through a qualified recruitment agency. Participants may need to be recruited in waves depending on the interest and response to advertisements. It is estimated that the majority of participant recruitment will be completed within a 5 month period. Interested participants will be invited to complete a screener questionnaire. Eligible participants will be sent an Information Sheet and Consent Form, and they will be invited to attend a group information session where full details of the study are provided. Participants that return the completed consent form will be included in the study, and participant numbers will be allocated in order of processing consent forms. Allocation to treatment of participants will be randomized by computer, and staff processing consent forms will be blinded to treatment. Staff conducting assessments will also be blinded to treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized to one of three groups via computer program (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study will be a randomised controlled trial with parallel design. The intervention will run for 5 weeks with a pre and post test measurement as well as a 3 month follow up.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A participant sample of 96 subjects is sought. Power was calculated for a repeated measures ANOVA design consisting of 3 groups, and allowing for within-subject (pre/post test comparisons) and between subject (group) comparisons of vegetable intake. Based on a power of 0.95, alpha of 0.05, an effect size of 0.25, and a correlation of 0.25 between measures, a sample size of 96 participants is needed (GPower v3.1.7, 2013).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2013
Actual
17/10/2013
Date of last participant enrolment
Anticipated
Actual
3/04/2014
Date of last data collection
Anticipated
Actual
16/09/2014
Sample size
Target
96
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287976 0
Government body
Name [1] 287976 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health Flagship
Country [1] 287976 0
Australia
Primary sponsor type
Government body
Name
CSIRO Animal, Food and Health Sciences
Address
11 Julius Avenue
North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 286698 0
None
Name [1] 286698 0
Address [1] 286698 0
Country [1] 286698 0
Other collaborator category [1] 277618 0
University
Name [1] 277618 0
Wageningen University
Address [1] 277618 0
Division of Human Nutrition
PO Box 8129
6700 EV Wageningen
Country [1] 277618 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289903 0
CSIRO Human Ethics Committee
Ethics committee address [1] 289903 0
PO Box 10041
Adelaide BC
SA 5000
Ethics committee country [1] 289903 0
Australia
Date submitted for ethics approval [1] 289903 0
03/09/2013
Approval date [1] 289903 0
17/09/2013
Ethics approval number [1] 289903 0
HREC13/11

Summary
Brief summary
The primary purpose of this study is to compare the effectiveness of two exposure-led interventions on children's vegetable acceptance and intake. Low acceptance is one of the key reasons for low consumption of vegetable in children. A randomized controlled design study will compare two exposure-led interventions to a control group, in 4-6 year old children, whose parents would like their child to eat more vegetables. Both intervention groups will be exposed to small quantities of vegetables in the home environment. Effect on vegetable acceptance and dietary intake will be compared between groups, and with the control group, before and after an at home exposure intervention, as well as after a three month follow up. It is hypothesized that the interventions will lead to increased vegetable acceptance and intake in children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42986 0
Mrs Astrid Poelman
Address 42986 0
CSIRO Animal, Food and Health Sciences
11 Julius Avenue
North Ryde NSW 2113
Country 42986 0
Australia
Phone 42986 0
+ 61 2 94908356
Fax 42986 0
Email 42986 0
[email protected]
Contact person for public queries
Name 42987 0
Mrs Astrid Poelman
Address 42987 0
CSIRO Animal, Food and Health Sciences
11 Julius Avenue
North Ryde NSW 2113
Country 42987 0
Australia
Phone 42987 0
+61 2 94908356
Fax 42987 0
Email 42987 0
[email protected]
Contact person for scientific queries
Name 42988 0
Mrs Astrid Poelman
Address 42988 0
CSIRO Animal, Food and Health Sciences
11 Julius Avenue
North Ryde NSW 2113
Country 42988 0
Australia
Phone 42988 0
+61 2 94908356
Fax 42988 0
Email 42988 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The target number of participants was not achieved... [More Details]

Documents added automatically
No additional documents have been identified.