Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000133437
Ethics application status
Approved
Date submitted
4/12/2015
Date registered
4/02/2016
Date last updated
4/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Increasing toddlers' vegetable consumption through interactive shared reading of a vegetable-promoting picture book and puppetry.
Scientific title
Promoting toddlers’ vegetable consumption through interactive shared reading and puppetry.
Secondary ID [1] 288073 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vegetable consumption 296937 0
Overweight 296938 0
Condition category
Condition code
Diet and Nutrition 297179 297179 0 0
Obesity
Public Health 297182 297182 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
STUDY DESIGN:
The intervention used in this experimental study consisted of shared reading a picture book about a rabbit that loves to eat carrots. The study had a 2 (reading style: passive vs. interactive) x 2 (puppet use: without vs. with hand puppet) between-subjects design. Toddlers (2-3 years old) were randomly assigned to one of these four conditions. During the interactive reading sessions, children were asked questions about the story, whereas no questions were asked during the passive reading sessions. Both types of shared reading were either performed with a puppet resembling the main book character (rabbit) or without a puppet.

PROCEDURE:
Reading sessions were conducted in a quiet room within the nursery school during one week. Because Dutch nursery schools are closed on Wednesday afternoon, the readings took place on Monday, Tuesday, Thursday, and Friday (thus, the intervention ran for one week only, with children participating in four reading sessions in total). The reading sessions took about ten minutes, each consisting of approximately four toddlers. Since there were no attendance requirements at the schools, the composition of shared reading groups could differ within the same condition. Toddlers were given name stickers, which facilitated observers to fill out a checklist of children’s behaviors shown during the reading sessions. Moreover, name stickers facilitated the storyteller to ask questions to the children during interactive shared reading. After the fourth reading session (on Friday), the dependent variable was measured with an eating task, in which toddlers could freely eat snacks for five minutes.
For the reading sessions, four young females with a pedagogical background were recruited and trained in the different reading styles and puppetry. These storytellers were teamed up with four female experimenters who observed the toddlers during the readings. The observers were trained in filling out the checklist, and observed the children from a distance to prevent session disruptions.
Intervention code [1] 293384 0
Behaviour
Intervention code [2] 293769 0
Prevention
Comparator / control treatment
The group in which children were read passively without the puppet was compared to all the other conditions, and thus considered as control group.
Control group
Active

Outcomes
Primary outcome [1] 296781 0
CARROT CONSUMPTION:
Toddlers were presented with 4 equal-sized bowls, each containing 4 pieces of a different snack. They could choose from 2 healthy snacks (carrots & cucumber), and 2 unhealthy snacks (cheese & salted sticks). It was counted how many pieces of each product toddlers had eaten after the maximum 5 minutes had elapsed. The proportion of consumed carrots was calculated by dividing the pieces of carrots the child had eaten by the total amount of pieces of foods the child had eaten.
Timepoint [1] 296781 0
After exposure to the intervention (i.e., after 4 days of reading)
Secondary outcome [1] 319333 0
CHARACTER IMITATION:
Observers registered the poses that toddlers physically imitated from the book characters during reading (e.g., eating carrots, being strong). The number of poses demonstrated were summed to create a single measure of character imitation, with a higher score indicating more character imitation.
Timepoint [1] 319333 0
Observed during each reading, thus 4 times, on Monday, Tuesday, Thursday, and Friday.

Eligibility
Key inclusion criteria
- Boys and girls aged 2-3 years without food allergies.
- From nursery schools without formal fruit and vegetable programs, with children from mostly low-SES households.
- Nursary schools provided active consent, and parents provided passive consent for their children.
Minimum age
2 Years
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nursery schools with formal fruit and vegetable programs, children with food allergies.

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)
Each nursery group was randomly assigned to the condition 'without puppet' or 'with puppet'. Within each group, children were randomly assigned to the condition 'interactive reading' or 'passive reading'. The independent researcher focused on having an equal amount of children within each experimental condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The targeted sample size was based on previous studies that demonstrated effects of picture books on young children's consumption (i.e., around 100 - 150). We targeted 200 children, and were able to recruit 199, with a drop-out of 36 toddlers. Thus, total sample was 163, still higher than the average sample size within this research domain.
The analyses used were: univariate analysis of variances (ANOVA's) with Eta-squared (?2) to determine effect sizes, Pearson's correlations, and mediation analyses according to the specifications set out by Hayes’ PROCESS for SPSS (using 95% bias-corrected bootstrap confidence intervals).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/02/2015
Date of last participant enrolment
Anticipated
Actual
27/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
199
Recruitment outside Australia
Country [1] 7393 0
Netherlands
State/province [1] 7393 0

Funding & Sponsors
Funding source category [1] 292501 0
Government body
Name [1] 292501 0
Dutch Ministry of Health, Welfare and Sport (VWS)
Country [1] 292501 0
Netherlands
Primary sponsor type
University
Name
Radboud University
Address
Address for visitors:
Thomas van Aquinostraat 8
6525 GD Nijmegen

Postal address:
P.O. Box 9104
6500 HE Nijmegen
Country
Netherlands
Secondary sponsor category [1] 291210 0
None
Name [1] 291210 0
Address [1] 291210 0
Country [1] 291210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293971 0
Ethics Committee Social Sciences of Radboud University
Ethics committee address [1] 293971 0
Ethics committee country [1] 293971 0
Netherlands
Date submitted for ethics approval [1] 293971 0
05/01/2015
Approval date [1] 293971 0
30/01/2015
Ethics approval number [1] 293971 0

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

Contacts
Principal investigator
Name 61974 0
Dr Simone M. de Droog
Address 61974 0
Radboud University
Communication Science
P.O. Box 9104
6500 HE Nijmegen
Country 61974 0
Netherlands
Phone 61974 0
+(31)(0)243612372
Fax 61974 0
Email 61974 0
[email protected]
Contact person for public queries
Name 61975 0
Simone M. de Droog
Address 61975 0
Radboud University
Communication Science
P.O. Box 9104
6500 HE Nijmegen
Country 61975 0
Netherlands
Phone 61975 0
+(31)(0)243612372
Fax 61975 0
Email 61975 0
[email protected]
Contact person for scientific queries
Name 61976 0
Simone M. de Droog
Address 61976 0
Radboud University
Communication Science
P.O. Box 9104
6500 HE Nijmegen
Country 61976 0
Netherlands
Phone 61976 0
+(31)(0)243612372
Fax 61976 0
Email 61976 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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