Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000737134
Ethics application status
Approved
Date submitted
9/05/2019
Date registered
16/05/2019
Date last updated
20/10/2021
Date data sharing statement initially provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Vegetables as first foods for babies study
Scientific title
The effect of a vegetables-first approach to complementary feeding on vegetable preferences in babies: a randomised control trial.
Secondary ID [1] 298191 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vegetable consumption in babies 312774 0
Condition category
Condition code
Diet and Nutrition 311276 311276 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Babies will be given a selection of 4 different vegetable baby foods over a 4-week trial starting from when baby is ready to start complementary feeding. Examples of vegetables include spinach and broccoli. Mothers provide food ad libitum but on the prescribed colour rotation for 4 weeks. This rotation is green vegetables, white vegetables, purple vegetables, orange vegetables (starting again from green vegetables); they change colour per meal. Adherence to this rotation will be monitored by a weekly survey and the weighed food diary. Mothers are asked to only provide the study's intervention baby foods only alongside breast or formula milk. At 9 months of age 3 test meals will be provided (green vegetable, familiar vegetable and novel vegetable). Liking and intake will be assessed using weighed food records, validated questionnaires and a video coding tool. Follow-ups at 12, 24 and 36 months of age will assess liking of vegetables using questionnaires.
Intervention code [1] 314430 0
Lifestyle
Intervention code [2] 314431 0
Behaviour
Intervention code [3] 314432 0
Prevention
Comparator / control treatment
Babies will be given a selection of 4 different vegetable baby foods over a 4-week trial starting from when baby is ready to start complementary feeding. Examples of vegetables include spinach and broccoli. Mothers provide food ad libitum but on the prescribed colour rotation for 4 weeks. This rotation is green vegetables, white vegetables, purple vegetables, orange vegetables (starting again from green vegetables); they change colour per meal. Adherence to this rotation will be monitored by a weekly survey and the weighed food diary. Mothers are asked to only provide the study's intervention baby foods only alongside breast or formula milk. At 9 months of age 3 test meals will be provided (green vegetable, familiar vegetable and novel vegetable). Liking and intake will be assessed using weighed food records, validated questionnaires and a video coding tool. Follow-ups at 12 and 24 months of age will assess liking of vegetables using questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 320025 0
Vegetable preferences will be measured using a weighed food diary, recording pace of eating, recording baby behaviours (e.g. pushed spoon away), using a 10-point liking scale and food frequency questionnaires.
Timepoint [1] 320025 0
Pre- post 4-week intervention, 9 months (primary end point), 12, 24 and 36 months of age
Secondary outcome [1] 370279 0
Infant microbiota composition will be measured on infant feacal samples using sequence based Gut Microbiome Profiling.
Timepoint [1] 370279 0
Pre- and post 4-week trial, then 12 months of age.

Eligibility
Key inclusion criteria
• 6 months of age or less
• healthy and born at term gestation (37+ weeks)
• with no known allergies or family history of allergies
• with no chronic diseases or medical conditions that may affect abilities to participate in the study
• at a stage where they have not started eating solids
• living in the Auckland region
Minimum age
0 Months
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
17/05/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
30/05/2020
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 21463 0
New Zealand
State/province [1] 21463 0
Auckland

Funding & Sponsors
Funding source category [1] 302732 0
University
Name [1] 302732 0
Massey University, College of Health
Country [1] 302732 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Cath Conlon
Address
Massey University Oteha Rohe Campus
Gate 4, Turitea Place
Albany 0632
Auckland
Country
New Zealand
Secondary sponsor category [1] 302665 0
Individual
Name [1] 302665 0
Professor Pamela von Hurst
Address [1] 302665 0
Massey University Oteha Rohe Campus
Gate 4, Turitea Place
Albany 0632
Auckland
Country [1] 302665 0
New Zealand
Other collaborator category [1] 282027 0
Individual
Name [1] 282027 0
Professor Marion M Hetherington
Address [1] 282027 0
University Rd, Woodhouse, Leeds LS2 9JU, UK
Country [1] 282027 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303337 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 303337 0
Ethics committee country [1] 303337 0
New Zealand
Date submitted for ethics approval [1] 303337 0
Approval date [1] 303337 0
27/09/2018
Ethics approval number [1] 303337 0

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

Contacts
Principal investigator
Name 93322 0
Miss Jeanette Rapson
Address 93322 0
Massey University Oteha Rohe Campus
Gate 4, Turitea Place
Albany 0632
Auckland
Country 93322 0
New Zealand
Phone 93322 0
+64 10773419
Fax 93322 0
Email 93322 0
[email protected]
Contact person for public queries
Name 93323 0
Jeanette Rapson
Address 93323 0
Massey University Oteha Rohe Campus
Gate 4, Turitea Place
Albany 0632
Auckland
Country 93323 0
New Zealand
Phone 93323 0
+64 10773419
Fax 93323 0
Email 93323 0
[email protected]
Contact person for scientific queries
Name 93324 0
Jeanette Rapson
Address 93324 0
Massey University Oteha Rohe Campus
Gate 4, Turitea Place
Albany 0632
Auckland
Country 93324 0
New Zealand
Phone 93324 0
+64 10773419
Fax 93324 0
Email 93324 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
SourceTitleYear of PublicationDOI
EmbaseImpact of a "vegetables first" approach to complementary feeding on later intake and liking of vegetables in infants: a study protocol for a randomised controlled trial.2021https://dx.doi.org/10.1186/s13063-021-05374-7
N.B. These documents automatically identified may not have been verified by the study sponsor.