Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000905167
Ethics application status
Approved
Date submitted
8/11/2018
Date registered
27/06/2019
Date last updated
16/07/2021
Date data sharing statement initially provided
27/06/2019
Date results provided
16/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
See How They Grow is a small feasibility study, enrolling 100 parents / whanau (families) with children under 2 years to test a child growth chart mobile phone application as a tool for supporting understanding of child growth trajectories.
Scientific title
See How They Grow is a small feasibility study enrolling 100 parents / whanau with children under 2 years to test an mHealth intervention designed to support child growth monitoring, and provide feedback on usability, acceptability, appropriateness and indications that it helped improve understanding of their child's growth.
Secondary ID [1] 298243 0
None
Universal Trial Number (UTN)
Trial acronym
SHTG
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Child growth 309278 0
Condition category
Condition code
Public Health 308153 308153 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents of 0-2 year olds, who are eligible for the study, will download the free mobile See How They Grow app onto their own smartphone and use it for 3 months. The study can take place at the participant’s convenience, anywhere in New Zealand. The app will include growth charts for recording and tracking child growth measurements, family pages for uploading photos and notes and resources e.g. immunisations, first aid, services, activities and tips.
During that 3 months participants will receive notifications about features, actions to take and tailored messages according to the age of the child. To begin with they will add any height, weight and head circumference information they already have into the app chart. Then add any new measurements that their family does at home or measurements from visits to health professionals, e.g. Plunket. Ideally there will be least 3 measurements for a child. If we notice there has been no usage of the app we will send them a reminder notification. At the end of the 3-month study period they will be asked to complete a brief online questionnaire to see if the app improved knowledge and understanding about child growth and wellbeing.
Intervention code [1] 312168 0
Behaviour
Comparator / control treatment
No control group. this is a feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308013 0
Using a purposely designed end of study survey sent to participants, we will gather if the app was acceptable


Timepoint [1] 308013 0
3 months from baseline.
Primary outcome [2] 308083 0
Using a purposely designed end of study survey sent to participants, to explore perceived change in knowledge on child growth measures particularly related to their own child.
Timepoint [2] 308083 0
3 months
Primary outcome [3] 308084 0
Using a purposely designed end of study survey sent to participants, to explore, perceived knowledge and behavioural changes (self-report) on nutrition, activity, lifestyle etc.
Timepoint [3] 308084 0
3 months
Secondary outcome [1] 353654 0
Using the within app transaction data, we will explore how the app is used.
Timepoint [1] 353654 0
3 months
Secondary outcome [2] 353908 0
How the app supports links to other sites or activities captured using transaction data.
Other sites refer to url links within the app to
- well child services,
-MoH web resources,
- play grounds
- age specfic activities in the participants local area such as play groups
- parenting services and support
Timepoint [2] 353908 0
3 months
Secondary outcome [3] 371286 0
Explore the how the participants found out about the app i.e. facebook, flyers, word of mouth other social media to understand best recruitment processes, from their responses in the purposely designed end of study survey..
Timepoint [3] 371286 0
3 months
Secondary outcome [4] 371287 0
Explore participant retention by reporting on loss to follow up by demographics
Timepoint [4] 371287 0
3 months
Secondary outcome [5] 371288 0
A specficially designed end of study survey will be sent to participants to gather if the app was perceived as useful
Timepoint [5] 371288 0
3 months

Eligibility
Key inclusion criteria
• A parent/whanau (family) of a child aged 0 – 21 months living in NZ
• Whanau/friends who are invited by parents/whanau to use the app (who can live outside of NZ)
• All adult participants aged 18 years or older
• Have use of a smartphone capable of downloading an app
• Are able to provide follow-up information at 3 months
• Are able to communicate in English
• Willing to give electronic consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If Parents / whanau meet the inclusion criteria there are no other exclusion criteria.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: As this is a small feasibility study there is no sample size calculation required. However, 100 parents / whanau is expected to provide sufficient information to gather feedback about the utility and acceptability of the prototype app. Additionally, this is a sufficient number of participants to provide information on the processes for recruitment, retention and indicator collection that will be required for the design of a larger study clinical trial aimed at testing the effectiveness of the app on increasing knowledge and contributing to reducing childhood obesity.
Statistical Analysis: The data will be analysed and summarised using descriptive quantitative analyses including means, standard deviation and proportions. Qualitative data will be analysed using simple content analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
7/06/2019
Date of last data collection
Anticipated
31/08/2019
Actual
30/09/2019
Sample size
Target
100
Accrual to date
Final
209
Recruitment outside Australia
Country [1] 21002 0
New Zealand
State/province [1] 21002 0
National

Funding & Sponsors
Funding source category [1] 300429 0
Charities/Societies/Foundations
Name [1] 300429 0
Cure Kids, A Better Start National Science Challenge and Precision Driven Health.
Country [1] 300429 0
New Zealand
Primary sponsor type
University
Name
National Institute for Health Innovation
Address
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 300738 0
None
Name [1] 300738 0
Address [1] 300738 0
Country [1] 300738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301233 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 301233 0
Ethics committee country [1] 301233 0
New Zealand
Date submitted for ethics approval [1] 301233 0
31/10/2018
Approval date [1] 301233 0
12/12/2018
Ethics approval number [1] 301233 0
02224

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

Contacts
Principal investigator
Name 86318 0
Ms Gayl Humphrey
Address 86318 0
Co Lead Health Informatics and Technology Programme
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 86318 0
New Zealand
Phone 86318 0
+64 21 110 0901
Fax 86318 0
+ 64 9 373 1710
Email 86318 0
g.humphrey@auckland.ac.nz
Contact person for public queries
Name 86319 0
Gayl Humphrey
Address 86319 0
Co Lead Health Informatics and Technology Programme
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 86319 0
New Zealand
Phone 86319 0
+64 21 110 0901
Fax 86319 0
+ 64 9 373 1710
Email 86319 0
g.humphrey@auckland.ac.nz
Contact person for scientific queries
Name 86320 0
Gayl Humphrey
Address 86320 0
Co Lead Health Informatics and Technology Programme
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 86320 0
New Zealand
Phone 86320 0
+64 21 110 0901
Fax 86320 0
+ 64 9 373 1710
Email 86320 0
g.humphrey@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small feasibility study. The main aim is to gather insights on the utility, acceptability and feasibility of a mobile app for supporting families to understand child growth. This information will inform the design of a large randomised control study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
173Ethical approvalAttached to this study registration   375815-(Uploaded-15-05-2019-07-10-51)-Study-related document.pdf



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.