Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000823279
Ethics application status
Approved
Date submitted
30/04/2018
Date registered
14/05/2018
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Date results information initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The 3 Pillars Study: a programme for busy parents of toddlers to help them engage in healthy routines
Scientific title
The 3 Pillars Study: a randomised controlled trial to help parents of toddlers improve engagement in household routines associated with a reduced risk of obesity
Secondary ID [1] 294746 0
None
Universal Trial Number (UTN)
U1111-1220-1905
Trial acronym
3PS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screen time 307640 0
Condition category
Condition code
Public Health 306709 306709 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 3PS intervention will consist of a half-day, group-based workshop with parents of toddlers, which will be run by a community worker. The workshop will focus on the home environment and organisation in the home, with the ultimate aim of reducing household chaos. Within this context, specific topics of sleep, diet, and play/screen use will be discussed, and simple solutions offered to busy parents to overcome barriers to their toddler engaging in health-promoting behaviours and routines, such as family meals and adequate sleep. The workshop will be run with approximately 10-15 parents, and will involve a mix of traditional presentations (e.g. PowerPoint presentation presented by the facilitator), videos, and group exercises. The workshop will be audio recorded to check fidelity of the content delivery.

The workshop will also be supplemented by a study website, which will provide an overview of each of the topics explored in the workshop, in addition to in-depth information for those parents seeking more information around a specific topic. The website will also contain short videos, which will focus on sleep, diet, and play/screen use in toddlers. Participants will have access to the website for a period of 6 weeks. Google analytics will be used to assess usage of the website, and participants will be sent an email each week for the first 4 weeks introducing them to each of the topics and linking to the specific page. For example, during the first week, participants will receive an email briefly discussing the importance of routines and rituals, and a link to this page on the study website.
Intervention code [1] 301048 0
Behaviour
Comparator / control treatment
Wait-list control. Participants in the wait-list control will not participate in the workshop or have access to the website for the duration of the study. However, once final follow-up is complete (12 weeks post-workshop) all control participants will be offered the opportunity to attend the half-day workshop and will be given access to the study website.
Control group
Active

Outcomes
Primary outcome [1] 305708 0
Screen use: Assessed using four questions from the New Zealand Health Survey. Parent-report of time (in hours) child spends watching TV or using ‘other’ screen devices during weekdays and on weekends. An average weighted score for TV and ‘other’ screen time will then be calculated and the proportion of children meeting international guidelines (0 hours for children aged under 2 years and <1 hour per day for children aged 2-3 years) will be calculated.
Timepoint [1] 305708 0
Baseline, 6 weeks (primary), 12 weeks post-intervention commencement.
Secondary outcome [1] 346210 0
Restrained time: Assessed using 6 questions. Parent-report of the amount of time (in minutes) and number of times per day (frequency) their child is restrained in a car seat, a pram, and a high chair. Time spent in each of the ‘restrictive’ devices and frequency of child being placed in each of the ‘restrictive’ devices will then be calculated.
Timepoint [1] 346210 0
Baseline, 6 weeks, 12 weeks post-intervention commencement.
Secondary outcome [2] 346211 0
Nutrition: Four questions from the New Zealand Health Survey investigating number of fruit and vegetable servings, fizzy drink consumption, and fast food consumption, and one question from the Family Routines Inventory, investigating number of days per week that the family sit together to eat the main meal. Parent-report of child behaviours.
Timepoint [2] 346211 0
Baseline, 6 weeks, 12 weeks post-intervention commencement.
Secondary outcome [3] 346214 0
Brief Screening Questionnaire for Infant Sleep Problems (BISQ) Extended. BISQ assess a number of aspects of infant and toddler sleep, including nocturnal sleep duration, night wakings, method of falling asleep, sleeping arrangements, bedtime rituals, and parental interventions during the night and at bedtime.
Timepoint [3] 346214 0
Baseline, 6 weeks, 12 weeks post-intervention commencement.
Secondary outcome [4] 346215 0
Child Routine Inventory (Daily living routines subscale)
Timepoint [4] 346215 0
Baseline, 6 weeks, 12 weeks post-intervention commencement.
Secondary outcome [5] 346216 0
Chaos, Hubbub, and Order Scale (CHAOS). CHAOS assess the level of household chaos in the family home, including household disorganisation and background stimulation/distractions.
Timepoint [5] 346216 0
Baseline, 6 weeks, 12 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Inclusion criteria:

Parent or primary caregiver ages at least 18 years of age with a child aged 18 months to <3 years who exceeds guidelines for TV/screen use (i.e. no screen time for children aged under 2 years, or >1 hour/day for children aged 2-3 years)

Currently lives in Auckland and can attend one half-day workshop

Has access to the internet

Able to provide written informed consent, and can speak and read English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parent of a child with a serious physical or medial illness or known developmental problem (e.g. sleep apnoea, feeding aversions, autism)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ratio to the intervention or wait-list control group using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarised using descriptive statistics. Continuous variables will be presented as mean and standard deviation (SD). Categorical variables will be presented as frequency and percentage. All statistical tests will be two-sided and maintained at a 5% significance level. Categorical variables will be reported as n and %. Simple chi-squared analyses will be used to evaluate the treatment effect on the proportions adherent to screen use guidelines after 6 weeks, with estimation of relative risks, 95% confidence intervals and two-sided p-values.
As this is a feasibility study, no power calculation will be performed to assess participant numbers.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
17/07/2018
Date of last participant enrolment
Anticipated
31/08/2018
Actual
10/09/2018
Date of last data collection
Anticipated
4/12/2018
Actual
14/12/2018
Sample size
Target
50
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 10359 0
New Zealand
State/province [1] 10359 0
Auckland

Funding & Sponsors
Funding source category [1] 299352 0
Government body
Name [1] 299352 0
Health Research Council
Country [1] 299352 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland, Private Bag 92019, Auckland 1142.
Country
New Zealand
Secondary sponsor category [1] 298629 0
None
Name [1] 298629 0
Address [1] 298629 0
Country [1] 298629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300258 0
University of Auckland Human Ethics Committee
Ethics committee address [1] 300258 0
Research Integrity Unit Level 10, Building 620 49 Symonds Street Auckland 1010
Ethics committee country [1] 300258 0
New Zealand
Date submitted for ethics approval [1] 300258 0
27/04/2018
Approval date [1] 300258 0
07/06/2018
Ethics approval number [1] 300258 0
021311

Summary
Brief summary
The aim of this research is to explore how reducing household chaos and encouraging engagement in positive family routines may promote development of healthy lifestyle behaviours that reduce the risk of overweight and improve well-being in young New Zealand children. A two-arm, 12-week RCT pilot study will be conducted to assess the Three Pillars Study (3PS) programme. Intervention participants will attend a half-day workshop and then have access to a supplementary website with more information, resources, and videos. Both the intervention group and wait-list control group will undergo study measures at baseline, 6 weeks (at the end of the programme) and 12 weeks (final follow-up). After final follow-up data collection has been completed, the control group will be offered the intervention, that is, participation in the half-day workshop and access to the study website.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83074 0
Dr Samantha Marsh
Address 83074 0
The University of Auckland, Private Bag 92019, Auckland 1142.
Country 83074 0
New Zealand
Phone 83074 0
+64 9 3737 999
Fax 83074 0
Email 83074 0
sam.marsh@auckland.ac.nz
Contact person for public queries
Name 83075 0
Dr Samantha Marsh
Address 83075 0
The University of Auckland, Private Bag 92019, Auckland 1142.
Country 83075 0
New Zealand
Phone 83075 0
+64 9 3737 999
Fax 83075 0
Email 83075 0
sam.marsh@auckland.ac.nz
Contact person for scientific queries
Name 83076 0
Dr Samantha Marsh
Address 83076 0
The University of Auckland, Private Bag 92019, Auckland 1142.
Country 83076 0
New Zealand
Phone 83076 0
+64 9 3737 999
Fax 83076 0
Email 83076 0
sam.marsh@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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12007Study protocol  enquiries@nihi.auckland.ac.nz
12009Statistical analysis plan  enquiries@nihi.auckland.ac.nz
12010Informed consent form  enquiries@nihi.auckland.ac.nz
12011Ethical approval  enquiries@nihi.auckland.ac.nz



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Marsh S, Taylor R, Galland B, Gerritsen S, Parag V... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseResults of the 3 Pillars Study (3PS), a relationship-based programme targeting parent-child interactions, healthy lifestyle behaviours, and the home environment in parents of preschool-aged children: A pilot randomised controlled trial.2020https://dx.doi.org/10.1371/journal.pone.0238977
N.B. These documents automatically identified may not have been verified by the study sponsor.