Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001184763
Ethics application status
Approved
Date submitted
23/08/2022
Date registered
5/09/2022
Date last updated
5/09/2022
Date data sharing statement initially provided
5/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can the co-creation of an action plan support healthy smartphone habits for new mothers?
Scientific title
Can the co-creation of an action plan support healthy smartphone habits for new mothers?
Secondary ID [1] 307661 0
nil known
Universal Trial Number (UTN)
U1111-1280-9197
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secure relational base (infants)
 327185 0
Loneliness (new mothers)
 327186 0
Condition category
Condition code
Mental Health 324324 324324 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pre- and post-partum study, and it follows a mode of communication trialled during a successfully implemented study published in 2020. During the third trimester of pregnancy, following the gathering of baseline data (using "RealizD", a smartphone-use tracking app, and a survey seeking demographic info, the WHO-5 wellbeing index, the Mobile Phone Problem Use Scale 10 question version aka MPPUS-10) the intervention group will receive their materials via post. These materials, which have been designed specifically for this intervention, are a "tool kit" designed to support mindful use of the smartphone, and will contain an action plan template/instruction (for the creation of a postpartum smartphone-use plan). . This template has been designed for this project, and we estimate that participants will need 20-30 minutes to fill in the action plan and its companion summary (a fridge magnet). The "tool kit" will also have a sticker for the back of one's phone, a printed/branded blanket to use in infant care, a fridge magnet template to create a mini version of the action plan, a "phone bed" charging station, and instructions to get a downloadable 'social media stamp', alerting online friends to possible delays in replying due to engagement in infant care activities. Participants will be able to decide their own level of participation in the study, although a member of the study team will contact them via email, a day or so after estimated receipt of the posted tool kit. This email will offer support in populating the action plan, and encourage participants to ask any questions about anything study-related.
At the end of the study, the second wave of online surveying (repeating the WHO-5 wellbeing index, repeating the MPPUS-10, and - once the women are mothers - the Maternal Distraction Questionnaire MDQ) will include questions to invite members of the intervention group to identify which items of the tool kit – if any - that they used (action plan, fridge magnet, blanket, sticker, phone bed, social media stamp), and which items – if any – they found useful. This ‘usefulness’ aspect will be via a Likert scale.
Intervention code [1] 324121 0
Behaviour
Intervention code [2] 324122 0
Lifestyle
Comparator / control treatment
The control group will receive treatment as usual. In this case, that will involve their existing treatment with their Lead Maternity Carer or other health professional.
Control group
Active

Outcomes
Primary outcome [1] 332121 0
Proportion of participants with a change in mean number of minutes per day spent on smartphone, measured using "RealzD" app
Timepoint [1] 332121 0
Baseline, approx. 6 weeks postpartum (primary). Please note difficulty in accurate prediction of second measurement timepoint, owing to the unpredictable nature of childbirth in relation to due dates.
Primary outcome [2] 332122 0
Proportion of participants with a change in mean number of smartphone pickups/unlocks per day, measured using "RealzD" app
Timepoint [2] 332122 0
Baseline, approx. 6 weeks postpartum (primary). Please note difficulty in accurate prediction of second measurement timepoint, owing to the unpredictable nature of childbirth in relation to due dates.
Secondary outcome [1] 413256 0
Changed scores on WHO-5 wellbeing index.
Timepoint [1] 413256 0
Postpartum measurement, approximately 6-8 weeks after the birth of the babies. This timing can be hard to predict owing to the unpredictable nature of babies' arrivals.

Eligibility
Key inclusion criteria
Participants will be in New Zealand, aged over 18, proficient in the English language, smartphone users, and expecting their first babies March-April 2023.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are already mothers will not be eligible for this study.

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)
Allocation will involve use of sealed opaque envelopes. Randomisation will be conducted by an independent study statistician, who will generate the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use permuted block (size 4) randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Parallel Group design (intervention, control)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will follow CONSORT statement (http://www.consort-statement.org/) best practice guidelines. An intention to treat (ITT) analysis will be the primary approach, followed by a per protocol (PP) analysis. Depending on instrument completion and patterns of any missing data, sensitivity analyses may also be conducted. Participant flow will be initially reported, with reasons for attrition. These numbers will be compared between treatment groups to ascertain acceptability of the treatment. Baseline comparisons between invention and control groups over collected sociodemographic and primary variables (time on phone and number of pick-ups) will then follow – to ascertain whether any systematic sampling differences exist between the treatment groups by chance alone. Analysis of covariance (ANCOVA) and Poisson (or negative binomial) regression methods which account for repeated individual observations will be used to assess treatment effect, after distributional assumptions and residual diagnostics have been checked. Robust estimators of variance will be employed. Analyses will be directed by the study statistician.

Sample size calculations were based on estimates derived from a previous directly related study (McCaleb M. How does the use of smartphones change for new mothers? : a pre- and postpartum, matched-controlled observational design. 2020. MHSc thesis: University of Canterbury). In that study minutes onscreen was approximately normally distributed with standard deviation 150 minutes. With the proposed sample size of 50 in each group, a detectable difference in the mean response of the intervention and control subjects is ±85 minutes per day with 80% power at the two-sided a=0.05 level. Mothers in the Masters study spent, on average, 253 minutes per day on their phone at approximately six weeks postpartum. This detectable difference equates to having intervention mothers using their phones for an average of 168 minutes per day. This is a clinically meaningful difference, yet remains higher than two hours, or 120 minutes, per day – a relevant threshold for new mothers.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
Date of last participant enrolment
Anticipated
13/03/2023
Actual
Date of last data collection
Anticipated
16/06/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 24921 0
New Zealand
State/province [1] 24921 0
online recruitment, likely from all over Aotearoa/New Zealand

Funding & Sponsors
Funding source category [1] 311929 0
University
Name [1] 311929 0
University of Canterbury, Child Wellbeing Research Institute (Doctoral Scholarship)
Country [1] 311929 0
New Zealand
Primary sponsor type
Individual
Name
Miriam McCaleb
Address
Miriam McCaleb
PhD Candidate, School of Health
University of Canterbury
20 Kirkwood Avenue,
Upper Riccarton,
Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 313407 0
Individual
Name [1] 313407 0
Prof. Philip Schluter
Address [1] 313407 0
University of Canterbury
20 Kirkwood Avenue,
Upper Riccarton,
Christchurch 8041
Country [1] 313407 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311357 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 311357 0
Ethics committee country [1] 311357 0
New Zealand
Date submitted for ethics approval [1] 311357 0
01/03/2022
Approval date [1] 311357 0
19/07/2022
Ethics approval number [1] 311357 0
2022 EXP 12220
Ethics committee name [2] 311496 0
University of Canterbury Human Ethics Committee
Ethics committee address [2] 311496 0
Ethics committee country [2] 311496 0
New Zealand
Date submitted for ethics approval [2] 311496 0
26/07/2022
Approval date [2] 311496 0
29/07/2022
Ethics approval number [2] 311496 0

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

Contacts
Principal investigator
Name 120834 0
Ms Miriam McCaleb
Address 120834 0
Miriam McCaleb
PhD Candidate, School of Health
University of Canterbury
20 Kirkwood Avenue,
Upper Riccarton,
Christchurch 8041
Country 120834 0
New Zealand
Phone 120834 0
+6433103141
Fax 120834 0
Email 120834 0
[email protected]
Contact person for public queries
Name 120835 0
Miriam McCaleb
Address 120835 0
Miriam McCaleb
PhD Candidate, School of Health
University of Canterbury
20 Kirkwood Avenue,
Upper Riccarton,
Christchurch 8041
Country 120835 0
New Zealand
Phone 120835 0
+6433103141
Fax 120835 0
Email 120835 0
[email protected]
Contact person for scientific queries
Name 120836 0
Miriam McCaleb
Address 120836 0
Miriam McCaleb
PhD Candidate, School of Health
University of Canterbury
20 Kirkwood Avenue,
Upper Riccarton,
Christchurch 8041
Country 120836 0
New Zealand
Phone 120836 0
+6433103141
Fax 120836 0
Email 120836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Quantitative results: pre- and postpartum, by treatment group.
When will data be available (start and end dates)?
Upon publication of the PhD thesis, approximately January 2026.
Available to whom?
Other researchers
Available for what types of analyses?
Quantitative analyses
How or where can data be obtained?
The datasets used for statistical analysis will be held by Miriam McCaleb, c/ the University of Canterbury. Application to use these data must be made through Miriam McCaleb, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17001Other    These supporting documents will be freely availabl... [More Details]



Results publications and other study-related documents

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