Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000921785
Ethics application status
Approved
Date submitted
23/06/2022
Date registered
28/06/2022
Date last updated
17/10/2022
Date data sharing statement initially provided
28/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects on sleep and wellbeing in New Zealand infants and families: the Moemoea Trial
Scientific title
The efficacy of a culturally relevant sleep and wellbeing intervention for New Zealand whanau (families) with pepi (infants) aged 2-12 months: The Moemoea Trial
Secondary ID [1] 307400 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant sleep 326732 0
Caregiver wellbeing 326733 0
Condition category
Condition code
Public Health 323968 323968 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is being run using the Multiphase Optimization Strategy (MOST) approach. The trial has three separate components ('interventions') so our optimization trial will be a 2 x 2 x 2 factorial trial, meaning that participants will be randomised to one of 8 conditions. The 8 conditions represent every possible combination (receive, do not receive) of the following three interventions:

1) Rongo Time. The tools and resources in this pou (pillar) look at creating a feeling of peace and connection within the whanau (family) prior to sleep by bringing ritual into food- and outdoor-related activities. Resources include karakia (prayers), short videos, and activities that promote ritual (rather than routine) and connection by encouraging healthy kai and activities for the whole whanau.
2) Uru Time. The second pou, Uru time has been named after Uru-te-Ngangana, the red light that expands across and ignites the sky at dawn and dusk. These tools and resources are designed to help pepi to transition from day to night, sleep well, and wake up well rested including waiata (songs) and karakia (prayers) to help pepi relax during bath time and mirimiri (massage), as well as oriori (songs), karakia and purakau (stories) to learn and play when putting pepi (baby) to sleep.
3) Whanau Support. The third pou, Whanau support relates to the whakatauki (proverb) ‘He waka eke noa’ - the idea that everyone has a role to play and something to contribute within a whanau (family). These interactive resources allow the participant build their own waka (canoe - acting as a metaphor) to lean into the strengths within your whanau networks while also helping to identify other potential sources of support at community, regional and national levels.

All resources have been designed specifically for this study. Each intervention has been designed as a 6-week programme which is delivered online using a website and an app. Each intervention has 6 steps; participants are recommended to complete 1 step each week, with each step building upon the last. There is no minimum or recommended time to spend on each step as it is a self-paced intervention. All interventions are provided simultaneously.

Participants in all interventions will be enrolled in the study for a total of 6 months. All 8 groups will also receive a 'Safe Sleep' video resource at the start of the study. This video has been specifically designed for Moemoea, is 7 minutes long, and outlines safe sleep practices for babies, addressing how to safely bed-share and keep baby's face clear.

Website analytics will be used to indicate how many steps and when (date) each participant progresses through. As the resources have been designed to be downloaded and used offline in an effort to limit data costs for participants, we cannot tell how many times each resource will be used. A brief questionnaire will also be used at the end of steps 3 and 6 to determine how useful they find the resources and any other feedback.
Intervention code [1] 323839 0
Behaviour
Intervention code [2] 323840 0
Prevention
Comparator / control treatment
Because of the MOST study design, the 8 groups will never be directly compared to each other and thus there is no comparator/control treatment as such. Instead, the main effects of, and interactions between, intervention components will be determined. This means that to determine the effect of Rongo time, we will compare all those who received Rongo (half the sample), with all those that did not receive Rongo (the other half). Similar analyses will be undertaken to determine then effect of Uru time and Whanau support.
Control group
Active

Outcomes
Primary outcome [1] 331765 0
Perception of Infant Sleep Scale (PoISS, final scores range from 0 to 1) generated from three questions posed to the caregiver: i) whether the night-time sleep of infant has been a problem (4 answer options), ii) how well do you think the infant has slept at night (5 answer options), and iii) how satisfied the caregiver felt with the way they settled the infant to sleep at night (5 answer options).
Timepoint [1] 331765 0
Baseline and 6 months post randomisation
Primary outcome [2] 331766 0
Caregiver wellbeing assessed using the WHO-5 wellbeing questionnaire
Timepoint [2] 331766 0
Baseline and 6 months post randomisation
Secondary outcome [1] 411062 0
Rongo time will be measured using 3 questions that assess the frequency of using waiata (songs) and karakia (prayers) when with whanau (family) when preparing food, eating, and spending time outside in nature anbd 3 questions that assess connection to the pepi (baby), whanau (family), and taiao (environment) using 4 or 5 point ordinal scales.
Timepoint [1] 411062 0
Baseline and 6 months post randomisation
Secondary outcome [2] 411063 0
Uru time will be measured using 5 questions that assess whether there is a bedtime ritual, the frequency and length of any ritual, confidence in settling the infant, and enjoyment in the settling process using 4 or 5 point ordinal scales.
Timepoint [2] 411063 0
Baseline and 6 months post randomisation
Secondary outcome [3] 411064 0
Whanau support will be measured using 4 questions about the level of support the mother (or other caregiver) feels they receive from whanau (family), health providers and in general, and how confident they feel in finding and using support using 4 or 5 point ordinal scales.
Timepoint [3] 411064 0
Baseline and 6 months post randomisation
Secondary outcome [4] 411066 0
Infant weight status
Timepoint [4] 411066 0
Data collected from Well Child (health records) at any time during the 6-month intervention. Specific timings will depend on when each family attends a health visit. Typically this will happen 1-3 times depending on the child's age within the 6-month intervention.

Eligibility
Key inclusion criteria
Participants must:
*Be a parent or caregiver of an infant aged 2-12 months
*Be 16 years of age or older
*Live in Aotearoa me Te Wai Pounamu/New Zealand
*Have access to the internet
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Not a parent or caregiver of an infant aged 2-12 months
*Aged less than 16 years
*Does not live in New Zealand
*Does not have access to the internet

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants complete an online eligibility questionnaire and if eligible and agree to participate, complete the baseline questionnaire before being randomised (as per below).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into one of eight groups using computerised sequence generation (Stata 17.0), stratified by age group (2-6; 7-12 months) and ethnicity (Maori/non-Maori). Random sized blocks will be used with a minimum size of 16.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Factorial
Other design features
2 x 2 x 2 factorial trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation: We aim to recruit 400 participants into the study. Allowing for a 12% drop-out (3 participants lost from each of the eight groups), this leaves 352 participants (176 to be compared per condition), with 22 in each of the 8 combination groups. This will give 90% power to detect a main effect of each component to alpha=0.05 for a mean difference of 0.08 PoITSS (Perception of Infant and Toddler Sleep Score) and 1.5 WHO-5 wellbeing score (SD=0.23 and 4.3, respectively). These equate to small (~0.34 SD) but meaningful differences: an average shift of one category in the 'sleep problem' item of the PoITSS; an average shift of 1 point for one or two items on the WHO-5.

The statistical analysis of this factorial trial will involve the inclusion of interaction terms between the intervention components in a regression model for the primary outcome (using effect coding rather than dummy coding to reduce collinearity and maintain power). The effect sizes of the different combinations are compared to assess which combinations are most effective. These combinations are then compared against the optimisation criteria to determine which intervention package should then be tested for effectiveness in a two-arm parallel randomised controlled trial. The optimisation criteria are: optimal effectiveness for both sleep and wellbeing outcomes.

Mediation will be explored using regression models that first assess how each component influenced the mediators in the conceptual model. There are questionnaires to assess each one of these constructs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
13/07/2022
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
400
Accrual to date
154
Final
Recruitment outside Australia
Country [1] 24846 0
New Zealand
State/province [1] 24846 0
Nationwide

Funding & Sponsors
Funding source category [1] 311677 0
Government body
Name [1] 311677 0
A Better Start - National Science Challenge
Country [1] 311677 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
362 Leith St
Dunedin North, 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313131 0
None
Name [1] 313131 0
Address [1] 313131 0
Country [1] 313131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311132 0
University of Otago Human Ethics Committee
Ethics committee address [1] 311132 0
Ethics committee country [1] 311132 0
New Zealand
Date submitted for ethics approval [1] 311132 0
26/11/2021
Approval date [1] 311132 0
10/12/2021
Ethics approval number [1] 311132 0
21/144

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

Contacts
Principal investigator
Name 120054 0
Prof Rachael Taylor
Address 120054 0
Department of Medicine
University of Otago
362 Leith St
Dunedin North
Dunedin 9016
Country 120054 0
New Zealand
Phone 120054 0
+64 21 479 556
Fax 120054 0
Email 120054 0
[email protected]
Contact person for public queries
Name 120055 0
Rachael Taylor
Address 120055 0
Department of Medicine
University of Otago
362 Leith St
Dunedin North
Dunedin 9016
Country 120055 0
New Zealand
Phone 120055 0
+64 21 479 556
Fax 120055 0
Email 120055 0
[email protected]
Contact person for scientific queries
Name 120056 0
Rachael Taylor
Address 120056 0
Department of Medicine
University of Otago
362 Leith St
Dunedin North
Dunedin 9016
Country 120056 0
New Zealand
Phone 120056 0
+64 21 479 556
Fax 120056 0
Email 120056 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?
De-identified individual participant data underlying published results will be shared.
When will data be available (start and end dates)?
Jan 2024 - Dec 2026
Available to whom?
On a case by case basis according to whether the intended usage is consistent with the principles of Kaupapa Maori research and Te Mana Raraunga (Maori Data Sovereignty), as decided by the project Maori governance group.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
From the Maori governance group (contact the Lead Investigator) at [email protected]


What supporting documents are/will be available?




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.