Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000575831
Ethics application status
Approved
Date submitted
15/03/2021
Date registered
17/05/2021
Date last updated
17/05/2021
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a multi-component intervention in post-natal mother’s groups on meeting the Physical Activity Guidelines for infants. A randomized controlled trial.
Scientific title
Effect of a multi-component intervention in post-natal mother’s groups on meeting the Physical Activity Guidelines for infants. A randomized controlled trial.
Secondary ID [1] 303696 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant physical inactivity 321111 0
Condition category
Condition code
Public Health 318906 318906 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves educational content (e.g. What is tummy time?), an exercise class (e.g. the exercise is practising tummy time together with their baby) and a WhatsApp group to enable the mothers in the mother’s group to share tips, encouragement and strategies they have found helpful regarding infant physical activity. The intervention will be delivered by a Physiotherapist from a local Health district in NSW (Illawarra Shoalhaven) as an additional component to the health district's current mother's groups (groups of 6-10). The intervention (online class) will be implemented once and is approximately 60 minutes duration. Following this class, the mothers will be placed in a WhatsAPp group and standardized messages will be sent 3 times per week for 4 weeks. The intervention (online session) occurs at the last week of the mothers groups (4th week). The educational content (e.g. what is tummy time, benefits of tummy time, how to practice tummy time) will be accessed during the mother's groups via discussion, WhatsApp and printed information handouts, which will be delivered by the Physiotherapist. The intervention has been designed by the investigators of this study but is consistent with WHO recommendations for tummy time. Session attendance and WhatsApp messaging will be monitored by a research assistant.
Intervention code [1] 319997 0
Lifestyle
Intervention code [2] 320301 0
Behaviour
Intervention code [3] 320302 0
Treatment: Other
Comparator / control treatment
The control group will recieve usual care, which is usual mother's groups (approxmately 2 hours duration), once per week, for three weeks, delivered by their Early Childhood Nurse. The usual care (groups of 6-10) will be delivered by Early Childhood Nurses from a local Health district in NSW (Illawarra Shoalhaven). Each session involves support relating to mothercraft, feeding, support and answer to questions posed by mothers about caring for their infant. Session attendance and topics covered will be monitored by a research assistant.
Control group
Active

Outcomes
Primary outcome [1] 326842 0
The primary outcome will be the amount of tummy time the infant received using the GENEActiv accelerometer. Mothers will be asked to place an accelerometer on their infant’s right hip (secured with a strap) for three, 24-hour periods during one week.
Timepoint [1] 326842 0
Post-intervention: 1 week after the completion of the intervention
Primary outcome [2] 327212 0
The primary outcome will be the amount of tummy time the infant received using a questionnaire. Mothers will be asked to complete a questionnaire to estimate the amount of time their infant spent in tummy time per day (a typical 24 hours in the last week). None; 1-15 minutes; 16-30 minutes; 31-60 minutes; >60 minutes.
Timepoint [2] 327212 0
Baseline: At least 1 week before starting mother's group
Post-intervention: 1 week after the completion of the intervention
Secondary outcome [1] 394250 0
Process measures: These will include intervention fidelity (measured by calculating (app analytics) the number of messages sent and received via WhatsApp®).
Timepoint [1] 394250 0
Post-intervention: 1 week post intervention

Eligibility
Key inclusion criteria
Parents and their infants who attend the local health district mother’s groups at their local Child and Family Centre.
Minimum age
0 Weeks
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infant's with a serious medical condition.

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)
Allocation will be conducted by a computer program who will place the participant into the intervention or control group. Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be used to determine differences between intervention and control groups in changes in the primary outcome between baseline and post intervention. Intention-to-treat principles will be followed, with all participants analyzed in the group in which they are randomized. To calculate group mean estimates, the direct likelihood estimation method will be used to deal with any missing data (assuming that data are missing at random). Covariates will include sex, age, socioeconomic status, baseline tummy time and accelerometer wear time.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2021
Actual
Date of last participant enrolment
Anticipated
27/01/2022
Actual
Date of last data collection
Anticipated
3/03/2022
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18928 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 18929 0
Shoalhaven Hospital - Nowra
Recruitment postcode(s) [1] 33432 0
2500 - Wollongong
Recruitment postcode(s) [2] 33433 0
2541 - Nowra

Funding & Sponsors
Funding source category [1] 308111 0
Other Collaborative groups
Name [1] 308111 0
Illawarra Health and Medical Research Institute
Country [1] 308111 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
Wollongong Hospital, Crown St, Wollongong, NSW, 2500
Country
Australia
Secondary sponsor category [1] 308865 0
None
Name [1] 308865 0
Address [1] 308865 0
Country [1] 308865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308096 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 308096 0
University of Wollongong, Northfields Ave, Wollongong, NSW 2522
Ethics committee country [1] 308096 0
Australia
Date submitted for ethics approval [1] 308096 0
06/11/2020
Approval date [1] 308096 0
11/05/2021
Ethics approval number [1] 308096 0
2020/ETH02970

Summary
Brief summary
A randomized controlled trial to determine the efficacy of a multi-component intervention incorporating WhatsApp® and group tummy time classes in post-natal mothers’ groups, on infant physical activity levels (tummy time). This will be accomplished by delivering an evidence-based intervention to mothers and their infants attending local post-natal mother’s groups. This work aligns with the “The First 2000 days” framework which is one of the priorities for the NSW Health Translational Research Grants Scheme. The participants are the parents/infants who attend ISLHD mothers’ groups and at their local Child and Family Centre. Mothers in the intervention group will be informally educated about the benefits of tummy time, positions, setting aside time and equipment. The control group will recieve usual care. We estimate that the infants in the intervention group will participate in more tummy time than those babies in the usual care group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109522 0
Dr Lyndel Hewitt
Address 109522 0
Wollongong Hospital, Crown St, Wollongong, NSW, 2500
Country 109522 0
Australia
Phone 109522 0
+61 02 42534801
Fax 109522 0
Email 109522 0
Lyndel.Hewitt@health.nsw.gov.au
Contact person for public queries
Name 109523 0
Lyndel Hewitt
Address 109523 0
Wollongong Hospital, Crown St, Wollongong, NSW, 2500
Country 109523 0
Australia
Phone 109523 0
+61 02 42534800
Fax 109523 0
Email 109523 0
Lyndel.Hewitt@health.nsw.gov.au
Contact person for scientific queries
Name 109524 0
Lyndel Hewitt
Address 109524 0
Wollongong Hospital, Crown St, Wollongong, NSW, 2500
Country 109524 0
Australia
Phone 109524 0
+61 02 42534800
Fax 109524 0
Email 109524 0
Lyndel.Hewitt@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Group results only as per ethical requirements.


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
EmbaseEffect of a multicomponent intervention in postnatal mothers' groups on meeting the Australian Physical Activity Guidelines for infants: protocol for a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-054183
N.B. These documents automatically identified may not have been verified by the study sponsor.