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Trial registered on ANZCTR


Registration number
ACTRN12617001298303
Ethics application status
Approved
Date submitted
31/08/2017
Date registered
11/09/2017
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility, acceptability and potential efficacy of group tummy time exercise classes to promote tummy time among infants
Scientific title
Feasibility, acceptability and potential efficacy of group tummy time exercise classes to promote tummy time among infants
Secondary ID [1] 292785 0
None
Universal Trial Number (UTN)
U1111-1201-5503
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 304593 0
Plagiocephaly 304594 0
Motor Development delay 304595 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303921 303921 0 0
Physiotherapy
Diet and Nutrition 303967 303967 0 0
Obesity
Reproductive Health and Childbirth 303968 303968 0 0
Childbirth and postnatal care
Musculoskeletal 303969 303969 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a weekly tummy time group exercise class which will be administered by a Physiotherapist. In addition, the early childhood nurse who conducts the mother's groups will provide assistance as required throughout the duration of the class. This program starts with beginner level tummy time exercises (prone on a parent’s chest, being held in prone) and will gradually be upgraded to advanced level tummy time exercises (playing on the floor on their tummy) for increased periods of time. Parents will also be informally educated about the benefits tummy time, positions, setting aside time and equipment during these sessions using current research. The class will run for 20 minutes as the end of their local mother’s group sessions which is held at the mother's local early childhood centre. The program will run for 4 weeks and participants will attend once per week. Attendance to the groups will be noted. In addition, to provide encouragement to attend, build relationships and enhance the learning in the group exercise class, a closed Facebook or WhatsApp group will also be created so mothers can contact each other and share tips and strategies they have found helpful during the week.
Intervention code [1] 299028 0
Behaviour
Comparator / control treatment
The control group will be given usual care which is their usual early childhood mothers group sessions. Mothers attending the usual care sessions are followed up by the early childhood nurse when the babies are approximately 4 months old and can refer to appropriate existing services as required.
Control group
Active

Outcomes
Primary outcome [1] 303256 0
Time spent in tummy time as measured by a wearable accelerometer which has been validated to measure time spent by an infant (0-6months) in different positions.
Timepoint [1] 303256 0
Pre intervention, post intervention and 1 month post intervention. Infants will wear the device at each stage for 3, 24 hour periods over 1 week.
Secondary outcome [1] 338448 0
Head shape measured by calculating cranial diagonal difference and the brachycephaly deformation index with cranial calipers.
Timepoint [1] 338448 0
Pre intervention, post intervention and 1 month post intervention
Secondary outcome [2] 338449 0
Sleep, measured by accelerometer and a parent questionnaire that has been specifically designed for this study.
Timepoint [2] 338449 0
Pre intervention, post intervention and 1 month post intervention. The accelerometer is worn for 3, 24 hour periods over. week at each stage (pre, post and 1 month post).
Secondary outcome [3] 338450 0
Screen time, measured by a parent questionnaire that has been specifically designed for this study.
Timepoint [3] 338450 0
Pre intervention, post intervention and 1 month post intervention
Secondary outcome [4] 338451 0
Parent education level
Timepoint [4] 338451 0
Pre intervention, asked in a parent questionnaire that has been specifically designed for this study
Secondary outcome [5] 338452 0
Accuracy of parent recall re: amount of tummy time given to the infant, measured by parent questionnaire specifically designed for this study and comparing to time spent prone as measured by the accelerometer.
Timepoint [5] 338452 0
Pre intervention, post intervention and 1 month post intervention. The accelerometer is worn for 3, 24 hour periods over. week at each stage (pre, post and 1 month post).
Secondary outcome [6] 338453 0
Motor development, measured by the Alberta Infant Motor Scale.
Timepoint [6] 338453 0
Pre intervention, post intervention and 1 month post intervention.
Secondary outcome [7] 338633 0
Age of parent
Timepoint [7] 338633 0
Pre intervention, asked in a parent questionnaire that has been specifically designed for this study.
Secondary outcome [8] 338634 0
Age of infant
Timepoint [8] 338634 0
Pre intervention, post intervention and 1-month post intervention asked in a parent questionnaire that has been specifically designed for this study
Secondary outcome [9] 338635 0
Infant sleeping position
Timepoint [9] 338635 0
Pre intervention, post intervention and 1-month post intervention, asked in a parent questionnaire that has been specifically designed for this study.
Secondary outcome [10] 338636 0
Amount of time in the bath (infant)
Timepoint [10] 338636 0
Pre intervention, post intervention and 1-month post intervention, asked in a parent questionnaire that has been specifically designed for this study.
Secondary outcome [11] 338637 0
Amount of time spent supine (infant)
Timepoint [11] 338637 0
Pre intervention, post intervention and 1-month post intervention, asked in a parent questionnaire that has been specifically designed for this study.
Secondary outcome [12] 338639 0
Parent's setting aside time for tummy time
Timepoint [12] 338639 0
Pre intervention, post intervention and 1-month post intervention, asked in a parent questionnaire that has been specifically designed for this study.

Eligibility
Key inclusion criteria
Mothers and their healthy infants (does not have a medical condition that affects their functional ability) who attend the mother's group will be recruited (babies aged from birth)
Minimum age
1 Weeks
Maximum age
15 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
An infant who has a medical condition that affects their functional ability

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)
Yes, subjects who are eligible for inclusion will be allocated by a person who will be unaware, when this decision was made, to which group the subject would be allocated. Allocation will be concealed by central randomisation by computer.
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
Mothers are blinded to what the measurement device is measuring (amount of time in tummy time). For example, they are going to be told it measures their infants 'physical activity'.
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 between baseline and post intervention outcome measures. All available data will be used and missing data will not be imputed. Intention-to-treat principles will be followed, with all participants analyzed in the group in which they are randomised. 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). If data for an infant is not obtained at one of the data collection time points, baseline data will be used for the purpose of calculating group means. Covariates will include sex, age, socioeconomic status, baseline tummy time, motor development and accelerometer wear time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2017
Actual
7/02/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
7/09/2018
Date of last data collection
Anticipated
30/12/2018
Actual
15/02/2019
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8922 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 17293 0
2500 - Wollongong
Recruitment postcode(s) [2] 23833 0
2517 - Woonona

Funding & Sponsors
Funding source category [1] 297417 0
Government body
Name [1] 297417 0
Australian Government Research Training Program Scholarship
Country [1] 297417 0
Australia
Primary sponsor type
University
Name
Early Start, University of Wollongong
Address
Early Start, University of Wollongong
Northfields Avenue
Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 296410 0
Hospital
Name [1] 296410 0
Child and Family Department, Wollongong Hospital
Address [1] 296410 0
Child and Family Department
Wollongong Hospital
Crown Street, Wollongong, NSW, 2500
Country [1] 296410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298523 0
Joint Human Research Ethics Committee and Illawarra Shoalhaven Local Health District
Ethics committee address [1] 298523 0
University of Wollongong
Northfields Avenue
Wollongong, NSW, 2522
Ethics committee country [1] 298523 0
Australia
Date submitted for ethics approval [1] 298523 0
21/08/2017
Approval date [1] 298523 0
13/10/2017
Ethics approval number [1] 298523 0

Summary
Brief summary
This study is looking to see if group tummy time exercise classes can be an effective way to promote tummy time. It will also see if there are any positive health effects by infants who engage in tummy time. Approximately 40 mothers and their healthy infants who agree to attend a mother's group will be recruited from the Illawarra region of New South Wales. Participants will be recruited from their home visit with their child and family health nurse. Those who would like to be involved in the study will be randomly assigned to either an intervention (group tummy time exercise class) or a control group (usual care). The measurements to assess the effectiveness of the classes will be the amount of time spent in tummy time by the infants, the infant’s ability to move, their head shape, the amount of sleep and screen time they have and the accuracy of the parents to recall the amount of tummy time the baby has been given. A measurement device that the infant wears around their waist will be used to determine the amount of tummy time the infant receives. They will wear this device for at least 3, 24-hour periods over 1 week. The parents will also be asked to complete a questionnaire which will have questions about their education, where they live, how much knowledge they have about tummy time etc. The group tummy time exercise class will run for about 20 minutes, once per week, for 4 weeks. They will be run by a Physiotherapist. To provide encouragement to attend, build relationships and enhance the learning in the group exercise class, a closed Facebook or WhatsApp group will also be created so mothers can contact each other and share tips and strategies they have found helpful about tummy time during the week.
Trial website
Trial related presentations / publications
Currently under review for publication
Public notes

Contacts
Principal investigator
Name 77346 0
Prof Tony Okely
Address 77346 0
Early Start
University of Wollongong
Northfields Avenue
Wollongong, NSW, 2522
Country 77346 0
Australia
Phone 77346 0
+61 2 4221 3247
Fax 77346 0
Email 77346 0
[email protected]
Contact person for public queries
Name 77347 0
Lyndel Hewitt
Address 77347 0
Early Start
University of Wollongong
Northfields Avenue
Wollongong, NSW, 2522
Country 77347 0
Australia
Phone 77347 0
+61 2 4221 3247
Fax 77347 0
Email 77347 0
[email protected]
Contact person for scientific queries
Name 77348 0
Lyndel Hewitt
Address 77348 0
Early Start
University of Wollongong
Northfields Avenue
Wollongong, NSW, 2522
Country 77348 0
Australia
Phone 77348 0
+61 2 4221 3247
Fax 77348 0
Email 77348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be shared, only group data 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
EmbaseWeekly group tummy time classes are feasible and acceptable to mothers with infants: a pilot cluster randomized controlled trial.2020https://dx.doi.org/10.1186/s40814-020-00695-x
N.B. These documents automatically identified may not have been verified by the study sponsor.