Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000119493
Ethics application status
Approved
Date submitted
29/01/2016
Date registered
3/02/2016
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Date results provided
23/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Time2bHealthy: The effects of an online behaviour change program for parents of preschool-aged children
Scientific title
Time2bHealthy: The effects of an online behaviour change program for parents of preschool-aged children
Secondary ID [1] 288445 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Obesity 297472 0
Condition category
Condition code
Diet and Nutrition 297657 297657 0 0
Obesity
Public Health 297658 297658 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Time2bHealthy intervention is a 12-week online behaviour change program, consisting of six modules on topics including nutrition, physical activity, screen-time and sleep. Each module takes approximately 30 minutes to complete and modules are completed over a two-week period. Each module can be completed in one session or a number of sessions over the two-week period. The modules requires some reading, watching videos, completing activities and setting goals. Feedback will be provided by health consultants via the website regarding the goals set, with advice provided to enhance the goals in line with the SMART goal framework. Feedback and support will be provided in regard to the participant’s progress with the goal. Feedback on goals and progress will be provided on a fortnightly basis. Additionally, participants will receive weekly emails to remind them to log onto the website. A closed (secret) Facebook group will be accessible to participants. The group will be regularly monitored and moderated to ensure that the information discussed is consistent with evidence-based guidelines. Participants will be asked to provide regular input to the group by sharing recipes/photos of meals, healthy snacks, suitable physical activities and personal ideas and experiences in regard to reducing screen time and improving sleep.
Intervention code [1] 293771 0
Prevention
Intervention code [2] 293772 0
Lifestyle
Intervention code [3] 293773 0
Behaviour
Comparator / control treatment
Participants assigned to the control group will receive fortnightly emails directing them to various topics on the evidence-based, government-funded parenting website: Raising Children Network. The topics provided will be of a similar nature to the intervention group (nutrition, physical activity, screen-time and sleep). The control group will not have access to any interactive components such as practical activities, goal setting and individualised feedback. Additionally, the control group will be offered access to the Time2bHealthy program at the completion of the follow-up data collection (approximately 12 months after the intervention group); however, due to budget and time constraints, participants will not receive feedback on the goals set or access to the Facebook group.
Control group
Active

Outcomes
Primary outcome [1] 297193 0
Child BMI / BMI zscore / BMI percentile
BMI will be assessed using a stadiometer and digital scales using standard procedures.
Timepoint [1] 297193 0
6 months and 12 months post commencement of intervention
Secondary outcome [1] 320295 0
Child dietary intake will be assessed using a 24-hour recall (using the Easy Diet Diary app) and dietary questions from the Eating and Physical Activity Questionnaire (EPAQ) (Bennett et al 2009)
Timepoint [1] 320295 0
3 months and 6 months post commencement of intervention.
Secondary outcome [2] 320296 0
Child physical activity. All child participants will wear an Actigraph accelerometer around the waist on an elasticised belt continuously for a period of seven days. Actigraphs will be fitted to participants at the time of the initial and subsequent appointment and participants will return them in a reply paid envelope. Parents will be provided with instructions on how to remove and re-fit the device.
Timepoint [2] 320296 0
3 months and 6 months post commencement of intervention.
Secondary outcome [3] 320297 0
Child screen-time. Parents will complete a questionnaire to estimate the usual amount of screen time for their child on a typical weekday and weekend day to determine average screen time per week, the availability of screens and rules about screen entertainment. The questions are based on a questionnaire previously assessed for reliability (Downing et al., 2015, Hinkley et al., 2012).
Timepoint [3] 320297 0
3 months and 6 months post commencement of intervention.
Secondary outcome [4] 320298 0
Child sleep behaviours. Eight sleep questions will be completed by parent participants. The questionnaire has been modified from a tool which has been previously validated in the preschool age group (Children’s Sleep Habits Questionnaire)(Sneddon et al., 2013) and includes questions about typical bedtime and wake up time, typical time and duration of daytime nap and other sleep habits. The information from this questionnaire will be utilised in conjunction with accelerometer data to determine sleep duration.
Timepoint [4] 320298 0
3 months and 6 months post commencement of intervention.
Secondary outcome [5] 320299 0
Parent self-efficacy. Parents will complete a questionnaire asking about their self-efficacy relating to their child’s nutrition, physical activity, screen time and sleep. This questionnaire consists of 13 questions and has been modified from a previously validated questionnaire -The Parental Self-efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children Scale (Bohman et al., 2013).
Timepoint [5] 320299 0
3 months and 6 months post commencement of intervention.

Eligibility
Key inclusion criteria
- Child aged 2-5 years
- Greater than or equal to 50th WHO BMI percentile
- Parent has a Facebook account (or is willing to create one)
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- WHO BMI percentile <50
- Prader-Willi syndrome
- Bardet-Biedl syndrome
- diabetes
- PKU or other metabolic disorders
- cystic fibrosis
- significant physical disability or developmental disability
- (eg. restricts age-appropriate play)
- any other diseases conditions or syndromes associated with obesity or other chronic disease
- Medications that may influence weight gain, such as Ritalin or other therapy for attention deficit hyper-activity disorder, long-term steroids (short-term for acute asthma & inhaled steroids acceptable) or anti-psychotic medications
- No Facebook account (and unwilling to create one)

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)
Participants will be enrolled in four cohorts of 40 parent and preschool-aged child dyads each. Participants will be recruited from a number of community settings. After eligibility is confirmed and baseline measures are collected, participants in each cohort will be randomly allocated to the intervention or control arm of the study. Randomisation will be conducted using a computer generated random number by a staff member who is not involved in the recruitment or intervention phases of the study.
In the implementation of the trial, participants were recruited into 6 cohorts of 8-22 participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to the intervention or control group after baseline measures using a computer generated random number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Data collectors will be blinded to the study arm that the participants are assigned to.
It is not possible for participants to be blinded to the study arm that they are assigned to.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
At the completion of the intervention, data will be analysed to determine the following:
1. Change in child BMI / BMI z-score of intervention group participants compared to control group participants
2. Change in dietary intake in the intervention group compared to the control group
3. Change in light, moderate and vigorous physical activity (LMVPA) duration of the intervention group compared to the control group (assessed via accelerometer)
4. Change in sedentary time in the intervention group compared to the control group (assessed via accelerometer)
5. Change in screen-time in the intervention group compared to the control group
6. Change in sleep duration in the intervention group compared to the control group
7. Change in parental self-efficacy in the intervention group compared to the control group
8. Influence of potential mediator variables
The research hypotheses will be tested by comparing the ‘Time2bHealthy’ (intervention) and control groups. ANCOVA or repeated measures tests will be used to analyse the data to determine differences by group (‘Time2bHealthy vs control) in changes between baseline and 12 weeks in all outcome measures. Because of the multiple follow-up time points at 6 and 12 months, linear mixed models will be used to analyse the data to determine differences by group (‘Time2bHealthy vs control) over time (baseline, 12 weeks, 6 months and 12 months) adjusting for potential covariates. Generalised Estimating Equations will be used to analyse non-parametric data.

Completer analyses will also be conducted which will include only participants who completed at least 5 (out of the 6) modules of the program.

Data will be further explored to determine the effect of participant engagement in the Facebook group on primary and secondary outcomes.

Based on a pilot study conducted, an effect size of 0.4 is estimated. Based on this effect size, a statistical consultant has confirmed that 136 participants would be required (68 each group) and considering an estimated attrition rate of 15%, 160 participants would need to be recruited (80 per group).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
31/05/2017
Actual
2/06/2017
Date of last data collection
Anticipated
30/11/2017
Actual
15/12/2017
Sample size
Target
160
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 292790 0
University
Name [1] 292790 0
University of Wollongong
Country [1] 292790 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Gwynneville NSW 2522
Country
Australia
Secondary sponsor category [1] 291527 0
Commercial sector/Industry
Name [1] 291527 0
Australian Health Management
Address [1] 291527 0
77 Market St, Wollongong NSW 2500
Country [1] 291527 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294282 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 294282 0
Ethics committee country [1] 294282 0
Australia
Date submitted for ethics approval [1] 294282 0
02/09/2015
Approval date [1] 294282 0
30/10/2015
Ethics approval number [1] 294282 0
HE15/354

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

Contacts
Principal investigator
Name 63178 0
Prof Anthony Okely
Address 63178 0
Early Start Research Institute
University of Wollongong
Northfields Ave,
Gwynneville NSW 2522
Country 63178 0
Australia
Phone 63178 0
+61 2 4221 4641
Fax 63178 0
Email 63178 0
[email protected]
Contact person for public queries
Name 63179 0
Megan Hammersley
Address 63179 0
Early Start Research Institute
University of Wollongong
Northfields Ave,
Gwynneville NSW 2522
Country 63179 0
Australia
Phone 63179 0
+61 403 233 875
Fax 63179 0
Email 63179 0
[email protected]
Contact person for scientific queries
Name 63180 0
Megan Hammersley
Address 63180 0
Early Start Research Institute
University of Wollongong
Northfields Ave,
Gwynneville NSW 2522
Country 63180 0
Australia
Phone 63180 0
+61 403 233 875
Fax 63180 0
Email 63180 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
Sharing of IPD was not requested in the ethics application


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1912Informed consent form    370030-(Uploaded-18-04-2019-12-05-00)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTime2bHealthy - An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol.2017https://dx.doi.org/10.1016/j.cct.2017.07.022
EmbaseInvestigating the mediators and moderators of child body mass index change in the Time2bHealthy childhood obesity prevention program for parents of preschool-aged children.2019https://dx.doi.org/10.1016/j.puhe.2019.04.017
N.B. These documents automatically identified may not have been verified by the study sponsor.