Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001571268
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
20/09/2018
Date last updated
15/02/2021
Date data sharing statement initially provided
10/05/2019
Date results provided
15/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and cost-effectiveness of telephone support with Short Message Service (SMS) in preventing obesity of children aged 2-4 years
Scientific title
Effectiveness and cost-effectiveness of maternal telephone support with Short Message Service (SMS) in preventing obesity of children aged 2-4 years: a randomised controlled trial
Secondary ID [1] 296070 0
CHAT: NSW TRGS No. 200
Universal Trial Number (UTN)
Trial acronym
Linked CHAT
Linked study record
ACTRN12616001470482

Health condition
Health condition(s) or problem(s) studied:
Child overweight and obesity 309627 0
Condition category
Condition code
Diet and Nutrition 308441 308441 0 0
Obesity
Public Health 308492 308492 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two-arm/parallel randomised controlled trial (RCT).

The proposed intervention is based upon the principles of the successful Healthy Beginnings Trial (HBT) intervention, and the RCT of Communicating Healthy Beginnings Advice by Telephone (CHAT) to Mothers with Infants to Prevent Childhood Obesity.

The Tel+SMS intervention will be delivered for 24 months from the child of 2 to 4 years of age. Starting from the child of 2 years old when baseline measurements and randomisation are completed, five telephone support sessions will be scheduled for 24-28, 28-32, 32-36, 39-41 and 44-46 months of the child’s age.

A telephone protocol and manual will be developed to ensure consistency of intervention delivery based on our current trial. Telephone sessions will be delivered by a Child and Family Health Nurse trained in telephone support, health behaviour change strategies, and infant development. Based on our current trial experience, we anticipate that each telephone session will be ~20 minutes in duration. The nurse will employ a motivational interviewing approach and aim to set goals, build skills and knowledge, address barriers, and manage any anxiety or stress which may act as a barrier to health behaviour change. To assist, an intervention booklet will be developed according to the key messages that support the developmental milestones at each age and mailed to the participants one week prior to the telephone call.

Following each telephone session, we will then send two SMS messages per week for the next eight weeks (i.e., 16 SMS messages following each telephone call) to enhance and reinforce the support provided in the telephone session. SMS wording will be tailored to: mother/primary caregiver/guardian’s first name, child’s first name and age, and a partner’s name (or other nominated support person). Abbreviations will be kept to a minimum to align with mothers/primary caregivers/guardians’ comprehension of SMS language. SMS will be generated and sent using a dedicated, secured web-based software program we used in the existing trial.
Intervention code [1] 312403 0
Behaviour
Intervention code [2] 312404 0
Prevention
Comparator / control treatment
Mothers in the control group will receive usual care, which all mothers (including the intervention mothers) receive if needed from the government health service. This usual care is via early childhood health clinics operated by NSW Health, providing a free service for all new parents in NSW (while the child is aged 0-5 years). They are staffed by trained health professionals and registered nurses who specialise in child and family health. Mothers and parents can phone their local clinic to arrange an appointment. To maximise the control group retention rate, we will post home safety promotion materials and a newsletter on “Kids’ Safety” three times during the child's third year (age 2 - 4 years).
Control group
Active

Outcomes
Primary outcome [1] 307411 0
Child's Body Mass Index
Timepoint [1] 307411 0
at 2, 3, and 4 years of age
Primary outcome [2] 307412 0
Child's Body Mass Index Z-score
Timepoint [2] 307412 0
at 2, 3, and 4 years of age
Secondary outcome [1] 351844 0
Child’s Fruit and Vegetable intake. Mothers will report their child’s eating habits using a validated short food frequency questionnaire (FFQ) specifically designed to assess children’s eating habits
Timepoint [1] 351844 0
at 2, 3, and 4 years of age
Secondary outcome [2] 351845 0
Child’s screen-based activities: mothers will report the total time their child spends doing screen-based activities per day in a usual week using a set of validated questions.
Timepoint [2] 351845 0
at 2, 3, and 4 years of age
Secondary outcome [3] 351846 0
Child’s outdoor play time: Mothers will report the total time their child spends doing outdoor play time as a proxy for active play time per day in a usual week using a set of validated questions.
Timepoint [3] 351846 0
at 2, 3, and 4 years of age
Secondary outcome [4] 351847 0
Mother’s nutrition (daily or weekly vegetable, fruit, soft drink, fast food consumption) self-reported by mother in study-specific survey, using questions sourced from the NSW Health Survey Program which we have used previously in HBT
Timepoint [4] 351847 0
at 2, 3, and 4 years of age
Secondary outcome [5] 351848 0
Mother’s physical activity assessed using questions sourced from the NSW Health Survey Program which we have used previously in HBT.
Timepoint [5] 351848 0
at 2, 3, and 4 years of age
Secondary outcome [6] 391842 0
Mother’s quality of life & health using questions from EuroQol Group EQ-5D.
Timepoint [6] 391842 0
2, 3, and 4 years of age
Secondary outcome [7] 391843 0
Healthcare utilization using data linkage to Medicare
Timepoint [7] 391843 0
2,3, and 4 years of age

Eligibility
Key inclusion criteria
The study participants from the existing CHAT 3-arm RCT will be invited to participate. These participants (pregnant women aged 16-50 years) were previously recruited from Sydney, South Eastern Sydney, South Western Sydney and Southern NSW Local Health Districts, and surrounding communities in NSW.
The children (both males and females) included in this study will be approximately 24 months of age at the time of recruitment.
Minimum age
22 Months
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers and their child will be excluded from the study if either have a severe medical condition based on advice given by doctors, or they have moved out of the study regions.

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 is concealed with sealed opaque envelopes using block random number technique.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After the baseline measurements, random allocation to either intervention or control group will be determined by a computer generated random number using random permuted blocks, stratified by the group allocation in the CHAT study. The use of stratified randomisation is to ensure that any carry-over effect of the previous intervention will be equally distributed between treatment groups in this study.

A research assistant who has no direct contact with participating women will be responsible for generating the random numbers and preparing the sealed opaque envelopes containing the group allocation.
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
Study 2 is collecting additional data from the same sample from the previous study 1. It will assess the same outcomes as the previous study 1.
For the previous CHAT trial at 2 years (Study 1), the sample size required was previously calculated in the published research protocol (1056 mothers: 352 in each of the 3 arms of the study).3 In fact, we recruited 1155 mothers into the trial (exceeding the required sample size by 100 mothers). It was estimated that a total sample size of 792 (264 per arm x 3) was needed at 2 years to have sufficient power to detect a difference in child BMI of 0.38kg/m2.
For Study 2, we will need a total sample size of 518 (259 per arm x 2) at the beginning of the study (2 years of age). The sample size was calculated on the basis of the null hypothesis (H0: µBMI from intervention group = µBMI from control group). A total of 310 participants will be needed at 4 years to detect a difference in mean BMI of 0.32 between intervention groups with a power of 0.80 for a two-sided t-test at significance level a=0.05. Allowing for a 20% drop-out rate from 3.5 to 4 years, a sample size of 388 participants (194 in each arm) will be needed at 3 years of age. With 25% drop-out rate from 2 to 3.5 years, a sample size of 518 participants will be recruited at 2 years of age. This sample size will also give enough power to detect differences in BMI z-score of 0.32 between intervention groups at 4 years.
In previous HBT follow up study, the drop-out rate from 2 to 5 years was 26%. If the same rates apply here, we will have 383 participants completing Study 2, allowing us to detect a difference of 0.29 kg/m2 in mean BMI.

All outcomes will be compared between the intervention and control groups using intention-to-treat principles and CONSORT guidelines. Both intention-to-treat analysis with multiple imputations and complete-case analysis will be conducted to see whether results from multiple imputations are supported by those from complete-case analysis.

For descriptive analysis will be conducted, mean and standard deviation will be reported for continuous variables; number and percentage will be reported for categorical variables. For intention-to-treat analysis with multiple imputations, Stata’s ‘mi estimate’ command will be used to estimate the means or proportions for continuous variables or categorical variables respectively.

The hypotheses will be tested by fitting multiple regression models (linear regression models for continuous outcomes, logistic regression models for binary outcomes). Recruitment sites and previous intervention allocation in Study 1 will be included in the models. Other potential confounding factors will be assessed and addressed. A 10% change in coefficient or odds ratio will be used as the cut-off to determine confounding factors. All P values are two sided and significance level is set at 5%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2019
Actual
2/03/2019
Date of last participant enrolment
Anticipated
30/10/2019
Actual
1/11/2019
Date of last data collection
Anticipated
30/11/2020
Actual
1/11/2019
Sample size
Target
600
Accrual to date
Final
662
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23966 0
2050 - Missenden Road
Recruitment postcode(s) [2] 23967 0
2170 - Liverpool
Recruitment postcode(s) [3] 23968 0
2194 - Campsie
Recruitment postcode(s) [4] 23969 0
2217 - Kogarah
Recruitment postcode(s) [5] 23970 0
2560 - Campbelltown
Recruitment postcode(s) [6] 23971 0
2031 - Randwick
Recruitment postcode(s) [7] 23972 0
2620 - Beard

Funding & Sponsors
Funding source category [1] 300659 0
Government body
Name [1] 300659 0
The NSW Ministry of Health Translational Research Grants Scheme
Country [1] 300659 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Li Ming Wen
Address
Health Promotion Unit, Sydney Local Health District
Level 9 North, King George V Building, Missenden Rd. Camperdown. NSW 2050
Country
Australia
Secondary sponsor category [1] 300177 0
Individual
Name [1] 300177 0
Prof Chris Rissel
Address [1] 300177 0
Level 6, The Hub, D17 Charles Perkins Centre, The University of Sydney, Camperdown, NSW 2006.
Country [1] 300177 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301444 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 301444 0
Ethics committee country [1] 301444 0
Australia
Date submitted for ethics approval [1] 301444 0
17/09/2018
Approval date [1] 301444 0
29/10/2018
Ethics approval number [1] 301444 0
X18-0387 & HREC/18/RPAH/545

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

Contacts
Principal investigator
Name 87022 0
A/Prof Li Ming Wen
Address 87022 0
Health Promotion Unit, Sydney Local Health District
Level 9 North, King George V Building, Missenden Rd.
Camperdown. NSW. 2050.
Country 87022 0
Australia
Phone 87022 0
+61 2 95159055
Fax 87022 0
+61 2 95159056
Email 87022 0
[email protected]
Contact person for public queries
Name 87023 0
Li Ming Wen
Address 87023 0
Health Promotion Unit, Sydney Local Health District
Level 9 North, King George V Building, Missenden Rd.
Camperdown. NSW. 2050.
Country 87023 0
Australia
Phone 87023 0
+61 2 95159055
Fax 87023 0
+61 2 95159056
Email 87023 0
[email protected]
Contact person for scientific queries
Name 87024 0
Li Ming Wen
Address 87024 0
Health Promotion Unit, Sydney Local Health District
Level 9 North, King George V Building, Missenden Rd.
Camperdown. NSW. 2050.
Country 87024 0
Australia
Phone 87024 0
+61 2 95159055
Fax 87024 0
+61 2 95159056
Email 87024 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?
outcome data will be shared.
When will data be available (start and end dates)?
The data will be available by the end of 2020 and no end date is determined.
Available to whom?
On request. Only researchers who provide a methodologically sound proposal with ethics approval can request.
Available for what types of analyses?
Meta analyses.
How or where can data be obtained?
De-identified data available pending on ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10678Study protocolWen LM , Rissel C, Xu H, Taki S, Smith W, Bedford K, Hayes AJ, Phongsavan P, Simpson JM, Shaw MJ, Moreton R and Baur LA. Linking two randomised controlled trials for Healthy Beginnings: optimising early obesity prevention programs for children under 3 years. BMC Public Health 2019;19:739.    375991-(Uploaded-19-04-2020-21-16-19)-Study-related document.pdf
10679Informed consent form    375991-(Uploaded-21-04-2020-09-36-50)-Study-related document.docx
10680Ethical approval    375991-(Uploaded-21-04-2020-09-40-08)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEthnicity matters in perceived impacts and information sources of COVID-19 among mothers with young children in Australia: A cross-sectional study.2021https://dx.doi.org/10.1136/bmjopen-2021-050557
EmbaseTwelve-month effectiveness of telephone and SMS support to mothers with children aged 2 years in reducing children's BMI: a randomized controlled trial.2023https://dx.doi.org/10.1038/s41366-023-01311-7
Dimensions AIEffectiveness and co-benefits of a telephone-based intervention in reducing obesity risk of children aged 2–4 years: findings from a pragmatic randomised controlled trial during the COVID-19 pandemic in Australia2023https://doi.org/10.1016/s2214-109x(23)00096-7
N.B. These documents automatically identified may not have been verified by the study sponsor.