ANZCTR - Registration

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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 information initially 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]

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

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

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]

Behaviour

Intervention code [2]

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]

Child's Body Mass Index

Timepoint [1]

at 2, 3, and 4 years of age

Primary outcome [2]

Child's Body Mass Index Z-score

Timepoint [2]

at 2, 3, and 4 years of age

Secondary outcome [1]

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]

at 2, 3, and 4 years of age

Secondary outcome [2]

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]

at 2, 3, and 4 years of age

Secondary outcome [3]

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]

at 2, 3, and 4 years of age

Secondary outcome [4]

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]

at 2, 3, and 4 years of age

Secondary outcome [5]

Mother’s physical activity assessed using questions sourced from the NSW Health Survey Program which we have used previously in HBT.

Timepoint [5]

at 2, 3, and 4 years of age

Secondary outcome [6]

Mother’s quality of life & health using questions from EuroQol Group EQ-5D.

Timepoint [6]

2, 3, and 4 years of age

Secondary outcome [7]

Healthcare utilization using data linkage to Medicare

Timepoint [7]

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]

2050 - Missenden Road

Recruitment postcode(s) [2]

2170 - Liverpool

Recruitment postcode(s) [3]

2194 - Campsie

Recruitment postcode(s) [4]

2217 - Kogarah

Recruitment postcode(s) [5]

2560 - Campbelltown

Recruitment postcode(s) [6]

2031 - Randwick

Recruitment postcode(s) [7]

2620 - Beard

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The NSW Ministry of Health Translational Research Grants Scheme

Address [1]

73 Miller St North Sydney NSW 2060

Country [1]

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]

Individual

Name [1]

Prof Chris Rissel

Address [1]

Level 6, The Hub, D17 Charles Perkins Centre, The University of Sydney, Camperdown, NSW 2006.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SLHD Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

RPAH Research Ethics and Governance Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/09/2018

Approval date [1]

29/10/2018

Ethics approval number [1]

X18-0387 & HREC/18/RPAH/545

Summary

Brief summary

Childhood obesity is a serious public health challenge. About one in five Australian children aged 2 to 3 years is now either overweight or obese. Early intervention is important as excess weight and fast weight gain in early childhood are related to being overweight later in life with considerable impact upon health and health services.

Over the past 8 years we have developed, implemented and evaluated an early obesity intervention program funded by NHMRC. The project titled Healthy Beginnings Trial (HBT) was designed to improve infant feeding practices, eating habits, active play, and reduce TV viewing time to prevent childhood obesity in the first two years of life through staged home visiting. However, the high cost associated with home visits potentially limits population reach. To translate the successful evidence from the HBT into scaled-up practice applicable across the state with low-cost and broad-reach approaches, we commenced the CHAT study, to promote healthy infant feeding and active play using telephone support and Short Message Service (SMS).

The CHAT trial is being conducted with 1155 mothers recruited from the third trimester of pregnancy providing intervention to 24 months of child age. The 24-month follow-up of the CHAT study will be an integral part of the recruitment process and baseline data collection for this new 2-arm RCT. By linking the two studies this study will add significant value to CHAT study by 1) examining the intervention effects at 2 years of age, and 2) conducting a new 2-arm RCT of an early obesity prevention program using a combined telephone support and SMS intervention for children aged 2-4 years. This study will address known gaps in universal obesity prevention strategies for children aged 0-2 years (CHAT study) and 2-4 years (this study) in the most efficient way possible. This unique opportunity of linking two studies will expedite project start up time and provide continuing support to the participants in the existing RCT.

Trial website

http://www.healthybeginnings.net.au/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

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

Phone

+61 2 95159055

Fax

+61 2 95159056

[email protected]

Contact person for public queries

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

Phone

+61 2 95159055

Fax

+61 2 95159056

[email protected]

Contact person for scientific queries

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

Phone

+61 2 95159055

Fax

+61 2 95159056

[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.	Type	Citation	Attachment
10678	Study protocol	Wen 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
10679	Informed consent form		375991-(Uploaded-21-04-2020-09-36-50)-Study-related document.docx
10680	Ethical approval		375991-(Uploaded-21-04-2020-09-40-08)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Wen LM, Rissel C, Xu H, Taki S, Buchanan L, Bedfor... [More Details]	375991-(Uploaded-02-09-2020-15-12-16)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Ethnicity matters in perceived impacts and information sources of COVID-19 among mothers with young children in Australia: A cross-sectional study.	2021	https://dx.doi.org/10.1136/bmjopen-2021-050557
Embase	Twelve-month effectiveness of telephone and SMS support to mothers with children aged 2 years in reducing children's BMI: a randomized controlled trial.	2023	https://dx.doi.org/10.1038/s41366-023-01311-7
Dimensions AI	Effectiveness 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 Australia	2023	https://doi.org/10.1016/s2214-109x(23)00096-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically