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Trial registered on ANZCTR

Registration number

ACTRN12616001470482

Ethics application status

Approved

Date submitted

1/09/2016

Date registered

21/10/2016

Date last updated

29/08/2019

Date data sharing statement initially provided

29/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Translating research evidence from the Healthy Beginnings Trial to prevent childhood obesity at the beginning of life: feasibility, effectiveness and cost-effectiveness

Scientific title

A Three Arm RCT of Communicating Healthy Beginnings Advice by Telephone (CHAT) to Mothers with Infants to Prevent Childhood Obesity

Secondary ID [1]

NSW TRGS No. 200

Universal Trial Number (UTN)

Trial acronym

The CHAT study

Linked study record

ACTRN 12607000168459

Health condition

Health condition(s) or problem(s) studied:

Child overweight and obese

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a three arm randomised controlled trial

The proposed interventions are based upon the principles of the successful HBT intervention, to be delivered starting in the late antenatal period and over the first 24 months after birth (26 months). The timing of the staged intervention corresponds to milestones in early childhood development, in particular with regard to healthy feeding practices, nutrition and play as well as parent-child interactions. Below are the stages and contents of the interventions as well as intervention approaches:

3rd trimester:
Health benefits of breastfeeding; strategies to address breastfeeding barriers; importance of ‘tummy time’ - when and for how long; social support mechanisms.

1 month:
Breastfeeding support, overcome problems initiating breastfeeding; referral to Child and Family Health nurse team establishment of breastfeeding pattern and management of problems; if formula feeding - safe preparation; baby cues; sleep and settling routines; “tummy time”.

3 months:
Establishment of breastfeeding patterns; support & management of problems; “tummy time”; introduction of solids around 6 months; discuss breastfeeding and work; postnatal exercise and nutrition.

5-6 months:
Reinforce breastfeeding pattern; support management of problems; when and what food to introduce from around 6 months; encourage continued breastfeeding; activities that help develop baby’s strength & control – continue ‘tummy time’; avoid distractions like TV.

8-9 months:
Encourage sustained breastfeeding; advice on balanced infant feeding; healthy snack ideas; quantity & variety of fruits and veg; introduce cup feeding; discuss healthy drinks; maternal-child relationship & feeding.

10-11 months:
Encourage active play and motor skills development; discuss play ideas and screen time

12-15 months:
Toddler nutrition including continuing breastfeeding and introducing family foods; toddler play and screen time, development of motor skill, emotional, social and language; immunisation

15-18 months
Reinforce toddler nutrition, establish healthy eating behaviour, food label reading and food marketing; reinforce toddler play, screen time and development

18-24 months
Toddler nutrition including milk feeding, lunch box ideas, portions, healthy meals and snack ideas; reinforce toddler play, screen time and development including positive rewards and managing tantrums

The SMS + Mail-outs intervention: Written materials and checklists will be posted according to the developmental stage of the main issues at set times (3rd trimester, 1 month, 3 months, 5-6 months, 8-9 months, 10-11 months, 12-15 months, 15-18 months, 18-24 months). The resources will be translated into Arabic or Chinese if indicated. Following the postage of the stage-specific intervention resource, mothers will be sent text messages to reinforce the health promotion messages 2 times/week for 4 weeks. We will employ three part-time research nurses to deliver both SMS and telephone support interventions. The SMS and telephone support will not be administered in Arabic or Chinese.

The telephone support + Mail-outs intervention: Following each posting of materials, the research nurses will contact mothers via phone to discuss the health promotion messages and address mothers’ concerns and needs regarding healthy beginnings of life and childhood obesity. It is anticipated that the duration of each telephone session will be ~20 minutes.

Ongoing process evaluations will be conducted by research officers supervised by research advisory committee.

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

Mothers in the control group will only receive usual care, which all new mothers (including the intervention mothers) receive, provided by the Local Health District Child & Family Health nursing service. To maximise the retention rate, we will post home safety promotion materials and a newsletter on “Kids’ Safety” to the control group 4 times within 14 months, as occurred in the previous Healthy Beginnings Trial, in order to keep them engaged in the study.

Control group

Active

Outcomes

Primary outcome [1]

Children's BMI

Timepoint [1]

at 12 and 24 months of age

Primary outcome [2]

Breastfeeding duration self-reported by mother in study-specific survey

Timepoint [2]

at 6 months and 12 months of age

Primary outcome [3]

timing of introduction of solids self-reported by mother in study-specific survey

Timepoint [3]

at 6 months of age

Secondary outcome [1]

time of starting tummy time and frequency of tummy time self-reported by mother in study-specific survey

Timepoint [1]

at 6 months of age

Secondary outcome [2]

whether child starts drinking from a cup self-reported by mother in study-specific survey

Timepoint [2]

at 12 months of age

Secondary outcome [3]

screen-time self-reported by mother in study-specific survey

Timepoint [3]

at 12 and 24 months of age

Secondary outcome [4]

outdoor playtime on a typical weekday and a weekend day self-reported by mother in study-specific survey

Timepoint [4]

at 12 and 24 months of age

Secondary outcome [5]

dietary/nutrition (daily or weekly vegetable, fruit, soft drink, fast food consumption) self-reported by mother in study-specific survey

Timepoint [5]

at 12 and 24 months of age

Secondary outcome [6]

Whether use food for reward self-reported by mother in study-specific survey

Timepoint [6]

at 12 and 24 months of age

Secondary outcome [7]

Whether using bottle to go to bed self-reported by mother in study-specific survey

Timepoint [7]

at 12 months of age

Eligibility

Key inclusion criteria

Women will be eligible to participate if they are aged 16 years and over, at third trimester, are able to communicate in English (or can communicate with written information in Chinese or Arabic), have a mobile phone and live in the recruitment areas.

Minimum age

16 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Women will be excluded from the study if they have a severe medical condition based on advice given by their doctors. Women who cannot give informed consent, and those with babies with known major fetal anomalies will also be excluded.

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

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The random allocation will be determined by a standard concealment with a computer generated random number using random permuted blocks, stratified by Local Health District. 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

a three arm RCT

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

With a Type I error rate=0.05 and 80% power, a sample size of 288 for per group is needed to detect a difference in mean body mass index (BMI) of 0.35 units between the intervention and control groups at age 2 years. This was based on a conservative estimate of mean effect size of 0.35 in BMI with standard deviation of 1.5 from the Healthy Beginnings Trial. To allow for an estimated 20% lost to follow-up, a total of 360 participants will be needed in each group. Therefore, the sample size will be 1080 in total.

Outcomes will be compared between the intervention group and the control group using intention-to-treat principles and CONSORT guidelines. For continuous variables, means will be compared using t-tests .For categorical variables, chi-squared tests will be used. Survival analysis will be used for breastfeeding time: Kaplan-Meier curves will be used to estimate median breastfeeding time and log-rank tests will be used to compare groups.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

16/01/2017

Actual

23/02/2017

Date of last participant enrolment

Anticipated

31/07/2017

Actual

27/07/2017

Date of last data collection

Anticipated

30/09/2020

Actual

Sample size

Target

1080

Accrual to date

Final

1155

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Liverpool Hospital - Liverpool

Recruitment hospital [3]

Canterbury Hospital - Campsie

Recruitment hospital [4]

St George Hospital - Kogarah

Recruitment hospital [5]

Campbelltown Hospital - Campbelltown

Recruitment hospital [6]

Queanbeyan District Hospital - Queanbeyan

Recruitment hospital [7]

Royal Hospital for Women - Randwick

Recruitment postcode(s) [1]

2050 - Camperdown

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]

2620 - Queanbeyan

Recruitment postcode(s) [7]

2031 - Randwick

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

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) (EC00113)

Ethics committee address [1]

Research Development Office
RPAH Medical Centre
Suite 210A
100 Carillon Avenue
NEWTOWN NSW 2042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/08/2016

Approval date [1]

17/10/2016

Ethics approval number [1]

640008 Dec 11

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 7 years we have developed, implemented and evaluated an early obesity intervention program funded by NHMRC. The project tilted 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 propose this study to promote healthy infant feeding and active play using telephone support and Short Message Service (SMS).

The proposed study aims to test the effectiveness of telephone support or SMS with mail-outs in reducing child BMI z-score, promoting healthy infant feeding practice and active play in the first 24 months of life; and examine the cost-effectiveness of these interventions.

We hypothesise that the staged early intervention using either mailed self-motivating written materials plus SMS or plus telephone support delivered in the antenatal period and over the first 24 months of life, relative to usual care, will:

1) lead to reduced child BMI z-score and rapid weight gain at age 12 and 24 months compared to usual care.
2) improve infant feeding practices and decrease the prevalence of obesity-related behaviours at 12 and 24 months compared to usual care.
3) be more cost-effective compared to usual care, and SMS will be more cost-effective than telephone support.

Both qualitative and quantitative methods will be used in this study. A total of 1155 women at late pregnancy were recruited from main hospitals in four Local Health Districts. They were randomly allocated to one of three arms. Randomisation was stratified by Local Health District. Telephone surveys were used to collect data at baseline, 6 months, 12 months, and will be used at 24 months. Children’s weight and length at 24 months will be measured by research nurses.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Li Ming Wen

Address

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

LiMing.Wen@health.nsw.gov.au

Contact person for public queries

Name

Li Ming Wen

Address

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

liming.wen@health.nsw.gov.au

Contact person for scientific queries

Name

Li Ming Wen

Address

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

liming.wen@health.nsw.gov.au

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 data 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 analysis.

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	Link	Email	Other Details	Attachment
4297	Study protocol	Wen, L., Rissel, C., Baur, L., Hayes, A., Xu, H., Whelan, A., Hua, M., Shaw, M., Phongsavan, P. (2017). A 3-Arm randomised controlled trial of Communicating Healthy Beginnings Advice by Telephone (CHAT) to mothers with infants to prevent childhood obesity. BMC Public Health, 17(1), 1-10.				371401-(Uploaded-26-08-2019-09-53-55)-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

Source	Title	Year of Publication	DOI
Embase	Facilitators and challenges in recruiting pregnant women to an infant obesity prevention programme delivered via telephone calls or text messages.	2018	https://dx.doi.org/10.1186/s13063-018-2871-5
Embase	Sources of information and the use of mobile applications for health and parenting information during pregnancy: Implications for health promotion.	2021	https://dx.doi.org/10.1177/14604582211043146

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

Trial Review

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