Trial Review

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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
Date results information 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] 290043 0
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 300397 0
Condition category
Condition code
Diet and Nutrition 300268 300268 0 0
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] 295768 0
Behaviour
Intervention code [2] 295988 0
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] 299462 0
Children's BMI
Timepoint [1] 299462 0
at 12 and 24 months of age
Primary outcome [2] 299746 0
Breastfeeding duration self-reported by mother in study-specific survey
Timepoint [2] 299746 0
at 6 months and 12 months of age
Primary outcome [3] 299804 0
timing of introduction of solids self-reported by mother in study-specific survey
Timepoint [3] 299804 0
at 6 months of age
Secondary outcome [1] 327231 0
time of starting tummy time and frequency of tummy time self-reported by mother in study-specific survey
Timepoint [1] 327231 0
at 6 months of age
Secondary outcome [2] 327984 0
whether child starts drinking from a cup self-reported by mother in study-specific survey
Timepoint [2] 327984 0
at 12 months of age
Secondary outcome [3] 327985 0
screen-time self-reported by mother in study-specific survey
Timepoint [3] 327985 0
at 12 and 24 months of age
Secondary outcome [4] 327986 0
outdoor playtime on a typical weekday and a weekend day self-reported by mother in study-specific survey
Timepoint [4] 327986 0
at 12 and 24 months of age
Secondary outcome [5] 327987 0
dietary/nutrition (daily or weekly vegetable, fruit, soft drink, fast food consumption) self-reported by mother in study-specific survey
Timepoint [5] 327987 0
at 12 and 24 months of age
Secondary outcome [6] 328203 0
Whether use food for reward self-reported by mother in study-specific survey
Timepoint [6] 328203 0
at 12 and 24 months of age
Secondary outcome [7] 328204 0
Whether using bottle to go to bed self-reported by mother in study-specific survey
Timepoint [7] 328204 0
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?
No
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] 6592 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 6595 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 6596 0
Canterbury Hospital - Campsie
Recruitment hospital [4] 6597 0
St George Hospital - Kogarah
Recruitment hospital [5] 6599 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [6] 6600 0
Queanbeyan District Hospital - Queanbeyan
Recruitment hospital [7] 6845 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 14510 0
2031 - Randwick
Recruitment postcode(s) [2] 14199 0
2050 - Camperdown
Recruitment postcode(s) [3] 14202 0
2170 - Liverpool
Recruitment postcode(s) [4] 14203 0
2194 - Campsie
Recruitment postcode(s) [5] 14204 0
2217 - Kogarah
Recruitment postcode(s) [6] 14206 0
2560 - Campbelltown
Recruitment postcode(s) [7] 14207 0
2620 - Queanbeyan

Funding & Sponsors
Funding source category [1] 294435 0
Government body
Name [1] 294435 0
The NSW Ministry of Health Translational Research Grants Scheme
Country [1] 294435 0
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] 293288 0
Individual
Name [1] 293288 0
Prof Chris Rissel
Address [1] 293288 0
Level 6, The Hub, D17 Charles Perkins Centre, The University of Sydney, Camperdown, NSW 2006.
Country [1] 293288 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295865 0
SLHD Ethics Review Committee (RPAH Zone) (EC00113)
Ethics committee address [1] 295865 0
Research Development Office
RPAH Medical Centre
Suite 210A
100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 295865 0
Australia
Date submitted for ethics approval [1] 295865 0
23/08/2016
Approval date [1] 295865 0
17/10/2016
Ethics approval number [1] 295865 0
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 68662 0
A/Prof Li Ming Wen
Address 68662 0
Sydney Local Health District. Level 9 North, King George V Building, Missenden Rd. Camperdown. NSW. 2050.
Country 68662 0
Australia
Phone 68662 0
+61 2 95159055
Fax 68662 0
+61 2 95159056
Email 68662 0
LiMing.Wen@health.nsw.gov.au
Contact person for public queries
Name 68663 0
A/Prof Li Ming Wen
Address 68663 0
Sydney Local Health District. Level 9 North, King George V Building, Missenden Rd. Camperdown. NSW. 2050.
Country 68663 0
Australia
Phone 68663 0
+61 2 95159055
Fax 68663 0
+61 2 95159056
Email 68663 0
liming.wen@health.nsw.gov.au
Contact person for scientific queries
Name 68664 0
A/Prof Li Ming Wen
Address 68664 0
Sydney Local Health District. Level 9 North, King George V Building, Missenden Rd. Camperdown. NSW. 2050.
Country 68664 0
Australia
Phone 68664 0
+61 2 95159055
Fax 68664 0
+61 2 95159056
Email 68664 0
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.TypeCitationLinkEmailOther DetailsAttachment
4297Study protocolWen, 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
SourceTitleYear of PublicationDOI
EmbaseSources of information and the use of mobile applications for health and parenting information during pregnancy: Implications for health promotion.2021https://dx.doi.org/10.1177/14604582211043146
EmbaseFacilitators and challenges in recruiting pregnant women to an infant obesity prevention programme delivered via telephone calls or text messages.2018https://dx.doi.org/10.1186/s13063-018-2871-5
N.B. These documents automatically identified may not have been verified by the study sponsor.