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Trial from ANZCTR

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

  • Recruitment status at the time of last update
    Active, not recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 24/9/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616001470482

Date registered

21 October 2016

Health condition

Child overweight and obese

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales

Recruitment status

Active, not recruiting

Anticipated date of first participant enrolment

16 January 2017

Ethics application status

Approved

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.

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

Gender

Females

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.

Contact details and further information

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

Contact person for information and recruitment

A/Prof Li Ming Wen
Sydney Local Health District. Level 9 North, King George V Building, Missenden Rd. Camperdown. NSW. 2050.
Australia
+61 2 95159055
liming.wen@health.nsw.gov.au