Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years

doi:10.1186/s12889-019-7058-9

Randomized Controlled Trial

. 2019 Jun 13;19(1):739.

doi: 10.1186/s12889-019-7058-9.

Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years

Li Ming Wen^{1

2

3

4}, Chris Rissel^{5

6

7}, Huilan Xu⁸, Sarah Taki^{8

6}, Wendy Smith^{8

9}, Karen Bedford⁸, Alison J Hayes^{5

6}, Philayrath Phongsavan⁵, Judy M Simpson⁵, Miranda J Shaw^{9

10}, Renee Moreton⁸, Louise A Baur^{5

6

11}

Affiliations

¹ Health Promotion Unit, Population Health, Sydney Local Health District, Level 9, King George V Building, Missenden Road, Camperdown, Sydney, New South Wales, 2050, Australia. liming.wen@health.nsw.gov.au.
² Sydney School of Public Health, Faculty of Medicine and Health, and the Charles Perkins Centre, the University of Sydney, Camperdown, Sydney, New South Wales, Australia. liming.wen@health.nsw.gov.au.
³ NHMRC Centre of Research Excellence in the Early Prevention of Obesity in Childhood (EPOCH), Charles Perkins Centre, The University of Sydney, Camperdown, Sydney, New South Wales, Australia. liming.wen@health.nsw.gov.au.
⁴ Sydney Institute for Women, Children & their Families, Sydney Local Health District, Camperdown, Sydney, New South Wales, Australia. liming.wen@health.nsw.gov.au.
⁵ Sydney School of Public Health, Faculty of Medicine and Health, and the Charles Perkins Centre, the University of Sydney, Camperdown, Sydney, New South Wales, Australia.
⁶ NHMRC Centre of Research Excellence in the Early Prevention of Obesity in Childhood (EPOCH), Charles Perkins Centre, The University of Sydney, Camperdown, Sydney, New South Wales, Australia.
⁷ NSW Office of Preventive Health, Ministry of Health, St Leonards, Sydney, New South Wales, Australia.
⁸ Health Promotion Unit, Population Health, Sydney Local Health District, Level 9, King George V Building, Missenden Road, Camperdown, Sydney, New South Wales, 2050, Australia.
⁹ Community Health Services, Sydney Local Health District, Camperdown, Sydney, New South Wales, Australia.
¹⁰ Sydney Institute for Women, Children & their Families, Sydney Local Health District, Camperdown, Sydney, New South Wales, Australia.
¹¹ Discipline of Child & Adolescent Health, The University of Sydney, Camperdown, Sydney, New South Wales, Australia.

PMID: 31196026
PMCID: PMC6567558
DOI: 10.1186/s12889-019-7058-9

Randomized Controlled Trial

Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years

Li Ming Wen et al. BMC Public Health. 2019.

. 2019 Jun 13;19(1):739.

doi: 10.1186/s12889-019-7058-9.

Authors

Affiliations

¹ Health Promotion Unit, Population Health, Sydney Local Health District, Level 9, King George V Building, Missenden Road, Camperdown, Sydney, New South Wales, 2050, Australia. liming.wen@health.nsw.gov.au.
² Sydney School of Public Health, Faculty of Medicine and Health, and the Charles Perkins Centre, the University of Sydney, Camperdown, Sydney, New South Wales, Australia. liming.wen@health.nsw.gov.au.
³ NHMRC Centre of Research Excellence in the Early Prevention of Obesity in Childhood (EPOCH), Charles Perkins Centre, The University of Sydney, Camperdown, Sydney, New South Wales, Australia. liming.wen@health.nsw.gov.au.
⁴ Sydney Institute for Women, Children & their Families, Sydney Local Health District, Camperdown, Sydney, New South Wales, Australia. liming.wen@health.nsw.gov.au.
⁵ Sydney School of Public Health, Faculty of Medicine and Health, and the Charles Perkins Centre, the University of Sydney, Camperdown, Sydney, New South Wales, Australia.
⁶ NHMRC Centre of Research Excellence in the Early Prevention of Obesity in Childhood (EPOCH), Charles Perkins Centre, The University of Sydney, Camperdown, Sydney, New South Wales, Australia.
⁷ NSW Office of Preventive Health, Ministry of Health, St Leonards, Sydney, New South Wales, Australia.
⁸ Health Promotion Unit, Population Health, Sydney Local Health District, Level 9, King George V Building, Missenden Road, Camperdown, Sydney, New South Wales, 2050, Australia.
⁹ Community Health Services, Sydney Local Health District, Camperdown, Sydney, New South Wales, Australia.
¹⁰ Sydney Institute for Women, Children & their Families, Sydney Local Health District, Camperdown, Sydney, New South Wales, Australia.
¹¹ Discipline of Child & Adolescent Health, The University of Sydney, Camperdown, Sydney, New South Wales, Australia.

PMID: 31196026
PMCID: PMC6567558
DOI: 10.1186/s12889-019-7058-9

Abstract

Background: Beginning in 2017 we have conducted a 3-arm randomised controlled trial (RCT) to determine the effectiveness of an early obesity intervention in the first two years of life using either telephone or Short Message Service (SMS) support for mothers. The trial recruited 1155 mothers from their third trimester of pregnancy. This protocol is for a new trial to build on the existing trial using the mother-child dyads retained at 24 months for recruitment to the new RCT. The aim of this new trial is to test whether use of a combination of telephone and SMS interventions is effective in promoting healthy eating and physical activity, as well as reducing child body mass index (BMI) at 3 years of age.

Methods: We will conduct a parallel RCT with an estimated sample of 750 mother-child dyads retained from the existing trial at 24 months. Mothers who completed the 24 months survey, including a telephone survey and measurement of child's height and weight will be invited to participate in the new trial. Informed consent will be obtained at the 24 months survey. The participating mother-child dyads will then be randomly allocated to the intervention (combined telephone and text messaging intervention) or the control group. The intervention will comprise three staged telephone consultations and text messages after each of the three intervention booklets is mailed to mothers at specific time-points between two and three years of child age. The main trial outcome measures include a) BMI and BMI z-score measured at 36 months, b) diet, physical activity and screen time c) cost-effectiveness, and d) feasibility and acceptability of the intervention.

Discussion: This unique opportunity to link two studies will expedite project start up time, utilise existing research infrastructure and systems to run the study, and optimise the use of an already engaged population of study participants. It can address a significant knowledge gap regarding early obesity prevention for children aged 2 to 3 years. The feasibility and effectiveness of the combined telephone and SMS intervention will indicate whether this is a scaleable, broad-reach and low-cost early obesity intervention.

Trial registration: The trial was registered with the Australian Clinical Trial Registry ( ACTRN12618001571268 ) on 20/09/2018.

Keywords: Body mass index; Children; Obesity; Prevention; Randomised controlled trial; Telephone consultation; Text messaging.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
Study Designs of Study 1 and 2

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References

1. World Health Organization, 2015. Interim report of the commission on ending childhood obesity (no. WHO/NMH/PND/ECHO/15.1). World Health Organization.
1. NCD Risk Factor Collaboration Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017;390(10113):2627–2642. doi: 10.1016/S0140-6736(17)32129-3. - DOI - PMC - PubMed
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[1] World Health Organization, 2015. Interim report of the commission on ending childhood obesity (no. WHO/NMH/PND/ECHO/15.1). World Health Organization.

[2] World Health Organization, 2015. Interim report of the commission on ending childhood obesity (no. WHO/NMH/PND/ECHO/15.1). World Health Organization.

[3] NCD Risk Factor Collaboration Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017;390(10113):2627–2642. doi: 10.1016/S0140-6736(17)32129-3. - DOI - PMC - PubMed

[4] NCD Risk Factor Collaboration Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017;390(10113):2627–2642. doi: 10.1016/S0140-6736(17)32129-3. - DOI - PMC - PubMed

[5] ABS . National Health Survey: First Results, 2014–15. ABS cat, no. 4364.0.55.001. Canberra: Australian Bureau of Statistics; 2015.

[6] ABS . National Health Survey: First Results, 2014–15. ABS cat, no. 4364.0.55.001. Canberra: Australian Bureau of Statistics; 2015.

[7] World Health Organisation 2013. Global Database on Child Growth and Malnutrition http://www.who.int/nutgrowthdb/database/countries/who_standards/aus_dat.... 2019-04-15. Available online only.

[8] World Health Organisation 2013. Global Database on Child Growth and Malnutrition http://www.who.int/nutgrowthdb/database/countries/who_standards/aus_dat.... 2019-04-15. Available online only.

[9] Baidal JAW, Locks LM, Cheng ER, Blake-Lamb TL, Perkins ME, Taveras EM. Risk factors for childhood obesity in the first 1,000 days: a systematic review. Am J Prev Med. 2016;50(6):761–779. doi: 10.1016/j.amepre.2015.11.012. - DOI - PubMed

[10] Baidal JAW, Locks LM, Cheng ER, Blake-Lamb TL, Perkins ME, Taveras EM. Risk factors for childhood obesity in the first 1,000 days: a systematic review. Am J Prev Med. 2016;50(6):761–779. doi: 10.1016/j.amepre.2015.11.012. - DOI - PubMed

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Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years

Affiliations

Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years

Authors

Affiliations

Abstract

Conflict of interest statement

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