Effects of an integrated mobile health lifestyle intervention among overweight and obese women planning for pregnancy in Singapore: protocol for the single-arm Healthy Early Life Moments in Singapore (HELMS) study
Effects of an integrated mobile health lifestyle intervention among overweight and obese women planning for pregnancy in Singapore: protocol for the single-arm Healthy Early Life Moments in Singapore (HELMS) study
Introduction Changes in social and lifestyle factors have led to increasing rates of metabolic and mental health problems. We hypothesise that a transformation of the current maternal and child health system is required to deliver interventions that effectively promote a good start to life in populations at risk of metabolic and mental health problems. We describe a single-arm implementation study 'Healthy Early Life Moments in Singapore', which aims to examine whether an integrated lifestyle intervention initiated at preconception and continuing throughout pregnancy and postpartum periods can improve the metabolic and mental health of overweight and obese women, and improve early child growth. Methods and analysis This single-centre implementation trial is conducted at KK Women's and Children's Hospital, Singapore. The trial aims to recruit 500 women, aged 21-40 years with a body mass index of 25-40 kg/m 2 who plan to get pregnant, with interventions delivered before conception, until 18 months postdelivery. Primary outcomes comprise pregnancy rate, maternal metabolic and mental health status. Secondary outcomes include maternal reproductive health, pregnancy outcomes and offspring growth. The intervention will be delivered using a mobile health application, to provide anticipatory guidance, raise awareness and guide goal-setting on lifestyle behaviours that include diet, physical activity, mental wellness and sleep hygiene from preconception to postpartum. Women who conceive within 1 year of recruitment will be followed through pregnancy and studied with their infants at six-time points during the first 18 months of life. Questionnaires, anthropometric measurements and multiple biosamples will be collected at each visit. Ethics and dissemination The study has been approved by the Centralised Institutional Review Board of SingHealth (2021/2247). Written informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and disseminated to national and international policy makers. Trial registration number NCT05207059.
MENTAL HEALTH, NUTRITION & DIETETICS, Other metabolic, e.g. iron, porphyria
Chan, Jerry Kok Yen
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Ku, Chee Wai
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Loy, See Ling
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Godfrey, Keith
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Fan, Yiping
acc4b60c-c4bc-4f48-a875-57258b39a5a2
Chua, Mei Chien
bafc2416-91c8-47b6-8301-bc1b41b1d6c1
Yap, Fabian
22f6b954-31fc-4696-a52b-e985a424b95b
12 December 2022
Chan, Jerry Kok Yen
42e59d61-c3d1-486b-b33a-22c4645acf12
Ku, Chee Wai
dfc052e9-1c22-473f-b11d-ed82b15b9ca6
Loy, See Ling
6fd10b64-1de2-419e-a5f4-b505be233e6e
Godfrey, Keith
0931701e-fe2c-44b5-8f0d-ec5c7477a6fd
Fan, Yiping
acc4b60c-c4bc-4f48-a875-57258b39a5a2
Chua, Mei Chien
bafc2416-91c8-47b6-8301-bc1b41b1d6c1
Yap, Fabian
22f6b954-31fc-4696-a52b-e985a424b95b
Chan, Jerry Kok Yen, Ku, Chee Wai, Loy, See Ling, Godfrey, Keith, Fan, Yiping, Chua, Mei Chien and Yap, Fabian
(2022)
Effects of an integrated mobile health lifestyle intervention among overweight and obese women planning for pregnancy in Singapore: protocol for the single-arm Healthy Early Life Moments in Singapore (HELMS) study.
BMJ Open, 12 (12), [e061556].
(doi:10.1136/bmjopen-2022-061556).
Abstract
Introduction Changes in social and lifestyle factors have led to increasing rates of metabolic and mental health problems. We hypothesise that a transformation of the current maternal and child health system is required to deliver interventions that effectively promote a good start to life in populations at risk of metabolic and mental health problems. We describe a single-arm implementation study 'Healthy Early Life Moments in Singapore', which aims to examine whether an integrated lifestyle intervention initiated at preconception and continuing throughout pregnancy and postpartum periods can improve the metabolic and mental health of overweight and obese women, and improve early child growth. Methods and analysis This single-centre implementation trial is conducted at KK Women's and Children's Hospital, Singapore. The trial aims to recruit 500 women, aged 21-40 years with a body mass index of 25-40 kg/m 2 who plan to get pregnant, with interventions delivered before conception, until 18 months postdelivery. Primary outcomes comprise pregnancy rate, maternal metabolic and mental health status. Secondary outcomes include maternal reproductive health, pregnancy outcomes and offspring growth. The intervention will be delivered using a mobile health application, to provide anticipatory guidance, raise awareness and guide goal-setting on lifestyle behaviours that include diet, physical activity, mental wellness and sleep hygiene from preconception to postpartum. Women who conceive within 1 year of recruitment will be followed through pregnancy and studied with their infants at six-time points during the first 18 months of life. Questionnaires, anthropometric measurements and multiple biosamples will be collected at each visit. Ethics and dissemination The study has been approved by the Centralised Institutional Review Board of SingHealth (2021/2247). Written informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and disseminated to national and international policy makers. Trial registration number NCT05207059.
Text
e061556.full
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More information
Accepted/In Press date: 15 November 2022
Published date: 12 December 2022
Additional Information:
Funding Information:
KG and YF received reimbursement for speaking at conferences sponsored by companies that sell nutritional products. KG is part of an academic consortium that received research funding from Abbott Nutrition, Nestle and Danone. All other authors declare no competing interests.
Funding Information:
This research was supported by the KKH Health Services Model of Care Transformation Fund (MoCTF) Grant (MoCTF/01/2020, MoCTF/02/2020 and MoCTF/03/2020) and the Lien Foundation Optimising Maternal and Child Health Programme Fund (grant number not applicable). CWK and JC are supported by the National Medical Research Council, Ministry of Health, Singapore (NMRC/MOH-000596-00 and NMRC/CSA-SI-008-2016, respectively). KG is supported by the National Institute for Health Research (NIHR Senior Investigator (NF-SI-0515-10042), NIHR Southampton 1000DaysPlus Global Nutrition Research Group (17/63/154) and NIHR Southampton Biomedical Research Center (IS-BRC-1215-20004), British Heart Foundation (RG/15/17/3174) and the European Union (Erasmus+ Programme ImpENSA 598488-EPP-1-2018-1-DE-EPPKA2-CBHE-JP).
Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Keywords:
MENTAL HEALTH, NUTRITION & DIETETICS, Other metabolic, e.g. iron, porphyria
Identifiers
Local EPrints ID: 473014
URI: http://eprints.soton.ac.uk/id/eprint/473014
ISSN: 2044-6055
PURE UUID: c438679f-fc76-4192-9cc9-23d0c77a4012
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Date deposited: 06 Jan 2023 18:10
Last modified: 17 Mar 2024 02:38
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Contributors
Author:
Jerry Kok Yen Chan
Author:
Chee Wai Ku
Author:
See Ling Loy
Author:
Yiping Fan
Author:
Mei Chien Chua
Author:
Fabian Yap
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