- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05099900
Exploration of Women's Experiences and Technology Usage Before, During, and After Pregnancy in Singapore
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
Maternal overweight and obesity is a growing public health concern in Singapore. A recent Singaporean prospective cohort study examined 724 pregnant women and reported that 26.2% of the women had a total gestational weight gain (GWG) which exceed the Institute of Medicine's (IOM) 2009 guidelines. When examined based on body mass index (BMI), overweight and obese women had significantly increased risk of gaining gestational weight above IOM recommendations, compared to normal weight women. Higher GWG have previously been linked to adverse maternal and infant outcomes including higher rates of gestational diabetes mellitus (GDM) and primary caesarean delivery, large for age (LGA) infant, macrosomia and increased risk of childhood overweight/obesity. Given the impact of maternal GWG on pregnancy and infant outcomes, there is a need for a targeted behavioural intervention. As effective health behaviour change requires early initiation and maintenance of change, women before, during and after pregnancy should be targeted. Furthermore, high pre-pregnancy BMI have been shown to be linked with increased risk of GDM and type 2 diabetes post-delivery, and higher infant birthweight, child obesity and atypical child neurodevelopment. Accordingly, this highlights the need for early behavioural intervention beginning with women trying to get pregnant. Current studies have focused predominantly on individual factors contributing to maternal obesity in relation to infant outcomes, both immediately postpartum and prospectively into early childhood. Based on Bronfenbrenner's ecological model, key contextual factors involving the micro-, meso-, exo-, macro- and chronosystem are important factors contributing to the efficacy of digital means on health behavioural change among pregnant women. From this theoretical orientation, understanding individual factors involving motivation and contextual influences is central to facilitating health behaviour change. Specifically, elucidating the proximal (e.g. peers, family) and distal factors (e.g. community, health services) embedded within specific cultural contexts ensure sustainability of behaviour change among pregnant women.
As Singapore is a culturally diverse society, there is a need to understand the impact of cultural factors on maternal behaviours and decision making. Accordingly, the current study will consist of a qualitative assessment of 60 participants who will undergo semi-structured interviews with the aim to understand motivations and contextual influences that induce and sustain behaviour change, so as to inform future interventions for women before, during and after pregnancy. As digital health intervention in pregnant women has been shown to be cost-effective and scalable, the current study also aims to understand women's usage of technology throughout the process of trying to conceive, being pregnant and being a new mother within the local Singapore context.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Xavier Tadeo, PhD
- Puhelinnumero: +65 66017766
- Sähköposti: lsixtc@nus.edu.sg
Tutki yhteystietojen varmuuskopiointi
- Nimi: Yoong Hun Ong, MSc
- Puhelinnumero: +65 66017766
- Sähköposti: yoong@nus.edu.sg
Opiskelupaikat
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Singapore, Singapore, 119074
- Ei vielä rekrytointia
- National University Hospital
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Ottaa yhteyttä:
- Delicia Shu Qin Ooi, PhD
- Sähköposti: paeosqd@nus.edu.sg
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Ottaa yhteyttä:
- Maria Catherine Dado Celes
- Sähköposti: obgcmcd@nus.edu.sg
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Päätutkija:
- Shiao-Yng Chan, PhD
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Alatutkija:
- Yung Seng Lee, PhD
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Alatutkija:
- Yijuan, Yvonne Lim, MMed
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Alatutkija:
- Anjian, Andrew Sng, MMed
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Alatutkija:
- Nicholas Beng Hui Ng, MMed
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Alatutkija:
- Lin Lin Su, MMed
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Alatutkija:
- Delicia Shu Qin Ooi, PhD
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Singapore, Singapore, 117456
- Rekrytointi
- The N.1 Institute for Health (N.1), NUS, Singapore
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Ottaa yhteyttä:
- Xavier Tadeo, PhD
- Sähköposti: lsixtc@nus.edu.sg
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Ottaa yhteyttä:
- Yoong Hun Ong, MSc
- Sähköposti: yoong@nus.edu.sg
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Alatutkija:
- V Vien Lee, PhD
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Alatutkija:
- Smrithi Vijayakumar, PhD
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Alatutkija:
- Qiao Ying Leong, BSc
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Alatutkija:
- Johan Eriksson, Prof
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Alatutkija:
- Yoann Sapanel, MBA
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Alatutkija:
- Ni Yin Lau, BSocSci (Hons)
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Alatutkija:
- Wei Ying Ng, BSocSci (Hons)
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- English fluency;
- Aged 21 years and above;
- Actively trying to conceive (pre-pregnancy) or currently in first to third trimester of pregnancy (during pregnancy) or have a child aged 0-2 years (post-pregnancy).
Exclusion Criteria:
- Evidence/diagnosis of cognitive impairment (e.g. history of dementia, intellectual disability, traumatic brain injury);
- Current diagnosis of psychiatric disorder (e.g. severe anxiety, depression, schizophrenia);
- Significant hearing impairment;
- Inability to complete the study at the judgement of the clinician investigators;
- Women requiring or who had any form of assisted conception.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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Pre-pregnancy
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During pregnancy
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Post-pregnancy
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Experiences and technology usage among women
Aikaikkuna: 1 year
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We will conduct semi-structured interviews with women who are either trying to conceive, pregnant or have a child aged 0 to 2 years.
The interviews seek to find out about the participants' pregnancy/maternal-related experiences including the challenges faced, lifestyle changes made, support systems and experience with the health system.
Participants will also be asked about their previous and current experiences with technology usage, such as the type of technology used and the purposes of technology usage.
Additionally, there will also be two questionnaires, conducted pre- and post-interview, on the participants' demographics and their opinions on technical aspects of digital platforms.
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1 year
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Dean Ho, Prof, National University of Singapore
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Goldstein RF, Abell SK, Ranasinha S, Misso M, Boyle JA, Black MH, Li N, Hu G, Corrado F, Rode L, Kim YJ, Haugen M, Song WO, Kim MH, Bogaerts A, Devlieger R, Chung JH, Teede HJ. Association of Gestational Weight Gain With Maternal and Infant Outcomes: A Systematic Review and Meta-analysis. JAMA. 2017 Jun 6;317(21):2207-2225. doi: 10.1001/jama.2017.3635.
- International Weight Management in Pregnancy (i-WIP) Collaborative Group. Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials. BMJ. 2017 Jul 19;358:j3119. doi: 10.1136/bmj.j3119. Erratum In: BMJ. 2017 Aug 23;358:j3991.
- Torloni MR, Betran AP, Horta BL, Nakamura MU, Atallah AN, Moron AF, Valente O. Prepregnancy BMI and the risk of gestational diabetes: a systematic review of the literature with meta-analysis. Obes Rev. 2009 Mar;10(2):194-203. doi: 10.1111/j.1467-789X.2008.00541.x. Epub 2008 Nov 24.
- Evans WD, Abroms LC, Poropatich R, Nielsen PE, Wallace JL. Mobile health evaluation methods: the Text4baby case study. J Health Commun. 2012;17 Suppl 1:22-9. doi: 10.1080/10810730.2011.649157.
- Frederick IO, Williams MA, Sales AE, Martin DP, Killien M. Pre-pregnancy body mass index, gestational weight gain, and other maternal characteristics in relation to infant birth weight. Matern Child Health J. 2008 Sep;12(5):557-67. doi: 10.1007/s10995-007-0276-2. Epub 2007 Aug 23.
- He S, Allen JC, Razali NS, Win NM, Zhang JJ, Ng MJ, Yeo GSH, Chern BSM, Tan KH. Are women in Singapore gaining weight appropriately during pregnancy: a prospective cohort study. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):290. doi: 10.1186/s12884-019-2443-z.
- Heslehurst N, Vieira R, Akhter Z, Bailey H, Slack E, Ngongalah L, Pemu A, Rankin J. The association between maternal body mass index and child obesity: A systematic review and meta-analysis. PLoS Med. 2019 Jun 11;16(6):e1002817. doi: 10.1371/journal.pmed.1002817. eCollection 2019 Jun.
- Hung TH, Hsieh TT. Pregestational body mass index, gestational weight gain, and risks for adverse pregnancy outcomes among Taiwanese women: A retrospective cohort study. Taiwan J Obstet Gynecol. 2016 Aug;55(4):575-81. doi: 10.1016/j.tjog.2016.06.016.
- Gaillard R, Santos S, Duijts L, Felix JF. Childhood Health Consequences of Maternal Obesity during Pregnancy: A Narrative Review. Ann Nutr Metab. 2016;69(3-4):171-180. doi: 10.1159/000453077. Epub 2016 Nov 18.
- Lindlof TR, Taylor BC. Sensemaking: Qualitative data analysis and interpretation. Qualitative communication research methods. 2011;3(1):241-81.
- Redman LM, Gilmore LA, Breaux J, Thomas DM, Elkind-Hirsch K, Stewart T, Hsia DS, Burton J, Apolzan JW, Cain LE, Altazan AD, Ragusa S, Brady H, Davis A, Tilford JM, Sutton EF, Martin CK. Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 2017 Sep 13;5(9):e133. doi: 10.2196/mhealth.8228.
- Sanchez CE, Barry C, Sabhlok A, Russell K, Majors A, Kollins SH, Fuemmeler BF. Maternal pre-pregnancy obesity and child neurodevelopmental outcomes: a meta-analysis. Obes Rev. 2018 Apr;19(4):464-484. doi: 10.1111/obr.12643. Epub 2017 Nov 22.
- Singapore Department of Statistics. (2010). Census of Population 2010. Retrieved from: http:// www.singstat.gov.sg/publications/publications-and-papers/population/census10_admin
- Voerman E, Santos S, Patro Golab B, Amiano P, Ballester F, Barros H, Bergstrom A, Charles MA, Chatzi L, Chevrier C, Chrousos GP, Corpeleijn E, Costet N, Crozier S, Devereux G, Eggesbo M, Ekstrom S, Fantini MP, Farchi S, Forastiere F, Georgiu V, Godfrey KM, Gori D, Grote V, Hanke W, Hertz-Picciotto I, Heude B, Hryhorczuk D, Huang RC, Inskip H, Iszatt N, Karvonen AM, Kenny LC, Koletzko B, Kupers LK, Lagstrom H, Lehmann I, Magnus P, Majewska R, Makela J, Manios Y, McAuliffe FM, McDonald SW, Mehegan J, Mommers M, Morgen CS, Mori TA, Moschonis G, Murray D, Chaoimh CN, Nohr EA, Nybo Andersen AM, Oken E, Oostvogels AJJM, Pac A, Papadopoulou E, Pekkanen J, Pizzi C, Polanska K, Porta D, Richiardi L, Rifas-Shiman SL, Ronfani L, Santos AC, Standl M, Stoltenberg C, Thiering E, Thijs C, Torrent M, Tough SC, Trnovec T, Turner S, van Rossem L, von Berg A, Vrijheid M, Vrijkotte TGM, West J, Wijga A, Wright J, Zvinchuk O, Sorensen TIA, Lawlor DA, Gaillard R, Jaddoe VWV. Maternal body mass index, gestational weight gain, and the risk of overweight and obesity across childhood: An individual participant data meta-analysis. PLoS Med. 2019 Feb 11;16(2):e1002744. doi: 10.1371/journal.pmed.1002744. eCollection 2019 Feb.
- Wang X, Zhang X, Zhou M, Juan J, Wang X. Association of prepregnancy body mass index, rate of gestational weight gain with pregnancy outcomes in Chinese urban women. Nutr Metab (Lond). 2019 Aug 19;16:54. doi: 10.1186/s12986-019-0386-z. eCollection 2019.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 2021/00034
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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