NCT05099900

Brief Summary

This study seek to understand the motivations and contextual influences that can induce and sustain behaviour change to inform future interventions for women before, during and after pregnancy, through a qualitative interview-based assessment of 60 participants. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2022

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

September 15, 2021

Last Update Submit

November 8, 2021

Conditions

Keywords

User experienceTechnology usageQualitative studyDigital healthObesityGestational WeightGestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Experiences and technology usage among women

    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.

    1 year

Study Arms (3)

Pre-pregnancy

During pregnancy

Post-pregnancy

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who are 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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The N.1 Institute for Health (N.1), NUS, Singapore

Singapore, 117456, Singapore

RECRUITING

National University Hospital

Singapore, 119074, Singapore

NOT YET RECRUITING

Related Publications (16)

  • 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.

    PMID: 22548595BACKGROUND
  • 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.

    PMID: 17713848BACKGROUND
  • 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.

    PMID: 28586887BACKGROUND
  • 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.

    PMID: 31409285BACKGROUND
  • 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.

    PMID: 31185012BACKGROUND
  • 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.

    PMID: 27590385BACKGROUND
  • 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.

    PMID: 28724518BACKGROUND
  • 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.

    PMID: 27855382BACKGROUND
  • Lindlof TR, Taylor BC. Sensemaking: Qualitative data analysis and interpretation. Qualitative communication research methods. 2011;3(1):241-81.

    BACKGROUND
  • 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.

    PMID: 28903892BACKGROUND
  • 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.

    PMID: 29164765BACKGROUND
  • Singapore Department of Statistics. (2010). Census of Population 2010. Retrieved from: http:// www.singstat.gov.sg/publications/publications-and-papers/population/census10_admin

    BACKGROUND
  • 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.

    PMID: 19055539BACKGROUND
  • 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.

    PMID: 30742624BACKGROUND
  • 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.

    PMID: 31452666BACKGROUND
  • Ng WY, Lau NY, Lee VV, Vijayakumar S, Leong QY, Ooi SQD, Su LL, Lee YS, Chan SY, Blasiak A, Ho D. Shaping Adoption and Sustained Use Across the Maternal Journey: Qualitative Study on Perceived Usability and Credibility in Digital Health Tools. JMIR Hum Factors. 2024 Oct 1;11:e59269. doi: 10.2196/59269.

MeSH Terms

Conditions

ObesityDiabetes, Gestational

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Dean Ho, Prof

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Tadeo, PhD

CONTACT

Yoong Hun Ong, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 29, 2021

Study Start

November 8, 2021

Primary Completion

May 8, 2022

Study Completion

November 8, 2022

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations