Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

IMPACT DIABETES B2B Collaboration Group, Sharleen L O'Reilly, Christy Burden, Cristina Campoy, Fionnuala M McAuliffe, Helena Teede, Jesper Andresen, Karen J Campbell, Aisling A Geraghty, Cheryce L Harrison, Rachel Laws, Jane E Norman, Helle T Maindal, Karsten Vrangbæk, Ricardo Segurado, Vincent L Versace, Timothy C Skinner

Research output: Contribution to journalArticle (Academic Journal)peer-review

10 Citations (Scopus)
50 Downloads (Pure)

Abstract

BACKGROUND: Gestational diabetes (GDM) impacts 8-18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM.

METHODS: Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks' gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received.

DISCUSSION: Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020.

Original languageEnglish
Article number963
Number of pages15
JournalTrials
Volume22
Issue number1
DOIs
Publication statusPublished - 28 Dec 2021

Bibliographical note

Funding Information:
This project is funded by the European Union Commission Horizon 2020 grant entitled ‘Implementation Action to Prevent Diabetes From Bump 2 Baby (IMPACT DIABETES B2B)’ under grant agreement 847984, with collaborative National Health and Medical Research Council, Australia co-funding under grant number APP1194234. The project is sponsored by the University College Dublin. The funders and the sponsor have no role in the design of the study; the collection, analysis, and interpretation of the data; or writing of the manuscript or decision to publish. Financial audits are carried out by the European Union Commission.

Publisher Copyright:
© 2021, The Author(s).

Keywords

  • Australia
  • Child
  • Diabetes Mellitus, Type 2
  • Diabetes, Gestational/diagnosis
  • Female
  • Gestational Weight Gain
  • Humans
  • Infant, Newborn
  • Mentoring
  • Multicenter Studies as Topic
  • Pregnancy
  • Pregnancy Complications/diagnosis
  • Randomized Controlled Trials as Topic
  • Telemedicine

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