Impact Diabetes Bump 2 Baby and Me
Research type
Research Study
Full title
Implementation action to prevent diabetes from Bump2Baby: A low-resource system of care intervention for appropriate gestational weight gain and improved postnatal outcomes.
IRAS ID
292039
Contact name
Christy Burden
Contact email
Sponsor organisation
University College Dublin
Clinicaltrials.gov Identifier
ACTRN12620001240932, Australia and New Zealand Clinical Trials Register
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
Objectives: This study will evaluate the effectiveness of an mHealth app-based coaching programme to support weight management in pregnant women who are at high risk of gestational diabetes, to deliver improved health outcomes in mother and their baby.
Design: This is a randomised trial across four sites (UK, Ireland, Australia, Spain- N in UK=200) where pregnant women will be allocated to receive the mHealth smartphone coaching application (app). The app will use video and text messaging, automated reminders and motivational messaging, and access to resources to manage weight gain, encourage breastfeeding, and support postpartum weight loss and prevent diabetes. Control participants will receive standard written information and links to approved websites on the prevention of gestational diabetes, managing weight gain, encouraging breastfeeding, postpartum weight loss and diabetes prevention. They will also be provided with details about the Bump2Baby and me website.
Participants will be women who own a smartphone, attending maternity services, who are at high risk of developing gestational diabetes mellitus (GDM), defined by the Monash Screening Questionnaire score >3.
Women will be assessed for eligibility at their first antenatal appointment (8-12 weeks pregnancy). Eligible women will be asked to give consent to randomisation, and then informed consent to participate in their study arm will be gathered. We will collect data from participants and their records during pregnancy and for 12 months after birth. Outcomes assessed will be body mass index (primary outcome), diagnosis of GDM and Type 2 diabetes, maternal weight, birth and neonatal outcomes, foetal growth, infant anthropometry, infant development, maternal wellbeing, and health costs. Data will be gathered during usual scheduled clinic appointments, and self-reported remotely using online data capture. Women will attend a final study visit at 12 months.REC name
Wales REC 7
REC reference
21/WA/0022
Date of REC Opinion
29 Jan 2021
REC opinion
Favourable Opinion