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Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.

Not Applicable
Not yet recruiting
Conditions
Gestational Diabetes Mellitus (GDM)
Registration Number
NCT07189221
Lead Sponsor
University College Dublin
Brief Summary

Gestational diabetes mellitus (GDM) affects approximately 1 in 7 pregnancies globally and is associated with significant short and long-term health consequences for both mothers and infants. While lifestyle interventions during pregnancy can effectively reduce GDM risk and its complications, there is limited guidance on how to translate this evidence into routine antenatal and postpartum care. This project looks to address this gap by exploring the effectiveness of the B2B\&Me+ programme within regular maternity services across four European countries and how best to implement it.

Women identified as being at higher risk of developing GDM using a GDM screening tool will receive access to the smartphone application that connects them with their health coach, who will provide personalised support about healthy eating, physical activity, mental wellbeing, and infant care from early pregnancy until 9 months after birth. The participants will be randomised initially to a specific referral pathway for the intervention.

Detailed Description

While lifestyle interventions during pregnancy can effectively reduce GDM risk and its complications, there is limited guidance on how to translate this evidence into routine antenatal and postpartum care. Building on the successful Horizon2020-funded Bump2Baby and Me trial, this implementation project seeks to address this gap by testing the real-world effectiveness of the B2B\&Me+ programme within regular maternity services across four European countries.

This is a hybrid type 3 implementation-effectiveness study using a non-randomised, ABA intervention design nested within a longitudinal cohort. As a type 3 hybrid, focus is primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to uptake or fidelity of the intervention. The study will compare the delivery of the Monash machine learning GDM screening tool (MMLGDST)12 and mHealth coaching referral during a 3-month intervention block (B) with two 3-month blocks of usual care, before and after the intervention (A blocks).

Block A (Usual care phases): The research staff will briefly explain the data collection aspect of the study and provide an information leaflet. Women will be informed that the study involves collecting anonymised data from their medical records for research purposes, with no additional procedures or interventions beyond their standard care.

Within the intervention block (B), different referral methods will be tested every 2 weeks:

1. Point-of-care (POC) active referral only

2. POC with follow-up phone call

3. Leaflet provided at time of consent with follow-up phone call

4. Leaflet referral only This real-world implementation design will allow us to evaluate not only the clinical effectiveness of the intervention but also the implementation processes, contextual factors, and sustainability of the programme within routine care.

The intervention (B2B\&Me+ programme) involved is a lifestyle intervention comprised of the following components:

I. A Bluetooth-enabled weighing scale that syncs with the app to facilitate self-monitoring of weight.

II. Synchronous coaching sessions conducted on a 1:1 basis between the mHealth coach and participants at enrolment and 6-8 weeks postpartum.

III. Asynchronous mHealth coaching that uses a combination of text and video messaging exchanges between the mHealth coach and participant.

IV. Automated push notifications are sent out to participants. V. Participants will receive personalised educational content from their mHealth coach during the asynchronous coaching sessions.

VI. Participants will receive automated push notifications referring to additional content available in the B2B\&Me+ app.

VII. Participants will also have access to a virtual social network, through the mHealth coaching app, with other women participating in the study.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
3600
Inclusion Criteria
  • Pregnant women attending their first/early antenatal appointments at participating sites
  • Gestation less than 24 weeks at enrolment
  • Age 18 years or older
  • Ability to provide informed consent

Additional for the intervention group (Block B):

  • Identified as higher risk for GDM using the MMLGDST
  • Ownership of a smartphone compatible with the B2B&Me+ app
Exclusion Criteria
  • 24 weeks gestation or higher
  • Multiple pregnancy (twins, triplets, etc.)

Additional for the intervention group (Block B):

  • Participation in another health behaviour change intervention study during pregnancy
  • Inability to understand the language of the intervention (English in Ireland, Spanish in Spain, Norwegian in Norway, Polish in Poland)
  • Severe mental illness, drug or alcohol abuse that would impair ability to participate
  • Cancer (not in remission)
  • Myocardial infarction in the last three months
  • Pre-existing diabetes (Type 1 or Type 2), or early GDM.
  • Not owning a smartphone capable of hosting the intervention app

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Primary Outcome Measures
NameTimeMethod
Penetration and participation rates in early pregnancy GDM screening and interventionImmediately following intervention.

The primary analysis will compare penetration across the different blocks (A vs B), participation rates and different referral methods within Block B. This will be analysed using chi-square tests for categorical data and t-tests or ANOVA for continuous data.

Secondary Outcome Measures
NameTimeMethod
Maternal Weight and BMI at baby's birthAt birth of baby.

Maternal weight (kg) and Body Mass Index (gestational weight gain)

GDM incidence at baby's birth.At birth of baby

GDM incidence rate.

Adverse Birth OutcomesUntil birth of last baby included.

Rates of adverse birth outcomes (pre-eclampsia, preterm birth, birth weight ≥4000g, birth trauma, neonatal respiratory distress, phototherapy, stillbirth/neonatal death, NICU admission or shoulder dystocia, caesarean section/interventions)

Breastfeeding Initiation.At discharge following birth of baby.

Breastfeeding initiation rates and on discharge

Healthcare Utilisation.At birth of baby.

Healthcare utilisation and costs (hospital stays, specialist consultations)

Maternal weight and BMI at 9 months postpartumAt 9 months postpartum.

Maternal weight (kg) and Body Mass Index.

Breastfeeding DurationUp to 9 months postpartum.

Duration of breastfeeding.

Diet qualityAt 9 months postpartum.

Quality of diet.

Physical ActivityAt 9 months postpartum.

Measure of physical activity.

Implementation Outcomes EvaluatedAt 9 months postpartum.

Evaluation of implementation outcomes per the RE-AIM frame work (Reach, Effectiveness, Adoption, Implementation, Maintenance)

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