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

NCT ID: NCT07189221

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-05-31

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Block A (Usual care phases)

The comparator is usual care (Block A women) as provided at each participating maternity hospital

Group Type: NO_INTERVENTION

No interventions assigned to this group

Block B (Intervention phase)

Women identified as being at risk and likely to benefit from lifestyle intervention will be invited to participate in the B2B&Me+ programme through one of four randomly allocated referral methods (randomisation at site level) that will be rotated every 2 weeks:

i. Point-of-care (POC) active referral: Women will be directly offered the programme after their appointment, and they will be supported to commence the app sign-up process ii. POC with follow-up phone call: As above plus follow-up call within 48 hours to support enrolment iii. Leaflet with follow-up call: Women will receive an information leaflet about the programme and sign-up process plus a follow-up call within 48 hours to support enrolment iv. Leaflet provided: Women will receive only an information leaflet about the programme and sign-up process

Group Type: EXPERIMENTAL

Life Style Intervention

Intervention Type: BEHAVIORAL

The intervention consists of seven related 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. There will be 2 synchronous sessions, the first at enrolment and the second between 6-8 weeks postpartum. These sessions typically last 45-50 minutes in length with a follow-up summary video message of the goals discussed and, at the beginning of the mother's journey, the establishing of a change agreement. This is mediated through the live-video feature in the B2B&Me+ mHealth coaching app, but the length and thus number of these sessions is determined by the woman. If the woman is diagnosed with GDM, there will be an opportunity for a third 15-minute synchronous coaching session to review and adjust any lifestyle goals to align with the individual's diabetes management plan.

III. Asynchronous mHealth coaching that uses a combi

Interventions

Life Style Intervention

The intervention consists of seven related 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. There will be 2 synchronous sessions, the first at enrolment and the second between 6-8 weeks postpartum. These sessions typically last 45-50 minutes in length with a follow-up summary video message of the goals discussed and, at the beginning of the mother's journey, the establishing of a change agreement. This is mediated through the live-video feature in the B2B&Me+ mHealth coaching app, but the length and thus number of these sessions is determined by the woman. If the woman is diagnosed with GDM, there will be an opportunity for a third 15-minute synchronous coaching session to review and adjust any lifestyle goals to align with the individual's diabetes management plan.

III. Asynchronous mHealth coaching that uses a combi

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Maternity Hospital, Ireland

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Liva Healthcare A/S

UNKNOWN

Sponsor Role: collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role: collaborator

University of Agder

OTHER

Sponsor Role: collaborator

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: collaborator

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

OTHER

Sponsor Role: collaborator

Deakin University

OTHER

Sponsor Role: collaborator

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharleen O'Reilly

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Central Contacts

Sharleen O'Reilly

Role: CONTACT

sharleen.oreilly@ucd.ie

00353 1 716 7777

Other Identifiers

B2B&ME+

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Bump2Baby and Me+

Identifier Type: -

Identifier Source: org_study_id