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

NCT07189221 | Not Yet Recruiting DMC

• 2 other identifiers: Bump2Baby and Me+B2B&ME+
• Study Type: interventional
• Target: 3,600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Pregnancy; GDM; Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• Penetration and participation rates in early pregnancy GDM screening and 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.

  Immediately following intervention.

Secondary Outcomes (10)

• Maternal Weight and BMI at baby's birth

  At birth of baby.

• GDM incidence at baby's birth.

  At birth of baby

• Adverse Birth Outcomes

  Until birth of last baby included.

• Breastfeeding Initiation.

  At discharge following birth of baby.

• Healthcare Utilisation.

  At birth of baby.

Study Arms (2)

Block A (Usual care phases)

NO INTERVENTION

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

Block B (Intervention phase)

EXPERIMENTAL

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

Behavioral: Life Style Intervention

Interventions

Life Style Intervention 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

Block B (Intervention phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• National Maternity Hospital, Ireland: collaborator
• Aarhus University Hospital: collaborator
• Liva Healthcare A/S: collaborator
• Western Norway University of Applied Sciences: collaborator
• University of Agder: collaborator
• Pomeranian Medical University Szczecin: collaborator
• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: collaborator
• Deakin University: collaborator

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sharleen O'Reilly

  University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharleen O'Reilly

CONTACT

00353 1 716 7777; sharleen.oreilly@ucd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employs a hybrid type 3 implementation-effectiveness design using a non-randomised, ABA intervention approach nested within a longitudinal cohort. The study will compare the delivery of the Monash machine learning GDM screening tool (MMLGST) and mHealth coaching referral during a 3-month intervention block with two 3-month blocks of usual care before and after the intervention. Women identified as being at higher risk of developing GDM using the MMLGST 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. Implementation outcomes will be assessed using the RE-AIM framework, and cost-effectiveness analyses will be conducted from a healthcare system perspective.

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share