Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Life Style Intervention.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus (GDM). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BUMP2BABY & ME+ (B2B&ME+): A Multi-Country, European Implementation Project to Reduce Adverse Birth Outcomes, Improve Maternal and Child Health and Reduce Non-Communicable Disease Risk
Overview
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.
Interventions
- Behavioral 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 beg
Primary outcome measures
- Penetration and participation rates in early pregnancy GDM screening and intervention [Time frame: Immediately following intervention.]
Secondary outcome measures (10)
- Maternal Weight and BMI at baby's birth [Time frame: At birth of baby.]
- GDM incidence at baby's birth. [Time frame: At birth of baby]
- Adverse Birth Outcomes [Time frame: Until birth of last baby included.]
- Breastfeeding Initiation. [Time frame: At discharge following birth of baby.]
- Healthcare Utilisation. [Time frame: At birth of baby.]
- Maternal weight and BMI at 9 months postpartum [Time frame: At 9 months postpartum.]
- Breastfeeding Duration [Time frame: Up to 9 months postpartum.]
- Diet quality [Time frame: At 9 months postpartum.]
- Physical Activity [Time frame: At 9 months postpartum.]
- Implementation Outcomes Evaluated [Time frame: At 9 months postpartum.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07189221 · Bump2Baby and Me+ · B2B&ME+