Gestational Diabetes Mellitus (GDM)B2B&ME+NCT07189221
Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.
A study testing Life Style Intervention in people with Gestational Diabetes Mellitus (GDM), run by University College Dublin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Life Style Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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:
- Point-of-care (POC) active referral only
- POC with follow-up phone call
- Leaflet provided at time of consent with follow-up phone call
- 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:
- 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)
- Being tested
- Life Style Intervention
- Keywords
- Pregnancy, GDM, Lifestyle Intervention
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Style InterventionBehavioural
The intervention consists of seven related components:
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Life Style Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately following intervention.
Secondary outcomes (10)
Maternal Weight and BMI at baby's birth
Maternal weight (kg) and Body Mass Index (gestational weight gain)
Measured: At birth of baby.
GDM incidence at baby's birth.
GDM incidence rate.
Measured: At birth of baby
Adverse Birth Outcomes
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)
Measured: Until birth of last baby included.
Breastfeeding Initiation.
Breastfeeding initiation rates and on discharge
Measured: At discharge following birth of baby.
Healthcare Utilisation.
Healthcare utilisation and costs (hospital stays, specialist consultations)
Measured: At birth of baby.
Maternal weight and BMI at 9 months postpartum
Maternal weight (kg) and Body Mass Index.
Measured: At 9 months postpartum.
Breastfeeding Duration
Duration of breastfeeding.
Measured: Up to 9 months postpartum.
Diet quality
Quality of diet.
Measured: At 9 months postpartum.
Physical Activity
Measure of physical activity.
Measured: At 9 months postpartum.
Implementation Outcomes Evaluated
Evaluation of implementation outcomes per the RE-AIM frame work (Reach, Effectiveness, Adoption, Implementation, Maintenance)
Measured: At 9 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- National Maternity Hospital, Ireland, Aarhus University Hospital, Liva Healthcare A/S, Western Norway University of Applied Sciences, University of Agder, Pomeranian Medical University Szczecin, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, Deakin University
- Responsible party
- Sponsor
- Investigators
- Sharleen O'Reilly, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189221
- Sponsor's protocol ID
- Bump2Baby and Me+
- Other IDs
- B2B&ME+
- Acronym
- B2B&ME+
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Reilly SL, McDonnell T, Reme Sagedal L, Bermudez MG, Herrmann F, Jasiak-Jozwik H, Overby NC, Refvik Riise HK, McAuliffe F, Maindal HT, Headley L, Campoy C, Kwiatkowski S, Strandberg RB, Rawal A, Angotti K, Foley H, Murphy L, Chen L, Le Cornu Q, Iversen MM, Skinner T. Bump2Baby & Me+ (B2B&Me+): Protocol for a multi-country, European hybrid type 3 implementation-effectiveness study to reduce the incidence of gestational diabetes mellitus and improve maternal and child health. PLoS One. 2026 Aug 31;21(8):e0354394. doi: 10.1371/journal.pone.0354394. eCollection 2026.
PubMed 42672070
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07189221
- Acronym / sponsor ID
- B2B&ME+ / Bump2Baby and Me+
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Pregnancy, GDM, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- National Maternity Hospital, Ireland, Aarhus University Hospital, Liva Healthcare A/S, Western Norway University of Applied Sciences, University of Agder, Pomeranian Medical University Szczecin, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, Deakin University
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Point-of-care (POC) active referral only
- POC with follow-up phone call
- Leaflet provided at time of consent with follow-up phone call
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Life Style InterventionWomen 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Identified as higher risk for GDM using the MMLGDST
Key exclusion criteria (10 listed)
- 24 weeks gestation or higher
- Multiple pregnancy (twins, triplets, etc.)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Style InterventionThe 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 | Behavioural | Block B (Intervention phase) |
Primary outcome
Penetration and participation rates in early pregnancy GDM screening and intervention
Time frame: Immediately 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.
10 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Derived from this study: PubMed 42672070O'Reilly SL, McDonnell T, Reme Sagedal L, Bermudez MG, Herrmann F, Jasiak-Jozwik H, Overby NC, Refvik Riise HK, McAuliffe F, Maindal HT, Headley L, Campoy C, Kwiatkowski S, Strandberg RB, Rawal A, Angotti K, Foley H, Murphy L, Chen L, Le Cornu Q, Iversen MM, Skinner T. Bump2Baby & Me+ (B2B&Me+): Protocol for a multi-country, European hybrid type 3 implementation-effectiveness study to reduce the incidence of gestational diabetes mellitus and improve maternal and child health. PLoS One. 2026 Aug 31;21(8):e0354394. doi: 10.1371/journal.pone.0354394. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharleen O'Reilly principal investigator
University College Dublin
Questions about this trial
What is this clinical trial studying?
A study testing Life Style Intervention in people with Gestational Diabetes Mellitus (GDM), run by University College Dublin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharleen O'Reilly (00353 1 716 7777, sharleen.oreilly@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration and participation rates in early pregnancy GDM screening and intervention (time frame: Immediately following intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07189221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.