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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,600
- 主要终点
- Penetration and participation rates in early pregnancy GDM screening and intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Block A (Usual care phases)
The comparator is usual care (Block A women) as provided at each participating maternity hospital
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
干预措施: Life Style Intervention (Behavioral)
结局指标
主要结局
Penetration and participation rates in early pregnancy GDM screening and intervention
时间窗: 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.
次要结局
- 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.)
- Maternal weight and BMI at 9 months postpartum(At 9 months postpartum.)
- Breastfeeding Duration(Up to 9 months postpartum.)
- Diet quality(At 9 months postpartum.)
- Physical Activity(At 9 months postpartum.)
- Implementation Outcomes Evaluated(At 9 months postpartum.)