BUMP2.0 Feasibility Study
NCT06882837 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-03-19
Summary
Most women in the UK gain more weight than recommended during pregnancy, which puts them and their babies at risk of medical complications. Studies which have interviewed women during pregnancy have shown that they recognise that controlling their weight is important, but this is rarely discussed with their clinical team. Some women reported they expected to be weighed during pregnancy, and that regular weighing should be part of routine antenatal care, but it is not. Trials which have trained midwives to regularly weigh women or to ask women to regularly weigh themselves, have not shown beneficial effects on gestational weight gain. However, these trials were either small, or reported low protocol adherence, or did not offer adequate feedback and advice in response to weight gain. A few programmes to manage weight during pregnancy have been effective, but were costly and burdensome for women. Regular self-weighing has been shown to be an effective strategy for weight control outside of pregnancy, and if it can be enacted in pregnancy and help manage weight gain, it could improve health outcomes for women and their babies.
The investigators have developed a mobile app to support women to weigh themselves regularly during pregnancy and track their weight gain, to provide feedback on whether weight gain is within, higher, or lower than recommended ranges, and to signpost to resources on weight management during pregnancy. The trial aims to test if it is possible to motivate participants to regularly weigh themselves during pregnancy and how well they engage with the app from early or mid-pregnancy until delivery. The investigators will also examine whether the processes of the study run as planned, whether there is an indication of an impact of the programme on gestational weight gain compared to a control group, and will explore participants' experiences of using the app through optional qualitative interviews. If feasible, after completion of this study, the next step will be a bigger trial to investigate whether this app-based programme is effective in helping women manage their weight gain and improve health outcomes during pregnancy.
Conditions
- Weight Gain During Pregnancy
Interventions
- BEHAVIORAL
-
BUMP app
Participants in the experimental group will have access to the BUMP app, which aims to support them to control the amount and rate of weight gain during pregnancy, from baseline (early or mid-pregnancy) until they give birth. The app will prompt participants to regularly self-monitor their weight gain during pregnancy, and will provide access to a weight gain chart for tracking. Participants will receive feedback notifications about their weight gain trajectory, and will have access to information and tips on weight management during pregnancy.
Sponsors & Collaborators
-
University of Oxford
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-10
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- United Kingdom
Study Locations
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