ClinicalTrials.gg
Not yet recruitingNCT06882837Updated Mar 19, 2025

BUMP2.0 Feasibility Study

An interventional study of BUMP app in Weight Gain During Pregnancy, sponsored by University of Oxford. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by University of Oxford · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Weight Gain During Pregnancy

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03

In context

Weight Gain

317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.

This study's planned enrollment of 120 is above the median of 83 across 251 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Pregnant women at \<20 weeks' gestation
  • 18 years of age or above
  • Singleton pregnancy
  • 18 years of age or above
  • Able to access the internet with a smartphone and/or tablet
  • Have access to weighing scales
  • Able to communicate in English
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    BUMP app

    Behavioral: BUMP app

  • No intervention
    Usual care

    No intervention

Interventions

  • BehavioralBUMP 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.

06

What researchers measure

Primary outcomes

  1. Percentage of participants in the BUMP app group who log their weight on at least half of all weeks of their participation

    Time frame: From randomization which can happen any time between the start of pregnancy and 20 weeks of pregnancy, until the end of the study for each participant, which is the date on which a participant gives birth, usually at 40-42 weeks of pregnancy.

  2. Percentage of participants in the BUMP app group who spontaneously log a weight measurement into the app at later stages of pregnancy

    Time frame: Late stages of pregnancy, defined as the time frame between 34 weeks of pregnancy and the date on which a participant gives birth usually at 40-42 weeks of pregnancy.

  3. Overall retention rate at study follow-up

    Time frame: Late stages of pregnancy, defined as the time frame between 34 weeks of pregnancy and the date on which a participant gives birth usually at 40-42 weeks of pregnancy.

07

Study locations

1 site
  • Nuffield Department of Primary Care Health Sciences, University of Oxford
    Oxford, Oxfordshire OX2 6GG, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2025; primary completion for Mar 2026, 12 months later.

Of 95 non-industry interventional studies with no phase under Weight Gain, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.

Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2025
First posted
Mar 19, 2025
StartEst.
Mar 10, 2025
Primary completionEst.
Mar 31, 2026
CompletionEst.
Mar 31, 2026
Last update
Mar 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06882837
Responsible party
DrMoschoMichalopoulou (Post-doctoral Researcher - Behavioural Scientist, University of Oxford) — Principal investigator
First posted
Mar 19, 2025
Start date
Mar 10, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Mar 19, 2025

Study contacts

Moscho Michalopoulou
Contact
bumpstudy@phc.ox.ac.uk
+44 (0) 1865 289505

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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