Weight Gain During PregnancyNCT06882837
BUMP2.0 Feasibility Study
A study testing BUMP app in people with Weight Gain During Pregnancy, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Weight Gain During Pregnancy
- What is being tested?
- BUMP app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Mar 2025to 31 Mar 2026
- 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 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Nuffield Department of Primary Care Health Sciences, University of Oxford
Oxford, Oxfordshire, OX2 6GG
Moscho Michalopoulou, +44 (0) 1865 289505, bumpstudy@phc.ox.ac.uk
About this study
Official title: Body Weight Awareness and SUpport for Mums During Pregnancy (BUMP2.0): a Feasibility Study
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
- Being tested
- BUMP app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUMP appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BUMP app | Experimental | Not described Receives: Behavioral: BUMP app |
| Usual care | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in the BUMP app group who log their weight on at least half of all weeks of their participation
Measured: 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.
Percentage of participants in the BUMP app group who spontaneously log a weight measurement into the app at later stages of pregnancy
Measured: 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.
Overall retention rate at study follow-up
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (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 Weight Gain During PregnancyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DrMoschoMichalopoulou, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882837
- Sponsor's protocol ID
- R95714/RE001
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Michalopoulou M, Haffner SJP, Jebb SA, MacKillop L, Chi Y, Astbury NM. Early Testing of a Mobile App-Based Intervention to Support Body Weight Awareness and Monitoring in Pregnancy: A Randomised Controlled Feasibility Trial (BUMP2.0). Diabetes Obes Metab. 2026 Oct 9. doi: 10.1111/dom.71426. Online ahead of print.
PubMed 42852495
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Weight Awareness and SUpport for Mums During Pregnancy (BUMP2.0): a Feasibility Study
- ClinicalTrials.gov ID
- NCT06882837
- Acronym / sponsor ID
- R95714/RE001
- Conditions
- Weight Gain During Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Mar 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUMP app | Experimental | Behavioral: BUMP app |
| Usual care | No intervention | –No intervention |
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 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BUMP appParticipants 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. | Behavioural | BUMP app |
Primary outcome
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.
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.
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.
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 19 Mar 2025.
- Derived from this study: PubMed 42852495Michalopoulou M, Haffner SJP, Jebb SA, MacKillop L, Chi Y, Astbury NM. Early Testing of a Mobile App-Based Intervention to Support Body Weight Awareness and Monitoring in Pregnancy: A Randomised Controlled Feasibility Trial (BUMP2.0). Diabetes Obes Metab. 2026 Oct 9. doi: 10.1111/dom.71426. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BUMP app in people with Weight Gain During Pregnancy, run by University of Oxford at 1 site in United Kingdom.
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 0 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Moscho Michalopoulou (+44 (0) 1865 289505, bumpstudy@phc.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. 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 NCT06882837, 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 19 Mar 2025.