BUMP2.0 Feasibility Study

NCT ID: NCT06882837

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BUMP app

Group Type: EXPERIMENTAL

BUMP app

Intervention Type: BEHAVIORAL

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.

Usual care

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

DrMoschoMichalopoulou

Post-doctoral Researcher - Behavioural Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nuffield Department of Primary Care Health Sciences, University of Oxford

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Central Contacts

Moscho Michalopoulou

Role: CONTACT

bumpstudy@phc.ox.ac.uk

+44 (0) 1865 289505

Facility Contacts

Moscho Michalopoulou

Role: primary

bumpstudy@phc.ox.ac.uk

+44 (0) 1865 289505

Other Identifiers

R95714/RE001

Identifier Type: -

Identifier Source: org_study_id