Plain English Summary
Background and study aims
Gaining too much weight whist pregnant causes risks to mother and baby. In 2009 the Institute
of medicine developed guidelines which help doctors and midwives guide women on an appropriate amount of weight to gain during pregnancy to achieve the best pregnancy outcomes. However, it is estimated that almost half of expectant mothers gain much more weight during pregnancy than is recommended. Whatsmore women who start pregnancy heavier are more likely to gain the most weight. This highlights the urgent need for effective ways to help women reduce the amount of weight they gain during pregnancy, particularly in women who enter pregnancy carrying too much weight
We already know that regular weighing yourself is one way that can help people to successfully manage their body weight, and might be useful to help pregnant women manage their weight.
However, little is known about the impact of self-weighing on weight gain during pregnancy. The
current guidelines for doctors and midwives is not to routinely weigh women during pregnancy.
Previous attempts to get pregnant women to weigh themselves regularly have been unsuccessful, but it is still unclear why pregnant women are resistant to regularly weighing themselves during pregnancy. The purpose of this study is to explore naturally occurring thoughts and feelings associated with self-weighting during pregnancy. The aim is that the views will help us identify barriers and facilitators to self-weighing during pregnancy
Who can participate?
Participants will be identified from patients attending the first-trimester scan. To be eligible to take part they must:
1. Have a BMI ≥25kg/m2 based on measured first-trimester weight
2. Be pregnant at gestational age 9 to 15 weeks at enrolment
3. Have the ability to provide informed consent
4. Have access to a mobile phone with voice recording capabilities
And must not:
1. Have a foetal anomaly detected on first-trimester scan
2. Be Planning a termination
3. Have a history of an eating disorder
4. Have had bariatric (weight loss) surgery in the past
What does the study involve?
Demographic and personal contact information will be collected from participants and they’ll be asked to complete a short questionnaire on their opinions, attitudes and beliefs to gestational weight gain and self-weighing during pregnancy.
Participants will be provided with verbal and written instructions on how to weigh themselves and record thoughts and feelings using the ‘think aloud’ procedure. They’ll be asked to weigh themselves at least weekly for the next eight weeks. We will provide them with scales for these purposes if they do not have scales at home. Participants will receive a demonstration of how to make the ‘think aloud’ audio recordings on their own smartphone. They will be coached that each thinks aloud recording should consist of:
1. The date
2. The weight displayed on scales (any difference in weight from the previous reading)
3. All naturally occurring thoughts and during the weighing process
Participants will be asked to send these ‘think-aloud’ recordings to the research team immediately using a secure messaging service enabled with end-to-end encryption so that the researchers can ensure that the quality of the recording is adequate and that the participant has included all the required information in the gobbet. Participants will receive reminder text messages every week for the duration of the 8 weeks to remind them to conduct the task, and they will be contacted by telephone mid-way through the study (approx. 4 weeks) to collect any feedback and address any issues that may arise. The information provided in the think-aloud recordings is regarded as sensitive and will be handled accordingly.
The follow-up session will be scheduled at the same time as the participants’ 20-week scan, which is usually scheduled immediately following the 12-week scan. During this appointment, participants will be asked to return any weighing scales borrowed, or return shipping will be arranged. Participants will be asked to complete a questionnaire about their experience of self-weighing.
What are the possible benefits and risks of participating?
Participants might feel embarrassed or distressed when talking about their weight.
Where is the study run from?
The study is being run by researchers from The University of Oxford
When is the study starting and how long is it expected to run for?
The study will start in November 2019 and will run for approximately 6 months
Who is funding the study?
The study is funded by the National Institutes of Health Research (NIHR) Biomedical Research Centre Oxford
Who is the main contact?
Dr Nerys Astbury:
nerys.astbury@phc.ox.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Nerys Astbury
ORCID ID
http://orcid.org/0000-0001-9301-7458
Contact details
Radcliffe Primary Care
Woodstock Road
Oxford
OX2 6GG
United Kingdom
01865 617871
swipe@phc.ox.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
19/NE/0083
Study information
Scientific title
Self-weighing In Pregnancy: Experiences
Acronym
SWIPE
Study hypothesis
This is a qualitative study to explore the thoughts and feelings of pregnant women to regular self-weighing
Ethics approval
Approved 12/03/2019, the North East- Newcastle and Tyneside 2 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; 0207 104 8082; nrescommittee.northeast-newcastleandnorthtyneside2@nhs.net), ref: 19/NE/0083.
Study design
Qualitative study
Primary study design
Observational
Secondary study design
Qualitative study
Trial setting
Home
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Pregnancy
Intervention
Participants are asked to weigh themselves at least weekly (but more often if they wish) for 8 weeks. Each time they do this they’re asked to use the voice memo function of their phone to record how they think and feel about the experience “Think Aloud”. After each recording they’ll be asked to send the recording to the research team using a secure messaging service.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Participant thoughts and feelings are determined using Think aloud audio recordings collected from participants during regular self-weighing.
Secondary outcome measures
none
Overall trial start date
01/01/2019
Overall trial end date
30/04/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Singleton viable pregnancy
2. BMI ≥25kg/m2 based on measured first-trimester weight
3. Gestational age 9 to 15 weeks at enrolment
4. Ability to provide informed consent
5. Access to a mobile phone with voice recording capabilities
Participant type
Other
Age group
Adult
Gender
Female
Target number of participants
Up to 30
Participant exclusion criteria
1. Maternal age <18 years
2. Foetal anomaly detected on first-trimester scan
3. Planned termination
4. History of eating disorder
5. Bariatric surgery
Recruitment start date
04/11/2019
Recruitment end date
31/01/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford University Hospitals NHS Foundation Trust
Joint Research Office
Second Floor
OUH Cowley
Unipart House Business Centre,
Garsington Road
Oxford
OX4 2PG
United Kingdom
Sponsor information
Organisation
University of Oxford
Sponsor details
Clinical Trials and Research Governance
Address: Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
01865 0000000
ctrg@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
NIHR Oxford Biomedical Research Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results may be presented at a conference and will be published in a peer-reviewed journal in 2020.
IPD sharing statement: the datasets generated during and/or analysed during the current study are not expected to be made available due to data being inherently identifiable.
Intention to publish date
30/09/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list