Plain English Summary
Background and study aims
The period before conception is increasingly regarded as important for the health of future generations. Many of the major threats to reproductive health are the same as those affecting public health more generally, including obesity, smoking, alcohol, diabetes and high blood pressure. In this study we aim to test how well an online education tool works in improving nutritional and lifestyle behaviours in women planning a pregnancy, through motivational coaching.
Who can participate?
Women who are planning a pregnancy within the next 12 months will be recruited through Health Visiting teams at their childs developmental review. These take place at 8-12 months and at 2.5 years after childbirth where we expect 1 in 5 women to be planning another pregnancy. We aim to recruit 300 women over 6 months.
What does the study involve?
Women who consent to enter the trial will be invited to complete a baseline questionnaire on a portable electronic device. On completing the baseline questionnaire, participants will be randomly put into either the intervention or the control group of the trial. Participants will have access to the online education tool (app) to input their dietary and lifestyle behaviours. Their answers will generate a risk score and a personal profile for each person. They will be reminded to input their information on the application every 6 weeks (intervention group) or every 12 weeks (control group) for 6 months. At each time point a risk score is generated so that we can see any changes over time. Coaching tips and messages are sent directly to each woman through email and SMS. Those in the intervention group will receive three recipes per week, whereas those in the control group will only receive one recipe a week to help motivate them. They will also receive a paper leaflet with information on planning a pregnancy that has been designed by the Family Planning Association. We will compare the changes in risk score between the two groups. After the 6-month follow up survey, a subgroup of consenting women will take part in an interview to discuss their thoughts and opinions on the app and the study as a whole.
What are the possible benefits and risks of participating?
All women will be given vouchers in appreciation of their participation worth £20 on completion of the final 6-month questionnaire. We do not anticipate the participants to experience any side effects from participation in this study.
Where is the study run from?
This study will take place at two NHS Trust sites, Homerton University Foundation Trust and Barts Health NHS Trust (UK).
When is the study starting and how long is it expected to run for?
The trial is funded for 15 months from January 2014 to March 2015.
Who is funding the study?
The study is funded from Health Education England (UK).
Who is the main contact?
The principal investigator for this trial is Professor Judith Stephenson and the main contact is Dilisha Patel (dilisha.patel@ucl.ac.uk).
Trial website
Contact information
Type
Scientific
Primary contact
Miss Dilisha Patel
ORCID ID
Contact details
Institute for Women's Health
University College London
74 Huntley Street
London
WC1E 6AU
United Kingdom
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dilisha.patel@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16827
Study information
Scientific title
Efficacy of a nutrition and lifestyle digital intervention for women planning a pregnancy: a pilot randomised controlled trial in primary care
Acronym
SATB
Study hypothesis
The trial hypothesis is that women receiving the web-based intervention, in addition to an information leaflet, will achieve a greater improvement in their preconception risk score than women receiving a lighter version of the app, with less frequent follow-up and the leaflet.
Ethics approval
NRES committee North West- Liverpool Central, 09/05/2014, ref: 14/NW/0316
Study design
Randomised; Interventional and Observational; Design type: Prevention, Qualitative
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth
Intervention
Participants will be randomized into either the intervention or the control group. All participants will have access to the online education tool (app) to input their dietary and lifestyle behaviours. They will be reminded to input their information on the application every 6 weeks (intervention group) or every 12 weeks (control group) for 6 months. Coaching tips and messages are sent directly to each woman through email and SMS. Those in the intervention group will receive three recipes per week, whereas those in the control group will only receive one recipe a week to help motivate them. They will also receive a paper leaflet with information on 'planning a pregnancy' that has been designed by the Family Planning Association. After the 6-month follow-up survey, a subgroup of consenting women will take part in a single qualitative interview to discuss their thoughts and opinions on the app and trial as a whole.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
A composite risk score is calculated at 6 months post randomisation from self-reported data on smoking, consumption of fruit, vegetables and supplementation with folic acid in both groups
Secondary outcome measures
1. Recruitment rate: the proportion of women planning a pregnancy at recruitment visits; the proportion eligible for the trial; proportion entering (randomised into) the trial
2. The number and rate (per participant) of queries and requests for help in using the web-based intervention
3. Follow-up rates by group at 3 and 6 months after randomisation
4. Participant experience of using both interventions will be assessed through qualitative interviews
5. Pregnancy: all women who become pregnant during the pilot trial will be asked to complete a short 6-item validated questionnaire, the London Measure of Unplanned Pregnancy (LMUP.com)
Overall trial start date
01/09/2014
Overall trial end date
30/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged between 18 and 45 who are planning a pregnancy within the following 12 months
2. Willingness to be randomised to either the control or intervention group
3. Ability to access the internet, via a desktop PC, laptop, smartphone, tablet, or any other device whereby the participant can access SmarterPregnancy
4. Enough understanding of English to be able to follow the online application and the leaflet
5. Willingness to participate in the trial, which includes following the protocol for 6 months
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 300; UK Sample Size: 300
Participant exclusion criteria
Specific dietary requirements that may conflicts with the online application advice, i.e. strict vegetarians and vegans
Recruitment start date
01/09/2014
Recruitment end date
30/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute for Women's Health
London
WC1E 6AU
United Kingdom
Funders
Funder type
Government
Funder name
Health Education England (UK); Grant Codes: 2003201401
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list