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Research type
Research Study
Full title
Efficacy of a nutrition and lifestyle digital intervention in women planning a pregnancy: a pilot randomised controlled trial in primary care.
IRAS ID
148421
Contact name
Judith Stephenson
Contact email
Sponsor organisation
University College London
Research summary
This is a pilot randomised control trial to assess the feasibility and efficacy of a web-based education tool in improving nutritional and lifestyle behaviours in women planning a pregnancy.
300 women will be recruited through Health Visiting teams at their child’s developmental review, which 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. Women who consent to enter the study will complete a baseline questionnaire and then be randomised to either arm of the trial. All women will be offered vouchers worth £20 on completion of the final 6 month questionnaire.
Participants will use a web-based education tool (app) to input their dietary and lifestyle behaviours. This will generate a personalised “risk score” based on their responses. The intervention group will be prompted to input their information at 6 week intervals for 6 months, the control group at 12 week intervals. Coaching tips and messages are sent directly to each woman through email and SMS. They will all receive a paper leaflet with information on “planning a pregnancy” that has been designed by the Family Planning Association.
The main outcome of the pilot trial will be a comparison of change in risk score between the intervention and control groups.Up to 20 consenting participants will take part in a qualitative interview to discuss their thoughts and opinions on the intervention and trial. Interviews will take place at a location convenient for the participant, if this is their home residence, the lone-worker policy will be implemented. Interviews will be audio recorded and transcribed verbatim.
Participants are able to withdraw their consent at any point.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0316
Date of REC Opinion
6 May 2014
REC opinion
Favourable Opinion