A pilot randomised controlled trial in primary care
The purpose of this pilot trial is to determine the feasibility and efficacy of a nutrition and lifestyle digital intervention in improving preconception nutrition in women planning a pregnancy. The pilot trial will also provide key data to design a definitive trial of a preconception intervention to improve pregnancy and birth outcomes in women planning a pregnancy.
The primary objective is to compare a composite risk score, based on self-reported on dietary factors, smoking and intake of folic acid, between women randomised to receive preconception care health information via a web-based intervention with frequent follow up and coaching in addition to a paper leaflet and women randomised to receive less coaching and advice.
Follow-up rates in each group at 3 and 6 months after randomisation
To describe any reasons given by eligible women for not taking part in the study
Women aged 18-45 attending a visit with a Health Visiting Team in North and North-East London and planning a pregnancy in the next 12 months and willing to be randomised to either of the two study groups.
The intervention group are followed up every 6 weeks with prompts to complete the information on the online app. The control group are prompted every 12 weeks.
All participants will be given follow up surveys at 3 months and 6 months.
At 6 months participants will be invited to complete an in-depth qualitative interview regarding their thoughts, opinions and experiences of using Smarter Pregnancy.
Health Education England
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