RT Journal Article
SR Electronic
T1 Effectiveness of a digital dietary intervention program targeting young adults before parenthood: protocol for the PREPARED randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e055116
DO 10.1136/bmjopen-2021-055116
VO 11
IS 12
A1 Nina Cecilie Øverby
A1 Anine C Medin
A1 Erlend Larsen Valen
A1 Lorentz Salvesen
A1 Andrew Keith Wills
A1 Dagrun Engeset
A1 Frøydis N Vik
A1 Elisabet R Hillesund
YR 2021
UL http://bmjopen.bmj.com/content/11/12/e055116.abstract
AB Introduction The importance of preconception health for lifelong physical and mental health in the next generation has gained increasing recognition in recent years. Preconception paternal and maternal risk factors such as obesity and inadequate diet affect the metabolic and cardiovascular health of their offspring later in life. This highlights the importance of diet and dietary behaviour in the years before parenthood. In our project, PREPARED, we will evaluate the effectiveness of a digital intervention targeting young adults. Our primary aim is to improve participants’ preconception diet, and our secondary aim is to improve preconception quality of life and maternal and child perinatal outcomes.Methods and analysis We plan to recruit 7000 men and women individually, aged 20–35 years without children, to be randomised to an intervention or a control group. The intervention group will receive access to a digital resource for 6 months promoting a healthy diet for their health now, later in life and for the next generation. Follow-up is up to 20 years or until they have their first child. To evaluate intervention effects, we will collect dietary data (2×24-hour dietary recalls and a screener). For those participants for which birth ensues, we will link study data with data from the Medical Birth Registry of Norway on maternal and child perinatal outcomes.Ethics and dissemination The study is approved by the Regional Ethics Committee, the Norwegian Data Protection Service and our Faculty Ethical Committee (REC: 78104, NSD: 907212, FEC 20/10119). Participation is voluntary and all participants will provide informed consent. Participants can withdraw their consent without giving any reason. Findings will be communicated to the public through a project website and social media, and to professionals through conferences and peer-reviewed papers.Trial registration number ISRCTN44294662.