Øverby Nina Cecilie, Medin Anine C, Valen Erlend Larsen, Salvesen Lorentz, Wills Andrew Keith, Engeset Dagrun, Vik Frøydis N, Hillesund Elisabet R
Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway
Department of Nutrition and Public Health, Universitetet i Agder, Kristiansand, Vest-Agder, Norway.
BMJ Open. 2021 Dec 1;11(12):e055116. doi: 10.1136/bmjopen-2021-055116.
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.
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.
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.
ISRCTN44294662.
近年来，孕前健康对下一代终身身心健康的重要性日益得到认可。孕前父母的风险因素，如肥胖和饮食不均衡，会影响其后代成年后的代谢和心血管健康。这凸显了孕前数年饮食和饮食行为的重要性。在我们的“准备好”（PREPARED）项目中，我们将评估针对年轻人的数字干预措施的有效性。我们的主要目标是改善参与者的孕前饮食，次要目标是提高孕前生活质量以及母婴围产期结局。
我们计划分别招募7000名年龄在20至35岁之间且无子女的男性和女性，将他们随机分为干预组或对照组。干预组将在6个月内获得一种数字资源，该资源宣传对他们当下、未来生活以及下一代健康有益的健康饮食。随访时间长达20年或直至他们生育第一个孩子。为评估干预效果，我们将收集饮食数据（两次24小时饮食回顾和一份筛选问卷）。对于那些随后生育的参与者，我们将把研究数据与挪威医疗出生登记处关于母婴围产期结局的数据相链接。
该研究已获得地区伦理委员会、挪威数据保护局以及我们学院伦理委员会的批准（伦理审查委员会编号：78104，挪威数据保护局编号：907212，学院伦理委员会编号：20/10119）。参与是自愿的所有参与者都将提供知情同意书。参与者可无理由撤回其同意。研究结果将通过项目网站和社交媒体向公众公布，并通过会议和同行评审论文向专业人士传达。
ISRCTN44294662。
