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一项针对孕前具有可改变风险因素的女性的孕前干预措施,以改善妊娠结局;“准备好!”可行性试验方案。

A preconception intervention targeted at women with modifiable risk factors before pregnancy to improve outcomes; protocol for the Get Ready! feasibility trial.

作者信息

Flynn Angela C, Pryke Emma, Wadhera Monal, Poston Lucilla, White Sara L

机构信息

Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.

LiveSmart, 37 Cremer Street, London, UK.

出版信息

Pilot Feasibility Stud. 2021 Mar 26;7(1):86. doi: 10.1186/s40814-021-00824-0.

Abstract

BACKGROUND

The health of a woman before conception not only influences the outcome of her pregnancy but also the lifelong health of mother and child. Many women in the UK are inadequately prepared for pregnancy, with reports of a high prevalence of smoking, low folic acid supplement use, and suboptimal diet and physical activity. Get Ready! will link an online digital tool to identify women planning pregnancy most at risk of complications with a personalised intervention to improve health behaviours and biomarkers of metabolic health.

METHODS

Women planning pregnancy will be identified from a free and widely used online preconception tool. A short online screening questionnaire will then be used to recruit women considered to be at high metabolic risk. Eligibility criteria include resident in the UK, age > 18-< 50 years, BMI ≥ 23 kg/m (South Asian) or ≥ 25 kg/m (all other ethnicities), and plus one or more of the following: 1st degree relative with type 2 diabetes, previous gestational diabetes (GDM), previous baby > 4 kg, or high risk ethnicity for GDM. Eligible women who consent to participate will be enrolled in a commercially available preconception intervention (Prepare Plans, LiveSmart UK Ltd). Following an online health assessment and home blood test, women will be provided with individualised lifestyle advice and coaching by dietitians. Process evaluation will provide an assessment of implementation of the intervention. Change in health behaviours and biomarkers of metabolic health will also be examined.

DISCUSSION

Suboptimal health behaviours amongst women planning pregnancy are widely prevalent in the UK. Personalised health checks and coaching are especially important for women at risk of pregnancy complications. Get Ready! introduces a novel approach to identifying high risk women planning pregnancy and provision of a targeted intervention.

REGISTRATION

Trial sponsor: King's College London.

摘要

背景

受孕前女性的健康状况不仅会影响其妊娠结局,还会影响母婴的终身健康。英国许多女性在妊娠准备方面不足,有报告称吸烟率高、叶酸补充剂使用率低、饮食和体育活动不理想。“准备好!”项目将把一个在线数字工具与个性化干预措施相联系,以识别妊娠计划最易出现并发症的女性,从而改善健康行为和代谢健康生物标志物。

方法

将从一个免费且广泛使用的在线孕前工具中识别出计划妊娠的女性。然后使用一份简短的在线筛查问卷招募被认为代谢风险高的女性。纳入标准包括居住在英国、年龄>18 - <50岁、BMI≥23 kg/m(南亚人)或≥25 kg/m(所有其他种族),以及以下一项或多项:2型糖尿病一级亲属、既往妊娠期糖尿病(GDM)、既往婴儿体重>4 kg,或GDM高风险种族。同意参与的符合条件女性将参加一项市售的孕前干预措施(Prepare Plans,LiveSmart UK Ltd)。在进行在线健康评估和家庭血液检测后,营养师将为女性提供个性化的生活方式建议和指导。过程评估将对干预措施的实施情况进行评估。还将检查健康行为和代谢健康生物标志物的变化。

讨论

在英国,计划妊娠的女性中存在不理想的健康行为是普遍现象。个性化的健康检查和指导对于有妊娠并发症风险的女性尤为重要。“准备好!”项目引入了一种新方法,用于识别计划妊娠的高风险女性并提供有针对性的干预措施。

注册情况

试验主办方:伦敦国王学院。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8280/7995688/43037dcaf0a1/40814_2021_824_Fig1_HTML.jpg

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