Gonzalez Andrea, Catherine Nicole, Boyle Michael, Jack Susan M, Atkinson Leslie, Kobor Michael, Sheehan Debbie, Tonmyr Lil, Waddell Charlotte, MacMillan Harriet L
Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.
Children's Health Policy Centre, Simon Fraser University, Vancouver, British Columbia, Canada.
BMJ Open. 2018 Jan 26;8(1):e018915. doi: 10.1136/bmjopen-2017-018915.
Adverse early experiences are associated with long-lasting disruptions in physiology, development and health. These experiences may be 'biologically embedded' into molecular and genomic systems that determine later expressions of vulnerability. Most studies to date have not examined whether preventive interventions can potentially reverse biological embedding. The Nurse-Family Partnership (NFP) is an evidence-based intervention with demonstrated efficacy in improving prenatal health, parenting and child functioning. The Healthy Foundations Study is an innovative birth cohort which will evaluate the impact of the NFP on biological outcomes of mothers and their infants.
Starting in 2013, up to 400 pregnant mothers and their newborns were recruited from the British Columbia Healthy Connections Project-a randomised controlled trial of the NFP, and will be followed to child aged 2 years. Women were recruited prior to 28 weeks' gestation and then individually randomised to receive existing services (comparison group) or NFP plus existing services (intervention group). Hair samples are collected from mothers at baseline and 2 months post partum to measure physiological stress. Saliva samples are collected from infants during all visits for analyses of stress and immune function. Buccal swabs are collected from infants at 2 and 24 months to assess DNA methylation. Biological samples will be related to child outcome measures at age 2 years.
The study received ethical approval from seven research ethics boards. Findings from this study will be shared broadly with the research community through peer-reviewed publications, and conference presentations, as well as seminars with our policy partners and relevant healthcare providers. The outcomes of this study will provide all stakeholders with important information regarding how early adversity may lead to health and behavioural disparities and how these may be altered through early interventions.
NCT01672060; Pre-results.
早期不良经历与生理、发育和健康方面的长期紊乱有关。这些经历可能会“生物性地嵌入”到决定后期脆弱性表现的分子和基因组系统中。迄今为止，大多数研究尚未考察预防性干预措施是否有可能逆转生物性嵌入。护士-家庭伙伴关系（NFP）是一项基于证据的干预措施，在改善产前健康、育儿和儿童功能方面已证明具有成效。健康基础研究是一项创新性的出生队列研究，将评估护士-家庭伙伴关系对母亲及其婴儿生物学指标的影响。
从2013年开始，从不列颠哥伦比亚健康联系项目（一项护士-家庭伙伴关系的随机对照试验）中招募了多达400名孕妇及其新生儿，并将对他们进行随访直至孩子2岁。在妊娠28周之前招募女性，然后将她们分别随机分配接受现有服务（对照组）或护士-家庭伙伴关系加现有服务（干预组）。在基线期和产后2个月从母亲处采集头发样本以测量生理应激。在每次访视时从婴儿处采集唾液样本以分析应激和免疫功能。在婴儿2个月和24个月时采集口腔拭子以评估DNA甲基化。生物样本将与孩子2岁时的结局指标相关联。
该研究获得了七个研究伦理委员会的伦理批准。本研究的结果将通过同行评审的出版物、会议报告以及与我们的政策伙伴和相关医疗服务提供者的研讨会广泛分享给研究界。本研究的结果将为所有利益相关者提供重要信息，说明早期逆境如何可能导致健康和行为差异，以及如何通过早期干预来改变这些差异。
NCT01672060；预结果。
