STUDY QUESTION Can we develop a preconception lifestyle programme for couples undergoing IVF that is in line with their needs. SUMMARY ANSWER A mobile preconception lifestyle programme was systematically developed based on expert opinion, literature and needs of IVF-patients. WHAT IS KNOWN ALREADY A healthy lifestyle prior to conception is not only beneficial for the general health of couples, but evidence on its importance for their reproductive health and the health of their children is also emerging. So far, the vast majority of fertility clinics do not offer a lifestyle programme for couples undergoing IVF. Therefore, the present study aimed to develop a lifestyle programme for IVF-couples. STUDY DESIGN, SIZE, DURATION The development of the PreLiFe-programme was guided by the steps of the Medical Research Council (MRC) framework for developing complex interventions, a systematic approach for developing theory- and evidence-based health promotion interventions. PARTICIPANTS/MATERIALS, SETTINGS, METHODS First, the evidence base on lifestyle programmes for IVF-couples was reviewed. Second, several iterations between an expert panel, the literature, and quantitative and qualitative data from IVF-patients identified the content, the format, behaviour change techniques and theory of the programme. Third, the PreLiFe-programme was produced and the expected process and outcomes of a randomized controlled trial assessing it were modelled. Finally, user tests among experts and patients and pilot tests among patients were conducted. MAIN RESULTS AND ROLE OF CHANCE The finally developed PreLiFe-programme is a mobile application to be used autonomously by both partners of IVF-couples during the first year of IVF, in combination with motivational interviewing over the telephone every three months (i.e. blended care). The PreLiFe-programme provides advice and skills training on physical activity, diet and mindfulness based stress reduction and is in part tailored based on monitoring and tracking the lifestyle of patients. Based on the literature the expert panel considers it plausible that all three components contribute to IVF-success rates. The PreLiFe-programme is likely to be acceptable to patients as it meets the need of patients for lifestyle advice and treatment information. LIMITATIONS, REASON FOR CAUTION The pilot in IVF-couples had a 3-month duration. The feasibility of the PreLiFe-programme in other infertile populations and/or upon longer use is yet to be examined. Whether the PreLiFe-programme effectively improves lifestyle and IVF-success rates is currently being examined in a trial randomizing heterosexual couples starting IVF to the PreLiFe-programme or an attention-control group for 12 months. WIDER IMPLICATIONS OF THE FINDINGS If the PreLiFe-programme improves lifestyle and the chance of IVF-success, it will be a powerful tool and provide guidance for implementing lifestyle programmes in fertility clinics. STUDY FUNDING/COMPETING INTEREST(S) Funded by the Research Foundation Flanders (FWO-TBM (Applied Biomedical Research with a Primary Social finality); reference: T005417N). The authors have no conflict of interest to report. TRIAL REGISTRATION NUMBER NCT03790449.

中文翻译：

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为接受体外受精的夫妇系统开发移动孕前生活方式计划：PreLiFe 计划

研究问题 我们能否为接受体外受精的夫妇制定符合其需求的孕前生活方式计划。总结答案 根据专家意见、文献和 IVF 患者的需求，系统地开发了一个移动的孕前生活方式计划。已知情况 受孕前的健康生活方式不仅有益于夫妻的整体健康，而且其对他们的生殖健康和孩子健康的重要性的证据也在不断涌现。到目前为止，绝大多数生育诊所都没有为接受体外受精的夫妇提供生活方式计划。因此，本研究旨在为 IVF 夫妇制定生活方式计划。研究设计，尺寸，持续时间 PreLiFe 计划的制定以医学研究委员会 (MRC) 框架的步骤为指导，该框架旨在开发复杂的干预措施，这是一种开发基于理论和证据的健康促进干预措施的系统方法。参与者/材料、设置、方法 首先，回顾了 IVF 夫妇生活方式计划的证据基础。其次，专家小组、文献以及来自 IVF 患者的定量和定性数据之间的多次迭代确定了该计划的内容、格式、行为改变技术和理论。第三，制作了 PreLiFe 计划，并对评估它的随机对照试验的预期过程和结果进行了建模。最后，在专家和患者中进行了用户测试，在患者中进行了试点测试。主要结果和机会的作用 最终开发的 PreLiFe 计划是一个移动应用程序，可在 IVF 的第一年由 IVF 夫妇的双方合作伙伴自主使用，并结合每三个月通过电话进行的激励性访谈（即混合护理） . PreLiFe 计划提供有关身体活动、饮食和正念减压的建议和技能培训，部分基于监测和跟踪患者的生活方式而量身定制。根据文献，专家小组认为所有三个组成部分都有助于 IVF 成功率是合理的。PreLiFe 计划很可能为患者所接受，因为它满足了患者对生活方式建议和治疗信息的需求。限制，谨慎的原因 IVF 夫妇中的试点有 3 个月的持续时间。PreLiFe 计划在其他不育人群和/或长期使用后的可行性还有待检验。PreLiFe 计划是否有效改善生活方式和 IVF 成功率目前正在一项试验中进行检验，将开始 IVF 的异性恋夫妇随机分配到 PreLiFe 计划或注意力控制组，为期 12 个月。研究结果的更广泛意义 如果 PreLiFe 计划改善生活方式和 IVF 成功的机会，它将成为一个强大的工具，并为在生育诊所实施生活方式计划提供指导。研究资金/竞争兴趣由法兰德斯研究基金会资助（FWO-TBM（具有主要社会结局的应用生物医学研究）；参考：T005417N）。作者没有利益冲突需要报告。试用注册号 NCT03790449。