A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomised controlled trial

IF 8.3 Q1 OBSTETRICS & GYNECOLOGY
Tessy Boedt, Eline Dancet, Diane De Neubourg, Sofie Vereeck, Jan Seghers, Katleen Van der Gucht, Ben Van Calster, Carl Spiessens, Sharon Lie Fong, Christophe Matthys
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引用次数: 0

Abstract

Abstract STUDY QUESTION What is the effect of a blended preconception lifestyle programme on reproductive and lifestyle outcomes of couples going through their first 12 months of IVF as compared to an attention control condition? SUMMARY ANSWER This randomized controlled trial (RCT) was stopped prematurely because of the coronavirus disease 2019 (Covid-19) pandemic but the available data did not suggest that a blended preconception lifestyle programme could meaningfully affect time to ongoing pregnancy or other reproductive and lifestyle outcomes. WHAT IS KNOWN ALREADY Increasing evidence shows associations between a healthy lifestyle and IVF success rates. Lifestyle programmes provided through a mobile phone application have yet to be evaluated by RCTs in couples undergoing IVF. STUDY DESIGN, SIZE, DURATION A multicentre RCT (1:1) was carried out. The RCT started in January 2019 and was prematurely stopped because of the Covid-19 pandemic, leading to a reduced sample size (211 couples initiating IVF) and change in primary outcome (cumulative ongoing pregnancy to time to ongoing pregnancy). PARTICIPANTS/MATERIALS, SETTING, METHODS Heterosexual couples initiating IVF in five fertility clinics were randomized between an attention control arm and an intervention arm for 12 months. The attention control arm received treatment information by mobile phone in addition to standard care. The intervention arm received the blended preconception lifestyle (PreLiFe)-programme in addition to standard care. The PreLiFe-programme included a mobile application, offering tailored advice and skills training on diet, physical activity and mindfulness, in combination with motivational interviewing over the telephone. The primary outcome was ‘time to ongoing pregnancy’. Secondary reproductive outcomes included the Core Outcome Measures for Infertility Trials and IVF discontinuation. Changes in the following secondary lifestyle outcomes over 3 and 6 months were studied in both partners: diet quality, fruit intake, vegetable intake, total moderate to vigorous physical activity, sedentary behaviour, emotional distress, quality of life, BMI, and waist circumference. Finally, in the intervention arm, acceptability of the programme was evaluated and actual use of the mobile application part of the programme was tracked. Analysis was according to intention to treat. MAIN RESULTS AND THE ROLE OF CHANCE A total of 211 couples were randomized (105 control arm, 106 intervention arm). The hazard ratio of the intervention for time to ongoing pregnancy was 0.94 (95% CI 0.63 to 1.4). Little to no effect on other reproductive or lifestyle outcomes was identified. Although acceptability of the programme was good (6/10), considerable proportions of men (38%) and 9% of women did not actively use all the modules of the mobile application (diet, physical activity, or mindfulness). LIMITATIONS, REASONS FOR CAUTION The findings of this RCT should be considered exploratory, as the Covid-19 pandemic limited its power and the actual use of the mobile application was low. WIDER IMPLICATIONS OF THE FINDINGS This is the first multicentre RCT evaluating the effect of a blended preconception lifestyle programme for women and their partners undergoing IVF on both reproductive and lifestyle outcomes. This exploratory RCT highlights the need for further studies into optimal intervention characteristics and actual use of preconception lifestyle programmes, as well as RCTs evaluating effectiveness. STUDY FUNDING/COMPETING INTEREST(S) Supported by the Research foundation Flanders (Belgium) (FWO-TBM; reference: T005417N). No competing interests to declare. TRIAL REGISTRATION NUMBER ClinicalTrials.gov Identifier: NCT03790449 TRIAL REGISTRATION DATE 31 December 2018 DATE OF FIRST PATIENT’S ENROLMENT 2 January 2019
接受体外受精夫妇的混合孕前生活方式计划:来自多中心随机对照试验的经验教训
摘要研究问题:与注意控制条件相比,混合孕前生活方式计划对试管婴儿前12个月夫妇的生殖和生活方式结果有什么影响?由于2019冠状病毒病(Covid-19)大流行,该随机对照试验(RCT)提前停止,但现有数据并未表明混合孕前生活方式计划会对持续怀孕的时间或其他生殖和生活方式结果产生有意义的影响。越来越多的证据表明,健康的生活方式与试管婴儿成功率之间存在关联。通过手机应用程序提供的生活方式项目尚未通过随机对照试验对接受体外受精的夫妇进行评估。研究设计、规模、持续时间采用多中心随机对照试验(1:1)。该随机对照试验于2019年1月开始,由于Covid-19大流行而过早停止,导致样本量减少(211对夫妇开始试管婴儿),主要结果发生变化(累积持续妊娠到持续妊娠的时间)。参与者/材料、环境、方法在5家生育诊所开始试管婴儿的异性夫妇被随机分为注意控制组和干预组,为期12个月。注意控制组除了接受标准治疗外,还通过手机接收治疗信息。干预组除标准治疗外,还接受了混合孕前生活方式(PreLiFe)方案。“pre - life”项目包括一个移动应用程序,提供量身定制的饮食、体育活动和正念方面的建议和技能培训,并结合电话上的动机访谈。主要结果是“持续怀孕时间”。次要生殖结局包括不孕不育试验和试管婴儿中止的核心结局指标。在3个月和6个月的时间里,研究了夫妻双方在以下次要生活方式方面的变化:饮食质量、水果摄入量、蔬菜摄入量、总的中度到剧烈的体育活动、久坐行为、情绪困扰、生活质量、BMI和腰围。最后,在干预部分,评估了程序的可接受性,并跟踪了程序的移动应用部分的实际使用情况。按意向治疗进行分析。随机选取211对夫妇(对照组105对,干预组106对)。干预时间与持续妊娠的风险比为0.94 (95% CI 0.63 ~ 1.4)。对其他生殖或生活方式的影响微乎其微。尽管该程序的可接受性很好(6/10),但相当比例的男性(38%)和9%的女性并没有积极使用移动应用程序的所有模块(饮食、体育活动或正念)。该随机对照试验的结果应被视为探索性的,因为Covid-19大流行限制了它的能力,而且移动应用程序的实际使用率很低。研究结果的更广泛意义这是第一项多中心随机对照试验,评估接受体外受精的妇女及其伴侣的混合孕前生活方式方案对生殖和生活方式结果的影响。这项探索性随机对照试验强调了进一步研究孕前生活方式方案的最佳干预特征和实际使用,以及评估有效性的随机对照试验的必要性。研究经费/竞争利益(S)由比利时弗兰德斯研究基金会(two - tbm;参考:T005417N)。没有竞争利益需要申报。试验注册号ClinicalTrials.gov标识符:NCT03790449试验注册日期2018年12月31日第一位患者入组日期2019年1月2日
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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