Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Cardiovascular Clinical Research Facility, University of Oxford, Oxford, UK.
BMC Pregnancy Childbirth. 2024 May 14;24(1):360. doi: 10.1186/s12884-024-06508-w.
Physical activity (PA) interventions have an encouraging role in gestational diabetes mellitus (GDM) management. Digital technologies can potentially be used at scale to support PA. The aim of this study was to assess the feasibility and acceptability of + Stay-Active: a complex intervention which combines motivational interviewing with a smartphone application to promote PA levels in women with GDM.
This non-randomised feasibility study used a mixed methods approach. Participants were recruited from the GDM antenatal clinic at Oxford University Hospitals. Following baseline assessments (visit 1) including self-reported and device determined PA measurements (wrist worn accelerometer), women participated in an online motivational interview, and then downloaded (visit 2) and used the Stay-Active app (Android or iOS). Women had access to Stay-Active until 36 weeks' gestation, when acceptability and PA levels were reassessed (visit 3). The primary outcome measures were recruitment and retention rates, participant engagement, and acceptability and fidelity of the intervention. Secondary outcome measures included PA levels, app usage, blood glucose and perinatal outcomes. Descriptive statistics were performed for assessments at study visits. Statistics software package Stata 14 and R were used.
Over the recruitment period (46 weeks), 114 of 285 women met inclusion criteria and 67 (58%) enrolled in the study. Mean recruitment rate of 1.5 participants/clinic with 2.5 women/clinic meeting inclusion criteria. Fifty-six (83%) received the intervention at visit 2 and 53 (79%) completed the study. Compliance to accelerometer measurement protocols were sufficient in 78% of participants (52/67); wearing the device for more than 10 h on 5 or more days at baseline and 61% (41/67) at 36 weeks. There was high engagement with Stay-Active; 82% (55/67) of participants set goals on Stay-Active. Sustained engagement was evident, participants regularly accessed and logged multiples activities on Stay-Active. The intervention was deemed acceptable; 85% of women rated their care was satisfactory or above, supported by written feedback.
This combined intervention was feasible and accepted. Recruitment rates were lower than expected. However, retention rates remained satisfactory and participant compliance with PA measurements and engagement was a high. Future work will explore the intervention's efficacy to increase PA and impact on clinical outcomes.
The study has received a favourable opinion from South Central-Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. ISRCTN11366562.
身体活动（PA）干预措施在妊娠糖尿病（GDM）管理中具有令人鼓舞的作用。数字技术有可能被大规模用于支持 PA。本研究的目的是评估+Stay-Active 的可行性和可接受性：这是一种复杂的干预措施，将动机访谈与智能手机应用程序相结合，以提高 GDM 女性的 PA 水平。
这项非随机可行性研究采用了混合方法。参与者从牛津大学医院的 GDM 产前诊所招募。在基线评估（第 1 次就诊）中，包括自我报告和设备确定的 PA 测量（腕戴加速度计）后，女性接受在线动机访谈，然后下载（第 2 次就诊）并使用 Stay-Active 应用程序（Android 或 iOS）。女性可以在妊娠 36 周前使用 Stay-Active，届时将重新评估可接受性和 PA 水平（第 3 次就诊）。主要结局指标是招募和保留率、参与者参与度以及干预措施的可接受性和一致性。次要结局指标包括 PA 水平、应用程序使用情况、血糖和围产期结局。在研究就诊时进行评估的描述性统计。使用统计软件包 Stata 14 和 R 进行统计分析。
在招募期间（46 周），285 名符合纳入标准的女性中有 114 名，67 名（58%）入组。平均招募率为 1.5 名参与者/诊所，2.5 名女性/诊所符合纳入标准。56 名（83%）在第 2 次就诊时接受了干预，53 名（79%）完成了研究。78%（52/67）的参与者遵守了加速度计测量方案；在基线时每天佩戴设备 10 小时以上 5 天或以上，而在 36 周时为 61%（41/67）。参与者对 Stay-Active 的参与度很高；82%（55/67）的参与者在 Stay-Active 上设定了目标。持续参与明显，参与者定期访问并在 Stay-Active 上记录多项活动。该干预措施被认为是可接受的；85%的女性认为她们的护理满意度或以上，这得到了书面反馈的支持。
这项联合干预措施是可行且可接受的。招募率低于预期。然而，保留率仍然令人满意，参与者对 PA 测量和参与的依从性很高。未来的工作将探讨该干预措施对增加 PA 和对临床结局的影响。
该研究已获得南中汉普郡 B 研究伦理委员会的有利意见；REC 参考号：20/SC/0342。ISRCTN81045434。
