Heslehurst Nicola, Rankin Judith, McParlin Catherine, Sniehotta Falko F, Howel Denise, Rice Stephen, McColl Elaine
1Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX UK.
2Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Pilot Feasibility Stud. 2018 Feb 9;4:47. doi: 10.1186/s40814-018-0241-4. eCollection 2018.
Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines.
GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial.
This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness.
ISRCTN46869894; retrospectively registered 25th May 2016.
孕期体重管理指南已经存在，但仅靠传播并不是有效的实施手段。助产士们认识到需要获得支持，以克服实践中的复杂障碍。对一项支持助产士实施指南的干预措施进行评估，需要开展大规模整群随机对照试验。在进行确定性试验之前，有必要开展一项试点研究，以探索实施和评估的可行性。妊娠肥胖体重管理：国家指南的实施（GLOWING）试验旨在检验对助产士实施体重管理指南提供行为改变干预措施是否可行且可接受。
GLOWING是一项多中心平行组试点整群随机对照试验，比较为助产士提供行为改变干预措施与常规做法的效果。四个国民保健服务信托机构（整群）将被随机分为干预组和对照组，并按产科服务规模进行分层。该干预措施采用社会认知理论，包括面对面的助产士培训以及日常实践的信息资源。主要结果是干预措施和试验程序对参与者来说是否可行且可接受，以及确定性试验的招募和数据收集的可行性。目标招募对象包括干预组中所有符合条件的助产士，每组招募30名助产士和孕妇用于收集基线和结果问卷数据，以及20名助产士和女性提供定性数据。所有定量和定性分析都将是描述性的，目的是为确定性试验的开展提供信息。
开展这项试点研究是为了支持社区助产士实施指南。选择社区助产士是因为她们通常进行预约登记，其中包括测量和讨论孕妇的体重指数。整群设计是实施研究的金标准，因为如果在个体助产士层面进行随机分组，污染风险会很高：社区助产士通常在基于地点的团队中工作，每天进行互动，并共同护理孕妇。在进行评估有效性和成本效益的确定性试验之前，试点试验的结果将用于进一步开发和完善GLOWING。
ISRCTN46869894；于2016年5月25日追溯注册。
