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. 2018 Feb 9:4:47.
doi: 10.1186/s40814-018-0241-4. eCollection 2018.

GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives

Nicola Heslehurst  1 , Judith Rankin  1 , Catherine McParlin  2 , Falko F Sniehotta  1 , Denise Howel  1 , Stephen Rice  1 , Elaine McColl  1
Affiliations

GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives

Nicola Heslehurst et al. Pilot Feasibility Stud. .

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ISRCTN46869894; retrospectively registered 25th May 2016.

Keywords: Behaviour change; Cluster RCT; Guidelines; Implementation; Midwives; Obesity; Pregnancy; Social cognitive theory; Weight management.

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Conflict of interest statement

This pilot study has received ethical approval from the Proportionate Review Sub-committee of the Yorkshire & The Humber—South Yorkshire Research Ethics Committee, 16/12/2015, ref.: 15/YH/0565. The protocol described here is based on the full protocol submitted to the ethics committee (V1.0, 23/11/2015). Research and development (R&D) approval has also been granted from the four pilot NHS Trusts (clusters). All midwives and pregnant women will need to provide informed consent before participating in this research. Separate consent will be sought for the different levels of involvement in the research: midwives will be required to consent to provide the questionnaire baseline and outcome data, to participate in the intervention sessions and to participate in the focus groups; pregnant women will be required to consent to provide the questionnaire baseline data and outcome data and to participate in the interviews. Copies of the information sheets and consent forms for each stage of the research are provided in Additional file 4. Any amendments to the protocol will be discussed with the ethics committee to determine if a minor amendment or substantial amendment is required before any changes to trial procedures are actioned. All amendments will be reported to the R&D departments at each participating NHS Trust and will be reported in the publication of the pilot study results. The trial sponsor is Newcastle upon Tyne Hospitals NHS Foundation Trust, Ms. Amanda Tortice, Research Operations Manager, amanda.tortice@ncl.ac.ukThis is not applicable to this pilot study as individuals will not be identified from any study report. It is planned to publish the results of this study in peer review journals and to present data at national and international meetings. Results of the study will also be reported to the sponsor and funder and will be available on their website. Midwives and pregnant women will be offered the option of receiving information about their contribution to the study at the end of the study, including a lay summary of the results. The results of this study will inform the development of a grant application for a definitive trial. Any arising publications will follow the International Committee of Medical Journal Editors requirements for authorship. No restrictions are placed on publication of the trial results.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Overview of cluster trial design
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