SORA

Advancing, promoting and sharing knowledge of health through excellence in teaching, clinical practice and research into the prevention and treatment of illness

Protocol for a two-arm feasibility RCT to support postnatal maternal weight management and positive lifestyle behaviour in women from an ethnically diverse inner city population: the SWAN feasibility trial

Bick, D; Taylor, C; Avery, A; Bhavnani, V; Craig, V; Healey, A; Khazaezadeh, N; McMullen, S; Oki, B; Oteng-Ntim, E; et al. Bick, D; Taylor, C; Avery, A; Bhavnani, V; Craig, V; Healey, A; Khazaezadeh, N; McMullen, S; Oki, B; Oteng-Ntim, E; O'Connor, S; Poston, L; Seed, P; Roberts, S; Ussher, M (2019) Protocol for a two-arm feasibility RCT to support postnatal maternal weight management and positive lifestyle behaviour in women from an ethnically diverse inner city population: the SWAN feasibility trial. Pilot Feasibility Stud, 5. p. 117. ISSN 2055-5784 https://doi.org/10.1186/s40814-019-0497-3
SGUL Authors: Ussher, Michael Henry

[img]
Preview
PDF Published Version
Available under License Creative Commons Attribution.

Download (1MB) | Preview
[img] Microsoft Word (.docx) Accepted Version
Available under License Creative Commons Attribution.

Download (66kB)

Abstract

Introduction A high BMI during and after pregnancy is linked to poor pregnancy outcomes and contributes to long-term maternal obesity, hypertension, and diabetes. Evidence of feasible, effective postnatal interventions is lacking. This randomised controlled trial will assess the feasibility of conducting a future definitive trial to determine effectiveness and cost-effectiveness of lifestyle information and access to Slimming World® (Alfreton, UK) groups for 12 weeks commencing from 8 to 16 weeks postnatally, in relation to supporting longer-term postnatal weight management in women in an ethnically diverse inner city population. Methods/analysis Women will be recruited from one maternity unit in London. To be eligible, women will be overweight (BMI 25–29.9 kg/m2) or obese (BMI ≥ 30 kg/m2) as identified at their first antenatal contact, or have a normal BMI (18.5–24.9 kg/m2) at booking but gain excessive gestational weight as assessed at 36 weeks gestation. Women will be aged 18 and over, can speak and read English, expecting a single baby, and will not have accessed weight management groups in this pregnancy. Women will be randomly allocated to standard care plus lifestyle information and access to Slimming World® (Alfreton, UK) groups or standard care only. A sample of 130 women is required. Feasibility trial objectives reflect those considered most important inform a decision about undertaking a definitive future trial. These include estimation of impact of lifestyle information and postnatal access to Slimming World® (Alfreton, UK) on maternal weight change between antenatal booking weight and weight at 12 months postbirth, recruitment rate and time to recruitment, retention rate, influence of lifestyle information and Slimming World® (Alfreton, UK) groups on weight management, diet, physical activity, breastfeeding, smoking cessation, alcohol intake, physical and mental health, infant health, and health-related quality of life 6 and 12 months postnatally. An embedded process evaluation will assess acceptability of study processes and procedures to women. Ethics/dissemination London–Camberwell St Giles Research Ethics Committee, reference: 16/LO/1422. Outcomes will be disseminated in peer-reviewed journals and presentations at national and international conferences. Trial registration Trial registration number: ISRCTN 39186148. Protocol version number: v7, 13 August 17. Trial sponsor: King’s College London.

Item Type: Article
Additional Information: © The Author(s). 2019Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: Health behaviour, Maternal health, Postpartum, Weight management
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Pilot Feasibility Stud
ISSN: 2055-5784
Language: eng
Dates:
DateEvent
23 October 2019Published
6 September 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
14/67/14National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 31666983
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/111169
Publisher's version: https://doi.org/10.1186/s40814-019-0497-3

Actions (login required)

Edit Item Edit Item