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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, Debra, Taylor, Cath, Avery, Amanda, Bhavnani, Vanita, Craig, Victoria, Healey, Andy, Khazaezadeh, Nina, McMullen, Sarah, Oki, Bimpe, Oteng-Ntim, Eugene , O’Connor, Sheila, Poston, Lucilla, Seed, Paul, Roberts, Sarah and Ussher, Michael (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 and Feasibility Studies, 5, 117.

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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
Divisions : Faculty of Health and Medical Sciences > School of Health Sciences
Authors :
NameEmailORCID
Bick, Debra
Taylor, Cathcath.taylor@surrey.ac.uk
Avery, Amanda
Bhavnani, Vanita
Craig, Victoria
Healey, Andy
Khazaezadeh, Nina
McMullen, Sarah
Oki, Bimpe
Oteng-Ntim, Eugene
O’Connor, Sheila
Poston, Lucilla
Seed, Paul
Roberts, Sarah
Ussher, Michael
Date : 23 October 2019
Funders : National Institute Health Research (NIHR) Public Health Research Programme
DOI : 10.1186/s40814-019-0497-3
Copyright Disclaimer : © The Author(s). 2019 Open 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.
Uncontrolled Keywords : Postpartum; Maternal health; Weight management; Health behaviour
Depositing User : Diane Maxfield
Date Deposited : 12 Nov 2019 15:05
Last Modified : 12 Nov 2019 15:05
URI: http://epubs.surrey.ac.uk/id/eprint/853114

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