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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.

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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 post-birth, 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, 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 number: ISRCTN 39186148

Protocol version number: v7, 13/08/17

Trial sponsor: King’s College London

Strengths and limitations of this study


• Postnatal interventions may be more effective than antenatal interventions at supporting weight management among women with higher BMIs but evidence is needed.

• This feasibility trial will assess if women with high BMIs at pregnancy commencement or have normal BMIs but gain excessive gestational weight would be prepared to be randomised to standard care plus Slimming World®(Alfreton, UK) groups offered from 8 to 16 weeks postnatally, or to standard care only.

• Women will only be recruited from one study site, however the site provides maternity care to a population with wide diversity. The intervention is available UK-wide.

• Blinding of study participants and assessors is not possible.

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 : 5 September 2019
Funders : National Institute Health Research (NIHR)
Copyright Disclaimer : Copyright 2019 The Authors
Uncontrolled Keywords : Postpartum; Maternal health; Weight management; Health behaviour
Related URLs :
Depositing User : Diane Maxfield
Date Deposited : 19 Sep 2019 10:06
Last Modified : 19 Sep 2019 10:06
URI: http://epubs.surrey.ac.uk/id/eprint/852671

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