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
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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
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<jats:title>Abstract</jats:title><jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods/analysis</jats:title><jats:p>Women will be recruited from one maternity unit in London. To be eligible, women will be overweight (BMI 25–29.9 kg/m<jats:sup>2</jats:sup>) or obese (BMI ≥ 30 kg/m<jats:sup>2</jats:sup>) as identified at their first antenatal contact, or have a normal BMI (18.5–24.9 kg/m<jats:sup>2</jats:sup>) 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.</jats:p><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics/dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>Trial registration number:<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.isrctn.com/ISRCTN39186148">ISRCTN 39186148</jats:ext-link>. Protocol version number: v7, 13 August 17. Trial sponsor: King’s College London.</jats:p></jats:sec>