Debra Bick
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; Ussher, Michael
Authors
Cath Taylor
AMANDA AVERY amanda.avery@nottingham.ac.uk
Associate Professor
Vanita Bhavnani
Victoria Craig
Andy Healey
Nina Khazaezadeh
Sarah McMullen
Bimpe Oki
Eugene Oteng-Ntim
Sheila O�Connor
Lucilla Poston
Paul Seed
Sarah Roberts
Michael Ussher
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.
Citation
Bick, D., Taylor, C., Avery, A., Bhavnani, V., Craig, V., Healey, A., …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 and Feasibility Studies, 5, 1-12. https://doi.org/10.1186/s40814-019-0497-3
Journal Article Type | Article |
---|---|
Acceptance Date | Sep 6, 2019 |
Online Publication Date | Oct 23, 2019 |
Publication Date | Oct 23, 2019 |
Deposit Date | Nov 7, 2019 |
Publicly Available Date | Mar 28, 2024 |
Journal | Pilot and Feasibility Studies |
Print ISSN | 2055-5784 |
Electronic ISSN | 2055-5784 |
Publisher | Springer Verlag |
Peer Reviewed | Peer Reviewed |
Volume | 5 |
Article Number | 117 |
Pages | 1-12 |
DOI | https://doi.org/10.1186/s40814-019-0497-3 |
Keywords | Postpartum; Maternal health; Weight management; Health behaviour |
Public URL | https://nottingham-repository.worktribe.com/output/3075242 |
Publisher URL | https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0497-3 |
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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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Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/
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