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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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Bick, Debra, Taylor, C., Avery, A., Bhavnani, V., Craig, C., Healey, A., Khazaezadeh, N., McMullen, S., Oki, B., Oteng-Ntim, E., O'Connor, S., Poston, L., Seed , P., Roberts , S. and 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 . 117. doi:10.1186/s40814-019-0497-3 ISSN 2055-5784.
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Official URL: https://doi.org/10.1186/s40814-019-0497-3
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.
| Item Type: | Journal Article | ||||||
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| Subjects: | H Social Sciences > HQ The family. Marriage. Woman R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine R Medicine > RG Gynecology and obstetrics |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Maternal health services -- Great Britain, Puerperium , Postnatal care -- Great Britain, Body mass index -- Health aspects, Body weight -- Research, Obesity -- Research, Pregnant women -- Weight gain, Pregnant women -- Health aspects | ||||||
| Journal or Publication Title: | Pilot and Feasibility Studies | ||||||
| Publisher: | BioMed Central Ltd. | ||||||
| ISSN: | 2055-5784 | ||||||
| Official Date: | 23 October 2019 | ||||||
| Dates: |
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| Volume: | 5 | ||||||
| Article Number: | 117 | ||||||
| DOI: | 10.1186/s40814-019-0497-3 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 13 September 2019 | ||||||
| Date of first compliant Open Access: | 13 September 2019 | ||||||
| RIOXX Funder/Project Grant: |
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