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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
Pilot and Feasibility Studies ( IF 1.5 ) Pub Date : 2019-10-23 , DOI: 10.1186/s40814-019-0497-3
Debra Bick 1 , Cath Taylor 2 , Amanda Avery 3 , Vanita Bhavnani 4 , Victoria Craig 5 , Andy Healey 6 , Nina Khazaezadeh 5 , Sarah McMullen 4 , Bimpe Oki 7 , Eugene Oteng-Ntim 8 , Sheila O'Connor 5 , Lucilla Poston 8 , Paul Seed 8 , Sarah Roberts 6 , Michael Ussher 9
Affiliation  

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. 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. 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 August 17. Trial sponsor: King’s College London.

中文翻译:

两臂可行性 RCT 协议以支持来自不同种族的内城人口的妇女的产后母亲体重管理和积极的生活方式行为:SWAN 可行性试验

怀孕期间和怀孕后的高 BMI 与不良的妊娠结局有关,并导致孕产妇长期肥胖、高血压和糖尿病。缺乏可行、有效的产后干预措施的证据。这项随机对照试验将评估开展未来确定性试验的可行性,以确定生活方式信息的有效性和成本效益,以及从产后 8 至 16 周开始为期 12 周的 Slimming World®(英国阿尔弗雷顿)小组的访问,与支持多种族内城人口中女性的长期产后体重管理。女性将从伦敦的一个产科单位招募。符合条件的女性将在第一次产前接触时确定为超重(BMI 25-29.9 kg/m2)或肥胖(BMI ≥ 30 kg/m2),或 BMI 正常(18.5-24. 9 公斤/平方米),但在妊娠 36 周时评估的妊娠体重增加。女性将年满 18 岁,会说和读英语,怀孕期间将不会参加体重管理小组。女性将被随机分配到标准护理和生活方式信息,并仅访问 Slimming World®(Alfreton,英国)团体或标准护理。需要 130 名女性的样本。可行性试验目标反映了那些被认为最重要的目标,这些目标可以为有关进行明确的未来试验的决定提供信息。这些包括估计生活方式信息和产后访问 Slimming World®(Alfreton,英国)对产前预订体重和出生后 12 个月体重之间的孕产妇体重变化、招募率和招募时间、保留率、生活方式信息和 Slimming World® (Alfreton, UK) 团体对体重管理、饮食、身体活动、母乳喂养、戒烟、酒精摄入、身心健康、婴儿健康和健康相关生活质量的影响 6 个月和 12 个月产后。嵌入式过程评估将评估研究过程和程序对女性的可接受性。伦敦-坎伯韦尔圣吉尔斯研究伦理委员会,参考:16/LO/1422。结果将在同行评审的期刊和国家和国际会议上的演讲中传播。试用注册号:ISRCTN 39186148。协议版本号:v7,17 年 8 月 13 日。试验赞助商:伦敦国王学院。母乳喂养、戒烟、饮酒、身心健康、婴儿健康以及出生后 6 个月和 12 个月与健康相关的生活质量。嵌入式过程评估将评估研究过程和程序对女性的可接受性。伦敦-坎伯韦尔圣吉尔斯研究伦理委员会,参考:16/LO/1422。结果将在同行评审的期刊和国家和国际会议上的演讲中传播。试用注册号:ISRCTN 39186148。协议版本号:v7,17 年 8 月 13 日。试验赞助商:伦敦国王学院。母乳喂养、戒烟、饮酒、身心健康、婴儿健康以及出生后 6 个月和 12 个月与健康相关的生活质量。嵌入式过程评估将评估研究过程和程序对女性的可接受性。伦敦-坎伯韦尔圣吉尔斯研究伦理委员会,参考:16/LO/1422。结果将在同行评审的期刊和国家和国际会议上的演讲中传播。试用注册号:ISRCTN 39186148。协议版本号:v7,17 年 8 月 13 日。试验赞助商:伦敦国王学院。嵌入式过程评估将评估研究过程和程序对女性的可接受性。伦敦-坎伯韦尔圣吉尔斯研究伦理委员会,参考:16/LO/1422。结果将在同行评审的期刊和国家和国际会议上的演讲中传播。试用注册号:ISRCTN 39186148。协议版本号:v7,17 年 8 月 13 日。试验赞助商:伦敦国王学院。嵌入式过程评估将评估研究过程和程序对女性的可接受性。伦敦-坎伯韦尔圣吉尔斯研究伦理委员会,参考:16/LO/1422。结果将在同行评审的期刊和国家和国际会议上的演讲中传播。试用注册号:ISRCTN 39186148。协议版本号:v7,17 年 8 月 13 日。试验赞助商:伦敦国王学院。
更新日期:2019-10-23
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