Lifestyle information and access to a commercial weight management group to promote maternal postnatal weight management and positive lifestyle behaviour: the SWAN feasibility RCT

D. Bick, Cath Taylor, V. Bhavnani, A. Healey, P. Seed, Sarah Roberts, M. Zasada, A. Avery, Victoria Craig, Nina Khazaezadah, S. McMullen, Sheila O’Connor, Bimpe Oki, E. Oteng-Ntim, L. Poston, M. Ussher
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Abstract

Background: Increasing numbers of UK women have overweight or obese BMIs when they become pregnant, or gain excessive weight in pregnancy, increasing their risk of adverse outcomes. Failure to manage postnatal weight is linked to smoking, non-healthy dietary choices, lack of regular exercise, and poorer longer-term health. Women living in areas of higher social deprivation are more likely to experience weight management problems postnatally. Objectives: To assess feasibility of conducting a definitive RCT to determine effectiveness of lifestyle information and access to a commercial weight management group focusing on self-monitoring, goal setting and motivation to achieve dietary change commencing 8 to 16 weeks postnatally to achieve and maintain weight management and positive lifestyle behaviours. Design: A randomised two arm feasibility trial, with a nested mixed-methods process evaluation. Setting: A single centre in an inner city setting in the south of England Participants: Women with BMIs>25kg/m2 at antenatal booking and women with normal BMIs (18.5kg/m2) at antenatal booking who developed excessive gestational weight gain as assessed at 36 weeks gestation. Feasibility objectives: Recruitment, retention, acceptability of study processes and identification of relevant economic data. The proposed primary outcome was difference between groups in weight 12 months postnatally, expressed as % weight change and weight loss from antenatal booking. Other proposed outcomes included assessment of diet, physical activity, smoking, alcohol, body image, maternal esteem, mental health, infant feeding and NHS costs. Results: Most objectives were achieved. 193 women were recruited, 98 allocated to the intervention and 95 to the control. High follow up rates (>80%) were achieved to 12 months. A possible 8.8% benefit in weight change at 12 months compared with booking BMI was found among intervention women, compared with control (4.2% compared to 13.0% p=0.062) , 47% of whom attended at least one weight management session, with low risk of contamination between groups. Greatest benefit was among women who attended 10+ sessions. Barriers to attending sessions included opportunity, capability and motivation issues. Data collection tools were appropriate to support economic evaluation in a definitive trial, and economic modelling is feasible to quantify resource impacts and outcomes not directly measurable within a trial. Limitations: The study only recruited from one site. It was not possible to recruit women with normal BMIs who developed excessive pregnancy weight gain. Conclusion: It was feasible to recruit and retain women with overweight or obese BMIs at pregnancy commencement to a trial of postnatal weight management plus standard care compared to standard care only, and collect relevant data to assess outcomes. Approaches to recruit women with normal BMIs who gain excessive gestational weight need to be considered. Commercial weight management groups could support women’s weight management as assessed at 12 months postnatally, with likely greater benefit from attending 10+ sessions. Process evaluation findings highlighted importance of providing more information about the intervention on study allocation, extended duration of time to commence sessions following birth, and extended number of sessions offered to enhance uptake and retention. Future work: Results support the conduct of a future effectiveness RCT.
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生活方式信息和进入商业体重管理小组以促进产妇产后体重管理和积极的生活方式行为:SWAN可行性随机对照试验
背景:越来越多的英国女性在怀孕时患有超重或肥胖的BMI,或在怀孕期间体重超标,增加了不良后果的风险。未能控制产后体重与吸烟、不健康的饮食选择、缺乏定期锻炼和长期健康状况较差有关。生活在社会贫困程度较高地区的女性更有可能在出生后出现体重管理问题。目的:评估进行最终随机对照试验的可行性,以确定生活方式信息的有效性,并获得商业体重管理小组,该小组专注于自我监测、目标设定和动机,从出生后8至16周开始实现饮食改变,以实现和保持体重管理和积极的生活方式行为。设计:一项随机双臂可行性试验,采用嵌套混合方法进行过程评估。环境:英格兰南部内城环境中的一个单一中心参与者:产前预约时体重指数>25kg/m2的女性和产前预约时身高指数正常(18.5kg/m2)的女性,在妊娠36周时评估为妊娠体重过度增加。可行性目标:招募、保留、研究过程的可接受性和相关经济数据的确定。建议的主要结果是出生后12个月各组体重的差异,表示为%体重变化和产前预约体重减轻。其他建议的结果包括对饮食、体育活动、吸烟、酒精、身体形象、母亲自尊、心理健康、婴儿喂养和NHS费用的评估。结果:大多数目标都实现了。招募了193名妇女,其中98名分配给干预组,95名分配给对照组。随访率高(>80%)达12个月。与预订BMI相比,干预组女性在12个月时的体重变化可能有8.8%的益处,而对照组女性(4.2%对13.0%,p=0.062),其中47%的女性至少参加了一次体重管理会议,两组之间的污染风险较低。受益最大的是参加了10多次会议的妇女。参加会议的障碍包括机会、能力和动机问题。数据收集工具适用于支持最终试验中的经济评估,经济建模可以量化试验中无法直接衡量的资源影响和结果。局限性:该研究仅从一个站点招募。不可能招募到BMI正常、妊娠期体重过度增加的女性。结论:招募并保留妊娠期超重或肥胖BMI的女性参加产后体重管理加标准护理的试验是可行的,与仅接受标准护理相比,并收集相关数据来评估结果。需要考虑招募BMI正常、妊娠期体重增加过多的女性的方法。商业体重管理小组可以支持产后12个月评估的女性体重管理,参加10多次会议可能会带来更大的好处。过程评估结果强调了提供更多关于研究分配干预措施、延长出生后开始治疗的时间以及延长治疗次数以提高吸收和保留的重要性。未来工作:结果支持开展未来有效性随机对照试验。
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