School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.
Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
Health Technol Assess. 2021 Aug;25(49):1-130. doi: 10.3310/hta25490.
BACKGROUND: Pregnancy is a high-risk time for excessive weight gain. The rising prevalence of obesity in women, combined with excess weight gain during pregnancy, means that there are more women with obesity in the postnatal period. This can have adverse health consequences for women in later life and increases the health risks during subsequent pregnancies. OBJECTIVE: The primary aim was to produce evidence of whether or not a Phase III trial of a brief weight management intervention, in which postnatal women are encouraged by practice nurses as part of the national child immunisation programme to self-monitor their weight and use an online weight management programme, is feasible and acceptable. DESIGN: The research involved a cluster randomised controlled feasibility trial and two semistructured interview studies with intervention participants and practice nurses who delivered the intervention. Trial data were collected at baseline and 3 months later. The interview studies took place after trial follow-up. SETTING: The trial took place in Birmingham, UK. PARTICIPANTS: Twenty-eight postnatal women who were overweight/obese were recruited via Birmingham Women's Hospital or general practices. Nine intervention participants and seven nurses were interviewed. INTERVENTIONS: The intervention was delivered in the context of the national child immunisation programme. The intervention group were offered brief support that encouraged self-management of weight when they attended their practice to have their child immunised at 2, 3 and 4 months of age. The intervention involved the provision of motivation and support by nurses to encourage participants to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. The role of the nurse was to provide regular external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a record card in their child's health record ('red book') or using the online programme. The behavioural goal was for women to lose 0.5-1 kg per week. The usual-care group received a healthy lifestyle leaflet. MAIN OUTCOME MEASURES: The primary outcome was the feasibility of a Phase III trial to test the effectiveness of the intervention, as assessed against three traffic-light stop-go criteria (recruitment, adherence to regular self-weighing and registration with an online weight management programme). RESULTS: The traffic-light criteria results were red for recruitment (28/80, 35% of target), amber for registration with the online weight loss programme (9/16, 56%) and green for adherence to weekly self-weighing (10/16, 63%). Nurses delivered the intervention with high fidelity. In the qualitative studies, participants indicated that the intervention was acceptable to them and they welcomed receiving support to lose weight at their child immunisation appointments. Although nurses raised some caveats to implementation, they felt that the intervention was easy to deliver and that it would motivate postnatal women to lose weight. LIMITATIONS: Fewer participants were recruited than planned. CONCLUSIONS: Although women and practice nurses responded well to the intervention and adherence to self-weighing was high, recruitment was challenging and there is scope to improve engagement with the intervention. FUTURE WORK: Future research should focus on investigating other methods of recruitment and, thereafter, testing the effectiveness of the intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12209332. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 49. See the NIHR Journals Library website for further project information.
背景:怀孕是体重过度增加的高风险时期。女性肥胖症的患病率不断上升,加上怀孕期间体重过度增加,意味着产后有更多的肥胖女性。这可能对女性以后的健康产生不利影响,并增加后续怀孕时的健康风险。
目的:主要目的是评估一项三期试验的可行性和可接受性,该试验中,实践护士鼓励参与产后妇女作为国家儿童免疫计划的一部分,自我监测体重并使用在线体重管理计划,以鼓励她们进行简短的体重管理干预。
设计:研究采用了一项聚类随机对照可行性试验和两项半结构化访谈研究,参与者为接受干预的产妇和实施干预的实践护士。试验数据在基线和 3 个月后收集。访谈研究在试验随访后进行。
地点:试验在英国伯明翰进行。
参与者:28 名超重/肥胖的产后妇女通过伯明翰妇女医院或普通诊所招募。9 名干预参与者和 7 名护士接受了访谈。
干预措施:该干预措施在国家儿童免疫计划的背景下提供。干预组在 2、3 和 4 个月龄时带着孩子到诊所接受免疫接种时,会获得简短的支持,鼓励他们自我管理体重。干预包括通过自我监测体重和为在线体重管理计划提供指导,护士为参与者提供动机和支持,鼓励他们通过自我监测体重和为在线体重管理计划提供指导,做出更健康的生活方式选择。护士的作用是为体重减轻提供定期的外部责任。妇女被要求每周称一次体重,并将其记录在孩子健康记录(“红皮书”)中的记录卡上或使用在线计划。行为目标是每周减轻 0.5-1 公斤。对照组接受了健康生活方式传单。
主要结果测量:主要结果是评估三期试验的可行性,以评估干预措施的有效性,根据三个红绿灯停走标准进行评估(招募、定期自我称重和在线体重管理计划注册)。
结果:红绿灯标准的结果是:招募为红色(28/80,目标的 35%),在线体重减轻计划注册为琥珀色(9/16,56%),每周自我称重的依从性为绿色(10/16,63%)。护士以高度的保真度实施了干预措施。在定性研究中,参与者表示,他们对干预措施感到满意,并欢迎在儿童免疫接种预约时获得减肥支持。尽管护士对实施提出了一些保留意见,但他们认为该干预措施易于实施,并将激励产后妇女减肥。
局限性:招募的参与者少于计划人数。
结论:尽管妇女和实践护士对干预措施反应良好,自我称重的依从性很高,但招募工作具有挑战性,有必要进一步提高对干预措施的参与度。
未来工作:未来的研究应侧重于探索其他招募方法,然后测试干预措施的有效性。
试验注册:当前对照试验 ISRCTN12209332。
资金:该项目由英国国家卫生研究所(NIHR)健康技术评估计划资助,将在 ; Vol. 25, No. 49 中全文发表。有关该项目的更多信息,请访问 NIHR 期刊库网站。
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