IES Platform: Scoping and feasibility preparation for an RCT on post partum weight loss (WeighWell)

肥胖及其并发症对全球健康构成重大挑战。人们认识到，怀孕是生命的一个阶段，体重可能会增加，许多妇女在产后（出生后一年）一直保持这种体重。对于超重的母亲来说，减轻体重是为了她自己的健康，减少与肥胖有关的并发症的风险，并促进未来的家庭健康。拟议的研究包括范围界定工作（第一阶段），为制定一个以理论为基础的体重管理方案（WeighWell）提供信息；以及一项探索性试验（第二阶段），评估该方案在低收入地区产后妇女中实施的可行性和可接受性。第一阶段包括与利益攸关方（如卫生视察员、社区药剂师）进行面谈，并与母亲进行焦点小组讨论，以确定潜在的招聘机会，探讨干预措施设计和实施的可接受性和偏好，以及以成功的糖尿病治疗方法为基础制定方案的可行性。第二阶段试验将招募60名生活在泰赛德的超重（BMI为25kg/m2）产后妇女，进行为期3个月的干预，其中包括饮食和活动评估以及具体的个性化改变目标。干预的目标是通过适度的能量不足饮食和每周150分钟的运动来减轻5%的体重。参与者还将接受行为咨询，并将确定具体的支持机制，以协助遵守干预目标。基线和随访措施（所有参与者）包括心理社会评估、饮食和身体活动记录以及身体成分的测量。此外，参与者将接受深入访谈，了解参与计划的经验、可接受性和干预实施中涉及的挑战。主要成果将是为确定的随机对照试验设计和实际交付干预措施的协议，可行的招募策略和为试验设计提供信息的减肥信息。还将收集与探索性干预的不同组成部分相关的过程数据，并为未来的干预设计提供信息。

Obesity and resulting complications present a major challenge to global health. It is recognised that pregnancy is a life stage where excess weight gain may occur and that many women retain this weight throughout the post partum period (one year after birth). For the overweight mother, weight loss is desirable for her own well-being, to reduce the risk of obesity-related complications in further pregnancies and to promote future family health. The proposed research comprises scoping work (Phase 1) to inform the development of a theory- based, weight management programme (WeighWell) and an exploratory trial (Phase 2) to assess the feasibility of delivery and acceptability of the programme in post partum women living in low income areas.Phase 1 involves interviews with stakeholders (e.g. health visitors, community pharmacists) and focus group discussions with mothers to identify potential recruitment opportunities and explore acceptability and preferences for the intervention design and delivery and the feasibility of basing a programme on successful approaches to diabetes. The Phase 2 trial will recruit 60 overweight (BMI 25kg/m2 ) post partum women living in Tayside for a 3 month intervention which will include dietary and activity assessments and specific, personalised goals for change. The intervention will aim to achieve a 5% weight loss through a modest energy deficit diet and 150 minutes of activity per week. Participants will also receive behavioural counselling and specific support mechanisms will be identified to assist compliance with the intervention aims. Baseline and follow up measures (all participants) include psycho-social assessments, diet and physical activity records and measurements of body composition. In addition, participants will undertake in-depth interviews on the experience of taking part in the programme, acceptability and challenges involved in the intervention implementation. The main output will be a protocol for the design and practical delivery of an intervention for a definitive randomised control trial, a feasible recruitment strategy and weight loss information to inform trial design. Process data relating to different components of the exploratory intervention will also be collected, and will inform future intervention designs.