Pakistan Prevention Programme for Gestational Diabetes Mellitus (PPP-GDM): a feasibility study

2型糖尿病（T2 DM）和妊娠期糖尿病（GDM）是世界范围内日益严重的问题。根据研究的人群，所有妊娠中有1-14%并发GDM。在巴基斯坦，我们估计GDM的患病率为8%，这给医疗保健带来了巨大的经济成本。此外，妊娠合并GDM增加了胎儿、母亲和儿童长期并发症的发生率。因此，迫切需要采取协调一致的方法来预防T2 DM。研究表明，通过减肥/适度运动改变生活方式可使高风险人群的T2 DM降低高达58%。我们未来的全随机试验的研究问题是“在妊娠期糖尿病妇女中，在发展中国家，以体力活动和体重维持为重点的生活方式干预计划是否可行，以降低糖尿病的风险？”为了设计更大规模的全面试验，我们将首先进行可行性研究，以测试主要研究的各个组成部分是否可以协同工作。具体而言，它侧重于主要研究的过程，以确保研究方案的完整性，包括：-研究招募-参与者接受随机化的意愿-随机化过程-血液检查同意书-干预措施的改进和实施-干预措施的可接受性和依从性-随访评估将分析这些组成部分的实现情况，以告知有关进展的决定，积累的经验将有助于完善整个试验的设计。此外，我们将估计主要结果的平均值和标准差，以确认试验样本量的计算。通过在同行评审的期刊上发表文章和在国家和国际会议上发表演讲，使学术界受益。由于在低收入和中等收入国家（LMICs）对这一主题的研究很少，我们将开发和试点一种新的干预措施，随后将在更大的试验中进行测试。这一做法有可能在其他中低收入国家推广。减少和/或减缓中低收入国家糖尿病发病率的上升对所有人来说都是一个挑战，我们的发展建议将引起巴基斯坦和全球临床医生和研究人员的兴趣和使用。4.英国伯明翰大学和巴基斯坦阿迦汗大学的研究人员之间的密切合作将进一步加强这种国际合作。这将提高英国和巴基斯坦的研究能力。我们还将在该可行性试验和随后的完整试验中生成数据，这些数据将可供其他研究人员使用-尽管从后续试验中收集的数据更可能是一个更丰富的定性和定量材料数据库。7.一旦在巴基斯坦扩大和全面实施干预措施，就可以预防妊娠期糖尿病妇女的糖尿病。巴基斯坦的政策制定者将有一个强有力的，以证据为基础的干预措施作为其卫生计划的一部分。

Type 2 diabetes (T2DM) and gestational diabetes mellitus (GDM) are escalating problems worldwide. Depending on the population studied, 1-14% of all pregnancies are complicated by GDM. In Pakistan, we estimate prevalence of GDM is 8% and this has huge financial costs to health care. Further, pregnancies complicated by GDM have increased incidence of fetal, maternal, and childhood long term complications. Therefore, there is an urgent need to implement a coordinated approach to prevent T2DM. It is established that lifestyle modification with weight loss/moderate exercise can reduce T2DM by up to 58% in high risk people. Our research question for the future full randomized trial is 'in women with gestational diabetes mellitus, is a lifestyle intervention programme focusing on physical activity and weight maintenance feasible in a developing country to decrease the risk of diabetes?To inform the design of a larger full trial, we will first undertake a feasibility study to test whether the components of the main study can all work together. Specifically, it is focused on the processes of the main study to ensure the integrity of the study protocol including:- recruitment to study- willingness of participants to be randomised- randomisation process- consent for blood tests- refinement and delivery of the intervention- acceptability and adherence to the intervention- follow-up assessmentsAchievement of these components will be analysed to inform decisions about progression and the experience accumulated will assist in the refinement of the design of the full trial. In addition, we will estimatethe mean and standard deviation of the primary outcome to confirm the trial sample size calculations.Many benefits will arise from this development grant proposal:1. Academic beneficiaries through publication in peer reviewed journals and presentations at national and international conferences.2. As there is little research on this topic in low- and middle-income countries (LMICs), we will develop and pilot a novel intervention that will subsequently be tested in a larger trial. This then has potential to be scaled-up in other LMICs.3. Reducing and/or slowing the rise in diabetes in LMICs is a challenge for all and our developmental proposal will be of interest and use to clinicians and researchers in Pakistan as well as globally. 4. The close collaboration between researchers based at the University of Birmingham, UK and Agha Khan University in Pakistan will further enhanced this international collaboration.5. This will then lead to increasing research capacity both in the UK and Pakistan.6. We will also generate data in this in this feasibility and subsequent full trial which will be available for other researchers - though the data collected from the follow-on trial is more likely to be a richer database of qualitative and quantitative material. 7. Prevention of diabetes in women with GDM once the intervention is scale up and fully implemented in Pakistan.8. Policy makers in Pakistan will have a robust, evidence-based intervention as part of their health plan.