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

巴基斯坦妊娠期糖尿病预防计划 (PPP-GDM)：可行性研究

• 批准号: MR/M022048/1
• 负责人: Paramjit Gill
• 金额: $ 17.34万
• 依托单位: University of Birmingham
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2015
• 资助国家: 英国
• 起止时间: 2015 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FM022048%2F1
• 关键词: Pakistan; Prevention; Programme; Gestational; Diabetes

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.

2型糖尿病(T2 DM)和妊娠期糖尿病(GDM)是全球范围内日益严重的问题。根据研究人群的不同，1-14%的妊娠合并妊娠期糖尿病。在巴基斯坦，我们估计妊娠期糖尿病的患病率为8%，这给医疗保健带来了巨大的财政成本。此外，妊娠合并妊娠期糖尿病增加了胎儿、母亲和儿童的长期并发症的发生率。因此，迫切需要实施一种协调一致的方法来预防T2 DM。研究证实，在高危人群中，通过减肥/适度运动改变生活方式可以减少高达58%的T2 DM。我们对未来完全随机试验的研究问题是：在患有妊娠期糖尿病的女性中，以体力活动和体重维持为重点的生活方式干预计划在发展中国家是否可行，以降低患糖尿病的风险？为了为更大规模的全面试验的设计提供信息，我们将首先进行一项可行性研究，以测试主要研究的各个组成部分是否都能协同工作。具体而言，它侧重于确保研究方案完整性的主要研究程序，包括：-招募研究人员--参与者的随机化意愿--随机程序--对血液测试的同意--改进和实施干预措施--可接受性和对干预措施的遵守--后续评估将分析这些部分的完成情况，以便做出关于进展的决定，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。这项发展赠款提案将带来许多好处：1.通过在同行评议的期刊上发表文章以及在国内和国际会议上发表演讲，使学术受益。由于在低收入和中等收入国家(LMIC)对这一主题的研究很少，我们将开发和试验一种新的干预措施，随后将在更大的试验中进行测试。这样，这就有可能在其他LMIC中得到放大。减少和/或减缓LMICs中糖尿病发病率的上升对所有人来说都是一项挑战，我们的开发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.设在英国伯明翰大学的研究人员与巴基斯坦阿哈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。我们还将在这次可行性试验和随后的全面试验中生成数据，供其他研究人员使用--尽管从后续试验中收集的数据更有可能是一个更丰富的定性和定量材料数据库。7.在巴基斯坦扩大和全面实施干预措施后，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、基于证据的干预措施，作为他们健康计划的一部分。