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UK - Department for Business, Energy and Industrial Strategy

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

Disclaimer: The data for this page has been produced from IATI data published by UK - Department for Business, Energy and Industrial Strategy. Please contact them (Show Email Address) if you have any questions about their data.

Project Data Last Updated: 10/11/2021

IATI Identifier: GB-GOV-13-FUND--GCRF-MR_M022048_1

Description

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 assessments Achievement 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 estimate the 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.

Objectives

Our research question for the future full randomized trial is 'in women with gestational diabetes mellitus (GDM), 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 assessments Achievement of these components will be analysed as a proportion 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 estimate the mean and standard deviation of the primary outcome to confirm the trial sample size calculations.

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Sectors groups as a percentage of country budgets according to the Development Assistance Committee's classifications.

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A comparison across six financial years of forecast spend and the total amount of money spent on the project to date.

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