Subsidy programme for gestational diabetes mellitus screening and lifestyle management in rural areas of western China: a study protocol for a multicentre randomised controlled trial

Introduction Gestational diabetes mellitus (GDM) has become an increasing health problem among pregnant women in western rural China. Insufficient compliance and motivation due to economic factors is one of the major contributors to the currently low GDM screening and management rate. A subsidy program offering GDM screening and lifestyle management might be an effective way to increase pregnant women's awareness of GDM, and further improve maternal and neonatal health in western rural China. This study had two primary purposes: (1) to examine whether the subsidy program would increase the screening and management rates of GDM and reduce adverse complications for mothers and new-born babies and (2) to evaluate whether the subsidy program is cost-effective from a societal perspective. Methods and analysis This randomised controlled trial will include 3000 pregnant women (at 24-28 weeks of pregnancy) who will be followed up at six hospitals in the provinces of Yunnan, Sichuan and Shaanxi in China. Pregnant women without overt diabetes, with a singleton pregnancy, with telephone access and with written informed consent will be invited. The intervention group will receive subsidies and standard care, and the control group will only receive usual antenatal care. The randomisation sequence will be stratified by study sites with balanced blocks of six patients. Data will be collected using self-report questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. The primary outcomes are the maternal and neonatal complications. Secondary outcomes are the mother's cognition scores, screening rate, number of re-examinations, weight gain during pregnancy, changes in diet and exercise, and quality of life. Group comparisons will be conducted using chi(2) test for categorical variables, and t-test or the Mann-Whitney-Wilcoxon test for continuous variables where applicable. Multiple logistic regression will also be performed for the primary outcomes. Ethics and dissemination This study was approved by the Ethics Review Committee of Peking University Health Science Center. Findings will be disseminated through publication in peer-reviewed journals, seminars and national and international conferences.