BMJ open · 2024
Digital therapeutics-based lifestyle intervention for gestational diabetes mellitus prevention of high-risk pregnant women: a study protocol for a non-randomised controlled trial.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lin Lihua, Dong Jiayi, Wang Youxin, Song Libin, Ye Xiaoyan, Chen Xingying, Miao Chong, Lin Juan
Аннотация
INTRODUCTION: Digital therapeutics have been approved as a treatment aid for various medical conditions and are increasingly prevalent. Despite numerous studies on the potential of digital therapeutic interventions in preventing gestational diabetes mellitus (GDM), there is a critical need for more high-quality, large-scale studies to validate their effectiveness. This need arises from the inconsistencies in results and variations in the quality of previous research.
METHODS AND ANALYSIS: We propose a non-randomised controlled trial involving 800 high-risk pregnant women in 6 maternity and child health hospitals in Fujian, China. This study aims to investigate the role and effectiveness of digital therapeutics-based lifestyle intervention in managing the health of pregnant women at high risk for GDM. The study will compare the differences in GDM prevalence, pregnancy weight management and other pregnancy-related health outcomes between pregnant women who received digital therapeutics-based lifestyle intervention and those in the control group. The intervention includes dietary guidance, a personalised physical activity programme and lifestyle improvement strategies delivered through a smartphone app. Primary outcomes include the incidence of GDM at 24-28 weeks gestation and gestational weight gain (GWG). Secondary outcomes comprise improvements in individual lifestyle and risk factors, nutritional issues, implementation outcomes and other pregnancy-related outcomes.
ETHICS AND DISSEMINATION SECTION: The trial was approved by the Ethics Committee of Fujian Maternity and Child Health Hospital (approval number: 2023KY046), Jianyang Maternity and Child Health Hospital (approval number: A202401), Fuqing Maternity and Child Health Hospital (approval number: FY2024003), Changting Maternity and Child Health Hospital (approval number: 202401), Datian Maternity and Child Health Hospital (approval number: dtfy202401) and Quanzhou Maternity and Child Health Hospital (approval number: 2024(50)). We will disseminate our findings by publishing articles in leading peer-reviewed journals.
TRIAL REGISTRATION NUMBER: ChiCTR2300071496.
METHODS AND ANALYSIS: We propose a non-randomised controlled trial involving 800 high-risk pregnant women in 6 maternity and child health hospitals in Fujian, China. This study aims to investigate the role and effectiveness of digital therapeutics-based lifestyle intervention in managing the health of pregnant women at high risk for GDM. The study will compare the differences in GDM prevalence, pregnancy weight management and other pregnancy-related health outcomes between pregnant women who received digital therapeutics-based lifestyle intervention and those in the control group. The intervention includes dietary guidance, a personalised physical activity programme and lifestyle improvement strategies delivered through a smartphone app. Primary outcomes include the incidence of GDM at 24-28 weeks gestation and gestational weight gain (GWG). Secondary outcomes comprise improvements in individual lifestyle and risk factors, nutritional issues, implementation outcomes and other pregnancy-related outcomes.
ETHICS AND DISSEMINATION SECTION: The trial was approved by the Ethics Committee of Fujian Maternity and Child Health Hospital (approval number: 2023KY046), Jianyang Maternity and Child Health Hospital (approval number: A202401), Fuqing Maternity and Child Health Hospital (approval number: FY2024003), Changting Maternity and Child Health Hospital (approval number: 202401), Datian Maternity and Child Health Hospital (approval number: dtfy202401) and Quanzhou Maternity and Child Health Hospital (approval number: 2024(50)). We will disseminate our findings by publishing articles in leading peer-reviewed journals.
TRIAL REGISTRATION NUMBER: ChiCTR2300071496.