Clinical Trials Logo

Clinical Trial Summary

With the opening up of the two-child policy , the composition of pregnant women in China has changed significantly . The proportion of high-risk pregnant women in the elderly has increased significantly , and the risk of adverse pregnancy outcomes has also increased . Among them , gestational diabetes mellitus ( GDM ) is the most common complication during pregnancy . The incidence of GDM in China is as high as 18 % due to the economic growth , lifestyle changes and dietary habits . GDM not only threatens perinatal maternal and child health , but also increases the risk of offspring insulin resistance , obesity and metabolic diseases in adulthood . But it is still lack of experience on intervening and managing them effectively. Therefore , on the basis of previous studies , this study intends to explore the effects of intensive diet and exercise intervention by obstetricians and nutritionists on pregnancy weight gain , pregnancy outcome , glucose and lipid metabolism and postpartum weight retention under the mobile medical platform through a large sample cluster intervention test in the real world. In order to supervise and improve the compliance of the intervention subjects and realize the ultimate change of their behaviors, this study intends to use the APP software, the mobile medical technology, to monitor and evaluate diet , exercise and weight. Through the above research , it aims to improve the current management schemes of diet and weight during pregnancy , not only helps to optimize and improve the quality of perinatal health care , but also prevents the adult chronic diseases from the fetal period. This research has important theoretical and practical value .


Clinical Trial Description

This is a cluster intervention study. A randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. Pregnant women who received routine antenatal examination in Beijing Obstetrics and Gynecology Hospital will be divided into two groups . One group contained 1000 cases as the control group , and the other group contained 1000 cases as a whole . The intervention contents included health education , nutritional analysis and individualized dietary guidance combined with mobile medical treatment and face-to-face teaching during the early , middle and late pregnancy stages. The primary outcome will be the incidence of GDM and the secondary outcome will be the incidence of hypertensive disorders of pregnancy , cesarean section , premature delivery , macrosomia, large for gestational age and so on. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04989634
Study type Interventional
Source Capital Medical University
Contact Guanghui Li, MD, PhD
Phone 008613124728821
Email liguanghui2007@163.com
Status Recruiting
Phase N/A
Start date July 1, 2019
Completion date January 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06099574 - A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
Completed NCT02890693 - Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring N/A
Completed NCT02744300 - Balance After Baby Intervention for Women With Recent Gestational Diabetes N/A
Completed NCT02384226 - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Completed NCT02436551 - Gestational Diabetes in Central Asia: Prevalence and Management
Recruiting NCT02275845 - Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus Phase 3
Recruiting NCT04621396 - The Next Generation Longitudinal Birth Cohort Diabetes Study
Completed NCT01916694 - Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus N/A
Completed NCT01931280 - A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring N/A
Not yet recruiting NCT01637727 - Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women N/A
Completed NCT01565564 - Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes N/A
Recruiting NCT00550979 - Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk N/A
Completed NCT00460018 - Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial) Phase 2
Not yet recruiting NCT04915716 - Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus
Completed NCT04422821 - Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial N/A
Recruiting NCT04369313 - Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers N/A
Recruiting NCT05348863 - SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes N/A
Recruiting NCT04272840 - The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus N/A
Completed NCT02588729 - A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With GDM - RCT N/A
Completed NCT01922791 - Nutrition and Pregnancy Intervention Study N/A