Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform

Gestational Diabetes Mellitus Clinical Trial

Official title:

Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989634
• Other study ID #: 2019-KY-036-02
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2021
• Source: Capital Medical University
• Contact: Guanghui Li, MD, PhD
• Phone: 008613124728821
• Email: liguanghui2007[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Regular check-ups in our hospital

• 18-44 years old

• 8-12 gestational weeks

Exclusion Criteria:

• Patients with incomplete medical records

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Hypertension
• Hypertensive Disorder of Pregnancy
• Toxemia

Intervention

Behavioral:
• Intensive dietary and weight management
health education , nutritional analysis and individualized dietary guidance
• Standard care
Standard prenatal education on diet, nutrition and physical activity

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital,Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of gestational diabetes mellitus		From enrollment to 24-28 weeks of gestation
Secondary	Incidence of gestational hypertension		From date of randomization until the date of delivery, assessed up to 9 months
Secondary	Incidence of cesarean section		From date of randomization until the date of delivery, assessed up to 9 months
Secondary	Incidence of premature birth		From date of randomization until the date of delivery, assessed up to 9 months