Clinical trial NCT04989634: Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform
Official title: Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Hypertensive Disorder of Pregnancy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 .

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Regular check-ups in our hospital
* 18-44 years old
* 8-12 gestational weeks

Exclusion Criteria:

* Patients with incomplete medical records

Primary outcomes:
measure: Incidence of gestational diabetes mellitus
timeFrame: From enrollment to 24-28 weeks of gestation
Secondary outcomes:
measure: Incidence of gestational hypertension
timeFrame: From date of randomization until the date of delivery, assessed up to 9 months
measure: Incidence of cesarean section
timeFrame: From date of randomization until the date of delivery, assessed up to 9 months
measure: Incidence of premature birth
timeFrame: From date of randomization until the date of delivery, assessed up to 9 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Study officials:
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Guanghui Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: