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

Not Applicable

• Conditions: Hypertensive Disorder of Pregnancy; Gestational Diabetes Mellitus
• Interventions: Behavioral: Intensive dietary and weight management; Behavioral: Standard care

• Registration Number: NCT04989634
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-26
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• Patients with incomplete medical records

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary and weight management	Intensive dietary and weight management	A randomized controlled trial in pregnant women will be initiated at 8-12 weeks of gestation util delivery. 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.
standard care	Standard care	In the early pregnancy ( 8-12 weeks of pregnancy ) , a group education on dietary weight management will be carried out according to the current medical system and the regulations of our hospital , followed by routine prenatal examination . According to the corresponding diagnosis and treatment guidelines, examinations and follow-up interventions will be carried out if the metabolic diseases are occurred during pregnancy.

Primary Outcome Measures

Name	Time	Method
Incidence of gestational diabetes mellitus	From enrollment to 24-28 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Incidence of gestational hypertension	From date of randomization until the date of delivery, assessed up to 9 months
Incidence of cesarean section	From date of randomization until the date of delivery, assessed up to 9 months
Incidence of premature birth	From date of randomization until the date of delivery, assessed up to 9 months

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University; 🇨🇳 Beijing, China