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

NCT ID: NCT04989634

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-01-31

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.

Conditions

Gestational Diabetes Mellitus; Hypertensive Disorder of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

Standard prenatal education on diet, nutrition and physical activity

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.

Group Type: EXPERIMENTAL

Intensive dietary and weight management

Intervention Type: BEHAVIORAL

health education , nutritional analysis and individualized dietary guidance

Interventions

Intensive dietary and weight management

health education , nutritional analysis and individualized dietary guidance

Intervention Type: BEHAVIORAL

Standard care

Standard prenatal education on diet, nutrition and physical activity

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guanghui Li

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guanghui Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Obstetrics and Gynecology Hospital

Locations

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Guanghui Li, MD, PhD

Role: CONTACT

liguanghui2007@163.com

008613124728821

Facility Contacts

Guanghui Li, MD,PHD

Role: primary

liguanghui2007@163.com

86-10-52273110

Other Identifiers

2019-KY-036-02

Identifier Type: -

Identifier Source: org_study_id