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

Primary Purpose

Gestational Diabetes Mellitus, Hypertensive Disorder of Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive dietary and weight management
Standard care
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with incomplete medical records

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital,Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard care

dietary and weight management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of gestational diabetes mellitus

Secondary Outcome Measures

Incidence of gestational hypertension
Incidence of cesarean section
Incidence of premature birth

Full Information

First Posted
July 26, 2021
Last Updated
July 26, 2021
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04989634
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Hypertensive Disorder of Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
dietary and weight management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive dietary and weight management
Intervention Description
health education , nutritional analysis and individualized dietary guidance
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
Standard prenatal education on diet, nutrition and physical activity
Primary Outcome Measure Information:
Title
Incidence of gestational diabetes mellitus
Time Frame
From enrollment to 24-28 weeks of gestation
Secondary Outcome Measure Information:
Title
Incidence of gestational hypertension
Time Frame
From date of randomization until the date of delivery, assessed up to 9 months
Title
Incidence of cesarean section
Time Frame
From date of randomization until the date of delivery, assessed up to 9 months
Title
Incidence of premature birth
Time Frame
From date of randomization until the date of delivery, assessed up to 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guanghui Li, MD, PhD
Phone
008613124728821
Email
liguanghui2007@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guanghui Li, MD, PhD
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
City
Beijing
ZIP/Postal Code
100026
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghui Li, MD,PHD
Phone
86-10-52273110
Email
liguanghui2007@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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