- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04989634
Effects of Dietary and Weight Management on Pregnancy Outcomes in Mobile Medical Platform
July 26, 2021 updated by: Guanghui Li, Capital Medical University
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 .
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guanghui Li, MD, PhD
- Phone Number: 008613124728821
- Email: liguanghui2007@163.com
Study Locations
-
-
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Beijing, China, 100026
- Recruiting
- Beijing Obstetrics and Gynecology Hospital,Capital Medical University
-
Contact:
- Guanghui Li, MD,PHD
- Phone Number: 86-10-52273110
- Email: liguanghui2007@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 44 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Regular check-ups in our hospital
- 18-44 years old
- 8-12 gestational weeks
Exclusion Criteria:
- Patients with incomplete medical records
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Standard prenatal education on diet, nutrition and physical activity
|
Experimental: 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.
|
health education , nutritional analysis and individualized dietary guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of gestational diabetes mellitus
Time Frame: From enrollment to 24-28 weeks of gestation
|
From enrollment to 24-28 weeks of gestation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of gestational hypertension
Time Frame: From date of randomization until the date of delivery, assessed up to 9 months
|
From date of randomization until the date of delivery, assessed up to 9 months
|
Incidence of cesarean section
Time Frame: From date of randomization until the date of delivery, assessed up to 9 months
|
From date of randomization until the date of delivery, assessed up to 9 months
|
Incidence of premature birth
Time Frame: From date of randomization until the date of delivery, assessed up to 9 months
|
From date of randomization until the date of delivery, assessed up to 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
January 31, 2022
Study Completion (Anticipated)
January 31, 2022
Study Registration Dates
First Submitted
July 26, 2021
First Submitted That Met QC Criteria
July 26, 2021
First Posted (Actual)
August 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 4, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-KY-036-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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