Prevention of Gestational Diabetes Mellitus With Lifestyle Intervention Among Women of Advanced Maternal Age.
1 other identifier
interventional
346
1 country
1
Brief Summary
This is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on GDM among women with advanced maternal age. It will be conducted in Beijing, with a sample size of 346. All eligible pregnant women will be randomly assigned to either the intervention or control group, and followed up to delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 16, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 16, 2022
June 1, 2022
1.5 years
June 8, 2022
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of gestational diabetes mellitus
diagnosed by the oral glucose tolerance test
from 24 weeks of gestation to delivery.
Secondary Outcomes (14)
maternal glycated hemoglobin level
at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal fasting plasma glucose level
at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal gestational weight gain
from recruitment to delivery
incidence of gestational hypertension
from 20 weeks of gestation to delivery.
incidence of pre-eclampsia
from 20 weeks of gestation to delivery.
- +9 more secondary outcomes
Study Arms (2)
Lifestyle intervention group
EXPERIMENTALParticipants will be given mobile- and hospital-based lifestyle interventions. The mobile-based interventions including dietary guidance, exercise supervision and weight monitoring will be conducted by trained physicians through WeChat group on cell phone every 1 to 2 weeks. Participants need to report their physical activity and weight information every week through WeChat group. Hospital-based intervention is a ≥5 minutes one-to-one and face-to-face personalized lifestyle counselling leading by a trained physician every 4 weeks during \<14 weeks of gestation, every 2 weeks during 14-28 weeks of gestation, and once a week during ≥28 weeks of gestation. Participants' dietary information will be collected for any 3 consecutive days chosen by participants during 12-14 weeks of gestation, 24-28 weeks of gestation and \>36 weeks of gestation respectively using a food frequency questionnaire.
control group
NO INTERVENTIONParticipants in control group will be managed in accordance with the standard practice.
Interventions
The same as that stated in arm descriptions.
Eligibility Criteria
You may qualify if:
- local resident in Beijing
- Singleton pregnancy
- Aged ≥35 years
- Overweight or obesity (Body mass index is between 24 and 27.9 kg/m2 or ≥28 kg/m2)
- ≤12 weeks of gestation
- written informed consent is obtained
You may not qualify if:
- Diagnosed with type 1 or type 2 diabetes before pregnancy
- Diagnosed with GDM or impaired glucose tolerance at enrollment
- use of medication that influences glucose metabolism currently, such as metformin, etc.
- multiple pregnancy
- current substance abuse
- unable to exercise due to physical disability
- diagnosed severe psychiatric disorder
- Other conditions not suitable for intervention as judged by physicians
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Universitylead
- Peking University First Hospitalcollaborator
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yumei Wei, PhD
Peking University First Hospital
- PRINCIPAL INVESTIGATOR
Yubo Zhou
Peking University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 16, 2022
Study Start
July 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
June 16, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- After the publication of the main paper (hopefully before the end of 2024), the data will be available to share to other researchers
- Access Criteria
- Researchers should request the data via the following Email: zhouyubo@bjmu.edu.cn or weiyumei1982@126.com
The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared