Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia
1 other identifier
interventional
604
1 country
1
Brief Summary
This study aims to explore whether early intervention for high-risk groups of gestational hyperglycemia can improve insulin resistance and effectively prevent the occurrence of GDM, and evaluate which pathophysiological subtypes of GDM have the best effect on improving maternal and fetal adverse prognosis, so as to provide evidence for stratified management and individualized clinical intervention of high glucose groups in pregnancy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Typical duration for not_applicable
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
August 18, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 20, 2027
August 26, 2025
August 1, 2025
2 years
August 18, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of gestational diabetes(GDM)
The 75g 2h oral glucose tolerance test is performed at 24-28 weeks of gestation, and the cut-off points of venous blood glucose values are 5.1mmol/L (fasting), 10.0mmol/L (1h after glucose load), 8.5mmol/L (2h after glucose load). If any one of the three blood glucose measures is above the cut-off points, then GDM is diagnosed..
24-28 weeks pregnant
Study Arms (2)
Intervention Group
EXPERIMENTALIndividual lifestyle management
control group
NO INTERVENTIONcontrol group
Interventions
Manage the diet, exercise, weight and healthy lifestyle of pregnant women
Eligibility Criteria
You may qualify if:
- years old
- weeks of pregnancy
- at least one risk factor for GDM
- signed a written informed consent
You may not qualify if:
- Individuals diagnosed with diabetes or prediabetes prior to pregnancy
- currently taking medications affecting blood glucose levels such as metformin
- women at risk of miscarriage
- individuals with chronic conditions (such as uncontrolled hypertension, severe heart disease)
- those with movement disorders or contraindicated conditions for physical activity
- patients undergoing gastrointestinal surgeries that alter glucose absorption
- those unable to maintain regular prenatal care (such as non-compliance with medical instructions or mental health issues).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, 300100, China
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 18, 2025
First Posted
August 26, 2025
Study Start
August 20, 2025
Primary Completion (Estimated)
August 20, 2027
Study Completion (Estimated)
August 20, 2027
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share