Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individual lifestyle management.
- Who it may be relevant to
- Registry conditions: GDM. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Behavioral Individual lifestyle management
Manage the diet, exercise, weight and healthy lifestyle of pregnant women
Primary outcome measures
- The incidence of gestational diabetes(GDM) [Time frame: 24-28 weeks pregnant]
Eligibility criteria
Inclusion criteria
- 18-55 years old
- 6-14 weeks of pregnancy
- at least one risk factor for GDM
- signed a written informed consent
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Tianjin Central Hospital of Gynecology Obstetrics — Tianjin
Identifiers
NCT: NCT07141173 · 2025KY107