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Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia

T

Tianjin Central Hospital of Gynecology Obstetrics

Status

Not yet enrolling

Conditions

GDM

Treatments

Behavioral: Individual lifestyle management

Study type

Interventional

Funder types

Other

Identifiers

NCT07141173
2025KY107

Details and patient eligibility

About

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

Enrollment

604 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

604 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Individual lifestyle management
Treatment:
Behavioral: Individual lifestyle management
control group
No Intervention group
Description:
control group

Trial contacts and locations

1

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Central trial contact

Yifan Fan

Data sourced from clinicaltrials.gov

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