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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07141173

Enrollment

604

Registered

2025-08-26

Start date

2025-08-20

Completion date

2027-08-20

Last updated

2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GDM

Keywords

GDM, RCT

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

Interventions

BEHAVIORALIndividual lifestyle management

Manage the diet, exercise, weight and healthy lifestyle of pregnant women

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
The incidence of gestational diabetes(GDM)	24-28 weeks pregnant	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..

Countries

China

Contacts

Primary ContactYifan Fan

Yvaine_FYF@163.com+86 18322337116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026