GDMNCT07141173
Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia
A study testing Individual lifestyle management in people with GDM, run by Tianjin Central Hospital of Gynecology Obstetrics at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM
- What is being tested?
- Individual lifestyle management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2025to 20 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years old
- 6-14 weeks of pregnancy
- at least one risk factor for GDM
- signed a written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, 300100
Yifan Fan, +86 58287942, 592773020@qq.com
About this study
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
- Conditions
- GDM
- Being tested
- Individual lifestyle management
- Keywords
- GDM, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual lifestyle managementBehavioural
Manage the diet, exercise, weight and healthy lifestyle of pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Individual lifestyle management Receives: Behavioral: Individual lifestyle management |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 24-28 weeks pregnant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Central Hospital of Gynecology Obstetrics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xu, Tianjin Central Hospital of Gynecology Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141173
- Sponsor's protocol ID
- 2025KY107
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia
- ClinicalTrials.gov ID
- NCT07141173
- Acronym / sponsor ID
- 2025KY107
- Conditions
- GDM
- Keywords
- GDM, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- Tianjin Central Hospital of Gynecology ObstetricsUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Individual lifestyle managementIndividual lifestyle management |
| control group | No intervention | –control group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-55 years old
- 6-14 weeks of pregnancy
- at least one risk factor for GDM
- signed a written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual lifestyle managementManage the diet, exercise, weight and healthy lifestyle of pregnant women | Behavioural | Intervention Group |
Primary outcome
The incidence of gestational diabetes(GDM)
Time frame: 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..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for GDM
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual lifestyle management in people with GDM, run by Tianjin Central Hospital of Gynecology Obstetrics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Fan (+86 18322337116, Yvaine_FYF@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of gestational diabetes(GDM) (time frame: 24-28 weeks pregnant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.