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Individualized Intensive Lifestyle Intervention for Gestational Diabetes Mellitus: A open-label multicenter randomized control trial

Individualized Intensive Lifestyle Intervention for Gestational Diabetes Mellitus: A open-label multicenter randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091534
Enrollment
Unknown
Registered
2024-10-30
Start date
2024-11-04
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Gestational Diabetes Mellitus

Interventions

Intervention group:Individual intensive behavioural interventions
Control group:Standard health promotion

Sponsors

Tongji University Obstetrics and Gynaecology Hospital (Shanghai First Maternity and Infant Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy; 2. Aged 20 to 45 years; 3. Gestational week at initial check-up= 5.1 mmol/L; 5b. a history of gestational diabetes mellitus; 5c. BMI >= 28 kg/m2; 5d. age >= 35 years; 5e. First-degree relative with diabetes. 6.Provides informed consent.

Exclusion criteria

Exclusion criteria: 1. Taking weight/glycemic control drugs during the 3 months before pregnancy; 2. Pre-pregnancy diabetes mellitus: Pre-pregnancy diabetes mellitus should be diagnosed if it is not diagnosed before pregnancy and if the blood glucose elevation reaches any of the following criteria during pregnancy, a. FPG >= 7.0 mmol/L; b. Accompanied by typical symptoms of hyperglycemia or hyperglycemic crisis, with arbitrary blood glucose >= 11.1 mmol/L; c.HbA1c >= 6.5% 3. Patients with contraindications to exercise during pregnancy (refer to the "Draft Expert Consensus on Exercise in Pregnancy" published by the Chinese Association of Maternal and Child Health and Diabetes in Pregnancy Committee 2021), or are unable to comply with exercise interventions due to trauma or orthopedic conditions. 4. Patients with special dietary habits who are unable to comply with nutritional interventions such as vegans, patients with a history of food allergy; 5. Shift work (night shift) by nature of work.

Design outcomes

Primary

MeasureTime frame
gestational diabetes mellitus;

Secondary

MeasureTime frame
birth weight;Trajectory of weight change during pregnancy;drug treatment for GDM ;Fetal growth trajectory;mode of delivery;Sleep quality;Quality of life;Mental health;Body composition;Postpartum blood glucose level;Gestational age;pregnancy complications;gestational hypertension;glucose level during pregnancy;prenatal lipids;thyroid function;inflammation status;

Countries

China

Contacts

Public ContactSu Xiujuan

Tongji University Obstetrics and Gynaecology Hospital (Shanghai First Maternity and Infant Hospital)

xiujuan_su@tongji.edu.cn+86 177 1781 7512

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 30, 2026