Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus

Not Applicable

• Conditions: Gestational Diabetes Mellitus (GDM)
• Interventions: Behavioral: lifestyle intervention with dietary and exercise recommendation

• Registration Number: NCT03062475
• Lead Sponsor: Peking University First Hospital

Brief Summary

Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM.

Detailed Description

Gestational diabetes mellitus(GDM) is a commom complication during pregnancy. and the incidence has reached as high as 19.2% in China. GDM is associated with various adverse pregnancy outcomes for both the mother and her offspring, and not only during the perinatal phase, but also in the long term.Thus finding effective way to reduce the risk of GDM is of great importance,especial for women with high GDM risk factors. GDM history is one of the risk factors. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM

Study Timeline

• Study First Submitted: 2017-02-11
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2019-05-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-01
• Last Update Posted: 2019-09-04
• Primary Completion: 2020-08-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

• Singleton;
• non-smoking ;
• before 12+6 weeks gestation.

Exclusion Criteria

• less than 18 years old;
• unwilling to provide informed consent;
• cervical insufficiency;
• women on any medication for pre-existing hypertension, diabetes, cardiac disease, renal disease, systemic lupus erythematosus, thyroid disease or psychosis;
• women who were currently being treated with metformin or corticosteroids.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifestyle intervention group	lifestyle intervention with dietary and exercise recommendation	Pregnant women allocated to this group receive lifestyle intervention. With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake. With respect to advice on physical activity, we focused on incremental increases in walking from a pedometer assessed or encourage them to do moderate cycling.

Primary Outcome Measures

Name	Time	Method
GDM	24-28 gestational weeks	According to the new criteria amended in August 2014 in China, GDM was diagnosed when any one value reaches or exceeds 5.1 mmol/L at 0 hours, 10.0 mmol/L at 1 hour, or 8.5 mmol/L at 2 hours. Values of 7.0 mmol/L at 0 hours or 11.1 mmol/L at 2 hours were diagnosed as DM, regardless of the pregnancy stage

Secondary Outcome Measures

Name	Time	Method
birth weight	up to 43 gestational weeks	birth weight measured after baby was delivered and accurate to 0.1 kg
delivery mode	up to 43 gestational weeks	this includes vaginal delivery, operative vaginal delivery or cesarean delivery
macrosomia	up to 43 gestational weeks	birth weight above 4000.0 g
LGA	up to 43 gestational weeks	birth weight above the 90th percentile for gestational age
SGA	up to 43 gestational weeks	birth weight below the 10th percentile for gestational age
gestational weeks	up to 43 gestational weeks	record the gestational weeks for delivery
gestational hypertention	up to 43 gestational weeks	defined as blood pressure elevation \[systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg\] after 20 weeks gestation in the absence of proteinuria
pre-eclampsia	up to 43 gestational weeks	defined as new-onset hypertension \[systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg\] and new-onset proteinuria \[300 mg of protein in 24 hours or a urine protein/creatinine ratio of 0.3 mg/dL\] after 20 weeks gestation or, in the absence of proteinuria, new-onset hypertension with new-onset thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual disturbances

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China