Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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

Official Title
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The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus

Conditions
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Gestational Diabetes Mellitus (GDM)

Intervention / Treatment
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* Behavioral: lifestyle intervention with dietary and exercise recommendation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle intervention group<br>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. | Behavioral: lifestyle intervention with dietary and exercise recommendation<br>* With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake.For example we suggested exchanging carbohydrate-rich foods with a medium-to-high glycaemic index for those with a lower glycaemic index to reduce the glycaemic load, and restricting dietary intake of saturated fat. 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 during pregnancy.<br>|
| No Intervention: control group<br>Pregnant women allocated to this group receive standard prenatal care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GDM | 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 | 24-28 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth weight | birth weight measured after baby was delivered and accurate to 0.1 kg | up to 43 gestational weeks | 
| gestational weeks | record the gestational weeks for delivery | up to 43 gestational weeks | 
| delivery mode | this includes vaginal delivery, operative vaginal delivery or cesarean delivery | up to 43 gestational weeks | 
| macrosomia | birth weight above 4000.0 g | up to 43 gestational weeks | 
| LGA | birth weight above the 90th percentile for gestational age | up to 43 gestational weeks | 
| SGA | birth weight below the 10th percentile for gestational age | up to 43 gestational weeks | 
| gestational hypertention | 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 | up to 43 gestational weeks | 
| pre-eclampsia | 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 | up to 43 gestational weeks |