Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT03062475|
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Mellitus (GDM)||Behavioral: lifestyle intervention with dietary and exercise recommendation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus|
|Estimated Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: lifestyle intervention group
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
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.
No Intervention: control group
Pregnant women allocated to this group receive standard prenatal care.
- GDM [ Time Frame: 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
- birth weight [ Time Frame: up to 43 gestational weeks ]birth weight measured after baby was delivered and accurate to 0.1 kg
- gestational weeks [ Time Frame: up to 43 gestational weeks ]record the gestational weeks for delivery
- delivery mode [ Time Frame: up to 43 gestational weeks ]this includes vaginal delivery, operative vaginal delivery or cesarean delivery
- macrosomia [ Time Frame: up to 43 gestational weeks ]birth weight above 4000.0 g
- LGA [ Time Frame: up to 43 gestational weeks ]birth weight above the 90th percentile for gestational age
- SGA [ Time Frame: up to 43 gestational weeks ]birth weight below the 10th percentile for gestational age
- gestational hypertention [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062475
|Contact: Chen Wangemail@example.com|
|Contact: Yumei Weifirstname.lastname@example.org|