Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes Mellitus (GDM)
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lifestyle intervention with dietary and exercise recommendation
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus (GDM)
Eligibility Criteria
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.
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
lifestyle intervention group
control group
Arm Description
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.
Pregnant women allocated to this group receive standard prenatal care.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
birth weight
birth weight measured after baby was delivered and accurate to 0.1 kg
gestational weeks
record the gestational weeks for delivery
delivery mode
this includes vaginal delivery, operative vaginal delivery or cesarean delivery
macrosomia
birth weight above 4000.0 g
LGA
birth weight above the 90th percentile for gestational age
SGA
birth weight below the 10th percentile for gestational age
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
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
Full Information
NCT ID
NCT03062475
First Posted
February 11, 2017
Last Updated
September 1, 2019
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03062475
Brief Title
Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus
Official Title
The Efficacy of Lifestyle Intervention in Preventing the the Recurrence of Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus (GDM)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lifestyle intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Pregnant women allocated to this group receive standard prenatal care.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention with dietary and exercise recommendation
Intervention Description
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.
Primary Outcome Measure Information:
Title
GDM
Description
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
Time Frame
24-28 gestational weeks
Secondary Outcome Measure Information:
Title
birth weight
Description
birth weight measured after baby was delivered and accurate to 0.1 kg
Time Frame
up to 43 gestational weeks
Title
gestational weeks
Description
record the gestational weeks for delivery
Time Frame
up to 43 gestational weeks
Title
delivery mode
Description
this includes vaginal delivery, operative vaginal delivery or cesarean delivery
Time Frame
up to 43 gestational weeks
Title
macrosomia
Description
birth weight above 4000.0 g
Time Frame
up to 43 gestational weeks
Title
LGA
Description
birth weight above the 90th percentile for gestational age
Time Frame
up to 43 gestational weeks
Title
SGA
Description
birth weight below the 10th percentile for gestational age
Time Frame
up to 43 gestational weeks
Title
gestational hypertention
Description
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
Time Frame
up to 43 gestational weeks
Title
pre-eclampsia
Description
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
Time Frame
up to 43 gestational weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Wang
Phone
18518079870
Email
kisskissy22@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yumei Wei
Phone
18601369529
Email
weiyumei1982@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huixia Yang
Organizational Affiliation
Peking Unviersity First Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Wang
Phone
18518079870
Email
kisskissy22@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus
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