Prevention of Gestational Diabetes Mellitus With Lifestyle Intervention Among Women of Advanced Maternal Age.
NCT ID: NCT05421845
Last Updated: 2022-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
346 participants
INTERVENTIONAL
2022-07-31
2023-12-31
Brief Summary
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Detailed Description
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In this randomized study, the investigators aim to examine whether mobile-based combining with hospital-based lifestyle interventions have preventive effects on GDM in AMA pregnancies. The investigators will enroll a total of 346 singleton pregnant women in Peking University First Hospital and randomly assign them to either the intervention or control group. Information of maternal characteristics will be obtained at recruitment. At each prenatal visit, weight and blood pressure of all participants will be measured. For each participant, fasting venous blood samples will be collected at \<14 weeks of gestation, 24-28 weeks of gestation and pre-labor, and respectively assayed for fasting plasma glucose, glycated hemoglobin. The primary outcome is the incidence of GDM. The secondary outcomes include maternal glycated hemoglobin level, maternal fasting plasma glucose level, maternal complications, pregnancy outcomes, etc.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Lifestyle intervention group
Participants will be given mobile- and hospital-based lifestyle interventions. The mobile-based interventions including dietary guidance, exercise supervision and weight monitoring will be conducted by trained physicians through WeChat group on cell phone every 1 to 2 weeks. Participants need to report their physical activity and weight information every week through WeChat group. Hospital-based intervention is a ≥5 minutes one-to-one and face-to-face personalized lifestyle counselling leading by a trained physician every 4 weeks during \<14 weeks of gestation, every 2 weeks during 14-28 weeks of gestation, and once a week during ≥28 weeks of gestation. Participants' dietary information will be collected for any 3 consecutive days chosen by participants during 12-14 weeks of gestation, 24-28 weeks of gestation and \>36 weeks of gestation respectively using a food frequency questionnaire.
mobile-based combining with hospital-based lifestyle interventions
The same as that stated in arm descriptions.
control group
Participants in control group will be managed in accordance with the standard practice.
No interventions assigned to this group
Interventions
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mobile-based combining with hospital-based lifestyle interventions
The same as that stated in arm descriptions.
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Aged ≥35 years
* Overweight or obesity (Body mass index is between 24 and 27.9 kg/m2 or ≥28 kg/m2)
* ≤12 weeks of gestation
* written informed consent is obtained
Exclusion Criteria
* Diagnosed with GDM or impaired glucose tolerance at enrollment
* use of medication that influences glucose metabolism currently, such as metformin, etc.
* multiple pregnancy
* current substance abuse
* unable to exercise due to physical disability
* diagnosed severe psychiatric disorder
* Other conditions not suitable for intervention as judged by physicians
35 Years
FEMALE
Yes
Sponsors
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Peking University First Hospital
OTHER
Peking University
OTHER
Responsible Party
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Principal Investigators
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Yumei Wei, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Yubo Zhou
Role: PRINCIPAL_INVESTIGATOR
Peking University
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BMU2022MX022
Identifier Type: -
Identifier Source: org_study_id
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