An interventional study of mobile-based combining with hospital-based lifestyle interventions in Gestational Diabetes Mellitus, sponsored by Peking University. Status unknown at 1 site in China. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by Peking University · Not applicable, Interventional, and Prevention
This is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on GDM among women with advanced maternal age. It will be conducted in Beijing, with a sample size of 346. All eligible pregnant women will be randomly assigned to either the intervention or control group, and followed up to delivery.
After the adjustment of fertility policy in China, the prevalence of advanced maternal age (AMA) has become a crucial issue in maternal health care. AMA can greatly increase the risk of gestational diabetes mellitus (GDM) during pregnancy. However, there is still a lack of high-quality evidence on GDM preventive interventions for AMA pregnancy in China.
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.
857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's planned enrollment of 346 is above the median of 110 across 560 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Peking University is the lead sponsor of 418 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: mobile-based combining with hospital-based lifestyle interventions
Participants in control group will be managed in accordance with the standard practice.
The same as that stated in arm descriptions.
incidence of gestational diabetes mellitus
diagnosed by the oral glucose tolerance test
Time frame: from 24 weeks of gestation to delivery.
maternal glycated hemoglobin level
obtained from fasting venous blood samples
Time frame: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal fasting plasma glucose level
obtained from fasting venous blood samples
Time frame: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
maternal gestational weight gain
in kilograms
Time frame: from recruitment to delivery
incidence of gestational hypertension
defined as a systolic blood pressure of ≥140 mmHg or diastolic blood pressure of ≥90 mmHg occurring after 20 weeks of gestation
Time frame: from 20 weeks of gestation to delivery.
incidence of pre-eclampsia
defined as a systolic blood pressure of ≥140 mmHg or diastolic blood pressure of ≥90 mmHg occurring after 20 weeks of gestation in a previously normotensive woman combined with new-onset proteinuria of ≥0.3 g/24 h
Time frame: from 20 weeks of gestation to delivery.
delivery mode
such as vaginal delivery, ceseran delivery, operative vaginal delivery
Time frame: at delivery
birthweight
in original scale (g) or z-score
Time frame: at delivery
Macrosomia
defined as a birth weight of \> 4000 g
Time frame: at delivery
low birthweight
defined as a birth weight of \< 2500 g
Time frame: at delivery
Gestational age at birth
in weeks
Time frame: at delivery
Premature delivery
less than 37 weeks' gestational age
Time frame: at delivery
Apgar score
Apagr score
Time frame: 1 min and 5 min
maternal dietary information
food species and servings
Time frame: any 3 consecutive days chosen randomly by participants during 12-14 weeks of gestation, 24~28 weeks of gestation and >36 weeks of gestation respectively
maternal physical activity information
type of physical activity and time spend on it weekly
Time frame: every 1-2 weeks during enrollment to delivery
Plan to share: Yes — The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: After the publication of the main paper (hopefully before the end of 2024), the data will be available to share to other researchers
Access criteria: Researchers should request the data via the following Email: zhouyubo@bjmu.edu.cn or weiyumei1982@126.com
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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