Gestational Diabetes Mellitus
Conditions
Keywords
advanced maternal age, gestational diabetes mellitus, lifestyle intervention, randomized controlled study
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALmobile-based combining with hospital-based lifestyle interventions
The same as that stated in arm descriptions.
Sponsors
Peking University First Hospital
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* local resident in Beijing * 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 type 1 or type 2 diabetes before pregnancy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of gestational diabetes mellitus | from 24 weeks of gestation to delivery. | diagnosed by the oral glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maternal fasting plasma glucose level | at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor | obtained from fasting venous blood samples |
| maternal gestational weight gain | from recruitment to delivery | in kilograms |
| incidence of gestational hypertension | from 20 weeks of gestation to delivery. | defined as a systolic blood pressure of ≥140 mmHg or diastolic blood pressure of ≥90 mmHg occurring after 20 weeks of gestation |
| incidence of pre-eclampsia | from 20 weeks of gestation to delivery. | 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 |
| delivery mode | at delivery | such as vaginal delivery, ceseran delivery, operative vaginal delivery |
| birthweight | at delivery | in original scale (g) or z-score |
| maternal glycated hemoglobin level | at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor | obtained from fasting venous blood samples |
| low birthweight | at delivery | defined as a birth weight of \< 2500 g |
| Gestational age at birth | at delivery | in weeks |
| Premature delivery | at delivery | less than 37 weeks' gestational age |
| Apgar score | 1 min and 5 min | Apagr score |
| maternal dietary information | 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 | food species and servings |
| maternal physical activity information | every 1-2 weeks during enrollment to delivery | type of physical activity and time spend on it weekly |
| Macrosomia | at delivery | defined as a birth weight of \> 4000 g |
Countries
China
Contacts
Primary ContactYubo Zhou, PhD
Backup ContactMingxuan Zhang, MD
Outcome results
None listed