Clinical trial NCT05421845: Prevention of Gestational Diabetes Mellitus With Lifestyle Intervention Among Women of Advanced Maternal Age.
Official title: Prevention of Gestational Diabetes Mellitus With Mobile- and Hospital-based Lifestyle Intervention Among Women of Advanced Maternal Age: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: advanced maternal age
gestational diabetes mellitus
lifestyle intervention
randomized controlled study
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
First posted: 2022-06-16
Enrollment: 346
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of gestational diabetes mellitus
timeFrame: from 24 weeks of gestation to delivery.
Secondary outcomes:
measure: maternal glycated hemoglobin level
timeFrame: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
measure: maternal fasting plasma glucose level
timeFrame: at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
measure: maternal gestational weight gain
timeFrame: from recruitment to delivery
measure: incidence of gestational hypertension
timeFrame: from 20 weeks of gestation to delivery.
measure: incidence of pre-eclampsia
timeFrame: from 20 weeks of gestation to delivery.
measure: delivery mode
timeFrame: at delivery
measure: birthweight
timeFrame: at delivery
measure: Macrosomia
timeFrame: at delivery
measure: low birthweight
timeFrame: at delivery
measure: Gestational age at birth
timeFrame: at delivery
measure: Premature delivery
timeFrame: at delivery
measure: Apgar score
timeFrame: 1 min and 5 min
measure: maternal dietary information
timeFrame: 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
measure: maternal physical activity information
timeFrame: every 1-2 weeks during enrollment to delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yumei Wei, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University
name: Yubo Zhou
role: PRINCIPAL_INVESTIGATOR
References: