Prevention of Gestational Diabetes Mellitus With Lifestyle Intervention Among Women of Advanced Maternal Age.

Peking University

Status: Not yet enrolling

Conditions: Gestational Diabetes Mellitus

Treatments: Behavioral: mobile-based combining with hospital-based lifestyle interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT05421845

BMU2022MX022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 346 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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346 participants in 2 patient groups

Lifestyle intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: mobile-based combining with hospital-based lifestyle interventions

control group

No Intervention group

Description:

Participants in control group will be managed in accordance with the standard practice.