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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Gestational Diabetes Mellitus With Mobile- and Hospital-based Lifestyle Intervention Among Women of Advanced Maternal Age: a Randomized Controlled Study.

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Behavioral: mobile-based combining with hospital-based lifestyle interventions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention group<br>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<br>* The same as that stated in arm descriptions.<br>|
| No Intervention: control group<br>Participants in control group will be managed in accordance with the standard practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of gestational diabetes mellitus | diagnosed by the oral glucose tolerance test | from 24 weeks of gestation to delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal glycated hemoglobin level | obtained from fasting venous blood samples | at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor | 
| maternal fasting plasma glucose level | obtained from fasting venous blood samples | at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor | 
| maternal gestational weight gain | in kilograms | 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 | 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 | from 20 weeks of gestation to delivery. | 
| delivery mode | such as vaginal delivery, ceseran delivery, operative vaginal delivery | at delivery | 
| birthweight | in original scale (g) or z-score | at delivery | 
| Macrosomia | defined as a birth weight of > 4000 g | at delivery | 
| low birthweight | defined as a birth weight of < 2500 g | at delivery | 
| Gestational age at birth | in weeks | at delivery | 
| Premature delivery | less than 37 weeks' gestational age | at delivery | 
| Apgar score | Apagr score | 1 min and 5 min | 
| maternal dietary information | food species and servings | 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 | every 1-2 weeks during enrollment to delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced maternal age, gestational diabetes mellitus, lifestyle intervention, randomized controlled study