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

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05421845
• Other study ID #: BMU2022MX022
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Peking University
• Contact: Yubo Zhou, PhD
• Phone: 86-10-188 1053 3987
• Email: zhouyubo[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 346
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• mobile-based combining with hospital-based lifestyle interventions
The same as that stated in arm descriptions.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of gestational diabetes mellitus	diagnosed by the oral glucose tolerance test	from 24 weeks of gestation to delivery.
Secondary	maternal glycated hemoglobin level	obtained from fasting venous blood samples	at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
Secondary	maternal fasting plasma glucose level	obtained from fasting venous blood samples	at <14 weeks of gestation, 24-28 weeks of gestation, and pre-labor
Secondary	maternal gestational weight gain	in kilograms	from recruitment to delivery
Secondary	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.
Secondary	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.
Secondary	delivery mode	such as vaginal delivery, ceseran delivery, operative vaginal delivery	at delivery
Secondary	birthweight	in original scale (g) or z-score	at delivery
Secondary	Macrosomia	defined as a birth weight of > 4000 g	at delivery
Secondary	low birthweight	defined as a birth weight of < 2500 g	at delivery
Secondary	Gestational age at birth	in weeks	at delivery
Secondary	Premature delivery	less than 37 weeks' gestational age	at delivery
Secondary	Apgar score	Apagr score	1 min and 5 min
Secondary	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
Secondary	maternal physical activity information	type of physical activity and time spend on it weekly	every 1-2 weeks during enrollment to delivery