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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Behavioral: mobile-based combining with hospital-based lifestyle interventions

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.

• Study Type: Interventional
• Enrollment (Anticipated): 346
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yubo Zhou, PhD; Phone Number: 86-10-188 1053 3987; Email: zhouyubo@bjmu.edu.cn
• Study Contact Backup: Name: Mingxuan Zhang, MD; Phone Number: 86-10-137 1867 2747; Email: zmxemma@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University first hospital
      • Contact: Yubo Zhou, PhD; Phone Number: 86-10-188 1053 3987; Email: zhouyubo@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lifestyle intervention group; 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; The same as that stated in arm descriptions.
NO_INTERVENTION: control group; Participants in control group will be managed in accordance with the standard practice.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Peking University First Hospital
• Investigators: Principal Investigator: Yumei Wei, PhD, Peking University first hospital; Principal Investigator: Yubo Zhou, Peking University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (ACTUAL): June 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: lifestyle intervention; gestational diabetes mellitus; randomized controlled study; advanced maternal age
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: BMU2022MX022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared
• IPD Sharing Time Frame: After the publication of the main paper (hopefully before the end of 2024), the data will be available to share to other researchers

IPD Sharing Access Criteria

Researchers should request the data via the following Email:

zhouyubo@bjmu.edu.cn or weiyumei1982@126.com

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No