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A Behavioral Intervention to Prevent Gestational Diabetes Mellitus

NCT03987412 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2019-09-04

No results posted yet for this study

Summary

Gestational diabetes mellitus (GDM) increases the risk of adverse pregnancy outcome and developing type 2 diabetes after delivery. It is well recognized that behavioral intervention is effective in preventing type 2 diabetes in high risk population. Recently, some studies showed that exercise, dietary and weight control reduced the risk of developing GDM in obese/over weight women or in women with GDM history. With the increasing use of smartphones, mobile applications (APPs) can be applied in the education and management of chronic diseases, including diabetes. Therefore, the investigators will conduct a multi-centered, two-armed, open-labeled, randomized controlled trial to evaluate whether early lifestyle intervention with a mobile APP can prevent the occurrence of GDM in pregnant women who are at high risk of this disease.

The investigators hypothesis that behavioral intervention from the first trimester of pregnancy with mobile APP that incorporates nutrition, exercise and phycological support will:

1. Reduce the risk of developing GDM in pregnant women with risks of GDM.
2. Improve the pregnant women's adherence of behavioral intervention and their satisfaction of prenatal medical care.

Conditions

  • Diabetes, Gestational

Interventions

BEHAVIORAL

Lifestyle intervention with APP

The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together. Then the lifestyle intervention will be launched by an APP that installed in participants' private mobile phones, including nutrition, exercise and phycological support. Nutrition guidance is conducted according to the Chinese Dietary Guide, Chinese and international guidelines of gestation diabetes management. Exercise support is given based on the Guidelines for National Fitness of China, Chinese and international guidelines of gestation diabetes. Phycological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP, and based on the data investigators will individualize the suggestions.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Hong Tianpei, MD,PhD · Department of Endocrinology and Metabolism, Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-16
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03987412 on ClinicalTrials.gov