NCT03987412

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 16, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

June 12, 2019

Last Update Submit

September 2, 2019

Conditions

Diabetes, Gestational

Keywords

Behavioral interventionFirst trimesterGestational diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • The risk of gestational diabetes mellitus (GDM)

    GDM will be diagnosed by a 75g OGTT according to the World Health Organization criteria as fasting plasma glucose level ≥5.1 mmol/L, or 1-hour value ≥10.0mmol/l, or 2-hour value ≥8.5mmol/L. Investigators will calculate the occurrence rate of GDM to represent the risk of GDM.

    24-28 gestational weeks

Secondary Outcomes (2)

  • Adherence of behavioral intervention during pregnancy

    up to 28 gestational weeks

  • Satisfaction of prenatal medical care; questionnaires

    up to 24-28 gestational weeks

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

Pregnant women randomized to the behavioral intervention group will recieve a face-to-face education about the risks of GDM at their local rearch centers. Then they will be provided with a mobile APP incorporating nutrition, exercise and phycological support. They will also have regular prenatal care in their local hospitals.

Behavioral: Lifestyle intervention with APP

Control group

NO INTERVENTION

Pregnant women randomized to the control group only have regular prenatal care in their local hospitals.

Interventions

Lifestyle intervention with APPBEHAVIORAL

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.

Behavioral intervention

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese pregnant women aged between 30 and 45 years who have one or more risk factors when they are on their first prenatal care visit. The risk factors are listed as following:
  • Fasting plasma glucose level ≥ 4.4 mmol/l.
  • Body mass index ≥ 24 kg/m\^2
  • Systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
  • First-degree family history of diabetes
  • History of GDM
  • History of polycystic ovary syndrome.
  • Willing to keep reading the education articles and supporting materials that delivered by the mobile APP.
  • Willing to provide informed consent.

You may not qualify if:

  • First prenatal care visit later than 12 gestational weeks
  • Fasting plasma glucose level value ≥5.6 mmol/l, or glycated hemoglobin value ≥ 5.6%.
  • Continuous use of antidiabetic medicine for 7 days or more within the current 3 months
  • Spontaneous abortion twice or more
  • Body weight loss for 10% or more within the current 3 months
  • History of other diseases including but not limited to:
  • Arteriosclerotic cardiovascular disease, heart failure or stroke
  • Systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥90 mmHg.
  • Hematological system diseases. For anemia patients, hemoglobin ≥90g/l is acceptable.
  • Renal dysfunction or liver dysfunction
  • Rheumatic diseases, currently receiving glucocorticoids or other immunosuppressors
  • Serious diseases of respiratory system with current use of glucocorticoids.
  • Diseases of endocrine system. But it is acceptable that the hypothyroidism has been controlled with levothyroxine.
  • Other conditions that investigators consider inappropriate for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haidian Maternal&Child Health Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hong Tianpei, MD,PhD

    Department of Endocrinology and Metabolism, Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Tianpei, MD,PhD

CONTACT

+8613683265725tpho66@bjmu.edu.cn

Yang Jin, PhD

CONTACT

+8615810298367yangjin@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 17, 2019

Study Start

August 16, 2019

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

September 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)