The Effect of E-Health Management on Gestational Diabetes Control

NCT ID: NCT03726983

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-05
• Study Completion Date: 2018-02-28

Brief Summary

The purpose of this study was to develop an e-heath management platform(eHMP) for women with high risk of gestational diabetes mellitus (GDM) and to evaluate the longitudinal effects between groups of eHMP intervention.

Detailed Description

Background: Women with previous gestational diabetes mellitus are at increased risk for developing type2 diabetes mellitus or metabolic syndrome in their later life. Infants of mothers with GDM are more susceptible to stillbirth and more serious health concerns. With limited time for visits and the predicament of education, applying web-based intervention has become a convenient tool for health management.

Objectives: The approved project aimed to develop an e-heath management platform(eHMP) for women with high risk of gestational diabetes mellitus (GDM) and to evaluate the longitudinal effects between groups of eHMP intervention. The eHMP integrate GDM health care knowledge, self-awareness of health, self-monitoring of health status (i.e., recording weight and measurement data of metabolic syndrome risk factors and monitoring changes in data trends); participation in discussions or browsing forums; healthy lifestyle guidance and counseling; reminder systems, a token system of earning points in exchange for prizes.

Methods: Pregnant women aged 18-45 years with high risk of metabolic syndrome who have a singleton pregnancy, are eligible to participate in this study. Women who agree to participate in the study will be given a participant information sheet and consent form. Participants will be recruited from the Pregnancy diabetes Clinic, at Chang Gung memorial hospital and introduced to the eHMP using the mobile phone in the clinic. Participants will also be given the URL to access to the program and they can learn the modules at home by using their home PCs, mobile phones, or tablets. They were followed up for three times: 28 weeks' gestation, 36-40 weeks' gestation and 6-12 weeks postpartum. SPSS version 20.0 software was used to compile and analyze the research data, including questionnaires and blood test for metabolic index.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

eHMP experimental group

The experimental group received health management support and counseling,including:

1. GDM health care knowledge

2. self-awareness of health

3. self-monitoring of health status (i.e., recording weight and measurement data of metabolic syndrome risk factors and monitoring changes in data trends)

4. participation in discussions or browsing forums

5. healthy lifestyle guidance and counseling

6. reminder systems

7. a token system of earning points in exchange for prizes.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: OTHER

Pregnant women who agree to take part will be assigned to a group: experimental group and control group. The experimental group will received health management support and counseling that were conducted by the researchers through the e-health management platform.

Control group

only received usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental group

Pregnant women who agree to take part will be assigned to a group: experimental group and control group. The experimental group will received health management support and counseling that were conducted by the researchers through the e-health management platform.

Intervention Type: OTHER

Other Intervention Names

e-Health Management Platform

Eligibility Criteria

Inclusion Criteria

Pregnant women (pre-pregnancy body mass index ≧ 24) must meet at least one of the following conditions and agree to be interviewed:

• Age over 34 years old;
• Ever had giant infant delivery (weight ≧ 4.5 kg);
• Previous diagnosed with gestational diabetes ;
• Family history of diabetes.

Exclusion Criteria

• Pre-existing diabetes (types 1 and 2);
• Unable to write and understand Chinese;
• Subject has cognitive impairment;
• Subject has intellectual disability or mental illness;
• Dependent on medical care (eg, anti-depressants, or any psychiatric medication)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mei-Chen Su

Director, Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei-Chen Su, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorail Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

105-4129C

Identifier Type: -

Identifier Source: org_study_id