The Effect of E-Health Management on Gestational Diabetes Control

Chang Gung Medical Foundation

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Other: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT03726983

105-4129C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

eHMP experimental group

Experimental group

Description:

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.

Treatment:

Other: Experimental group

Control group

No Intervention group

Description:

only received usual care