Clinical trial NCT03726983: The Effect of E-Health Management on Gestational Diabetes Control
Official title: Randomized Controlled Trail of e-Health Management for Women With Prior Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: gestational diabetes mellitus
pregnant women
e-health management
metabolic syndrome
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was longitudinal approach and repeated testing using an experimental design to evaluate the follow-up outcomes of the e-heath management platform intervention.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change of Triglyceride Level
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of Fasting Blood Glucose (FBG) Level
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of high-density lipoprotein cholesterol (HDL) level
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of Cholesterol level
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of systolic blood pressure
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of diastolic blood pressure
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of body weight
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Newborn baby weight
timeFrame: at birth
Secondary outcomes:
measure: Change of Pregnancy Physical Activity Assessment
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of Dietary Behavioral Characteristics Scale
timeFrame: Change from Baseline at 6-12 weeks after delivery
measure: Change of Health Promotion Scale
timeFrame: Change from Baseline at 6-12 weeks after delivery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorail Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Mei-Chen Su, Dr.
role: PRINCIPAL_INVESTIGATOR
References: