Randomized Controlled Trail of e-Health Management for Women With Prior Gestational Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Change of high-density lipoprotein cholesterol (HDL) level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
eHMP experimental group
The experimental group received health management support and counseling,including:
- 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.
Intervention: Experimental group (Other)
Control group
only received usual care
Outcomes
Primary Outcomes
Change of high-density lipoprotein cholesterol (HDL) level
Time Frame: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal HDL was ≥50 mg/dl; \<50mg/dl was abnormal
Change of Triglyceride Level
Time Frame: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal triglyceride was \<150 mg/dl; ≥150mg/dl was abnormal
Change of Cholesterol level
Time Frame: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal Cholesterol was \< 200 mg/dl; ≥200mg/dl was abnormal
Newborn baby weight
Time Frame: at birth
Newborn baby weight in normal range (\>2500g - \<4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.
Change of Fasting Blood Glucose (FBG) Level
Time Frame: Change from Baseline at 6-12 weeks after delivery
Blood sampling was performed in the fasting state. Normal FBG was \< 100 mg/dl; ≥100mg/dl was abnormal
Change of systolic blood pressure
Time Frame: Change from Baseline at 6-12 weeks after delivery
Normal systolic blood pressure was \<130mmHg; ≥130mmHg was abnormal. Blood pressure was measured at the right arm twice after a 10-min rest in the supine position by using a calibrated sphygmomanometer and averaged.
Change of body weight
Time Frame: Change from Baseline at 6-12 weeks after delivery
Women's weight following as assessed using calibrated digital scales
Change of diastolic blood pressure
Time Frame: Change from Baseline at 6-12 weeks after delivery
Normal diastolic blood pressure was \<85mmHg; ≥85mmHg was abnormal. Blood pressure was measured at the right arm twice after a 10-min rest in the supine position by using a calibrated sphygmomanometer and averaged.
Secondary Outcomes
- Change of Pregnancy Physical Activity Assessment(Change from Baseline at 6-12 weeks after delivery)
- Change of Dietary Behavioral Characteristics Scale(Change from Baseline at 6-12 weeks after delivery)
- Change of Health Promotion Scale(Change from Baseline at 6-12 weeks after delivery)
Investigators
Mei-Chen Su
Director, Clinical Research
Chang Gung Memorial Hospital