Gestational Diabetes Mellitus in PregnancyNCT03726983
The Effect of E-Health Management on Gestational Diabetes Control
A study testing Experimental group in people with Gestational Diabetes Mellitus in Pregnancy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trail of e-Health Management for Women With Prior Gestational Diabetes Mellitus
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.
Read the 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.
- Being tested
- Experimental group
- Keywords
- gestational diabetes mellitus, pregnant women, e-health management, metabolic syndrome
- Medical subject headings
- Diabetes, Gestational, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Also called e-Health Management Platform
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.
| Study group | Role | What they receive |
|---|---|---|
| eHMP experimental group | Experimental | 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. Receives: Other: Experimental group |
| Control group | No intervention | only received usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Triglyceride Level
Blood sampling was performed in the fasting state. Normal triglyceride was <150 mg/dl; ≥150mg/dl was abnormal
Measured: Change from Baseline at 6-12 weeks after delivery
Change of Fasting Blood Glucose (FBG) Level
Blood sampling was performed in the fasting state. Normal FBG was < 100 mg/dl; ≥100mg/dl was abnormal
Measured: Change from Baseline at 6-12 weeks after delivery
Change of high-density lipoprotein cholesterol (HDL) level
Blood sampling was performed in the fasting state. Normal HDL was ≥50 mg/dl; <50mg/dl was abnormal
Measured: Change from Baseline at 6-12 weeks after delivery
Change of Cholesterol level
Blood sampling was performed in the fasting state. Normal Cholesterol was < 200 mg/dl; ≥200mg/dl was abnormal
Measured: Change from Baseline at 6-12 weeks after delivery
Change of systolic blood pressure
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.
Measured: Change from Baseline at 6-12 weeks after delivery
Change of diastolic blood pressure
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.
Measured: Change from Baseline at 6-12 weeks after delivery
Change of body weight
Women's weight following as assessed using calibrated digital scales
Measured: Change from Baseline at 6-12 weeks after delivery
Newborn baby weight
Newborn baby weight in normal range (>2500g - <4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.
Measured: at birth
Secondary outcomes (3)
Change of Pregnancy Physical Activity Assessment
There are 12 items in this questionnaire, including two dimensions: exercise and inactivity. Exercise dimension contained four items to assess the type of physical activity, intensity, duration, frequency during pregnancy. At least 3 days per week, and each time at least 20-30 minutes, counted as regular exercise (dichotomous outcome Yes/No assessed). Inactivity dimension contained 8 items, dichotomous outcome Yes/No assessed (score 0-8), higher values represent an inactivity lifestyle.
Measured: Change from Baseline at 6-12 weeks after delivery
Change of Dietary Behavioral Characteristics Scale
The instrument is 17-item Likert-type self-report instrument, used a 5-point response format to obtain data regarding the frequency of reported behaviors (never, rarely, sometimes, usually, always). It including two dimensions and each scale range as: balanced diet (5 items, scale range 5-25) and diet control behavior (12 items, scale range 12-60). Higher values represent a better maternal dietary patterns during pregnancy.
Measured: Change from Baseline at 6-12 weeks after delivery
Change of Health Promotion Scale
The instrument is 40-item Likert-type self-report instrument, used a 5-point response format to obtain data regarding the frequency of reported behaviors (never, rarely, sometimes, usually, always). It including six dimensions and each scale range as: social-support (6 items, scale range 6-30), life-appreciation (8 items, scale range 8-40), health-responsibility (8 items, scale range 8-40), stress-management (9 items, scale range 9-45), nutritional behaviors (5 items, scale range 5-25) and exercise behaviors (4 items, scale range 4-20). The total score was 40 to 200, higher values represent a better health promotion lifestyle.
Measured: Change from Baseline at 6-12 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start5 Jan 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Chen Su, Chang Gung Memorial Hospital
- Investigators
- Mei-Chen Su, Dr., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726983
- Sponsor's protocol ID
- 105-4129C
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Su MC, Chao AS, Chang MY, Chang YL, Sun JC. Effects of a Mobile Health Intervention on Weight Control and Pregnancy Outcomes in Overweight Pregnant Women: A Randomized Controlled Trial. Matern Child Health J. 2025 Oct;29(10):1445-1457. doi: 10.1007/s10995-025-04135-1. Epub 2025 Jul 12.
PubMed 40650844
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trail of e-Health Management for Women With Prior Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03726983
- Acronym / sponsor ID
- 105-4129C
- Keywords
- gestational diabetes mellitus, pregnant women, e-health management, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| eHMP experimental group | Experimental | Other: Experimental groupThe 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. |
| Control group | No intervention | –only received usual care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupAlso: e-Health Management PlatformPregnant 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. | Other | eHMP experimental group |
Primary outcome
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 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 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 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
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 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.
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
Newborn baby weight
Time frame: at birth
Newborn baby weight in normal range (>2500g - <4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.
3 secondary outcomes
Change of Pregnancy Physical Activity Assessment
Time frame: Change from Baseline at 6-12 weeks after delivery
Change of Dietary Behavioral Characteristics Scale
Time frame: Change from Baseline at 6-12 weeks after delivery
Change of Health Promotion Scale
Time frame: Change from Baseline at 6-12 weeks after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Derived from this study: PubMed 40650844Su MC, Chao AS, Chang MY, Chang YL, Sun JC. Effects of a Mobile Health Intervention on Weight Control and Pregnancy Outcomes in Overweight Pregnant Women: A Randomized Controlled Trial. Matern Child Health J. 2025 Oct;29(10):1445-1457. doi: 10.1007/s10995-025-04135-1. Epub 2025 Jul 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Chen Su, Dr. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Gestational Diabetes Mellitus in Pregnancy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Triglyceride Level (time frame: Change from Baseline at 6-12 weeks after delivery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03726983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.