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The Effect of E-Health Management on Gestational Diabetes Control

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Experimental group
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring gestational diabetes mellitus, pregnant women, e-health management, metabolic syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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)

Sites / Locations

  • Chang Gung Memorail Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eHMP experimental group

Control group

Arm Description

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.

only received usual care

Outcomes

Primary Outcome Measures

Change of Triglyceride Level
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
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
Blood sampling was performed in the fasting state. Normal HDL was ≥50 mg/dl; <50mg/dl was abnormal
Change of Cholesterol level
Blood sampling was performed in the fasting state. Normal Cholesterol was < 200 mg/dl; ≥200mg/dl was abnormal
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.
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.
Change of body weight
Women's weight following as assessed using calibrated digital scales
Newborn baby weight
Newborn baby weight in normal range (>2500g - <4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 29, 2018
Last Updated
October 30, 2018
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03726983
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
Keywords
gestational diabetes mellitus, pregnant women, e-health management, metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eHMP experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
only received usual care
Intervention Type
Other
Intervention Name(s)
Experimental group
Other Intervention Name(s)
e-Health Management Platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Triglyceride Level
Description
Blood sampling was performed in the fasting state. Normal triglyceride was <150 mg/dl; ≥150mg/dl was abnormal
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of Fasting Blood Glucose (FBG) Level
Description
Blood sampling was performed in the fasting state. Normal FBG was < 100 mg/dl; ≥100mg/dl was abnormal
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of high-density lipoprotein cholesterol (HDL) level
Description
Blood sampling was performed in the fasting state. Normal HDL was ≥50 mg/dl; <50mg/dl was abnormal
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of Cholesterol level
Description
Blood sampling was performed in the fasting state. Normal Cholesterol was < 200 mg/dl; ≥200mg/dl was abnormal
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of systolic blood pressure
Description
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.
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of diastolic blood pressure
Description
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.
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of body weight
Description
Women's weight following as assessed using calibrated digital scales
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Newborn baby weight
Description
Newborn baby weight in normal range (>2500g - <4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.
Time Frame
at birth
Secondary Outcome Measure Information:
Title
Change of Pregnancy Physical Activity Assessment
Description
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.
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of Dietary Behavioral Characteristics Scale
Description
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.
Time Frame
Change from Baseline at 6-12 weeks after delivery
Title
Change of Health Promotion Scale
Description
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.
Time Frame
Change from Baseline at 6-12 weeks after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chen Su, Dr.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorail Hospital
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of E-Health Management on Gestational Diabetes Control

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