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The Effect of E-Health Management on Gestational Diabetes Control

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ClinicalTrials.gov Identifier: NCT03726983
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mei-Chen Su, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus in Pregnancy Other: Experimental group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trail of e-Health Management for Women With Prior Gestational Diabetes Mellitus
Actual Study Start Date : January 5, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eHMP experimental group

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.
Other: Experimental group
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.
Other Name: e-Health Management Platform

No Intervention: Control group
only received usual care



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. Newborn baby weight [ Time Frame: at birth ]
    Newborn baby weight in normal range (>2500g - <4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.


Secondary Outcome Measures :
  1. Change of Pregnancy Physical Activity Assessment [ Time Frame: Change from Baseline at 6-12 weeks after delivery ]
    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.

  2. Change of Dietary Behavioral Characteristics Scale [ Time Frame: Change from Baseline at 6-12 weeks after delivery ]
    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.

  3. Change of Health Promotion Scale [ Time Frame: Change from Baseline at 6-12 weeks after delivery ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726983


Locations
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Taiwan
Chang Gung Memorail Hospital
Taipei, Taiwan, 10507
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Mei-Chen Su, Dr. Chang Gung Memorial Hospital

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Responsible Party: Mei-Chen Su, Director, Clinical Research, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03726983     History of Changes
Other Study ID Numbers: 105-4129C
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mei-Chen Su, Chang Gung Memorial Hospital:
gestational diabetes mellitus
pregnant women
e-health management
metabolic syndrome
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy in Diabetics
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications