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Completed

NCT Number: NCT03726983

The Effect of E-Health Management on Gestational Diabetes Control

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorail Hospital

Taipei, 10507, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

experimental group

Other

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 names: e-Health Management Platform

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Randomized Controlled Trail of e-Health Management for Women With Prior Gestational Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2018
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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