The Effect of E-Health Management on Gestational Diabetes Control

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: Experimental group

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10507
    • Chang Gung Memorail Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Names: e-Health Management Platform
No Intervention: Control group; only received usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Triglyceride Level	Blood sampling was performed in the fasting state. Normal triglyceride was <150 mg/dl; ≥150mg/dl was abnormal	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	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	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	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.	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.	Change from Baseline at 6-12 weeks after delivery
Change of body weight	Women's weight following as assessed using calibrated digital scales	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.	at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	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.	Change from Baseline at 6-12 weeks after delivery

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Mei-Chen Su, Dr., Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pregnant women; metabolic syndrome; gestational diabetes mellitus; e-health management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 105-4129C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No