The Effect of E-Health Management on Gestational Diabetes Control

NCT03726983 | Completed DMC

• 1 other identifier: 105-4129C
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

gestational diabetes mellitus; pregnant women; e-health management; metabolic syndrome

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Change of Pregnancy Physical Activity Assessment

  Change from Baseline at 6-12 weeks after delivery

• Change of Dietary Behavioral Characteristics Scale

  Change from Baseline at 6-12 weeks after delivery

• Change of Health Promotion Scale

  Change from Baseline at 6-12 weeks after delivery

Study Arms (2)

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.

Other: Experimental group

Control group

NO INTERVENTION

only received usual care

Interventions

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.

Also known as: e-Health Management Platform

eHMP experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorail Hospital

Taipei, 10507, Taiwan

Location

MeSH Terms

Conditions

Diabetes, Gestational; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Mei-Chen Su, Dr.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 1, 2018
• Study Start: January 5, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)