NCT03748576

Brief Summary

A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was: 1. more effective in improving pregnancy outcomes in normal pregnant women. 2. more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

July 24, 2020

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

October 31, 2018

Last Update Submit

July 22, 2020

Conditions

Maternal BehaviorMobile HealthPregnancy OutcomeGDMBlood GlucoseDiet HabitCompliance, Patient

Outcome Measures

Primary Outcomes (2)

  • weight gain during pregnancy

    Participants record their body weight twice a month. Weight gain from third-trimester and the whole pregnancy period are calculated.

    up to 40 gestatinal weeks

  • Glycemic qualification rate in women with GDM

    Glycemic qualification rate was calculated by the number of BG within the control range /30\*100%. BG control range were fasting BG (fasting and before-sleep BG)#95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)#120 mg/dL (6.7 mmol/L)

    From enrollment to 42 days postpartum

Secondary Outcomes (1)

  • The incidence rate of specific pregnant outcomes in both normal pregnant women and women with GDM

    at delivery

Study Arms (2)

Mobile technologies group

EXPERIMENTAL

m-health group (Intervention Group) participants were managed continuously through WeChat group chat during prenatal clinic interval.

Behavioral: telemedicine: management through WeChat group chat

control group

NO INTERVENTION

Standard Clinic Prenatal Care (Control Group): regular routine prenatal care following Chinese standard.

Interventions

telemedicine: management through WeChat group chatBEHAVIORAL

Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care

Mobile technologies group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 45 years.
  • With singleton pregnancy
  • Diagnosed or not diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
  • Be able to use smart phone for chatting, read and write basic Chinese.
  • Volunteer for research.

You may not qualify if:

  • Pregnancies with diagnosed chronic disease
  • Pregnancies with other pregnancy complications except GDM
  • Pregnancies had recent trauma and treatment of glucocorticoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ob gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

  • Tian Y, Zhang S, Huang F, Ma L. Comparing the Efficacies of Telemedicine and Standard Prenatal Care on Blood Glucose Control in Women With Gestational Diabetes Mellitus: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 25;9(5):e22881. doi: 10.2196/22881.

    PMID: 33783365DERIVED

  • Huang F, Zhang S, Tian Y, Li L, Li Y, Chen X, Sun X, Fan Y, Ma W, Liu C, Gao L, Xue X, Ma L. Effect of mobile health based peripartum management of gestational diabetes mellitus on postpartum diabetes: A randomized controlled trial. Diabetes Res Clin Pract. 2021 May;175:108775. doi: 10.1016/j.diabres.2021.108775. Epub 2021 Mar 23.

    PMID: 33771645DERIVED

MeSH Terms

Conditions

Feeding BehaviorPatient Compliance

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • liangkun ma

    Peking union medical college hosiptal

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 21, 2018

Study Start

November 1, 2017

Primary Completion

December 31, 2019

Study Completion

May 31, 2020

Last Updated

July 24, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)