the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes

NCT04424238 | Unknown DMC

• 1 other identifier: JS-1012
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

GDM; Blood Glucose; Compliance, Patient; Diet Habit

Keywords

GDM; CGM; m-health; diet modification; blood glucose; compliance

Outcome Measures

Primary Outcomes (1)

• glycemic qualification rate

  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)

• pregnancy outcome

  delivery

Study Arms (2)

Standard Clinic Prenatal Care (Control Group)

NO INTERVENTION

pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered.

m-health group (Intervention Group)

EXPERIMENTAL

participants were managed continuously through WeChat group chat.

Behavioral: m-health management

Interventions

m-health management BEHAVIORAL

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

m-health group (Intervention Group)

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 45 years.
• With singleton pregnancy
• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Patient Compliance; Feeding Behavior

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Behavior, Animal

Study Officials

• Liangkun Ma

  Chinese Academy of Medical Science & Peking Union Medical College Hospital

  STUDY CHAIR

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: June 5, 2020
• First Posted: June 9, 2020
• Study Start: March 15, 2016
• Primary Completion: June 15, 2020
• Study Completion: June 30, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share