Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

September 12, 2024 updated by: Tzu Tsun Luk, The University of Hong Kong

Mobile Instant Messaging-based Lifestyle Interventions for Preventing Gestational Diabetes in High-risk Pregnant Women: a Randomised Controlled Trial

The goal of this randomised controlled trial is to test the effectiveness of a mobile instant messaging-based lifestyle intervention in pregnant women at risk of gestational diabetes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gestational diabetes mellitus (GDM) is one of the most common medical conditions during pregnancy, affecting about 1 in 7 live births worldwide. There remains a lack of proven preventive strategies for GDM that could be readily adopted in clinical practice. Recent studies have suggested that lifestyle intervention delivered via mobile phone could help pregnant women prevent GDM, but more evidence is needed. This study aims to test a mobile instant messaging-based lifestyle intervention for GDM prevention in pregnant women at risk of GDM.

Study Type

Interventional

Enrollment (Estimated)

944

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Kwong Wah Hospital
        • Contact:
        • Contact:
          • Wing Cheong Leung, MD (HK)
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital/ Tsan Yuk Hospital
        • Contact:
        • Contact:
          • Ka Wang Cheung, MD (HK)
      • Hong Kong, Hong Kong
        • Recruiting
        • United Christian Hospital/ Tseung Kwan O Hospital
        • Contact:
        • Contact:
          • Carina Kwa, MBChB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ethnic Chinese singleton pregnant woman in <14 weeks of gestation
  2. Aged 18 years or above
  3. Own a mobile phone with an instant messaging app
  4. Not participating in similar trials on diabetes or lifestyle modifications

  5. Have at least one of the following risk factors for GDM:

    • Age ≥35 years at the expected date of delivery
    • Body mass index (BMI) ≥ 25 kg/m2 pre-pregnancy or in the first trimester
    • Family history of diabetes in first-degree relative
    • Previous GDM or delivered a baby with birthweight ≥4 kg

Exclusion Criteria:

  • Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Mobile instant messaging-based lifestyle intervention
Behavioral: Mobile instant messaging-based lifestyle intervention
Nurse-led personalised lifestyle intervention grounded in social cognitive theory via WhatsApp or WeChat from baseline to the 28th gestational week, which aims to maintain optimal gestational weight gain using dietary and exercise advice and behavioural change techniques.
Behavioral: Brief advice on GDM prevention
Brief advice on GDM prevention aided by an A4-sized, half-fold leaflet, which covered the risk factors and complications of GDM, optimal gestational weight gain targets, and advice on dietary and exercise during pregnancy
Behavioral: Usual care
Usual care provided by the prenatal clinic.
Active Comparator: Control group
Brief advice on GDM prevention
Behavioral: Brief advice on GDM prevention
Brief advice on GDM prevention aided by an A4-sized, half-fold leaflet, which covered the risk factors and complications of GDM, optimal gestational weight gain targets, and advice on dietary and exercise during pregnancy
Behavioral: Usual care
Usual care provided by the prenatal clinic.
Behavioral: Text messaging reminders
Follow-up reminders via text messaging as attention control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GDM diagnosis
Time Frame: About 28th gestational week
GDM diagnosed by a 2-hour 75g oral glucose tolerance test interpreted according to the World Health Organization's 2013 criteria
About 28th gestational week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small for gestational age
Time Frame: At birth
At birth
Gestational weight gain
Time Frame: From baseline to the end of pregnancy (delivery)
Measured in kilograms
From baseline to the end of pregnancy (delivery)
Hypertensive disorders of pregnancy
Time Frame: During pregnancy
Including gestational hypertension and preeclampsia
During pregnancy
Pharmacological therapy for hyperglycaemia
Time Frame: During pregnancy
Such as metformin and insulin
During pregnancy
Mode of birth
Time Frame: At delivery
Such as normal spontaneous delivery, caesarean section, assisted vaginal delivery
At delivery
Gestational age at birth
Time Frame: At delivery
Measured in weeks and days
At delivery
Birthweight
Time Frame: At birth
Measured in grams
At birth
Large for gestational age
Time Frame: At birth
At birth
Preterm birth
Time Frame: At birth
Defined as birth before the 37th gestational week
At birth
Neonatal hypoglycaemia
Time Frame: At birth
At birth
Stillbirth
Time Frame: During pregnancy
Defined as fetal death after the 20th gestational week
During pregnancy
Neonatal death
Time Frame: Within 28 days after birth
Defined as death within 28 days after birth
Within 28 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Research Grants Council, Hong Kong

Investigators

  • Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17101423

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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