Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

Not Applicable

Recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT06061991
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-09-29
• Study Start: 2024-01-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2026-07-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 944

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
GDM diagnosis	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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Kwong Wah Hospital; 🇭🇰 Hong Kong, Hong Kong

Princess Margaret Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital/ Tsan Yuk Hospital; 🇭🇰 Hong Kong, Hong Kong

United Christian Hospital/ Tseung Kwan O Hospital; 🇭🇰 Hong Kong, Hong Kong