Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention
- Conditions
- Gestational Diabetes
- Interventions
- Behavioral: Mobile instant messaging-based lifestyle interventionBehavioral: Text messaging remindersBehavioral: Brief advice on GDM preventionBehavioral: Usual care
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 944
-
Ethnic Chinese singleton pregnant woman in <14 weeks of gestation
-
Aged 18 years or above
-
Own a mobile phone with an instant messaging app
-
Not participating in similar trials on diabetes or lifestyle modifications
-
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
- 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
- Arm && Interventions
Group Intervention Description Intervention group Brief advice on GDM prevention Mobile instant messaging-based lifestyle intervention Intervention group Usual care Mobile instant messaging-based lifestyle intervention Control group Usual care Brief advice on GDM prevention Intervention group Mobile instant messaging-based lifestyle intervention Mobile instant messaging-based lifestyle intervention Control group Text messaging reminders Brief advice on GDM prevention Control group Brief advice on GDM prevention Brief advice on GDM prevention
- 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 Hypertensive disorders of pregnancy During pregnancy Including gestational hypertension and preeclampsia
Gestational weight gain From baseline to the end of pregnancy (delivery) Measured in kilograms
Birthweight At birth Measured in grams
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
Trial Locations
- Locations (4)
Kwong Wah Hospital
🇭🇰Hong Kong, Hong Kong
United Christian Hospital/ Tseung Kwan O Hospital
🇭🇰Hong Kong, Hong Kong
Princess Margaret Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital/ Tsan Yuk Hospital
🇭🇰Hong Kong, Hong Kong