Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Behavioral: Mobile instant messaging-based lifestyle intervention
* Behavioral: Text messaging reminders
* Behavioral: Brief advice on GDM prevention
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Mobile instant messaging-based lifestyle intervention | Behavioral: Mobile instant messaging-based lifestyle intervention<br>* 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.<br>Behavioral: Brief advice on GDM prevention<br>* 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<br>Behavioral: Usual care<br>* Usual care provided by the prenatal clinic.<br>|
| Active Comparator: Control group<br>Brief advice on GDM prevention | Behavioral: Text messaging reminders<br>* Follow-up reminders via text messaging as attention control.<br>Behavioral: Brief advice on GDM prevention<br>* 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<br>Behavioral: Usual care<br>* Usual care provided by the prenatal clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle modification, gestational weight gain, Chinese, digital health, mHealth, WhatsApp