Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Gestational Diabetes

Treatments: Behavioral: Usual care; Behavioral: Brief advice on GDM prevention; Behavioral: Mobile instant messaging-based lifestyle intervention; Behavioral: Text messaging reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT06061991

17101423

Details and patient eligibility

About

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

Full 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.

Enrollment: 944 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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944 participants in 2 patient groups

Intervention group

Experimental group

Description:

Mobile instant messaging-based lifestyle intervention

Treatment:

Behavioral: Mobile instant messaging-based lifestyle intervention

Behavioral: Brief advice on GDM prevention

Behavioral: Usual care

Control group

Active Comparator group

Description:

Brief advice on GDM prevention

Treatment:

Behavioral: Text messaging reminders

Behavioral: Brief advice on GDM prevention

Behavioral: Usual care