Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061991
• Other study ID #: 17101423
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: October 30, 2026

Study information

• Verified date: February 2024
• Source: The University of Hong Kong
• Contact: Tzu Tsun Luk, PhD, RN
• Phone: +852-3917-7574
• Email: luktt[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 944
• Est. completion date: October 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

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.
• Text messaging reminders
Follow-up reminders via text messaging as attention control.
• 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
• Usual care
Usual care provided by the prenatal clinic.

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Queen Mary Hospital/ Tsan Yuk Hospital	Hong Kong
Hong Kong	United Christian Hospital/ Tseung Kwan O Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Research Grants Council, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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