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RecruitingNCT06061991Updated Sep 19, 2024

Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

An interventional study of Mobile instant messaging-based lifestyle intervention and Text messaging reminders in Gestational Diabetes, sponsored by The University of Hong Kong. Recruiting at 4 sites in Hong Kong. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
944
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Gestational Diabetes

Keywords

  • lifestyle modification
  • gestational weight gain
  • Chinese
  • digital health
  • mHealth
  • WhatsApp
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 944 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
944 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Mobile instant messaging-based lifestyle intervention

    Behavioral: Mobile instant messaging-based lifestyle intervention · Behavioral: Brief advice on GDM prevention · Behavioral: Usual care

  • Active comparator
    Control group

    Brief advice on GDM prevention

    Behavioral: Text messaging reminders · Behavioral: Brief advice on GDM prevention · Behavioral: Usual care

Interventions

  • BehavioralMobile 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.

  • BehavioralText messaging reminders

    Follow-up reminders via text messaging as attention control.

  • BehavioralBrief 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

  • BehavioralUsual care

    Usual care provided by the prenatal clinic.

06

What researchers measure

Primary outcomes

  1. GDM diagnosis

    GDM diagnosed by a 2-hour 75g oral glucose tolerance test interpreted according to the World Health Organization's 2013 criteria

    Time frame: About 28th gestational week

Secondary outcomes

  1. Gestational weight gain

    Measured in kilograms

    Time frame: From baseline to the end of pregnancy (delivery)

  2. Hypertensive disorders of pregnancy

    Including gestational hypertension and preeclampsia

    Time frame: During pregnancy

  3. Pharmacological therapy for hyperglycaemia

    Such as metformin and insulin

    Time frame: During pregnancy

  4. Mode of birth

    Such as normal spontaneous delivery, caesarean section, assisted vaginal delivery

    Time frame: At delivery

  5. Gestational age at birth

    Measured in weeks and days

    Time frame: At delivery

  6. Birthweight

    Measured in grams

    Time frame: At birth

  7. Large for gestational age

    Time frame: At birth

  8. Small for gestational age

    Time frame: At birth

  9. Preterm birth

    Defined as birth before the 37th gestational week

    Time frame: At birth

  10. Neonatal hypoglycaemia

    Time frame: At birth

  11. Neonatal death

    Defined as death within 28 days after birth

    Time frame: Within 28 days after birth

  12. Stillbirth

    Defined as fetal death after the 20th gestational week

    Time frame: During pregnancy

07

Study locations

4 of 4 sites recruiting
  • Kwong Wah Hospital
    Hong Kong, Hong Kong
    • Wing Cheong Leung, MD (HK) · Contact · leungwc@ha.org.hk · +852-4658-5091
    • Wing Cheong Leung, MD (HK) · Contact
    Recruiting
  • Princess Margaret Hospital
    Hong Kong, Hong Kong
    Recruiting
  • Queen Mary Hospital/ Tsan Yuk Hospital
    Hong Kong, Hong Kong
    Recruiting
  • United Christian Hospital/ Tseung Kwan O Hospital
    Hong Kong, Hong Kong
    • Carina Kwa, MBChB · Contact · kc451@ha.org.hk · +852-3949-4851
    • Carina Kwa, MBChB · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06061991
Lead sponsor
The University of Hong Kong
Collaborators
Research Grants Council, Hong Kong
Responsible party
Tzu Tsun Luk (Research Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Sep 29, 2023
Start date
Jan 30, 2024
Primary completion
Jul 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Tzu Tsun Luk, PhD, RN
Contact
luktt@connect.hku.hk
+852-3917-7574
Tzu Tsun Luk, PhD, RN
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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