NCT06061991

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
944

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2024Oct 2026

First Submitted

Initial submission to the registry

September 25, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

September 25, 2023

Last Update Submit

September 12, 2024

Conditions

Gestational Diabetes

Keywords

lifestyle modificationgestational weight gainChinesedigital healthmHealthWhatsApp

Outcome Measures

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

    About 28th gestational week

Secondary Outcomes (12)

  • Gestational weight gain

    From baseline to the end of pregnancy (delivery)

  • Hypertensive disorders of pregnancy

    During pregnancy

  • Pharmacological therapy for hyperglycaemia

    During pregnancy

  • Mode of birth

    At delivery

  • Gestational age at birth

    At delivery

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Mobile instant messaging-based lifestyle intervention

Behavioral: Mobile instant messaging-based lifestyle interventionBehavioral: Brief advice on GDM preventionBehavioral: Usual care

Control group

ACTIVE COMPARATOR

Brief advice on GDM prevention

Behavioral: Text messaging remindersBehavioral: Brief advice on GDM preventionBehavioral: Usual care

Interventions

Mobile instant messaging-based lifestyle interventionBEHAVIORAL

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.

Intervention group
Text messaging remindersBEHAVIORAL

Follow-up reminders via text messaging as attention control.

Control group
Brief advice on GDM preventionBEHAVIORAL

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

Control groupIntervention group
Usual careBEHAVIORAL

Usual care provided by the prenatal clinic.

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kwong Wah Hospital

Hong Kong, Hong Kong

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

RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalGestational Weight Gain

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesWeight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tzu Tsun Luk, PhD, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu Tsun Luk, PhD, RN

CONTACT

+852-3917-7574luktt@connect.hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

September 25, 2023

First Posted

September 29, 2023

Study Start

January 30, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(4)