Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

NCT ID: NCT06061991

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

944 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2026-10-30

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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Mobile instant messaging-based lifestyle intervention

Group Type EXPERIMENTAL

Mobile instant messaging-based lifestyle intervention

Intervention Type BEHAVIORAL

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.

Brief advice on GDM prevention

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Usual care provided by the prenatal clinic.

Control group

Brief advice on GDM prevention

Group Type ACTIVE_COMPARATOR

Text messaging reminders

Intervention Type BEHAVIORAL

Follow-up reminders via text messaging as attention control.

Brief advice on GDM prevention

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Usual care provided by the prenatal clinic.

Interventions

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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.

Intervention Type BEHAVIORAL

Text messaging reminders

Follow-up reminders via text messaging as attention control.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Usual care

Usual care provided by the prenatal clinic.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Research Grants Council, Hong Kong

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Tzu Tsun Luk

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tzu Tsun Luk, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Kwong Wah Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Princess Margaret Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital/ Tsan Yuk Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

United Christian Hospital/ Tseung Kwan O Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Tzu Tsun Luk, PhD, RN

Role: CONTACT

+852-3917-7574

Facility Contacts

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Wing Cheong Leung, MD (HK)

Role: primary

+852-4658-5091

Wing Cheong Leung, MD (HK)

Role: backup

Tsz-kin Lo, MBBS

Role: primary

Ka Wang Cheung, MD (HK)

Role: primary

+852-2855-0947

Ka Wang Cheung, MD (HK)

Role: backup

Carina Kwa, MBChB

Role: primary

+852-3949-4851

Carina Kwa, MBChB

Role: backup

Other Identifiers

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17101423

Identifier Type: -

Identifier Source: org_study_id

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