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Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

Primary Purpose

Gestational Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile instant messaging-based lifestyle intervention
Text messaging reminders
Brief advice on GDM prevention
Usual care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring lifestyle modification, gestational weight gain, Chinese, digital health, mHealth, WhatsApp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group

    Control group

    Arm Description

    Mobile instant messaging-based lifestyle intervention

    Brief advice on GDM prevention

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Gestational weight gain
    Measured in kilograms
    Hypertensive disorders of pregnancy
    Including gestational hypertension and preeclampsia
    Pharmacological therapy for hyperglycaemia
    Such as metformin and insulin
    Mode of birth
    Such as normal spontaneous delivery, caesarean section, assisted vaginal delivery
    Gestational age at birth
    Measured in weeks and days
    Birthweight
    Measured in grams
    Large for gestational age
    Small for gestational age
    Preterm birth
    Defined as birth before the 37th gestational week
    Neonatal hypoglycaemia
    Neonatal death
    Defined as death within 28 days after birth
    Stillbirth
    Defined as fetal death after the 20th gestational week

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 28, 2023
    Sponsor
    The University of Hong Kong
    Collaborators
    Research Grants Council, Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061991
    Brief Title
    Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention
    Official Title
    Mobile Instant Messaging-based Lifestyle Interventions for Preventing Gestational Diabetes in High-risk Pregnant Women: a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    June 30, 2026 (Anticipated)
    Study Completion Date
    September 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong
    Collaborators
    Research Grants Council, Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes
    Keywords
    lifestyle modification, gestational weight gain, Chinese, digital health, mHealth, WhatsApp

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    944 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Mobile instant messaging-based lifestyle intervention
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Brief advice on GDM prevention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mobile instant messaging-based lifestyle intervention
    Intervention Description
    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
    Intervention Name(s)
    Text messaging reminders
    Intervention Description
    Follow-up reminders via text messaging as attention control.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brief advice on GDM prevention
    Intervention Description
    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
    Intervention Name(s)
    Usual care
    Intervention Description
    Usual care provided by the prenatal clinic.
    Primary Outcome Measure Information:
    Title
    GDM diagnosis
    Description
    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 Outcome Measure Information:
    Title
    Gestational weight gain
    Description
    Measured in kilograms
    Time Frame
    From baseline to the end of pregnancy (delivery)
    Title
    Hypertensive disorders of pregnancy
    Description
    Including gestational hypertension and preeclampsia
    Time Frame
    During pregnancy
    Title
    Pharmacological therapy for hyperglycaemia
    Description
    Such as metformin and insulin
    Time Frame
    During pregnancy
    Title
    Mode of birth
    Description
    Such as normal spontaneous delivery, caesarean section, assisted vaginal delivery
    Time Frame
    At delivery
    Title
    Gestational age at birth
    Description
    Measured in weeks and days
    Time Frame
    At delivery
    Title
    Birthweight
    Description
    Measured in grams
    Time Frame
    At birth
    Title
    Large for gestational age
    Time Frame
    At birth
    Title
    Small for gestational age
    Time Frame
    At birth
    Title
    Preterm birth
    Description
    Defined as birth before the 37th gestational week
    Time Frame
    At birth
    Title
    Neonatal hypoglycaemia
    Time Frame
    At birth
    Title
    Neonatal death
    Description
    Defined as death within 28 days after birth
    Time Frame
    Within 28 days after birth
    Title
    Stillbirth
    Description
    Defined as fetal death after the 20th gestational week
    Time Frame
    During pregnancy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tzu Tsun Luk, PhD, RN
    Phone
    +852-3917-7574
    Email
    luktt@connect.hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tzu Tsun Luk, PhD, RN
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

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