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NCT Number: NCT06061991

Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

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

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile instant messaging-based lifestyle intervention

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.

Text messaging reminders

Behavioral

Follow-up reminders via text messaging as attention control.

Brief advice on GDM prevention

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

Behavioral

Usual care provided by the prenatal clinic.

Primary outcomes

  1. GDM diagnosis

    Time frame: About 28th gestational week

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

Secondary outcomes

  1. Gestational weight gain

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

    Measured in kilograms

  2. Hypertensive disorders of pregnancy

    Time frame: During pregnancy

    Including gestational hypertension and preeclampsia

  3. Pharmacological therapy for hyperglycaemia

    Time frame: During pregnancy

    Such as metformin and insulin

  4. Mode of birth

    Time frame: At delivery

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

  5. Gestational age at birth

    Time frame: At delivery

    Measured in weeks and days

  6. Birthweight

    Time frame: At birth

    Measured in grams

  7. Large for gestational age

    Time frame: At birth

  8. Small for gestational age

    Time frame: At birth

  9. Preterm birth

    Time frame: At birth

    Defined as birth before the 37th gestational week

  10. Neonatal hypoglycaemia

    Time frame: At birth

  11. Neonatal death

    Time frame: Within 28 days after birth

    Defined as death within 28 days after birth

  12. Stillbirth

    Time frame: During pregnancy

    Defined as fetal death after the 20th gestational week

Study contacts

Contact information is provided by the study sponsor or research team.

Tzu Tsun Luk, PhD, RN

CONTACT

[email protected]

+852-3917-7574

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Research Grants Council, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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