Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Text messaging reminders
  Follow-up reminders via text messaging as attention control.
• Поведенческое 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
• Поведенческое Usual care
  Usual care provided by the prenatal clinic.

Первичные конечные точки

• GDM diagnosis [Срок оценки: About 28th gestational week]

Вторичные конечные точки (12)

• Gestational weight gain [Срок оценки: From baseline to the end of pregnancy (delivery)]
• Hypertensive disorders of pregnancy [Срок оценки: During pregnancy]
• Pharmacological therapy for hyperglycaemia [Срок оценки: During pregnancy]
• Mode of birth [Срок оценки: At delivery]
• Gestational age at birth [Срок оценки: At delivery]
• Birthweight [Срок оценки: At birth]
• Large for gestational age [Срок оценки: At birth]
• Small for gestational age [Срок оценки: At birth]
• Preterm birth [Срок оценки: At birth]
• Neonatal hypoglycaemia [Срок оценки: At birth]
• Neonatal death [Срок оценки: Within 28 days after birth]
• Stillbirth [Срок оценки: During pregnancy]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 4 центра

• Kwong Wah Hospital — Гонконг
• Princess Margaret Hospital — Гонконг
• Queen Mary Hospital/ Tsan Yuk Hospital — Гонконг
• United Christian Hospital/ Tseung Kwan O Hospital — Гонконг

Идентификаторы

NCT: NCT06061991 · 17101423

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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