Clinical trial NCT06061991: 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
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Keywords: lifestyle modification
gestational weight gain
Chinese
digital health
mHealth
WhatsApp
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2023-09-29
Enrollment: 944
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: GDM diagnosis
timeFrame: About 28th gestational week
Secondary outcomes:
measure: Gestational weight gain
timeFrame: From baseline to the end of pregnancy (delivery)
measure: Hypertensive disorders of pregnancy
timeFrame: During pregnancy
measure: Pharmacological therapy for hyperglycaemia
timeFrame: During pregnancy
measure: Mode of birth
timeFrame: At delivery
measure: Gestational age at birth
timeFrame: At delivery
measure: Birthweight
timeFrame: At birth
measure: Large for gestational age
timeFrame: At birth
measure: Small for gestational age
timeFrame: At birth
measure: Preterm birth
timeFrame: At birth
measure: Neonatal hypoglycaemia
timeFrame: At birth
measure: Neonatal death
timeFrame: Within 28 days after birth
measure: Stillbirth
timeFrame: During pregnancy
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital/ Tsan Yuk Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital/ Tseung Kwan O Hospital
Study officials:
affiliation: The University of Hong Kong
name: Tzu Tsun Luk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: