Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group Mobile instant messaging-based lifestyle intervention |
Behavioral: 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.
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
Behavioral: Usual care
Usual care provided by the prenatal clinic.
|
| Active Comparator: Control group Brief advice on GDM prevention |
Behavioral: Text messaging reminders
Follow-up reminders via text messaging as attention control.
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
Behavioral: Usual care
Usual care provided by the prenatal clinic.
|
Outcome Measures
Primary Outcome Measures
- GDM diagnosis [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 Outcome Measures
- Gestational weight gain [From baseline to the end of pregnancy (delivery)]
Measured in kilograms
- Hypertensive disorders of pregnancy [During pregnancy]
Including gestational hypertension and preeclampsia
- Pharmacological therapy for hyperglycaemia [During pregnancy]
Such as metformin and insulin
- Mode of birth [At delivery]
Such as normal spontaneous delivery, caesarean section, assisted vaginal delivery
- Gestational age at birth [At delivery]
Measured in weeks and days
- Birthweight [At birth]
Measured in grams
- Large for gestational age [At birth]
- Small for gestational age [At birth]
- Preterm birth [At birth]
Defined as birth before the 37th gestational week
- Neonatal hypoglycaemia [At birth]
- Neonatal death [Within 28 days after birth]
Defined as death within 28 days after birth
- Stillbirth [During pregnancy]
Defined as fetal death after the 20th gestational week
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The University of Hong Kong
- Research Grants Council, Hong Kong
Investigators
- Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17101423