Gestational Diabetes
Conditions
Keywords
lifestyle modification, gestational weight gain, Chinese, digital health, mHealth, WhatsApp
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.
Interventions
BEHAVIORALMobile 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.
BEHAVIORALText messaging reminders
Follow-up reminders via text messaging as attention control.
BEHAVIORALBrief 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
BEHAVIORALUsual care
Usual care provided by the prenatal clinic.
Sponsors
Research Grants Council, Hong Kong
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Gestational weight gain | From baseline to the end of pregnancy (delivery) | Measured in kilograms |
| 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 |
| Large for gestational age | At birth | — |
Countries
Hong Kong
Contacts
Primary ContactTzu Tsun Luk, PhD, RN
Outcome results
None listed