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| Name | Class |
|---|---|
| Research Grants Council, Hong Kong | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Mobile instant messaging-based lifestyle intervention |
|
| Control group | Active Comparator | Brief advice on GDM prevention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| GDM diagnosis | GDM diagnosed by a 2-hour 75g oral glucose tolerance test interpreted according to the World Health Organization's 2013 criteria | About 28th gestational week |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain | Measured in kilograms | From baseline to the end of pregnancy (delivery) |
| Hypertensive disorders of pregnancy | Including gestational hypertension and preeclampsia |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzu Tsun Luk, PhD, RN | Contact | +852-3917-7574 | luktt@connect.hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Tzu Tsun Luk, PhD, RN | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwong Wah Hospital | Recruiting | Hong Kong | Hong Kong |
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|
| 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. |
|
| During pregnancy |
| Pharmacological therapy for hyperglycaemia | Such as metformin and insulin | During pregnancy |
| Mode of birth | Such as normal spontaneous delivery, caesarean section, assisted vaginal delivery | At delivery |
| Gestational age at birth | Measured in weeks and days | At delivery |
| Birthweight | Measured in grams | At birth |
| Large for gestational age | At birth |
| Small for gestational age | At birth |
| Preterm birth | Defined as birth before the 37th gestational week | At birth |
| Neonatal hypoglycaemia | At birth |
| Neonatal death | Defined as death within 28 days after birth | Within 28 days after birth |
| Stillbirth | Defined as fetal death after the 20th gestational week | During pregnancy |
| Princess Margaret Hospital | Recruiting | Hong Kong | Hong Kong |
|
| Queen Mary Hospital/ Tsan Yuk Hospital | Recruiting | Hong Kong | Hong Kong |
|
| United Christian Hospital/ Tseung Kwan O Hospital | Recruiting | Hong Kong | Hong Kong |
|
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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