Gestational DiabetesNCT06061991
Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention
A study testing Mobile instant messaging-based lifestyle intervention, Text messaging reminders and Brief advice on GDM prevention in people with Gestational Diabetes, run by The University of Hong Kong at 4 sites in Hong Kong.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Mobile instant messaging-based lifestyle intervention, Text messaging reminders and Brief advice on GDM prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 944 participants
- Where
- 4 sitesHong Kong
- Study dates
- 30 Jan 2024to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites, 4 recruiting
- Recruiting
Kwong Wah Hospital
Hong Kong
Wing Cheong Leung, MD (HK), +852-4658-5091, leungwc@ha.org.hk
Wing Cheong Leung, MD (HK)
- Recruiting
Princess Margaret Hospital
Hong Kong
Tsz-kin Lo, MBBS, 64610278, lotk@ha.org.hk
- Recruiting
Queen Mary Hospital/ Tsan Yuk Hospital
Hong Kong
Ka Wang Cheung, MD (HK), +852-2855-0947, kelvincheung82@hotmail.com
Ka Wang Cheung, MD (HK)
- Recruiting
United Christian Hospital/ Tseung Kwan O Hospital
Hong Kong
Carina Kwa, MBChB, +852-3949-4851, kc451@ha.org.hk
Carina Kwa, MBChB
About this study
Official title: Mobile Instant Messaging-based Lifestyle Interventions for Preventing Gestational Diabetes in High-risk Pregnant Women: a Randomised Controlled Trial
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
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Mobile instant messaging-based lifestyle intervention, Text messaging reminders, Brief advice on GDM prevention, Usual care
- Keywords
- lifestyle modification, gestational weight gain, Chinese, digital health, mHealth, WhatsApp
- Medical subject headings
- Diabetes, Gestational, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile instant messaging-based lifestyle interventionBehavioural
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.
Text messaging remindersBehavioural
Follow-up reminders via text messaging as attention control.
Brief advice on GDM preventionBehavioural
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 careBehavioural
Usual care provided by the prenatal clinic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Mobile instant messaging-based lifestyle intervention Receives: Behavioral: Mobile instant messaging-based lifestyle intervention; Behavioral: Brief advice on GDM prevention; Behavioral: Usual care |
| Control group | Active comparator | Brief advice on GDM prevention Receives: Behavioral: Text messaging reminders; Behavioral: Brief advice on GDM prevention; Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
GDM diagnosis
GDM diagnosed by a 2-hour 75g oral glucose tolerance test interpreted according to the World Health Organization's 2013 criteria
Measured: About 28th gestational week
Secondary outcomes (12)
Gestational weight gain
Measured in kilograms
Measured: From baseline to the end of pregnancy (delivery)
Hypertensive disorders of pregnancy
Including gestational hypertension and preeclampsia
Measured: During pregnancy
Pharmacological therapy for hyperglycaemia
Such as metformin and insulin
Measured: During pregnancy
Mode of birth
Such as normal spontaneous delivery, caesarean section, assisted vaginal delivery
Measured: At delivery
Gestational age at birth
Measured in weeks and days
Measured: At delivery
Birthweight
Measured in grams
Measured: At birth
Large for gestational age
Measured: At birth
Small for gestational age
Measured: At birth
Preterm birth
Defined as birth before the 37th gestational week
Measured: At birth
Neonatal hypoglycaemia
Measured: At birth
Neonatal death
Defined as death within 28 days after birth
Measured: Within 28 days after birth
Stillbirth
Defined as fetal death after the 20th gestational week
Measured: During pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start30 Jan 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Tzu Tsun Luk, The University of Hong Kong
- Investigators
- Tzu Tsun Luk, PhD, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061991
- Sponsor's protocol ID
- 17101423
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Instant Messaging-based Lifestyle Interventions for Preventing Gestational Diabetes in High-risk Pregnant Women: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06061991
- Acronym / sponsor ID
- 17101423
- Conditions
- Gestational Diabetes
- Keywords
- lifestyle modification, gestational weight gain, Chinese, digital health, mHealth, WhatsApp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 944 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mobile instant messaging-based lifestyle intervention, Behavioral: Brief advice on GDM prevention, Behavioral: Usual careMobile instant messaging-based lifestyle intervention |
| Control group | Active comparator | Behavioral: Text messaging reminders, Behavioral: Brief advice on GDM prevention, Behavioral: Usual careBrief advice on GDM prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (1 listed)
- Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile instant messaging-based lifestyle interventionNurse-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. | Behavioural | Intervention group |
| Text messaging remindersFollow-up reminders via text messaging as attention control. | Behavioural | Control group |
| Brief advice on GDM preventionBrief 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 | Behavioural | Control group, Intervention group |
| Usual careUsual care provided by the prenatal clinic. | Behavioural | Control group, Intervention group |
Primary outcome
GDM diagnosis
Time frame: 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
12 secondary outcomes
Gestational weight gain
Time frame: From baseline to the end of pregnancy (delivery)
Hypertensive disorders of pregnancy
Time frame: During pregnancy
Pharmacological therapy for hyperglycaemia
Time frame: During pregnancy
Mode of birth
Time frame: At delivery
Gestational age at birth
Time frame: At delivery
Birthweight
Time frame: At birth
Large for gestational age
Time frame: At birth
Small for gestational age
Time frame: At birth
Preterm birth
Time frame: At birth
Neonatal hypoglycaemia
Time frame: At birth
Neonatal death
Time frame: Within 28 days after birth
Stillbirth
Time frame: During pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu Tsun Luk, PhD, RN principal investigator
The University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile instant messaging-based lifestyle intervention, Text messaging reminders and Brief advice on GDM prevention in people with Gestational Diabetes, run by The University of Hong Kong at 4 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu Tsun Luk, PhD, RN (+852-3917-7574, luktt@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GDM diagnosis (time frame: About 28th gestational week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.