A smartphone application providing diet and physical activity information for the prevention of gestational diabetes
| ISRCTN | ISRCTN59044843 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59044843 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | TCTR20210317002 |
| Sponsor | Thailand Research Fund |
| Funders | Thailand Research Fund, Medical Research Council |
- Submission date
- 05/04/2021
- Registration date
- 12/04/2021
- Last edited
- 14/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The study aims to evaluate a specific behavioral intervention for the prevention of the development of gestational diabetes during 24-28 weeks of gestation among pregnant women whose initial screening before 20 weeks of gestation does not show gestational diabetes.
Who can participate?
Pregnant women aged 18-50 years who previously received gestational diabetes screening before 20 weeks of gestation according to institutional guidelines with normal results.
What does the study involve?
Participants will either receive standard antenatal care or individual counseling on diet and physical activity and weekly information on behavioral modification will be provided via the LINE smartphone application. Participants will be followed to determine the development of gestational diabetes at 24-28 weeks of gestation as well as other pregnancy outcomes.
What are the possible benefits and risks of participating?
Participants would benefit by reducing the risk of gestational diabetes along with developing healthier behavior during pregnancy.
Where is the study run from?
Faculty of Medicine Siriraj Hospital (Thailand)
When is the study starting and how long is it expected to run for?
From July 2020 to February 2023
Who is funding the study?
Thailand Research Fund (Thailand) and the Medical Research Council (UK)
Who is the main contact?
Dr Dittakarn Boriboonhirunsarn, dittakarn.bor@mahidol.ac.th
Contact information
Scientific
2 Wanglang Road
Siriraj
Bangkoknoi
Bangkok
10700
Thailand
 ORCID ID |
0000-0002-5901-5923 |
|---|---|
| Phone | +66 818085718 |
| dittakarn.bor@mahidol.ac.th |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Behavioral intervention for prevention of gestational diabetes |
| Study objectives | Behavioral intervention can prevent development of GDM during 24-28 weeks of gestation in women with normal initial GDM screening before 20 weeks of gestation. |
| Ethics approval(s) | Approved 22/11/2019, Siriraj Institutional Review Board (SIRB) (Human Research Protection Unit, Faculty of Medicine Siriraj Hospital, Mahidol University, His Majesty the King's 80th Birthday Anniversary 5th December 2007 Building, 2nd floor, Room 210, 2 Wang Lang Road Bangkoknoi, Bangkok 10700, Thailand; +662419 2667 - 72; siethics@mahidol.ac.th), ref: Si 796/2019 |
| Health condition(s) or problem(s) studied | Gestational diabetes during 24-28 weeks of gestation in women with normal initial GDM screening |
| Intervention | The intervention group receives individual counseling on nutrition and physical activity together with weekly information about behavioral modification via smartphone (LINE application) until gestational diabetes mellitus (GDM) screening at 24-28 weeks of gestation. The control group receives standard antenatal care. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Development of gestational diabetes mellitus (GDM) during 24-28 weeks of gestation measured using GDM screening at 24-28 weeks |
| Key secondary outcome measure(s) |
Pregnancy outcomes related to gestational diabetes mellitus (GDM), such as preterm delivery, Large for Gestational Age (LGA), macrosomia, or cesarean section measured from participant notes at delivery |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 820 |
| Total final enrolment | 820 |
| Key inclusion criteria | 1. Aged between 18 and 50 years 2. Gestational age <20 weeks 3. Received gestational diabetes mellitus (GDM) screening according to institutional guideline 4. Have a smartphone with the LINE application |
| Key exclusion criteria | 1. Pre-pregnancy diabetes 2. Intrauterine fetal death or major anomalies or any conditions that pregnancy termination is indicated 3. Do not agree to participate |
| Date of first enrolment | 31/07/2020 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Siriraj
Bangkoknoi
Bangkok
10700
Thailand
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2022 to 28/02/2023.
2. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
08/04/2021: Trial’s existence confirmed by Siriraj Institutional Review Board.
