Gestational DiabetesiSelf-LearnNCT05188625
Online Self-learning for Women With Gestational Diabetes Mellitus
A study testing Telesupport - Telehealth in people with Gestational Diabetes, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This study aims to determine the feasibility and acceptability of using telehealth in the care of women with Gestational Diabetes Mellitus (GDM) by providing a self-learning alternative via an online portal compared to a one-to-one dietary education, conducted face-to-face in a dietitian clinic. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Telesupport - Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Jan 2021to 13 Aug 2021
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Women diagnosed with GDM before 32 weeks
- Women willing and have provided written consent to participate
- Women with ability to use telemedicine services after briefed
- Women who have sufficient communication abilities (written, listening and spoken) to be fully involved
- Women who have access to phone and internet
- Women willing to download and send blood glucose readings to research team.
Who cannot join
- Multiple pregnancies
- Gestational age 35 weeks and above
- Women with existing Type 1 or Type 2 Diabetes
- Women receiving oral steroid therapy
- Women with evidence of fetal complications (such as fetal anomalies, intrauterine growth retardation) and known history of pregnancy complications (e.g. pre-eclampsia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Conventional Face-to-face Dietary Education With Online Self-learning for Women With GDM - a Pilot Study
This study aims to determine the feasibility and acceptability of using telehealth in the care of women with Gestational Diabetes Mellitus (GDM) by providing a self-learning alternative via an online portal compared to a one-to-one dietary education, conducted face-to-face in a dietitian clinic. The investigators hypothesize that the use of technology would enable a higher percentage of women to receive the necessary dietary education, thereby empowering behaviour change and resulting in positive maternal blood glucose control and pregnancy outcomes.
The primary hypothesis is that the new care model will reach out to a higher proportion compared to the conventional model (Service utilization), as determined by the completion of the online self-learning, comparing it to attendance rates with the conventional model.
The secondary hypothesis is that the new care model will be able to provide care that would be comparable to those in the traditional outpatient clinic setting, as measured by the blood glucose and pregnancy outcomes, as well as patient satisfaction and patient experience.
Read the detailed description
GDM is a significant health issue amongst women. Medical nutrition therapy is established as the first-line treatment for GDM. The goal is to support maternal and foetal nutrition in order to ensure adequate pregnancy weight gain and foetal growth, whilst at the same time, maintain optimal glycemic control. Health education continues to play an important role in managing GDM. However, not all women with GDM receive dietary education as recommended, due to a multitude of personal and circumstantial factors. Failure to attend diabetes-related appointment has been associated with poorer glycaemic control by 36 weeks' gestation, which leads to a higher risk of macrosomia and an unfavourable set-up for neonatal outcomes. Therefore, this pilot study aims to determine the feasibility and acceptability of using telehealth in the dietary management of GDM compared with the current standard care, i.e. traditional face-to-face dietary education.
A total of 50 women diagnosed with GDM will be randomized to the standard care or telehealth, where self-education will be done via an online portal and subsequently followed up by teleconsult. Both groups will be followed up by the dietitian every 2-4 weeks until delivery either face-to-face (control group) or telehealth video consultation (intervention group). Each participant will be provided with a set of glucometer and the required consumables for home blood glucose monitoring.
Outcomes to determine the success of the study will be the percentage of women who completed dietary education. Other outcomes will include birth outcome data - birth weight to assess for large-for-gestational age baby, type of delivery, incidence of neonatal hypoglycaemia and total maternal weight gain, to establish the efficacy of this model of care. The effectiveness of self-learning will be assessed using pre- and post-test assessment quizzes. The experience and satisfaction of this model will also be surveyed.
- Conditions
- Gestational Diabetes
- Being tested
- Telesupport - Telehealth
- Keywords
- Gestational Diabetes Mellitus, GDM, Medical Nutrition Therapy, Telehealth
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telesupport - TelehealthOther
Online self-paced dietary education videos; Dietary counselling via video consultation; Blood glucose monitoring via a specially-designed health app
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | This group will receive the standard care of face-to-face dietitian counselling sessions. |
| Intervention arm | Experimental | This group will receive online self-paced dietary education, and followed up by telehealth video consultation with dietitian for dietary counselling. Receives: Other: Telesupport - Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate
The completion of online dietary education
Measured: Completion of online dietary education at Day 3
Attendance rate
The attendance of each dietitian visit
Measured: Mean attendance of each dietitian visit throughout study completion for an average of up to 12 weeks.
Secondary outcomes (7)
Knowledge assessment using a quiz
The change in knowledge assessment, assessed as difference in score of quiz before and after dietary education
Measured: At baseline Day 0 and between Day 3 (for intervention group) and Day 14 (for control group)
Patient experience
The Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) is used to collect information on how satisfied patients are with their healthcare providers; includes questions on level of care \& concern, treated with kindness \& compassion, courtesy \& respect, being listened to
Measured: At end of study up to 12 weeks
Telehealth usability
Usefulness, ease of use, reliability, interface and interaction quality of the telesupport-telehealth service using a specific questionnaire (International Journal of Telerehabilitation 2016; 8(1): 3-10)
Measured: At end of study up to 12 weeks
Glycaemic control
Blood glucose profile ranges pre- and post-meals
Measured: Every 2-4 weeks throughout the study, up to 12 weeks
Maternal outcome
Total gestational weight gain in kilograms
Measured: At end of study, up to 12 weeks
Foetal outcome 1
Birth weight in grams
Measured: At end of study, up to 12 weeks
Foetal outcome 2
Neonatal hypoglycaemia as defined by blood glucose level below 3.0mmol/L
Measured: At end of study, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start13 Jan 2021
- Primary completion23 Jun 2021
- Study completion13 Aug 2021
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 KK Women's and Children's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Han Wee Meng, KK Women's and Children's Hospital
- Investigators
- Wee Meng Han, PhD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188625
- Sponsor's protocol ID
- 2019-2927 CIRB
- Acronym
- iSelf-Learn
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2021
- Last updated
- 12 Jan 2022
- 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 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Face-to-face Dietary Education With Online Self-learning for Women With GDM - a Pilot Study
- ClinicalTrials.gov ID
- NCT05188625
- Acronym / sponsor ID
- iSelf-Learn / 2019-2927 CIRB
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes Mellitus, GDM, Medical Nutrition Therapy, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 12 Jan 2022 (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.
This study aims to determine the feasibility and acceptability of using telehealth in the care of women with Gestational Diabetes Mellitus (GDM) by providing a self-learning alternative via an online portal compared to a one-to-one dietary education, conducted face-to-face in a dietitian clinic. The investigators hypothesize that the use of technology would enable a higher percentage of women to receive the necessary dietary education, thereby empowering behaviour change and resulting in positive maternal blood glucose control and pregnancy outcomes.
The primary hypothesis is that the new care model will reach out to a higher proportion compared to the conventional model (Service utilization), as determined by the completion of the online self-learning, comparing it to attendance rates with the conventional model.
The secondary hypothesis is that the new care model will be able to provide care that would be comparable to those in the traditional outpatient clinic setting, as measured by the blood glucose and pregnancy outcomes, as well as patient satisfaction and patient experience.
Detailed description
GDM is a significant health issue amongst women. Medical nutrition therapy is established as the first-line treatment for GDM. The goal is to support maternal and foetal nutrition in order to ensure adequate pregnancy weight gain and foetal growth, whilst at the same time, maintain optimal glycemic control. Health education continues to play an important role in managing GDM. However, not all women with GDM receive dietary education as recommended, due to a multitude of personal and circumstantial factors. Failure to attend diabetes-related appointment has been associated with poorer glycaemic control by 36 weeks' gestation, which leads to a higher risk of macrosomia and an unfavourable set-up for neonatal outcomes. Therefore, this pilot study aims to determine the feasibility and acceptability of using telehealth in the dietary management of GDM compared with the current standard care, i.e. traditional face-to-face dietary education.
A total of 50 women diagnosed with GDM will be randomized to the standard care or telehealth, where self-education will be done via an online portal and subsequently followed up by teleconsult. Both groups will be followed up by the dietitian every 2-4 weeks until delivery either face-to-face (control group) or telehealth video consultation (intervention group). Each participant will be provided with a set of glucometer and the required consumables for home blood glucose monitoring.
Outcomes to determine the success of the study will be the percentage of women who completed dietary education. Other outcomes will include birth outcome data - birth weight to assess for large-for-gestational age baby, type of delivery, incidence of neonatal hypoglycaemia and total maternal weight gain, to establish the efficacy of this model of care. The effectiveness of self-learning will be assessed using pre- and post-test assessment quizzes. The experience and satisfaction of this model will also be surveyed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –This group will receive the standard care of face-to-face dietitian counselling sessions. |
| Intervention arm | Experimental | Other: Telesupport - TelehealthThis group will receive online self-paced dietary education, and followed up by telehealth video consultation with dietitian for dietary counselling. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Singleton pregnancy
- Women diagnosed with GDM before 32 weeks
- Women willing and have provided written consent to participate
- Women with ability to use telemedicine services after briefed
- Women who have sufficient communication abilities (written, listening and spoken) to be fully involved
Key exclusion criteria (5 listed)
- Multiple pregnancies
- Gestational age 35 weeks and above
- Women with existing Type 1 or Type 2 Diabetes
- Women receiving oral steroid therapy
- Women with evidence of fetal complications (such as fetal anomalies, intrauterine growth retardation) and known history of pregnancy complications (e.g. pre-eclampsia)
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 |
|---|---|---|
| Telesupport - TelehealthOnline self-paced dietary education videos; Dietary counselling via video consultation; Blood glucose monitoring via a specially-designed health app | Other | Intervention arm |
Primary outcome
Completion rate
Time frame: Completion of online dietary education at Day 3
The completion of online dietary education
Attendance rate
Time frame: Mean attendance of each dietitian visit throughout study completion for an average of up to 12 weeks.
The attendance of each dietitian visit
7 secondary outcomes
Knowledge assessment using a quiz
Time frame: At baseline Day 0 and between Day 3 (for intervention group) and Day 14 (for control group)
Patient experience
Time frame: At end of study up to 12 weeks
Telehealth usability
Time frame: At end of study up to 12 weeks
Glycaemic control
Time frame: Every 2-4 weeks throughout the study, up to 12 weeks
Maternal outcome
Time frame: At end of study, up to 12 weeks
Foetal outcome 1
Time frame: At end of study, up to 12 weeks
Foetal outcome 2
Time frame: At end of study, up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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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.
Wee Meng Han, PhD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telesupport - Telehealth in people with Gestational Diabetes, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: Completion of online dietary education at Day 3). The study lists 2 primary outcomes in all. 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 12 Jan 2022.