KK Women's and Children's Hospital
Singapore, 229899
NCT Number: NCT05188625
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.
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Notify Me21 year and older
Female
Interventional
Not applicable
Singapore, 229899
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Online self-paced dietary education videos; Dietary counselling via video consultation; Blood glucose monitoring via a specially-designed health app
Time frame: Completion of online dietary education at Day 3
The completion of online dietary education
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
Time frame: At baseline Day 0 and between Day 3 (for intervention group) and Day 14 (for control group)
The change in knowledge assessment, assessed as difference in score of quiz before and after dietary education
Time frame: At end of study up to 12 weeks
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
Time frame: At end of study up to 12 weeks
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)
Time frame: Every 2-4 weeks throughout the study, up to 12 weeks
Blood glucose profile ranges pre- and post-meals
Time frame: At end of study, up to 12 weeks
Total gestational weight gain in kilograms
Time frame: At end of study, up to 12 weeks
Birth weight in grams
Time frame: At end of study, up to 12 weeks
Neonatal hypoglycaemia as defined by blood glucose level below 3.0mmol/L
KK Women's and Children's Hospital
Other Gov
Comparison of Conventional Face-to-face Dietary Education With Online Self-learning for Women With GDM - a Pilot Study
Acronym: iSelf-Learn
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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