Clinical Trials Directory

Trials / Completed

CompletedNCT05188625

Online Self-learning for Women With Gestational Diabetes Mellitus

Comparison of Conventional Face-to-face Dietary Education With Online Self-learning for Women With GDM - a Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
KK Women's and Children's Hospital · Other Government
Sex
Female
Age
21 Years
Healthy volunteers
Accepted

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. 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.

Conditions

Interventions

TypeNameDescription
OTHERTelesupport - TelehealthOnline self-paced dietary education videos; Dietary counselling via video consultation; Blood glucose monitoring via a specially-designed health app

Timeline

Start date
2021-01-13
Primary completion
2021-06-23
Completion
2021-08-13
First posted
2022-01-12
Last updated
2022-01-12

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT05188625. Inclusion in this directory is not an endorsement.