Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05188625
Study type Interventional
Source KK Women's and Children's Hospital
Contact
Status Completed
Phase N/A
Start date January 13, 2021
Completion date August 13, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05081037 - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) N/A
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Terminated NCT03749889 - Low Carb vs Normal Carb in Pregnancy N/A
Enrolling by invitation NCT03859193 - Education Nutritional Video for Gestational Diabetics N/A
Not yet recruiting NCT03981328 - The Effectiveness of Rt-CGM to Improve Glycemic Control and Pregnancy Outcome in Patients With GDM N/A
Recruiting NCT02590016 - Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial Phase 4
Withdrawn NCT01947699 - Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide Phase 4
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Recruiting NCT03008824 - Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby N/A
Active, not recruiting NCT01340924 - Relationship Between Gestational Diabetes and Type 2 Diabetes
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00371306 - Comparison of Glucovance to Insulin for Diabetes During Pregnancy N/A
Completed NCT03388723 - Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
Recruiting NCT04521712 - Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia N/A
Enrolling by invitation NCT03307486 - Gestational Diabetes: a Cohort Study N/A
Not yet recruiting NCT05037526 - Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes N/A
Active, not recruiting NCT03301792 - Group Versus Traditional Prenatal Care for Diabetes N/A
Active, not recruiting NCT03669887 - Lifestyle Modification to Improve Diet in Women With GDM N/A
Completed NCT02218931 - ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes N/A
Recruiting NCT05148130 - Construction and Biological Study of Blood and Placenta Samples Associated With Gestational Diabetes Mellitus