Clinical trial NCT05188625: Online Self-learning for Women With Gestational Diabetes Mellitus
Official title: Comparison of Conventional Face-to-face Dietary Education With Online Self-learning for Women With GDM - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational Diabetes Mellitus
GDM
Medical Nutrition Therapy
Telehealth
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Completion rate
timeFrame: Completion of online dietary education at Day 3
measure: Attendance rate
timeFrame: Mean attendance of each dietitian visit throughout study completion for an average of up to 12 weeks.
Secondary outcomes:
measure: Knowledge assessment using a quiz
timeFrame: At baseline Day 0 and between Day 3 (for intervention group) and Day 14 (for control group)
measure: Patient experience
timeFrame: At end of study up to 12 weeks
measure: Telehealth usability
timeFrame: At end of study up to 12 weeks
measure: Glycaemic control
timeFrame: Every 2-4 weeks throughout the study, up to 12 weeks
measure: Maternal outcome
timeFrame: At end of study, up to 12 weeks
measure: Foetal outcome 1
timeFrame: At end of study, up to 12 weeks
measure: Foetal outcome 2
timeFrame: At end of study, up to 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Wee Meng Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: