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Completed

NCT Number: NCT05188625

Online Self-learning for Women With Gestational Diabetes Mellitus

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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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telesupport - Telehealth

Other

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

Primary outcomes

  1. Completion rate

    Time frame: Completion of online dietary education at Day 3

    The completion of online dietary education

  2. 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

Secondary outcomes

  1. Knowledge assessment using a quiz

    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

  2. Patient experience

    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

  3. Telehealth usability

    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)

  4. Glycaemic control

    Time frame: Every 2-4 weeks throughout the study, up to 12 weeks

    Blood glucose profile ranges pre- and post-meals

  5. Maternal outcome

    Time frame: At end of study, up to 12 weeks

    Total gestational weight gain in kilograms

  6. Foetal outcome 1

    Time frame: At end of study, up to 12 weeks

    Birth weight in grams

  7. Foetal outcome 2

    Time frame: At end of study, up to 12 weeks

    Neonatal hypoglycaemia as defined by blood glucose level below 3.0mmol/L

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Acronym: iSelf-Learn

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

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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