Online Self-learning for Women With Gestational Diabetes Mellitus

NCT05188625 | Completed

• 1 other identifier: 2019-2927 CIRB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes Mellitus; GDM; Medical Nutrition Therapy; Telehealth

Outcome Measures

Primary Outcomes (2)

• Completion rate

  The completion of online dietary education

  Completion of online dietary education at Day 3

• Attendance rate

  The attendance of each dietitian visit

  Mean attendance of each dietitian visit throughout study completion for an average of up to 12 weeks.

Secondary Outcomes (7)

• Knowledge assessment using a quiz

  At baseline Day 0 and between Day 3 (for intervention group) and Day 14 (for control group)

• Patient experience

  At end of study up to 12 weeks

• Telehealth usability

  At end of study up to 12 weeks

• Glycaemic control

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

• Maternal outcome

  At end of study, up to 12 weeks

Study Arms (2)

Control arm

NO INTERVENTION

This group will receive the standard care of face-to-face dietitian counselling sessions.

Intervention arm

EXPERIMENTAL

This group will receive online self-paced dietary education, and followed up by telehealth video consultation with dietitian for dietary counselling.

Other: Telesupport - Telehealth

Interventions

Telesupport - Telehealth OTHER

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

Intervention arm

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wee Meng Han, PhD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Dietitian, Head of Nutrition & Dietetics Department, Principal Investigator

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: January 12, 2022
• Study Start: January 13, 2021
• Primary Completion: June 23, 2021
• Study Completion: August 13, 2021
• Last Updated: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)