Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to test the following hypotheses in a randomized controlled trial of post-partum women with a history of gestational diabetes mellitus (GDM) that will be followed up for up to 4 years: 1. Post-partum pregnancy is ideal for behavioural modification and adopting a healthy lifestyle. Using the continous glucose monitoring (CGM) sensor and an exercise tracker will promote self-motivation and awareness by positive reinforcement and behavioural changes to improve diet, control body weight and increase physical activity in this group of post-partum women who are at high risk for developing Type II Diabetes. 2. The use of the continous glycose monitoring (CGM) sensor and exercise tracker will motivate women to modify their dietary food intake and physical activity over time, reducing their cardiovascular risk factors for developing metabolic syndrome by lowering their baseline blood pressure, BMI, reducing their waist circumference and body fat mass, glycaemic levels and fasting lipids within the targeted healthy range. 3. There will be an increase in the quality adjusted life years (QALYs) gained based on improvements in HbA1C and other proximal outcomes at the end of the trial.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 45
Healthy Volunteers: t
View:

• Women diagnosed antenatally with GDM by IADPSG criteria (15)

• Normal 6 weeks post-natal OGTT

• BMI range from 20-40

• Physically fit to participate in moderate intensity walking

Locations
Other Locations
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
Contact Information
Primary
Kok Hian Tan, MD
tan.kok.hian@singhealth.com.sg
65 6394 1099
Backup
Phaik Ling Quah, PhD
quah.phaik.ling@kkh.com.sg
97732543
Time Frame
Start Date: 2021-09-06
Estimated Completion Date: 2026-05-26
Participants
Target number of participants: 300
Treatments
Experimental: Wearable Care Group
This group will receive both a continous glucose monitoring sensor and an exercise tracker to be worn for at least 2 weeks at each study visit timepoint.
No_intervention: Scheduled Care Group
This group will receive standard medical care with dietary and nutritional advice alone.
Sponsors
Leads: KK Women's and Children's Hospital
Collaborators: Duke-NUS Graduate Medical School, Institute for Human Development and Potential (IHDP), Singapore

This content was sourced from clinicaltrials.gov