Study to Prevent Dysglycemia in Women With GDM

NCT07269405 | Enrolling By Invitation DMC

• 1 other identifier: 2025.127
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Women with a history of gestational diabetes mellitus (GDM) have a 7-fold increased risk of type 2 diabetes (T2D), with the risk at its highest during the 3-6 years postpartum. GDM thus represents one of the strongest known risk factors for T2D. Only 30-60% of women with GDM returned for postpartum visits, with the majority defaulting on postpartum glucose tolerance testing. Women with GDM also have an increased risk of hypertension, cardiovascular disease (CVD), non-alcoholic fatty liver disease, and other comorbidities. Through this study, participants will receive lifestyle advice that may help them prevent diabetes. The study will help determine whether a multicomponent intervention will prevent incident dysglycemia and improve offspring cardiometabolic health. This will inform healthcare professionals and policymakers if these interventions are helpful. The control group will receive basic dietary information leaflets and will have access to the e-care platform for the three-year period (8-166 weeks postnatal). They will receive routine lifestyle advice and counseling. The intervention groups will receive information on basic dietary information and have access to the e-platform. Participants will attend individualized/group dietary counseling sessions biweekly in the first 4 months during the intensive phase (V1-V7) and thereafter bimonthly (V8-10, 28-50 weeks postnatal) and biyearly between year 1 to year 3. This will include 16 sessions with a dietitian/nutritionist and 4 sessions with an exercise instructor. Participants will be given an individualized menu plan aiming at achieving a varied, balanced diet with an emphasis on fiber intake and moderate-carbohydrate, low-fat, low-glycemic index products in appropriate portions. The lifestyle intervention program will incorporate motivational interviewing and behavioral modification to enhance health knowledge on daily diet and physical activity. The lifestyle intervention aims to achieve targets on body weight, dietary intake, and physical activities.

Conditions

GDM; Gestatiaonl Diabetes Mellitus

Keywords

Gestatiaonl diabetes mellitus; GDM; Postpartum; Lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Proportion with deterioration in glycaemic status (ie. from NGT to pre-diabetes (IFG or IGT), or pre-diabetes to T2D, based on annual OGTT

  1 Year, 2 Year, 3 Year

Secondary Outcomes (13)

• Fasting glucose and post challenge glucose

  1 Year, 2 Year, 3 Year

• Body weight

  End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year

• BMI

  End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year

• Body composition

  End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year

• Systolic and diastolic blood pressure

  End of intensive intervention period (Postnatal week 20-26) and 1 Year, 2 Year, 3 Year

Study Arms (2)

Multicomponent Lifestyle Intervention

EXPERIMENTAL

Multicomponent intervention include e-care and wearables

Behavioral: Intervention

Conventional Care

OTHER

Conventional care

Other: Conventional care

Interventions

Intervention BEHAVIORAL

The intervention groups will receive information on basic dietary information and have access to e-platform. Participants will attend individualised/ group dietary counselling sessions biweekly in the first 4 months during the intensive phase and thereafter bimonthly and biyearly between year 1 to year 3. This will include 16 sessions with a dietitian/nutritionist and 4 sessions with an exercise instructor. Participants will be given an individualized menu plan aiming at achieving a varied balanced diet with an emphasis on fibre intake and moderate-carbohydrate, low-fat, low-glycaemic index products in appropriate portions.

Multicomponent Lifestyle Intervention

Conventional care OTHER

The control group will receive basic dietary information leaflets and will have access to the e-care platform for the three-year period. The control group will receive routine lifestyle advice.

Conventional Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a history of gestational diabetes mellitus and one additional risk factor (obesity, family history of diabetes, impaired fasting glycemia and/or impaired glucose tolerance and/ and or risk understanding by yourself RUBY score of ≥ 8) at 6-12 weeks postpartum
• Singleton pregnancy
• Willingness, ability and commitment to comply with study procedures
• In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
• Normally residing in Hong Kong
• Able to communicate in Chinese
• Written informed consent to participate in the study provided by the patient

You may not qualify if:

• Known current diabetes
• Current or previous use of glucose-lowering or weight loss drugs at screening
• Concurrent participation in other weight loss or lifestyle intervention programmes
• Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study
• Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff
• Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device
• Known uncontrolled thyrotoxicosis
• Current use of steroids
• Known current or recent alcohol or drug abuse
• Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection
• An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analysts
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multi-component lifestyle intervention

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: December 8, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: December 23, 2025

Record last verified: 2025-11

Locations

HK (1)