By InvitationNot Applicable

Study to Prevent Dysglycemia in Women With GDM

Hong Kong800 participantsStarted 2025-09-26

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Known current diabetes
✕. Current or previous use of glucose-lowering or weight loss drugs at screening

What they're measuring

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

Timeframe: 1 Year, 2 Year, 3 Year

Trial details

NCT IDNCT07269405

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-03

View on ClinicalTrials.gov More Gestatiaonl Diabetes Mellitus trials