Study to Prevent Dysglycemia in Women With GDM

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

• Gestatiaonl Diabetes Mellitus
• GDM

Interventions

BEHAVIORAL

Intervention

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.

OTHER

Conventional care

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.

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-26

Primary Completion

2030-03-31

Completion

2030-03-31

Countries

• Hong Kong

Study Locations