RecruitingNot ApplicableNCT05081037

Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)

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


Sponsor

KK Women's and Children's Hospital

Enrollment

300 participants

Start Date

Sep 6, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 21 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study (I-HIPS) is testing whether a structured walking program plus incentives can help women who had gestational diabetes during pregnancy reduce their risk of developing type 2 diabetes in the years after giving birth. **You may be eligible if...** - You were diagnosed with gestational diabetes (high blood sugar during pregnancy) - Your blood sugar test (OGTT) at 6 weeks after delivery came back normal - Your BMI is between 20 and 40 - You are physically able to do moderate-intensity walking **You may NOT be eligible if...** - You have a serious skin condition (e.g., eczema) that prevents wearing a glucose sensor for 14 days - You have another serious chronic illness such as kidney disease or heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWearable Care Group

Continous glucose monitoring sensor: Study participants wear the sensor on the back of either right or left upper arm for up to 14 days. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. Exercise tracker: A FitBit watch will be given to the participants for use to track physical activity levels.


Locations(1)

KK Women's and Children's Hospital

Singapore, Singapore

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NCT05081037


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