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| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
| Institute for Human Development and Potential (IHDP), Singapore | OTHER |
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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:
The increased incidence of gestational diabetes mellitus (GDM) resulting from increased insulin resistance has become a major health concern. GDM affects 5-10% of pregnant women in Europe, while the prevalence in Asian populations is significantly higher at approximately 15-20%. There is a need for early postpartum intervention strategies beginning soon after birth, but yet there are limited of such intervention studies conducted in Asia.
This is a randomized controlled trial and hospital-based study. A total of 300 post-partum women who attended KK Women's and Children's Hospital (KKH) for antenatal consultation and were diagnosed with GDM using International association of diabetes and pregnancy study groups (IADPSG) guidelines at KKH, with a BMI range from 20-40, and physically fit to participate in moderate intensity walking will be approached for prospective recruitment. These subjects will be followed-up to determine if they will have normal oral glucose tolerance test (OGTT) results at 6 weeks postpartum. If all the inclusion criteria is met, these women will be recruited into the study.
The recruited women will be randomly allocated to the intervention or control group. Those placed in the intervention group, which will also be known as the Wearable Care Group, will receive both a continous glucose monitoring (CGM) and an exercise tracker which will be a FitBit watch. Those placed in the control group, which will also be known as the Scheduled Care Group will receive standard medical care.
Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group) will be followed up in the specialist outpatient clinics with a total of 7 visits for up to 4 years. Various testing will be carried out at relevant time points.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, a quality of life questionnaire, maternal diet, medical histories, lifestyle factors, health status, and home environment. Bio-physical measurements will be obtained from anthropometric measurements of participants, human biological materials such as blood, are collected from the participants at their follow-up time points with the I-HIPS study upon their consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable Care Group | Experimental | 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. |
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| Scheduled Care Group | No Intervention | This group will receive standard medical care with dietary and nutritional advice alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Care Group | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically diagnosed Type II Diabetes Mellitus | Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test | At 6 months (23-26 weeks) from baseline visit |
| Clinically diagnosed Type II Diabetes Mellitus | Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test | At 10-14 months from baseline visit |
| Clinically diagnosed Type II Diabetes Mellitus | Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test | At 22-26 months from baseline visit |
| Clinically diagnosed Type II Diabetes Mellitus | Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test | At 34-38 months from baseline visit |
| Body mass index at the end of the 6 month intervention period | Using weight and height measures | At 6 months (23-26 weeks) from baseline |
| Body fat mass at the end of the 6 month intervention period | Measured using the bioelectrical impedance analysis scale | At 6 months (23-26 weeks) from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total energy intake from baseline at 6 months (23-26 weeks) | Assess the effect of continous glucose monitoring sensor use on total energy intake calculated using data captured from the 24-Hour recall food diary. | Baseline and 6 months (23-26 weeks) |
| Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life from baseline at 12 months (10-14 months) | Quality of life score measured using the EQ-5D-5L instrument | Baseline and 12 months (10-14 months) and 36 months (34-38 months) |
| Change in quality of life from baseline at 36 months (34-38 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kok Hian Tan, MD | Contact | 65 6394 1099 | tan.kok.hian@singhealth.com.sg | |
| Phaik Ling Quah, PhD | Contact | 97732543 | quah.phaik.ling@kkh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Kok Hian Tan, MD | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Recruiting | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41673699 | Derived | Quah PL, Song H, Han WM, Lim EJK, Bakar MAA, Fadzully F, Tan LK, Suzanna S, Eriksson JG, Chan SY, Finkelstein EA, Tan KH. Lifestyle intervention to prevent postpartum type 2 diabetes in Asian women with recent gestational diabetes and normal post-pregnancy glucose tolerance: study protocol for a randomized controlled trial with a targeted postpartum lifestyle programme. Trials. 2026 Feb 11;27(1):159. doi: 10.1186/s13063-026-09516-7. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group).
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|
Assess the effect of continous glucose monitoring sensor use on total energy intake captured using data captured from the 24-Hour recall food diary. |
| Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in diet quality from baseline at 6 months (23-26 weeks) | Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary. | Baseline and 6 months (23-26 weeks) |
| Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months | Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary. | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in physical activity from baseline at 6 months (23-26 weeks) | Assess the effect of exercise tracker use on frequency and duration of physical activity using self-reported data from the International Physical Activity Questionnaire (IPAQ) | Baseline and 6 months (23-26 weeks) |
| Change in physical activity from baseline, 6 months, 12 months, 24 months and 36 months | Assess the effect of exercise tracker use on frequency and duration of physical activity using self-reported data from the International Physical Activity Questionnaire (IPAQ) | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in diastolic and systolic blood pressure measures from baseline at 6 months (23-26 weeks) | Using diastolic and systolic blood pressure measures | Baseline and 6 months (23-26 weeks) |
| Change in diastolic and systolic blood pressure measures from baseline, 6 months, 12 months, 24 months and 36 months | Using diastolic and systolic blood pressure measures | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in body mass index measures from baseline at 6 months (23-26 weeks) | Calculating body mass index using height and weight measures | Baseline and 6 months (23-26 weeks) |
| Change in body mass index measures from baseline, 6 months, 12 months, 24 months and 36 months | Calculating body mass index using height and weight measures | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in waist circumference measures from baseline at 6 months (23-26 weeks) | Using waist circumference measures | Baseline and 6 months (23-26 weeks) |
| Change in waist circumference measures from from baseline, 6 months, 12 months, 24 months and 36 months | Using waist circumference measures | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in body fat mass measures from baseline at 6 months (23-26 weeks) | Using body fat mass measured using the bioelectrical impedance analysis scale | Baseline and 6 months (23-26 weeks) |
| Change in body fat mass measures from baseline, 6 months, 12 months, 24 months and 36 months | Using body fat mass measured using the bioelectrical impedance analysis scale | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in HbA1c measures from baseline at 6 months (23-26 weeks) | Using HbA1c levels measured from blood samples | Baseline and 6 months (23-26 weeks) |
| Change in HbA1c measures from baseline, 6 months, 12 months, 24 months and 36 months | Using HbA1c levels measured from blood samples | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
| Change in fasting lipid profile from baseline at 6 months (23-26 weeks) | Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples | Baseline and 6 months (23-26 weeks) |
| Change in fasting lipid profile from baseline, 6 months, 12 months, 24 months and 36 months | Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples | Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months) |
Quality of life score measured using the EQ-5D-5L instrument |
| Baseline and 36 months (34-38 months) |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |