Gestational Diabetes Clinical Trial
— I-HIPSOfficial title:
Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 26, 2026 |
Est. primary completion date | May 26, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Women diagnosed antenatally with GDM by IADPSG criteria (15) 2. Normal 6 weeks post-natal OGTT 3. BMI range from 20-40 4. Physically fit to participate in moderate intensity walking Exclusion Criteria: 1. Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days 2. Women who have any other serious chronic disease such as chronic kidney disease and heart disease |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital | Duke-NUS Graduate Medical School, Singapore Institute for Clinical Sciences |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | |
Other | Change in quality of life from baseline at 36 months (34-38 months) | Quality of life score measured using the EQ-5D-5L instrument | Baseline and 36 months (34-38 months) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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) | |
Secondary | Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Change in waist circumference measures from baseline at 6 months (23-26 weeks) | Using waist circumference measures | Baseline and 6 months (23-26 weeks) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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