NCT Number: NCT05081037
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.
Interested in participating?
Request Info21 year–45 year
Female
Interventional
Not applicable
Singapore, 229899
Location status: Recruiting
KK WAC Hospital, MD
CONTACT
Kok Hian Tan, MD
PRINCIPAL_INVESTIGATOR
Phaik Ling Quah, PhD
CONTACT
Phaik Ling Quah, PhD
SUB_INVESTIGATOR
Wai Kheong,Ryan Lee, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At 6 months (23-26 weeks) from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame: At 10-14 months from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame: At 22-26 months from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame: At 34-38 months from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Time frame: At 6 months (23-26 weeks) from baseline
Using weight and height measures
Time frame: At 6 months (23-26 weeks) from baseline
Measured using the bioelectrical impedance analysis scale
Time frame: Baseline and 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.
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 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.
Time frame: Baseline and 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.
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary.
Time frame: Baseline and 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)
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 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)
Time frame: Baseline and 6 months (23-26 weeks)
Using diastolic and systolic blood pressure measures
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Using diastolic and systolic blood pressure measures
Time frame: Baseline and 6 months (23-26 weeks)
Calculating body mass index using height and weight measures
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Calculating body mass index using height and weight measures
Time frame: Baseline and 6 months (23-26 weeks)
Using waist circumference measures
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Using waist circumference measures
Time frame: Baseline and 6 months (23-26 weeks)
Using body fat mass measured using the bioelectrical impedance analysis scale
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Using body fat mass measured using the bioelectrical impedance analysis scale
Time frame: Baseline and 6 months (23-26 weeks)
Using HbA1c levels measured from blood samples
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Using HbA1c levels measured from blood samples
Time frame: Baseline and 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
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples
Time frame: Baseline and 12 months (10-14 months) and 36 months (34-38 months)
Quality of life score measured using the EQ-5D-5L instrument
Time frame: Baseline and 36 months (34-38 months)
Quality of life score measured using the EQ-5D-5L instrument
Contact information is provided by the study sponsor or research team.
Kok Hian Tan, MD
CONTACT
Phaik Ling Quah, PhD
CONTACT
KK Women's and Children's Hospital
Other Gov
Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus
Acronym: I-HIPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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