- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05081037
Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) (I-HIPS)
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:
- 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.
- 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.
- 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kok Hian Tan, MD
- Phone Number: 65 6394 1099
- Email: tan.kok.hian@singhealth.com.sg
Study Contact Backup
- Name: Phaik Ling Quah, PhD
- Phone Number: 97732543
- Email: quah.phaik.ling@kkh.com.sg
Study Locations
-
-
-
Singapore, Singapore, 229899
- Recruiting
- KK Women's and Children's Hospital
-
Contact:
- Phaik Ling Quah, PhD
- Phone Number: 97732543
- Email: quah.phaik.ling@kkh.com.sg
-
Contact:
- KK WAC Hospital, MD
- Phone Number: 97732543
- Email: tan.kok.hian@singhealth.com.sg
-
Principal Investigator:
- Kok Hian Tan, MD
-
Sub-Investigator:
- Phaik Ling Quah, PhD
-
Sub-Investigator:
- Wai Kheong,Ryan Lee, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women diagnosed antenatally with GDM by IADPSG criteria (15)
- Normal 6 weeks post-natal OGTT
- BMI range from 20-40
- Physically fit to participate in moderate intensity walking
Exclusion Criteria:
- Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days
- Women who have any other serious chronic disease such as chronic kidney disease and heart disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wearable Care Group
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.
|
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. |
No Intervention: Scheduled Care Group
This group will receive standard medical care with dietary and nutritional advice alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically diagnosed Type II Diabetes Mellitus
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
|
At 6 months (23-26 weeks) from baseline visit
|
Clinically diagnosed Type II Diabetes Mellitus
Time Frame: At 10-14 months from baseline visit
|
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
Time Frame: At 22-26 months from baseline visit
|
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
Time Frame: At 34-38 months from baseline visit
|
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
Time Frame: At 6 months (23-26 weeks) from baseline
|
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
Time Frame: At 6 months (23-26 weeks) from baseline
|
Measured using the bioelectrical impedance analysis scale
|
At 6 months (23-26 weeks) from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total energy intake from baseline at 6 months (23-26 weeks)
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.
|
Baseline and 6 months (23-26 weeks)
|
Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months
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.
|
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)
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.
|
Baseline and 6 months (23-26 weeks)
|
Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months
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.
|
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)
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)
|
Baseline and 6 months (23-26 weeks)
|
Change in physical activity from baseline, 6 months, 12 months, 24 months and 36 months
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)
|
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)
Time Frame: Baseline and 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
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
|
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)
Time Frame: Baseline and 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
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
|
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)
Time Frame: Baseline and 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
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
|
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)
Time Frame: Baseline and 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
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
|
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)
Time Frame: Baseline and 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
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
|
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)
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
|
Baseline and 6 months (23-26 weeks)
|
Change in fasting lipid profile from baseline, 6 months, 12 months, 24 months and 36 months
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
|
Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life from baseline at 12 months (10-14 months)
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
|
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)
Time Frame: Baseline and 36 months (34-38 months)
|
Quality of life score measured using the EQ-5D-5L instrument
|
Baseline and 36 months (34-38 months)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kok Hian Tan, MD, KK Women's and Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/3070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glucose Metabolism Disorders
-
University of AberdeenCompletedMetabolism Disorder, GlucoseUnited Kingdom
-
Columbia UniversityCompletedMetabolism Disorder, GlucoseUnited States
-
University of LeipzigInstitut für Gesundheits- und Praxismanagement GmbHWithdrawn
-
Purdue UniversityAlmond Board of CaliforniaActive, not recruitingGlucose Intolerance | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
University of Missouri-ColumbiaCompletedGlucose | Blood Sugar; High | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
University of South CarolinaCompletedPhysical Activity | Sedentary Lifestyle | Metabolism Disorder, GlucoseUnited States
-
Solvay PharmaceuticalsTerminatedDyslipidemia | Glucose Metabolism DisorderPoland, Croatia, Finland, France, Germany, Netherlands, Romania, Ukraine
-
DLR German Aerospace CenterCompletedGlucose Metabolism Disorders | Local Glucose Uptake
-
Solvay PharmaceuticalsCompletedDyslipidemia/Glucose Metabolism DisorderPoland, Ukraine, United Kingdom
-
Solvay PharmaceuticalsCompletedDyslipidemia/Glucose Metabolism DisorderCzech Republic, France, Hungary, India, Lithuania, Poland, Slovakia
Clinical Trials on Wearable Care Group
-
University Health Network, TorontoUniversity of TorontoCompletedBreast Cancer | Fatigue | Physical Activity | Prostate Cancer | Sedentary BehaviourCanada
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedSchizophrenia | Physical Activity | Health Knowledge, Attitudes, PracticeTaiwan
-
Rijnstate HospitalUniversity of Twente; Philips Research EindhovenRecruitingAcute Disease | Monitoring | Clinical DeteriorationNetherlands
-
Western University, CanadaCompletedType 2 Diabetes | Comorbidities and Coexisting ConditionsCanada
-
University of IdahoUniversity of California, IrvineNot yet recruitingHemiparesis; Poststroke/CVA
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI); Duke UniversityRecruitingStroke, IschemicUnited States
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationCompleted
-
Cedars-Sinai Medical CenterUnited States Department of DefenseRecruitingProstate CancerUnited States
-
Marmara UniversityUnknownDiabetes Mellitus, Type 2Turkey
-
Zoll Medical CorporationTerminatedMyocardial Ischemia | Ventricular Fibrillation | Ventricular Tachycardia | Ventricular Dysfunction | Sudden Cardiac DeathUnited States