Gestational Diabetes, Glucose Metabolism Disorders, Metabolic Disease
Conditions
Keywords
gestational diabetes, post-partum intervention, Body composition
Brief 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.
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.
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.
Sponsors
KK Women's and Children's Hospital
Duke-NUS Graduate Medical School
Institute for Human Development and Potential (IHDP), Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group).
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically diagnosed Type II Diabetes Mellitus | At 6 months (23-26 weeks) from baseline visit | Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test |
| Body mass index at the end of the 6 month intervention period | At 6 months (23-26 weeks) from baseline | Using weight and height measures |
| Body fat mass at the end of the 6 month intervention period | At 6 months (23-26 weeks) from baseline | Measured using the bioelectrical impedance analysis scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total energy intake from baseline at 6 months (23-26 weeks) | 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. |
| Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Change in diet quality from baseline at 6 months (23-26 weeks) | 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. |
| Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months | 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. |
| Change in physical activity from baseline at 6 months (23-26 weeks) | 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) |
| Change in physical activity from baseline, 6 months, 12 months, 24 months and 36 months | 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) |
| Change in diastolic and systolic blood pressure measures from baseline at 6 months (23-26 weeks) | Baseline and 6 months (23-26 weeks) | Using diastolic and systolic blood pressure measures |
| Change in diastolic and systolic blood pressure measures from baseline, 6 months, 12 months, 24 months and 36 months | 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 |
| Change in body mass index measures from baseline at 6 months (23-26 weeks) | Baseline and 6 months (23-26 weeks) | Calculating body mass index using height and weight measures |
| Change in body mass index measures from baseline, 6 months, 12 months, 24 months and 36 months | 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 |
| Change in waist circumference measures from baseline at 6 months (23-26 weeks) | Baseline and 6 months (23-26 weeks) | Using waist circumference measures |
| Change in waist circumference measures from from baseline, 6 months, 12 months, 24 months and 36 months | 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 |
| Change in body fat mass measures from baseline at 6 months (23-26 weeks) | Baseline and 6 months (23-26 weeks) | Using body fat mass measured using the bioelectrical impedance analysis scale |
| Change in body fat mass measures from baseline, 6 months, 12 months, 24 months and 36 months | 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 |
| Change in HbA1c measures from baseline at 6 months (23-26 weeks) | Baseline and 6 months (23-26 weeks) | Using HbA1c levels measured from blood samples |
| Change in HbA1c measures from baseline, 6 months, 12 months, 24 months and 36 months | 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 |
| Change in fasting lipid profile from baseline at 6 months (23-26 weeks) | 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 |
| Change in fasting lipid profile from baseline, 6 months, 12 months, 24 months and 36 months | 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 |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORKok Hian Tan, MD
KK Women's and Children's Hospital
Outcome results
None listed