Clinical trial NCT05081037: Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
Official title: Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Glucose Metabolism Disorders
Metabolic Disease
Keywords: gestational diabetes
post-partum intervention
Body composition
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Duke-NUS Graduate Medical School
name: Institute for Human Development and Potential (IHDP), Singapore
First posted: 2021-10-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinically diagnosed Type II Diabetes Mellitus
timeFrame: At 6 months (23-26 weeks) from baseline visit
measure: Clinically diagnosed Type II Diabetes Mellitus
timeFrame: At 10-14 months from baseline visit
measure: Clinically diagnosed Type II Diabetes Mellitus
timeFrame: At 22-26 months from baseline visit
measure: Clinically diagnosed Type II Diabetes Mellitus
timeFrame: At 34-38 months from baseline visit
measure: Body mass index at the end of the 6 month intervention period
timeFrame: At 6 months (23-26 weeks) from baseline
measure: Body fat mass at the end of the 6 month intervention period
timeFrame: At 6 months (23-26 weeks) from baseline
Secondary outcomes:
measure: Change in total energy intake from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in diet quality from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in physical activity from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in physical activity from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in diastolic and systolic blood pressure measures from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in diastolic and systolic blood pressure measures from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in body mass index measures from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in body mass index measures from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in waist circumference measures from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in waist circumference measures from from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in body fat mass measures from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in body fat mass measures from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in HbA1c measures from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in HbA1c measures from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
measure: Change in fasting lipid profile from baseline at 6 months (23-26 weeks)
timeFrame: Baseline and 6 months (23-26 weeks)
measure: Change in fasting lipid profile from baseline, 6 months, 12 months, 24 months and 36 months
timeFrame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Other outcomes:
measure: Change in quality of life from baseline at 12 months (10-14 months)
timeFrame: Baseline and 12 months (10-14 months) and 36 months (34-38 months)
measure: Change in quality of life from baseline at 36 months (34-38 months)
timeFrame: Baseline and 36 months (34-38 months)
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Kok Hian Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: