GluCoach - Technology-enabled Lifestyle Intervention Study

Not Applicable

• Conditions: Pre-diabetes
• Interventions: Device: CGM lifestyle tracking and coaching

• Registration Number: NCT04905680
• Lead Sponsor: National University of Singapore

Brief Summary

This study seeks to address two questions. Firstly, how might a suite of interventions and data feedback (activity, diet, mood\*, continuous blood glucose) through coaching be effective in influencing behaviour change for individuals at-risk of developing type 2 diabetes? Secondly, what elements of coaching might be extracted for automated implementation in a scalable coach-light model?

Detailed Description

Face-to-face health coaching is a common lifestyle intervention for healthy individuals who are at risk of chronic diseases such as diabetes. However, it is highly resource-intensive and has limitations in scaling up to reach wider populations. Advances in technology present opportunities to scale health coaching to the wider population through automation, enabling the delivery of personalised messages for individuals via mobile applications.

In addition, continuous glucose monitoring (CGM) devices could also potentially augment the effectiveness of health coaching by providing coaches with a tool for coachees' self-discovery of their individual physiological responses to lifestyles and modifications such as diet and exercise.

As such, the present study seeks to leverage smart wearable devices (e.g., Bluetooth smartwatches) and CGM devices accompanying a customized mobile application to deliver lifestyle coaching interventions. This suite of lifestyle interventions, including feedback about their own blood glucose levels, aims to influence participant's lifestyles and behaviours through guided self-discovery and face-to-face coaching. This intervention will be compared with a control group to examine its effects on lifestyle change, anthropometric measures and biometric measures. In addition, the findings from this study will contribute to the development of a novel coach-light intervention that can be implemented at a wider population level via Singapore's Health Promotion Board's (HPB) existing programmes and channels.

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-23
• Study First Posted: 2021-05-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-01
• Primary Completion: 2022-01
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Singaporean Citizens and Permanent Residents
2. Aged 21 to 55
3. Must be literate in English (i.e. able to read and communicate in English) because the primary mode of communication is English
4. Willing and able to use a smartphone
5. Must be at risk of developing Type 2 Diabetes, defined as:

i) Glycated haemoglobin (HbA1c) - At least 5.7% to 6.5% OR Fasting blood glucose of 6.1 to 6.9mmol/L, AND ii) BMI of at least 20kg/m2

Exclusion Criteria

1. Non-Singaporean Citizens and Permanent Residents
2. Under age 21 or above age 55
3. Ever diagnosed as Type 1 or Type 2 Diabetic (does not include previously diagnosed GDM)
4. Pregnant or planning to be pregnant in the next 6 months or lactating
5. History of skin allergies
6. Taking medications that are known to alter blood sugar levels/ glucose tolerance e.g.

glucocorticoids g) History of mental illness/conditions h) Work requirement that does not allow the carrying of electronic devices (e.g., phone and smartwatch) i) Frequent overseas travelling (e.g., more frequently than once a month, daily or weekly commuting across borders etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	CGM lifestyle tracking and coaching	The activities during health screening before the study and at the end of study is similar to the control. Individuals are provided with an educational brochure upon receiving their screening results. Participants will then go through a baseline lifestyle tracking session using a study-issued smartphone and smartwatch, pre-installed with certain study applications, which will be used for the lifestyle tracking sessions. The experimental arm will go through 4 additional lifestyle tracking sessions (i.e., total of 5 including baseline), of which 1 will include Continuous Glucose Monitoring (CGM) tracking. For this CGM tracking session, participants will receive real-time feedback through the study applications, which will display the CGM trace. The data collected during the lifestyle tracking sessions will be discussed with the participants during 3 face-to-face coaching and 2 tele-coaching sessions, where the participants will develop and implement lifestyle change action plans.

Primary Outcome Measures

Name	Time	Method
Behaviour, self-efficacy and attitudes	Baseline and at month 3	Change in behaviour, self-efficacy and attitudes towards diet and exercise from baseline to 3rd month

Secondary Outcome Measures

Name	Time	Method
HbA1c concentration	Baseline and at month 3	Change in fasting plasma HbA1c concentration from baseline to 3rd month
Plasma glucose concentration	Baseline and at month 3	Change in fasting plasma glucose concentration from baseline to 3rd month
BMI	Baseline and at month 3	Change in BMI from baseline to 3rd month
Lipid profile	Baseline and at month 3	Change in lipid profile from baseline to 3rd month
Systolic and Diastolic Blood pressure	Baseline and at month 3	Change in systolic and diastolic blood pressure from baseline to 3rd month

Trial Locations

Locations (1)

Saw Swee Hock School of Public Health, National University of Singapore; 🇸🇬 Singapore, Singapore