GluCoach - Technology-enabled Lifestyle Intervention Study

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?

Study Overview

• Status: Recruiting
• Conditions: Pre-diabetes
• Intervention / Treatment: Device: CGM lifestyle tracking and coaching

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 Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Cheong; Phone Number: +65-64353673; Email: Karen_Cheong@hpb.gov.sg
• Study Contact Backup: Name: Chelsea Chang; Phone Number: +65-64353818; Email: Chelsea_Chang@hpb.gov.sg

Study Locations

• Singapore
  • Singapore, Singapore, 117549
    • Recruiting
    • Saw Swee Hock School of Public Health, National University of Singapore
    • Contact: Linda Tan; Phone Number: +65-6601 4973; Email: linda_tan@nus.edu.sg
    • Principal Investigator: Falk Müller-Riemenschneider

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The health screening before the study and at the end of study will collect anthropometric data (height, weight, waist and hip circumference), blood pressure data, and blood samples (for testing of HbA1c, fasting blood glucose, fasting insulin and lipid profile). 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. For participants in the control arm, there is no health coaching or study activities until the end of the study, where individuals will attend a 20- to 30-minute session with a coach to have their baseline lifestyle tracking results explained to them and receive personalised suggestions on lifestyle modifications.
Experimental: Experimental group; 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.	Device: CGM lifestyle tracking and coaching; Participants in the experimental group will go through a total of 5 lifestyle tracking sessions (including baseline), of which 1 will include CGM tracking. For this CGM lifestyle tracking session, experimental group 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behaviour, self-efficacy and attitudes	Change in behaviour, self-efficacy and attitudes towards diet and exercise from baseline to 3rd month	Baseline and at month 3

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National University, Singapore
• Collaborators: Health Promotion Board, Singapore
• Investigators: Principal Investigator: Falk Müller-Riemenschneider, National University, Singapore

Publications and helpful links

General Publications

• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
• Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.
• Dunkley AJ, Bodicoat DH, Greaves CJ, Russell C, Yates T, Davies MJ, Khunti K. Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis. Diabetes Care. 2014 Apr;37(4):922-33. doi: 10.2337/dc13-2195. Erratum In: Diabetes Care. 2014 Jun;37(6):1775-6.
• Fukuoka Y, Gay CL, Joiner KL, Vittinghoff E. A Novel Diabetes Prevention Intervention Using a Mobile App: A Randomized Controlled Trial With Overweight Adults at Risk. Am J Prev Med. 2015 Aug;49(2):223-37. doi: 10.1016/j.amepre.2015.01.003. Epub 2015 May 30.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: mHealth; Lifestyle coaching
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: Glucoach

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No