GluCoach - Technology-enabled Lifestyle Intervention Study

Pre-diabetes Clinical Trial

Official title:

GluCoach - Technology-enabled Lifestyle Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905680
• Other study ID #: Glucoach
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: April 2022

Study information

• Verified date: November 2021
• Source: National University, Singapore
• Contact: Karen Cheong
• Phone: +65-64353673
• Email: Karen_Cheong[@]hpb.gov.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: April 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Pre-diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
Singapore	Saw Swee Hock School of Public Health, National University of Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University, Singapore	Health Promotion Board, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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. — View Citation

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. Review. Erratum in: Diabetes Care. 2014 Jun;37(6):1775-6. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c concentration	Change in fasting plasma HbA1c concentration from baseline to 3rd month	Baseline and at month 3
Secondary	Plasma glucose concentration	Change in fasting plasma glucose concentration from baseline to 3rd month	Baseline and at month 3
Secondary	BMI	Change in BMI from baseline to 3rd month	Baseline and at month 3
Secondary	Lipid profile	Change in lipid profile from baseline to 3rd month	Baseline and at month 3
Secondary	Systolic and Diastolic Blood pressure	Change in systolic and diastolic blood pressure from baseline to 3rd month	Baseline and at month 3