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GluCoach - Technology-enabled Lifestyle Intervention Study

Primary Purpose

Pre-diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
CGM lifestyle tracking and coaching
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre-diabetes focused on measuring Lifestyle coaching, mHealth

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Saw Swee Hock School of Public Health, National University of SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Behaviour, self-efficacy and attitudes
Change in behaviour, self-efficacy and attitudes towards diet and exercise from baseline to 3rd month

Secondary Outcome Measures

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

Full Information

First Posted
May 19, 2021
Last Updated
November 30, 2021
Sponsor
National University of Singapore
Collaborators
Health Promotion Board, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04905680
Brief Title
GluCoach - Technology-enabled Lifestyle Intervention Study
Official Title
GluCoach - Technology-enabled Lifestyle Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Health Promotion Board, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Lifestyle coaching, mHealth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an experimental-control study design where up to 260 individuals at risk of developing diabetes (blood glucose levels of 6.1 to 6.9 mmol/L) will be randomly allocated to the experimental and control groups (1:1 randomization). Participants in the control group will not receive any health coaching and are not required to carry out any study activities after they have completed the baseline lifestyle tracking session. At the end of the study, they 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CGM lifestyle tracking and coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behaviour, self-efficacy and attitudes
Description
Change in behaviour, self-efficacy and attitudes towards diet and exercise from baseline to 3rd month
Time Frame
Baseline and at month 3
Secondary Outcome Measure Information:
Title
HbA1c concentration
Description
Change in fasting plasma HbA1c concentration from baseline to 3rd month
Time Frame
Baseline and at month 3
Title
Plasma glucose concentration
Description
Change in fasting plasma glucose concentration from baseline to 3rd month
Time Frame
Baseline and at month 3
Title
BMI
Description
Change in BMI from baseline to 3rd month
Time Frame
Baseline and at month 3
Title
Lipid profile
Description
Change in lipid profile from baseline to 3rd month
Time Frame
Baseline and at month 3
Title
Systolic and Diastolic Blood pressure
Description
Change in systolic and diastolic blood pressure from baseline to 3rd month
Time Frame
Baseline and at month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Singaporean Citizens and Permanent Residents Aged 21 to 55 Must be literate in English (i.e. able to read and communicate in English) because the primary mode of communication is English Willing and able to use a smartphone 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: Non-Singaporean Citizens and Permanent Residents Under age 21 or above age 55 Ever diagnosed as Type 1 or Type 2 Diabetic (does not include previously diagnosed GDM) Pregnant or planning to be pregnant in the next 6 months or lactating History of skin allergies 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Cheong
Phone
+65-64353673
Email
Karen_Cheong@hpb.gov.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsea Chang
Phone
+65-64353818
Email
Chelsea_Chang@hpb.gov.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Falk Müller-Riemenschneider
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saw Swee Hock School of Public Health, National University of Singapore
City
Singapore
ZIP/Postal Code
117549
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Tan
Phone
+65-6601 4973
Email
linda_tan@nus.edu.sg
First Name & Middle Initial & Last Name & Degree
Falk Müller-Riemenschneider

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24652723
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. Erratum In: Diabetes Care. 2014 Jun;37(6):1775-6.
Results Reference
background
PubMed Identifier
26033349
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.
Results Reference
background
PubMed Identifier
26499966
Citation
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.
Results Reference
background
PubMed Identifier
11832527
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. doi: 10.1056/NEJMoa012512.
Results Reference
background

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GluCoach - Technology-enabled Lifestyle Intervention Study

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