Clinical trial NCT04905680: GluCoach - Technology-enabled Lifestyle Intervention Study
Official title: GluCoach - Technology-enabled Lifestyle Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetes
Keywords: Lifestyle coaching
mHealth
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Health Promotion Board, Singapore
First posted: 2021-05-28
Enrollment: 260
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Behaviour, self-efficacy and attitudes
timeFrame: Baseline and at month 3
Secondary outcomes:
measure: HbA1c concentration
timeFrame: Baseline and at month 3
measure: Plasma glucose concentration
timeFrame: Baseline and at month 3
measure: BMI
timeFrame: Baseline and at month 3
measure: Lipid profile
timeFrame: Baseline and at month 3
measure: Systolic and Diastolic Blood pressure
timeFrame: Baseline and at month 3
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Saw Swee Hock School of Public Health, National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Falk Müller-Riemenschneider
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.