NCT04905680

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

May 19, 2021

Last Update Submit

November 30, 2021

Conditions

Pre-diabetes

Keywords

Lifestyle coachingmHealth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • HbA1c concentration

    Baseline and at month 3

  • Plasma glucose concentration

    Baseline and at month 3

  • BMI

    Baseline and at month 3

  • Lipid profile

    Baseline and at month 3

  • Systolic and Diastolic Blood pressure

    Baseline and at month 3

Study Arms (2)

Control group

NO INTERVENTION

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 group

EXPERIMENTAL

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

Interventions

CGM lifestyle tracking and coachingDEVICE

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.

Experimental group

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saw Swee Hock School of Public Health, National University of Singapore

Singapore, 117549, Singapore

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24652723BACKGROUND

  • 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.

    PMID: 26033349BACKGROUND

  • 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.

    PMID: 26499966BACKGROUND

  • 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.

    PMID: 11832527BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Falk Müller-Riemenschneider

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Cheong

CONTACT

+65-64353673Karen_Cheong@hpb.gov.sg

Chelsea Chang

CONTACT

+65-64353818Chelsea_Chang@hpb.gov.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 28, 2021

Study Start

May 4, 2021

Primary Completion

January 1, 2022

Study Completion

April 1, 2022

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)