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Behavioural Economics-based Incentives in Adults With Type 2 Diabetes (BET2) (BET2)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Financial and social incentives
Financial incentives
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chinese adults aged 30-70 years
  • Capable of providing informed consent
  • Resident in Hong Kong
  • Able to communicate in English or Chinese
  • Diagnosed with type 2 diabetes within past year
  • 6.5% ≤ HbA1c ≤ 9.0%
  • Willing to take blood tests
  • Access to a smartphone to track physical activity and receive text messages
  • Physically mobile for duration of the trial

Exclusion Criteria:

  • Planned surgery in the next 6 months
  • Biological impairment or health condition affecting the ability to walk, such as blindness, physical immobility, and paralysis
  • Pregnant or breastfeeding
  • On insulin for diabetes control

Sites / Locations

  • School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Financial and social intervention

Control

Financial intervention

Arm Description

Participants will receive the usual standard care (same as control group), loss-framed financial incentives, social incentives and weekly feedback on performance for 6 months.

Participants will receive standard care including patient screening and education on diet, physical activity, and smoking conducted by a multi-disciplinary team. Participants in the control group will neither be told their baseline step count nor receive any feedback messages.

Participants will receive the usual standard care (same as control group), loss-framed financial incentives, and weekly feedback on performance for 6 months.

Outcomes

Primary Outcome Measures

Glycaemic control
The change in HbA1c levels

Secondary Outcome Measures

Diabetes control
Proportion of participants with good/excellent diabetes control (HbA1c threshold ≤ 7% & ≤ 6.5%)
Body weight control
Change in body weight in kilograms; weight and height will be combined to report BMI in kg/m^2
Changes in lipid profile
Changes in Total, HDL- and LDL-cholesterol, and Triglycerides
Change in blood pressure
Assessed by the change in systolic and diastolic blood pressure
Glycaemic control
Proportion of participants requiring an initiation of medication in diabetes management
Glycaemic control (addition of medications)
Proportion of participants requiring an addition of medication(s) or increase in drug dosage in diabetes management
Walking performance
Assessed by proportion of participants meeting their daily step counts every week
Level of physical activity
Assessed by the structured and validated International Physical Activity Questionnaires (IPAQ); Both walking performance (Outcome 6) and the IPAQ score can be used for assessing the level of physical activity of participants

Full Information

First Posted
April 28, 2021
Last Updated
May 8, 2023
Sponsor
The University of Hong Kong
Collaborators
University Grants Committee, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04917926
Brief Title
Behavioural Economics-based Incentives in Adults With Type 2 Diabetes (BET2)
Acronym
BET2
Official Title
Effectiveness of Behavioural Economics-based Incentives on Glycaemic Control and Lifestyle in Adults With Newly Diagnosed Type 2 Diabetes: a Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
University Grants Committee, Hong Kong

4. Oversight

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

5. Study Description

Brief Summary
A randomised control trial of adults with newly diagnosed type 2 diabetes to assess the effectiveness of behavioural economics-based incentives on healthy lifestyle behaviour, using a pragmatic trial approach.
Detailed Description
This is a randomised control trial of adults aged 30-70 with newly diagnosed type 2 diabetes within a year in Hong Kong to compare the effectiveness of financial incentives and combined financial and social incentives against a control group receiving standard care. We plan to recruit 261 participants and follow them for 9-months (6-month intervention period and a 3-month post-intervention follow-up period) to assess glycemic control and other health indicators. Participants will be randomly assigned to one of three groups (in ratio 1:1:1): arm A (financial incentives in addition to standard care), arm B (financial and social incentives in addition to standard care), and arm C (control arm receiving standard care). Financial incentives will be framed around loss aversion and the endowment effect. Social incentives will include peer competition, and social support. Financial and social incentives are to encourage increased physical activity and participants will use a pedometer to track activity. Participants are followed for an additional 3-months after the cessation of incentives to assess the sustainability of lifestyle changes. This trial adopts a pragmatic study design based on the PRECIS-2 tool and RE-AIM frameworks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Financial and social intervention
Arm Type
Experimental
Arm Description
Participants will receive the usual standard care (same as control group), loss-framed financial incentives, social incentives and weekly feedback on performance for 6 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive standard care including patient screening and education on diet, physical activity, and smoking conducted by a multi-disciplinary team. Participants in the control group will neither be told their baseline step count nor receive any feedback messages.
Arm Title
Financial intervention
Arm Type
Experimental
Arm Description
Participants will receive the usual standard care (same as control group), loss-framed financial incentives, and weekly feedback on performance for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Financial and social incentives
Intervention Description
Participants will be credited with HK$1,000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, they will lose HK$40 for each subsequent week that they do not meet their personal weekly step target. Regarding social incentives, participants will be placed in teams of six, receiving feedback of their physical activity performance, rankings within their groups, and positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support.
Intervention Type
Behavioral
Intervention Name(s)
Financial incentives
Intervention Description
Participants will be credited with HK$1,000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, they will lose HK$40 for each subsequent week that they do not meet their personal weekly step target.
Primary Outcome Measure Information:
Title
Glycaemic control
Description
The change in HbA1c levels
Time Frame
Baseline, 6-months, and 9-months
Secondary Outcome Measure Information:
Title
Diabetes control
Description
Proportion of participants with good/excellent diabetes control (HbA1c threshold ≤ 7% & ≤ 6.5%)
Time Frame
Baseline, 6-months, and 9-months
Title
Body weight control
Description
Change in body weight in kilograms; weight and height will be combined to report BMI in kg/m^2
Time Frame
Baseline, 6-months, and 9-months
Title
Changes in lipid profile
Description
Changes in Total, HDL- and LDL-cholesterol, and Triglycerides
Time Frame
Baseline, 6-months, and 9-months
Title
Change in blood pressure
Description
Assessed by the change in systolic and diastolic blood pressure
Time Frame
Baseline, 6-months, and 9-months
Title
Glycaemic control
Description
Proportion of participants requiring an initiation of medication in diabetes management
Time Frame
6-months and 9-months
Title
Glycaemic control (addition of medications)
Description
Proportion of participants requiring an addition of medication(s) or increase in drug dosage in diabetes management
Time Frame
6-months and 9-months
Title
Walking performance
Description
Assessed by proportion of participants meeting their daily step counts every week
Time Frame
Weekly
Title
Level of physical activity
Description
Assessed by the structured and validated International Physical Activity Questionnaires (IPAQ); Both walking performance (Outcome 6) and the IPAQ score can be used for assessing the level of physical activity of participants
Time Frame
Baseline, 6-months and 9-months
Other Pre-specified Outcome Measures:
Title
Frequency of health service utilisation
Description
Number of medical appointment attendances and hospital admissions
Time Frame
Baseline, 6-months, and 9-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese adults aged 30-70 years Capable of providing informed consent Resident in Hong Kong Able to communicate in English or Chinese Diagnosed with type 2 diabetes within past year 6.5% ≤ HbA1c ≤ 9.0% Willing to take blood tests Access to a smartphone to track physical activity and receive text messages Physically mobile for duration of the trial Exclusion Criteria: Planned surgery in the next 6 months Biological impairment or health condition affecting the ability to walk, such as blindness, physical immobility, and paralysis Pregnant or breastfeeding On insulin for diabetes control
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianchao Quan, MPH, BM BCh
Phone
(852)39179909
Email
jquan@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianchao Quan, MPH, BM BCh
Organizational Affiliation
School of Public Health, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianchao Quan, MPH, BM BCh
Phone
(852)39179909
Email
jquan@hku.hk
First Name & Middle Initial & Last Name & Degree
Jianchao Quan, MPH, BM BCh
First Name & Middle Initial & Last Name & Degree
Gabriel M Leung, MD, MPH
First Name & Middle Initial & Last Name & Degree
Parco Ming-fai Siu, PhD, MPhil
First Name & Middle Initial & Last Name & Degree
Helen Hui Zhi, PhD, BA
First Name & Middle Initial & Last Name & Degree
Tsun-kit Chu, FHKAM, MBBS
First Name & Middle Initial & Last Name & Degree
Jenny Hua-li Wang, MD
First Name & Middle Initial & Last Name & Degree
Ming-chuen Sin, FHKAM, MBChB

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information will be shared in accordance with the University of Hong Kong Data Management Plan (DMP)
IPD Sharing Time Frame
Data will become available for at least 5 years after the release of publication of this study.
IPD Sharing Access Criteria
Only data without personal information will be shared. The data will be shared for academic use only.
IPD Sharing URL
https://hub.hku.hk/researchdata/staff2.htm

Learn more about this trial

Behavioural Economics-based Incentives in Adults With Type 2 Diabetes (BET2)

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