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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Financial and social incentives
* Behavioral: Financial incentives


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Financial and social intervention<br>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. | Behavioral: Financial and social incentives<br>* 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.<br>|
| No Intervention: Control<br>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. | |
| Experimental: Financial intervention<br>Participants will receive the usual standard care (same as control group), loss-framed financial incentives, and weekly feedback on performance for 6 months. | Behavioral: Financial incentives<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control | The change in HbA1c levels | Baseline, 6-months, and 9-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control | Proportion of participants with good/excellent diabetes control (HbA1c threshold ≤ 7% & ≤ 6.5%) | Baseline, 6-months, and 9-months | 
| Body weight control | Change in body weight in kilograms; weight and height will be combined to report BMI in kg/m^2 | Baseline, 6-months, and 9-months | 
| Changes in lipid profile | Changes in Total, HDL- and LDL-cholesterol, and Triglycerides | Baseline, 6-months, and 9-months | 
| Change in blood pressure | Assessed by the change in systolic and diastolic blood pressure | Baseline, 6-months, and 9-months | 
| Glycaemic control | Proportion of participants requiring an initiation of medication in diabetes management | 6-months and 9-months | 
| Glycaemic control (addition of medications) | Proportion of participants requiring an addition of medication(s) or increase in drug dosage in diabetes management | 6-months and 9-months | 
| Walking performance | Assessed by proportion of participants meeting their daily step counts every week | Weekly | 
| 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 | Baseline, 6-months and 9-months |