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

Effectiveness of Behavioural Economics-based Incentives on Glycaemic Control and Lifestyle in Adults With Newly Diagnosed Type 2 Diabetes: a Randomised Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Financial and social incentives; Behavioral: Financial incentives

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 phone 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Financial and social intervention; 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; 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.
No Intervention: Control; 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; 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; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of health service utilisation	Number of medical appointment attendances and hospital admissions	Baseline, 6-months, and 9-months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: University Grants Committee, Hong Kong
• Investigators: Principal Investigator: Jianchao Quan, MPH, BM BCh, School of Public Health, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BET2-v4-202106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No