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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04917926
• Other study ID #: BET2-v4-202106
• Status: Completed
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	University Grants Committee, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of health service utilisation	Number of medical appointment attendances and hospital admissions	Baseline, 6-months, and 9-months
Primary	Glycaemic control	The change in HbA1c levels	Baseline, 6-months, and 9-months
Secondary	Diabetes control	Proportion of participants with good/excellent diabetes control (HbA1c threshold = 7% & = 6.5%)	Baseline, 6-months, and 9-months
Secondary	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
Secondary	Changes in lipid profile	Changes in Total, HDL- and LDL-cholesterol, and Triglycerides	Baseline, 6-months, and 9-months
Secondary	Change in blood pressure	Assessed by the change in systolic and diastolic blood pressure	Baseline, 6-months, and 9-months
Secondary	Glycaemic control	Proportion of participants requiring an initiation of medication in diabetes management	6-months and 9-months
Secondary	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
Secondary	Walking performance	Assessed by proportion of participants meeting their daily step counts every week	Weekly
Secondary	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