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

NCT ID: NCT04917926

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2023-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Financial and social incentives

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Financial incentives

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Grants Committee, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianchao Quan, MPH, BM BCh

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, The University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

BET2-v4-202106

Identifier Type: -

Identifier Source: org_study_id