Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study

NCT ID: NCT04443842

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-12-07

Brief Summary

A feasibility pilot study of a randomised control trial of adults newly diagnosed with type 2 diabetes to compare the effectiveness of financial and social incentives on healthy lifestyle behaviour.

Detailed Description

This is a pilot study of testing the feasibility of the interventions being implemented in our main trial in local settings. Adults newly diagnosed with type 2 diabetes without receiving any anti-diabetic medication in Hong Kong are randomised to compare the effectiveness of financial and social incentives against a control group receiving standard care. The investigators follow participants 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 two groups (in ratio 3:1): arm A (financial and social incentives in addition to standard care), and arm B (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.

Conditions

Diabetes Mellitus, Type 2

Study Design

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

Study Groups

Intervention

Participants will receive the usual standard care (same as control group), loss-framed financial incentive, 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$1000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, participants will lose HK$40 for each subsequent week that they do not meet their personal weekly step target.

The social incentives are peer comparison and social support. Participants receive feedback of their physical activity performance by assessing whether they met or exceeded their step count target, followed by 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

Interventions

Financial and social incentives

Participants will be credited with HK$1000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, participants will lose HK$40 for each subsequent week that they do not meet their personal weekly step target.

The social incentives are peer comparison and social support. Participants receive feedback of their physical activity performance by assessing whether they met or exceeded their step count target, followed by positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support.

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
• Newly diagnosed with type 2 diabetes within a year according to World Health Organization guidelines: HbA1c ≥ 48 mmol/mol (≥ 6.5%); fasting plasma glucose ≥ 7.0 mmol/l (≥ 126 mg/dl); oral glucose tolerance test (OGTT) ≥ 11.1 mmol/l (200 mg/dl) with symptoms, or on two separate occasions if asymptomatic
• HbA1c ≤ 7.5%
• Not taking any medication for glycaemic control
• Willing to take blood tests
• Access to a smart phone to track physical activity
• Physically mobile for duration of the trial

Exclusion Criteria

• Already participating in another intervention study
• Any health condition prohibiting them from completing the 9-month trial, such as history of eating disorder, cancer, serious illness, breastfeeding
• Medical conditions that can affect HbA1c measurements including anaemia, haemoglobinopathies, haemodialysis, iron/B12 deficiency or supplements, chronic liver diseases, splenectomy, rheumatoid arthritis, use of anti-retroviral drugs, ribavirin, or aspirin
• Intend to receive medication for glycaemic control in the next 6 months
• Intend to seek private medical treatment for diabetes in the next 6 months

• 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-v2-202005

Identifier Type: -

Identifier Source: org_study_id