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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443842
• Other study ID #: BET2-v2-202005
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 7, 2021

Study information

• Verified date: September 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 7, 2021
• Est. primary completion date: September 6, 2021
• 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

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.

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	Change in health service utilisation	Number of attendances and hospital admission	Baseline, 6 and 9 months
Primary	Glycemic control	Change in HbA1c levels	Baseline, 6 and 9 months
Secondary	Change in physical activity (step count)	Step counts	Baseline, 6 and 9 months
Secondary	Change in body weight	kg	Baseline, 6 and 9 months
Secondary	Changes in lipid profile	Total, HDL- and LDL-cholesterol; Triglycerides	Baseline, 6 and 9 months
Secondary	Change in physical activity level	International Physical Activity Questionnaires (IPAQ)	Baseline, 6 and 9 months