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

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

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• 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
• Genders Eligible for Study: All

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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Change in HbA1c levels	Baseline, 6 and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity (step count)	Step counts	Baseline, 6 and 9 months
Change in body weight	kg	Baseline, 6 and 9 months
Changes in lipid profile	Total, HDL- and LDL-cholesterol; Triglycerides	Baseline, 6 and 9 months
Change in physical activity level	International Physical Activity Questionnaires (IPAQ)	Baseline, 6 and 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health service utilisation	Number of attendances and hospital admission	Baseline, 6 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): November 1, 2020
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: September 1, 2021

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-v2-202005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Information will shared in accordance with the University of Hong Kong Data Management Plan (DMP)
• 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