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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Financial and social incentives
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glycemic control
Change in HbA1c levels

Secondary Outcome Measures

Change in physical activity (step count)
Step counts
Change in body weight
kg
Changes in lipid profile
Total, HDL- and LDL-cholesterol; Triglycerides
Change in physical activity level
International Physical Activity Questionnaires (IPAQ)

Full Information

First Posted
June 17, 2020
Last Updated
May 17, 2022
Sponsor
The University of Hong Kong
Collaborators
University Grants Committee, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04443842
Brief Title
Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 6, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
University Grants Committee, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Financial and social incentives
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic control
Description
Change in HbA1c levels
Time Frame
Baseline, 6 and 9 months
Secondary Outcome Measure Information:
Title
Change in physical activity (step count)
Description
Step counts
Time Frame
Baseline, 6 and 9 months
Title
Change in body weight
Description
kg
Time Frame
Baseline, 6 and 9 months
Title
Changes in lipid profile
Description
Total, HDL- and LDL-cholesterol; Triglycerides
Time Frame
Baseline, 6 and 9 months
Title
Change in physical activity level
Description
International Physical Activity Questionnaires (IPAQ)
Time Frame
Baseline, 6 and 9 months
Other Pre-specified Outcome Measures:
Title
Change in health service utilisation
Description
Number of attendances and hospital admission
Time Frame
Baseline, 6 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianchao Quan, MPH, BM BCh
Organizational Affiliation
School of Public Health, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information will shared in accordance with the University of Hong Kong Data Management Plan (DMP)
IPD Sharing URL
https://hub.hku.hk/researchdata/staff2.htm

Learn more about this trial

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

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