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

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04917926
Collaborator
University Grants Committee, Hong Kong (Other)
261
1
3
18.3
14.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Financial and social incentives
  • Behavioral: Financial incentives
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
261 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Behavioural Economics-based Incentives on Glycaemic Control and Lifestyle in Adults With Newly Diagnosed Type 2 Diabetes: a Randomised Control Trial
Actual Study Start Date :
Jun 21, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

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: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Glycaemic control [Baseline, 6-months, and 9-months]

    The change in HbA1c levels

Secondary Outcome Measures

  1. Diabetes control [Baseline, 6-months, and 9-months]

    Proportion of participants with good/excellent diabetes control (HbA1c threshold ≤ 7% & ≤ 6.5%)

  2. Body weight control [Baseline, 6-months, and 9-months]

    Change in body weight in kilograms; weight and height will be combined to report BMI in kg/m^2

  3. Changes in lipid profile [Baseline, 6-months, and 9-months]

    Changes in Total, HDL- and LDL-cholesterol, and Triglycerides

  4. Change in blood pressure [Baseline, 6-months, and 9-months]

    Assessed by the change in systolic and diastolic blood pressure

  5. Glycaemic control [6-months and 9-months]

    Proportion of participants requiring an initiation of medication in diabetes management

  6. Glycaemic control (addition of medications) [6-months and 9-months]

    Proportion of participants requiring an addition of medication(s) or increase in drug dosage in diabetes management

  7. Walking performance [Weekly]

    Assessed by proportion of participants meeting their daily step counts every week

  8. Level of physical activity [Baseline, 6-months and 9-months]

    Assessed by the structured and validated International Physical Activity Questionnaires (IPAQ); Both walking performance (Outcome 6) and the IPAQ score can be used for assessing the level of physical activity of participants

Other Outcome Measures

  1. Frequency of health service utilisation [Baseline, 6-months, and 9-months]

    Number of medical appointment attendances and hospital admissions

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 smartphone 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong
  • University Grants Committee, Hong Kong

Investigators

  • Principal Investigator: Jianchao Quan, MPH, BM BCh, School of Public Health, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04917926
Other Study ID Numbers:
  • BET2-v4-202106
First Posted:
Jun 8, 2021
Last Update Posted:
Jul 9, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2021