Diabetes Mellitus, Type 2BET2NCT04917926
Behavioural Economics-based Incentives in Adults With Type 2 Diabetes (BET2)
A study testing Financial and social incentives and Financial incentives in people with Diabetes Mellitus, Type 2, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Financial and social incentives and Financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Jun 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 9Show fewer
- Willing to take blood tests
- Access to a phone to track physical activity and receive text messages
- Physically mobile for duration of the trial
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong
Hong Kong
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Financial and social incentives, Financial incentives
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial and social incentivesBehavioural
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.
Financial incentivesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Financial and social intervention | Experimental | 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. Receives: Behavioral: Financial and social incentives |
| Control | No intervention | 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. |
| Financial intervention | Experimental | Participants will receive the usual standard care (same as control group), loss-framed financial incentives, and weekly feedback on performance for 6 months. Receives: Behavioral: Financial incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic control
The change in HbA1c levels
Measured: Baseline, 6-months, and 9-months
Secondary outcomes (8)
Diabetes control
Proportion of participants with good/excellent diabetes control (HbA1c threshold ≤ 7% \& ≤ 6.5%)
Measured: Baseline, 6-months, and 9-months
Body weight control
Change in body weight in kilograms; weight and height will be combined to report BMI in kg/m^2
Measured: Baseline, 6-months, and 9-months
Changes in lipid profile
Changes in Total, HDL- and LDL-cholesterol, and Triglycerides
Measured: Baseline, 6-months, and 9-months
Change in blood pressure
Assessed by the change in systolic and diastolic blood pressure
Measured: Baseline, 6-months, and 9-months
Glycaemic control
Proportion of participants requiring an initiation of medication in diabetes management
Measured: 6-months and 9-months
Glycaemic control (addition of medications)
Proportion of participants requiring an addition of medication(s) or increase in drug dosage in diabetes management
Measured: 6-months and 9-months
Walking performance
Assessed by proportion of participants meeting their daily step counts every week
Measured: Weekly
Level of physical activity
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
Measured: Baseline, 6-months and 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start21 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Jianchao Quan, MPH, BM BCh, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917926
- Sponsor's protocol ID
- BET2-v4-202106
- Acronym
- BET2
- Status last verified
- Oct 2022
- First submitted
- 28 Apr 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information will be shared in accordance with the University of Hong Kong Data Management Plan (DMP)
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04917926
- Acronym / sponsor ID
- BET2 / BET2-v4-202106
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Financial and social intervention | Experimental | Behavioral: Financial and social incentivesParticipants will receive the usual standard care (same as control group), loss-framed financial incentives, social incentives and weekly feedback on performance for 6 months. |
| Control | No intervention | –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. |
| Financial intervention | Experimental | Behavioral: Financial incentivesParticipants will receive the usual standard care (same as control group), loss-framed financial incentives, and weekly feedback on performance for 6 months. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial and social incentivesParticipants 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. | Behavioural | Financial and social intervention |
| Financial incentivesParticipants 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. | Behavioural | Financial intervention |
Primary outcome
Glycaemic control
Time frame: Baseline, 6-months, and 9-months
The change in HbA1c levels
8 secondary outcomes
Diabetes control
Time frame: Baseline, 6-months, and 9-months
Body weight control
Time frame: Baseline, 6-months, and 9-months
Changes in lipid profile
Time frame: Baseline, 6-months, and 9-months
Change in blood pressure
Time frame: Baseline, 6-months, and 9-months
Glycaemic control
Time frame: 6-months and 9-months
Glycaemic control (addition of medications)
Time frame: 6-months and 9-months
Walking performance
Time frame: Weekly
Level of physical activity
Time frame: Baseline, 6-months and 9-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Yes. Information will be shared in accordance with the University of Hong Kong Data Management Plan (DMP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianchao Quan, MPH, BM BCh principal investigator
School of Public Health, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial and social incentives and Financial incentives in people with Diabetes Mellitus, Type 2, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (time frame: Baseline, 6-months, and 9-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.