Clinical trial NCT04917926: Behavioural Economics-based Incentives in Adults With Type 2 Diabetes (BET2)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University Grants Committee, Hong Kong
First posted: 2021-06-08
Enrollment: 122
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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
* Diagnosed with type 2 diabetes within past year
* 6.5% ≤ HbA1c ≤ 9.0%
* Willing to take blood tests
* Access to a phone 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

Primary outcomes:
measure: Glycaemic control
timeFrame: Baseline, 6-months, and 9-months
Secondary outcomes:
measure: Diabetes control
timeFrame: Baseline, 6-months, and 9-months
measure: Body weight control
timeFrame: Baseline, 6-months, and 9-months
measure: Changes in lipid profile
timeFrame: Baseline, 6-months, and 9-months
measure: Change in blood pressure
timeFrame: Baseline, 6-months, and 9-months
measure: Glycaemic control
timeFrame: 6-months and 9-months
measure: Glycaemic control (addition of medications)
timeFrame: 6-months and 9-months
measure: Walking performance
timeFrame: Weekly
measure: Level of physical activity
timeFrame: Baseline, 6-months and 9-months
Other outcomes:
measure: Frequency of health service utilisation
timeFrame: Baseline, 6-months, and 9-months
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Jianchao Quan, MPH, BM BCh
role: PRINCIPAL_INVESTIGATOR
References: