Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALFinancial 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.
BEHAVIORALFinancial 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.
Sponsors
University Grants Committee, Hong Kong
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic control | Baseline, 6-months, and 9-months | The change in HbA1c levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes control | Baseline, 6-months, and 9-months | Proportion of participants with good/excellent diabetes control (HbA1c threshold ≤ 7% & ≤ 6.5%) |
| 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 |
| Changes in lipid profile | Baseline, 6-months, and 9-months | Changes in Total, HDL- and LDL-cholesterol, and Triglycerides |
| Change in blood pressure | Baseline, 6-months, and 9-months | Assessed by the change in systolic and diastolic blood pressure |
| 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 |
| Walking performance | Weekly | Assessed by proportion of participants meeting their daily step counts every week |
| 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 |
| Glycaemic control | 6-months and 9-months | Proportion of participants requiring an initiation of medication in diabetes management |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of health service utilisation | Baseline, 6-months, and 9-months | Number of medical appointment attendances and hospital admissions |
Countries
Hong Kong
Outcome results
None listed