Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALFinancial and social incentives
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.
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | Baseline, 6 and 9 months | Change in HbA1c levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity (step count) | Baseline, 6 and 9 months | Step counts |
| Change in body weight | Baseline, 6 and 9 months | kg |
| Changes in lipid profile | Baseline, 6 and 9 months | Total, HDL- and LDL-cholesterol; Triglycerides |
| Change in physical activity level | Baseline, 6 and 9 months | International Physical Activity Questionnaires (IPAQ) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in health service utilisation | Baseline, 6 and 9 months | Number of attendances and hospital admission |
Countries
Hong Kong
Outcome results
None listed