Clinical trial NCT04443842: Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study
Official title: Effectiveness of Behavioural Economics-based Incentives on Glycaemic Control and Lifestyle in Adults With Newly Diagnosed Type 2 Diabetes: a Feasibility Pilot Study
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: 2020-06-23
Enrollment: 11
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 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.

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
* 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

Primary outcomes:
measure: Glycemic control
timeFrame: Baseline, 6 and 9 months
Secondary outcomes:
measure: Change in physical activity (step count)
timeFrame: Baseline, 6 and 9 months
measure: Change in body weight
timeFrame: Baseline, 6 and 9 months
measure: Changes in lipid profile
timeFrame: Baseline, 6 and 9 months
measure: Change in physical activity level
timeFrame: Baseline, 6 and 9 months
Other outcomes:
measure: Change in health service utilisation
timeFrame: Baseline, 6 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: