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Completed

NCT Number: NCT04443842

Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Financial and social incentives

Behavioral

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.

Primary outcomes

  1. Glycemic control

    Time frame: Baseline, 6 and 9 months

    Change in HbA1c levels

Secondary outcomes

  1. Change in physical activity (step count)

    Time frame: Baseline, 6 and 9 months

    Step counts

  2. Change in body weight

    Time frame: Baseline, 6 and 9 months

    kg

  3. Changes in lipid profile

    Time frame: Baseline, 6 and 9 months

    Total, HDL- and LDL-cholesterol; Triglycerides

  4. Change in physical activity level

    Time frame: Baseline, 6 and 9 months

    International Physical Activity Questionnaires (IPAQ)

Other outcomes

  1. Change in health service utilisation

    Time frame: Baseline, 6 and 9 months

    Number of attendances and hospital admission

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • University Grants Committee, Hong Kong

Registry information

Official study title

Effectiveness of Behavioural Economics-based Incentives on Glycaemic Control and Lifestyle in Adults With Newly Diagnosed Type 2 Diabetes: a Feasibility Pilot Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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