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NCT Number: NCT04917926

Behavioural Economics-based Incentives in Adults With Type 2 Diabetes (BET2)

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

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 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.

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
  • 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

Treatment and study plan

Financial and social incentives

Behavioral

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.

Financial Incentives

Behavioral

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.

Primary outcomes

  1. Glycaemic control

    Time frame: Baseline, 6-months, and 9-months

    The change in HbA1c levels

Secondary outcomes

  1. Diabetes control

    Time frame: Baseline, 6-months, and 9-months

    Proportion of participants with good/excellent diabetes control (HbA1c threshold ≤ 7% & ≤ 6.5%)

  2. Body weight control

    Time frame: 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

  3. Changes in lipid profile

    Time frame: Baseline, 6-months, and 9-months

    Changes in Total, HDL- and LDL-cholesterol, and Triglycerides

  4. Change in blood pressure

    Time frame: Baseline, 6-months, and 9-months

    Assessed by the change in systolic and diastolic blood pressure

  5. Glycaemic control

    Time frame: 6-months and 9-months

    Proportion of participants requiring an initiation of medication in diabetes management

  6. Glycaemic control (addition of medications)

    Time frame: 6-months and 9-months

    Proportion of participants requiring an addition of medication(s) or increase in drug dosage in diabetes management

  7. Walking performance

    Time frame: Weekly

    Assessed by proportion of participants meeting their daily step counts every week

  8. Level of physical activity

    Time frame: 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

Other outcomes

  1. Frequency of health service utilisation

    Time frame: Baseline, 6-months, and 9-months

    Number of medical appointment attendances and hospital admissions

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 Randomised Control Trial

Acronym: BET2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2021
Registry last updated
May 9, 2024

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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