<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443842</url>
  </required_header>
  <id_info>
    <org_study_id>BET2-v2-202005</org_study_id>
    <nct_id>NCT04443842</nct_id>
  </id_info>
  <brief_title>Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Grants Committee, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A feasibility pilot study of a randomised control trial of adults newly diagnosed with type 2&#xD;
      diabetes to compare the effectiveness of financial and social incentives on healthy lifestyle&#xD;
      behaviour.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study of testing the feasibility of the interventions being implemented in&#xD;
      our main trial in local settings. Adults newly diagnosed with type 2 diabetes without&#xD;
      receiving any anti-diabetic medication in Hong Kong are randomised to compare the&#xD;
      effectiveness of financial and social incentives against a control group receiving standard&#xD;
      care. The investigators follow participants for 9-months (6-month intervention period and a&#xD;
      3-month post-intervention follow-up period) to assess glycemic control and other health&#xD;
      indicators. Participants will be randomly assigned to one of two groups (in ratio 3:1): arm A&#xD;
      (financial and social incentives in addition to standard care), and arm B (control arm&#xD;
      receiving standard care). Financial incentives will be framed around loss aversion and the&#xD;
      endowment effect. Social incentives will include peer competition, and social support.&#xD;
      Financial and social incentives are to encourage increased physical activity and participants&#xD;
      will use a pedometer to track activity. Participants are followed for an additional 3-months&#xD;
      after the cessation of incentives to assess the sustainability of lifestyle changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">December 7, 2021</completion_date>
  <primary_completion_date type="Actual">September 6, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Baseline, 6 and 9 months</time_frame>
    <description>Change in HbA1c levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity (step count)</measure>
    <time_frame>Baseline, 6 and 9 months</time_frame>
    <description>Step counts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Baseline, 6 and 9 months</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid profile</measure>
    <time_frame>Baseline, 6 and 9 months</time_frame>
    <description>Total, HDL- and LDL-cholesterol; Triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity level</measure>
    <time_frame>Baseline, 6 and 9 months</time_frame>
    <description>International Physical Activity Questionnaires (IPAQ)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in health service utilisation</measure>
    <time_frame>Baseline, 6 and 9 months</time_frame>
    <description>Number of attendances and hospital admission</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the usual standard care (same as control group), loss-framed financial incentive, social incentives and weekly feedback on performance for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive standard care including patient screening and education on diet, physical activity, and smoking conducted by a multi-disciplinary team. Participants in the control group will neither be told their baseline step count nor receive any feedback messages.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial and social incentives</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese adults aged 30-70 years&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
          -  Resident in Hong Kong&#xD;
&#xD;
          -  Able to communicate in English or Chinese&#xD;
&#xD;
          -  Newly diagnosed with type 2 diabetes within a year according to World Health&#xD;
             Organization guidelines: HbA1c ≥ 48 mmol/mol (≥ 6.5%); fasting plasma glucose ≥ 7.0&#xD;
             mmol/l (≥ 126 mg/dl); oral glucose tolerance test (OGTT) ≥ 11.1 mmol/l (200 mg/dl)&#xD;
             with symptoms, or on two separate occasions if asymptomatic&#xD;
&#xD;
          -  HbA1c ≤ 7.5%&#xD;
&#xD;
          -  Not taking any medication for glycaemic control&#xD;
&#xD;
          -  Willing to take blood tests&#xD;
&#xD;
          -  Access to a smart phone to track physical activity&#xD;
&#xD;
          -  Physically mobile for duration of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already participating in another intervention study&#xD;
&#xD;
          -  Any health condition prohibiting them from completing the 9-month trial, such as&#xD;
             history of eating disorder, cancer, serious illness, breastfeeding&#xD;
&#xD;
          -  Medical conditions that can affect HbA1c measurements including anaemia,&#xD;
             haemoglobinopathies, haemodialysis, iron/B12 deficiency or supplements, chronic liver&#xD;
             diseases, splenectomy, rheumatoid arthritis, use of anti-retroviral drugs, ribavirin,&#xD;
             or aspirin&#xD;
&#xD;
          -  Intend to receive medication for glycaemic control in the next 6 months&#xD;
&#xD;
          -  Intend to seek private medical treatment for diabetes in the next 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianchao Quan, MPH, BM BCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Public Health, The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Information will shared in accordance with the University of Hong Kong Data Management Plan (DMP)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_url>https://hub.hku.hk/researchdata/staff2.htm</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443842
org study id: BET2-v2-202005
nct id: NCT04443842
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Glycemic control
time frame: Baseline, 6 and 9 months
description: Change in HbA1c levels
measure: Change in physical activity (step count)
time frame: Baseline, 6 and 9 months
description: Step counts
measure: Change in body weight
time frame: Baseline, 6 and 9 months
description: kg
measure: Changes in lipid profile
time frame: Baseline, 6 and 9 months
description: Total, HDL- and LDL-cholesterol; Triglycerides
measure: Change in physical activity level
time frame: Baseline, 6 and 9 months
description: International Physical Activity Questionnaires (IPAQ)
measure: Change in health service utilisation
time frame: Baseline, 6 and 9 months
description: Number of attendances and hospital admission
arm group label: Intervention
arm group type: Experimental
description: Participants will receive the usual standard care (same as control group), loss-framed financial incentive, social incentives and weekly feedback on performance for 6 months.
arm group label: Control
arm group type: No Intervention
description: Participants will receive standard care including patient screening and education on diet, physical activity, and smoking conducted by a multi-disciplinary team. Participants in the control group will neither be told their baseline step count nor receive any feedback messages.
intervention type: Behavioral
intervention name: Financial and social incentives
description: 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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jianchao Quan, MPH, BM BCh
role: Principal Investigator
affiliation: School of Public Health, The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: Information will shared in accordance with the University of Hong Kong Data Management Plan (DMP)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd url: https://hub.hku.hk/researchdata/staff2.htm