<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/NCT03305172</url>
  </required_header>
  <id_info>
    <org_study_id>SG-STEP</org_study_id>
    <nct_id>NCT03305172</nct_id>
  </id_info>
  <brief_title>Structuring Financial Incentives to Increase Physical Activity</brief_title>
  <official_title>Structuring Financial Incentives to Increase Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University of Singapore</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>
      The purpose of this study is to evaluate the effectiveness of different structures of long&#xD;
      term financial incentives on increasing physical activity performed by subjects, as measured&#xD;
      by the number of steps walked per day.&#xD;
&#xD;
      Investigators are interested in studying whether physical activity increases during an&#xD;
      intervention period (with incentives) and a post-intervention period (with no incentives).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a field experiment. Adults within the ages of 25 and 60 years of age,&#xD;
      and with a body mass index of 22 or higher will be eligible to participate.&#xD;
&#xD;
      The study will consist of (1) a two-week baseline period, (2) a 36-week intervention period,&#xD;
      and (3) a 12-week follow-up period.&#xD;
&#xD;
      At the beginning of the study, subjects will be given a wearable fitness device and their&#xD;
      daily step count will be monitored for two weeks; this is the baseline period. After the&#xD;
      two-week baseline period, the subjects will be randomly assigned to one of the five different&#xD;
      conditions (Control, Gain, Loss, Gain Streak, or Loss Streak) and will be given the goal to&#xD;
      increase their baseline step counts by 2,500 steps.&#xD;
&#xD;
      =====&#xD;
&#xD;
      HYPOTHESES -- Investigators expect the following:&#xD;
&#xD;
        1. Loss Aversion: Subjects in the Loss treatment will achieve the goal on a greater number&#xD;
           of days than subjects in the Gain treatment.&#xD;
&#xD;
        2. Streak: Subjects in the Gain treatment will achieve the goal on a greater number of days&#xD;
           than subjects in the Gain Streak treatment.&#xD;
&#xD;
        3. Loss Streak: Subjects in the Loss treatment will achieve the goal on a greater number of&#xD;
           days than subjects in the Loss Streak treatment. Whether subjects in the Loss Streak&#xD;
           treatment will perform better or worse than subjects in the other two treatments will be&#xD;
           investigated.&#xD;
&#xD;
      CONTRIBUTION -- Prior research has not examined the effect of a long term financial incentive&#xD;
      (36 weeks) on individual behavior in achieving a goal. In this study, the investigators also&#xD;
      examine two additional financial incentive structures: Gain Streak and Loss Streak. If the&#xD;
      hypotheses are correct, the results have important implications for designing financial&#xD;
      incentives to encourage good behavior and to encourage good habit formation across domains.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 17, 2019</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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Step count goal -- Intervention</measure>
    <time_frame>36-week intervention period following the baseline period.</time_frame>
    <description>Proportion of participant-days on which the goal (baseline +2,500 steps) was achieved during the intervention period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean daily steps -- Intervention</measure>
    <time_frame>36-week intervention period following the baseline period.</time_frame>
    <description>Change in mean daily steps during the intervention period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Step count goal -- Post-intervention</measure>
    <time_frame>12-week post-intervention period.</time_frame>
    <description>Proportion of participant-days on which the goal (baseline +2,500 steps) was achieved during the post-intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean daily steps -- Post-intervention</measure>
    <time_frame>12-week post-intervention period.</time_frame>
    <description>Change in mean daily steps during the post-intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Pattern -- Intervention</measure>
    <time_frame>36-week intervention period following the baseline period.</time_frame>
    <description>Changes in sleep pattern (deep sleep, hours of continuous sleep) during the intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Pattern -- Post-intervention</measure>
    <time_frame>12-week post-intervention period.</time_frame>
    <description>Changes in sleep pattern (deep sleep, hours of continuous sleep) during the post-intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (in kilograms) Loss -- Intervention</measure>
    <time_frame>36-week intervention period following the baseline period.</time_frame>
    <description>Drop in weight from baseline to the end of the intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (in kilograms) Loss -- Post-intervention</measure>
    <time_frame>48-week period following the baseline period.</time_frame>
    <description>Drop in weight from baseline to the end of the post-intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Measurement (in inches) -- Intervention</measure>
    <time_frame>36-week intervention period following the baseline period</time_frame>
    <description>Change in waist measurements from baseline to the end of the intervention period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Waist Measurement (in inches) -- Post-intervention</measure>
    <time_frame>48-week period following the baseline period.</time_frame>
    <description>Change in waist measurements from baseline to the end of the post-intervention period.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">620</enrollment>
  <condition>Physical Activity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the Control treatment are not given any financial incentive to achieve the goal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gain Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Financial Incentive: Each subject in the Gain treatment will earn a certain amount of money for each day the goal is achieved. The money earned will be added to a virtual account that the subject has, and will be paid to the subject at the end of the intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loss Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Financial Incentive: Each subject in the Loss treatment will be given a certain amount of money in his/her virtual account at the beginning of every week. For each day that the subject does not achieve the goal, a small portion of that money will be deducted from the virtual account. The balance that is left in the virtual account will be paid to the subject at the end of the intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gain Streak Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Financial Incentive: Each subject in the Gain Streak treatment get an increasing amount of money added to his/her virtual account for every continuous day that they achieve the goal. The maximum cumulative amount per week is same as in the other treatment conditions. The payment is reset at the beginning of each week, or if the subject misses the goal on any day. The money in the virtual account will be paid to the subject at the end of the intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loss Streak Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Financial Incentive: Each subject in the Loss Streak treatment will be given a certain amount of money in his/her virtual account at the beginning of every week. An increasing amount of money will be deducted for each consecutive day the subject does not achieve the goal. The payment is reset at the beginning of each week, or when the subject achieves the goal (i.e., deductions are reset when the streak is broken). The balance that is left in the virtual account will be paid to the subject at the end of the intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial Incentive</intervention_name>
    <description>Giving different structures of long term (36 weeks) financial incentives to increase physical activity</description>
    <arm_group_label>Gain Streak Treatment</arm_group_label>
    <arm_group_label>Gain Treatment</arm_group_label>
    <arm_group_label>Loss Streak Treatment</arm_group_label>
    <arm_group_label>Loss Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singapore citizens and permanent residents&#xD;
&#xD;
          -  Adults with BMI greater than 22&#xD;
&#xD;
          -  Ownership of a smartphone or tablet&#xD;
&#xD;
          -  Only one member per household can participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breast feeding, or who intend to become pregnant over next&#xD;
             year&#xD;
&#xD;
          -  Subjects who are already participating in another physical activity program or study&#xD;
&#xD;
          -  Subjects who are unable to participate for a total of 1 year&#xD;
&#xD;
          -  Subjects who are unwilling to wear the fitness device&#xD;
&#xD;
          -  Subjects who already walk more than 10,000 steps a day (self-reported per-day-average&#xD;
             over seven days)&#xD;
&#xD;
          -  Subjects who have any of the following health conditions:&#xD;
&#xD;
               -  high blood pressure&#xD;
&#xD;
               -  high cholesterol&#xD;
&#xD;
               -  heart attack&#xD;
&#xD;
               -  heart failure&#xD;
&#xD;
               -  stroke&#xD;
&#xD;
               -  chronic obstructive pulmonary disease&#xD;
&#xD;
               -  kidney disease&#xD;
&#xD;
               -  diabetes (type 2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teck H Ho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National University of Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>119077</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Singapore</investigator_affiliation>
    <investigator_full_name>Prof Ho Teck Hua</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Investigators will not be storing or sharing any personal identifiers. All individual level data will be anonymized, and only anonymized data will be shared with other researchers, upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After completion of all analysis. It will be made available in the supporting documentation.</ipd_time_frame>
    <ipd_access_criteria>It will be made available in the supporting documentation.</ipd_access_criteria>
  </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/NCT03305172
org study id: SG-STEP
nct id: NCT03305172
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effectiveness of different structures of long
      term financial incentives on increasing physical activity performed by subjects, as measured
      by the number of steps walked per day.

      Investigators are interested in studying whether physical activity increases during an
      intervention period (with incentives) and a post-intervention period (with no incentives).
The proposed study is a field experiment. Adults within the ages of 25 and 60 years of age,
      and with a body mass index of 22 or higher will be eligible to participate.

      The study will consist of (1) a two-week baseline period, (2) a 36-week intervention period,
      and (3) a 12-week follow-up period.

      At the beginning of the study, subjects will be given a wearable fitness device and their
      daily step count will be monitored for two weeks; this is the baseline period. After the
      two-week baseline period, the subjects will be randomly assigned to one of the five different
      conditions (Control, Gain, Loss, Gain Streak, or Loss Streak) and will be given the goal to
      increase their baseline step counts by 2,500 steps.

      =====

      HYPOTHESES -- Investigators expect the following:

        1. Loss Aversion: Subjects in the Loss treatment will achieve the goal on a greater number
           of days than subjects in the Gain treatment.

        2. Streak: Subjects in the Gain treatment will achieve the goal on a greater number of days
           than subjects in the Gain Streak treatment.

        3. Loss Streak: Subjects in the Loss treatment will achieve the goal on a greater number of
           days than subjects in the Loss Streak treatment. Whether subjects in the Loss Streak
           treatment will perform better or worse than subjects in the other two treatments will be
           investigated.

      CONTRIBUTION -- Prior research has not examined the effect of a long term financial incentive
      (36 weeks) on individual behavior in achieving a goal. In this study, the investigators also
      examine two additional financial incentive structures: Gain Streak and Loss Streak. If the
      hypotheses are correct, the results have important implications for designing financial
      incentives to encourage good behavior and to encourage good habit formation across domains.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Step count goal -- Intervention
time frame: 36-week intervention period following the baseline period.
description: Proportion of participant-days on which the goal (baseline +2,500 steps) was achieved during the intervention period.
measure: Change in mean daily steps -- Intervention
time frame: 36-week intervention period following the baseline period.
description: Change in mean daily steps during the intervention period.
measure: Step count goal -- Post-intervention
time frame: 12-week post-intervention period.
description: Proportion of participant-days on which the goal (baseline +2,500 steps) was achieved during the post-intervention period.
measure: Change in mean daily steps -- Post-intervention
time frame: 12-week post-intervention period.
description: Change in mean daily steps during the post-intervention period.
measure: Sleep Pattern -- Intervention
time frame: 36-week intervention period following the baseline period.
description: Changes in sleep pattern (deep sleep, hours of continuous sleep) during the intervention period.
measure: Sleep Pattern -- Post-intervention
time frame: 12-week post-intervention period.
description: Changes in sleep pattern (deep sleep, hours of continuous sleep) during the post-intervention period.
measure: Weight (in kilograms) Loss -- Intervention
time frame: 36-week intervention period following the baseline period.
description: Drop in weight from baseline to the end of the intervention period.
measure: Weight (in kilograms) Loss -- Post-intervention
time frame: 48-week period following the baseline period.
description: Drop in weight from baseline to the end of the post-intervention period.
measure: Change in Waist Measurement (in inches) -- Intervention
time frame: 36-week intervention period following the baseline period
description: Change in waist measurements from baseline to the end of the intervention period.
measure: Change in Waist Measurement (in inches) -- Post-intervention
time frame: 48-week period following the baseline period.
description: Change in waist measurements from baseline to the end of the post-intervention period.
arm group label: Control
arm group type: No Intervention
description: Subjects in the Control treatment are not given any financial incentive to achieve the goal.
arm group label: Gain Treatment
arm group type: Experimental
description: Financial Incentive: Each subject in the Gain treatment will earn a certain amount of money for each day the goal is achieved. The money earned will be added to a virtual account that the subject has, and will be paid to the subject at the end of the intervention period.
arm group label: Loss Treatment
arm group type: Experimental
description: Financial Incentive: Each subject in the Loss treatment will be given a certain amount of money in his/her virtual account at the beginning of every week. For each day that the subject does not achieve the goal, a small portion of that money will be deducted from the virtual account. The balance that is left in the virtual account will be paid to the subject at the end of the intervention period.
arm group label: Gain Streak Treatment
arm group type: Experimental
description: Financial Incentive: Each subject in the Gain Streak treatment get an increasing amount of money added to his/her virtual account for every continuous day that they achieve the goal. The maximum cumulative amount per week is same as in the other treatment conditions. The payment is reset at the beginning of each week, or if the subject misses the goal on any day. The money in the virtual account will be paid to the subject at the end of the intervention period.
arm group label: Loss Streak Treatment
arm group type: Experimental
description: Financial Incentive: Each subject in the Loss Streak treatment will be given a certain amount of money in his/her virtual account at the beginning of every week. An increasing amount of money will be deducted for each consecutive day the subject does not achieve the goal. The payment is reset at the beginning of each week, or when the subject achieves the goal (i.e., deductions are reset when the streak is broken). The balance that is left in the virtual account will be paid to the subject at the end of the intervention period.
intervention type: Behavioral
intervention name: Financial Incentive
description: Giving different structures of long term (36 weeks) financial incentives to increase physical activity
arm group label: Gain Streak Treatment
arm group label: Gain Treatment
arm group label: Loss Streak Treatment
arm group label: Loss Treatment
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Teck H Ho, PhD
role: Principal Investigator
affiliation: National University of Singapore
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: National University of Singapore
investigator full name: Prof Ho Teck Hua
investigator title: Professor
mesh term: Weight Loss
sharing ipd: Yes
ipd description: Investigators will not be storing or sharing any personal identifiers. All individual level data will be anonymized, and only anonymized data will be shared with other researchers, upon request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: After completion of all analysis. It will be made available in the supporting documentation.
ipd access criteria: It will be made available in the supporting documentation.