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Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives (EPAWROSFI)

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
smartcare
financial incentives
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

19 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. male students aged between 19 to 45;
  2. body mass index ≥ 27;
  3. smartphone user (either Android or iPhone);
  4. able and willing to attend a four pre-specified visit during the study period.

Exclusion Criteria:

  1. any treatment involving pharmacotherapy, procedure, or surgery;
  2. use of any activity tracker device during the last three months.
  3. Those who answered positively to any Physical Activity Readiness Questionnaire (PAR-Q) question were also excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    control

    smartcare

    smartcare plus financial incentives

    Arm Description

    A standardized education material on diet, exercise, and behavior modification were provided to all participants, and each participant received a one-to-one education on diet and exercise from a trained nurse for 5 minutes each session.

    Participants allocated to a smartcare arms received the Fit.life™ wireless physical activity tracker (Fit.life™, Suwon, Korea) that measures daily and weekly physical activity. It is convenient for data upload via Bluetooth on participant mobile phone or wirelessly via a personal computer, and has been validated for measurement of free-living physical activity in adults [REF]. Participants allocated to a smartcare arms were also provided a standardized education material on diet, exercise, and behavior modification.

    Participants in the 'smartcare plus financial incentive' arms were told that they are entitled to receive financial incentives depending on their achievement of the physical activity and weight target, and the amount they ca expect .The investigators provide financial incentives classified as process-based incentive and outcome-based incentive in addition to smartcare group intervention. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group.

    Outcomes

    Primary Outcome Measures

    the amount of weight loss (kg)
    Body weight change from the baseline body weight at each visit (4, 8, 12 week)

    Secondary Outcome Measures

    the level of physical activity (METs*hour/week)
    Average weekly physical activity(METs*hour/week) calculated by the IPAQ(International Physical Activity Questionnaire) at visit 4 (12 week), Physical activity change (METs*hour/week) from the baseline body weight at visit 4 (12 week)

    Full Information

    First Posted
    September 7, 2015
    Last Updated
    September 11, 2015
    Sponsor
    Seoul National University Hospital
    Collaborators
    Korea Health Industry Development Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02548182
    Brief Title
    Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives
    Acronym
    EPAWROSFI
    Official Title
    Enhancing Physical Activity and Weight Reduction Through Smartcare and Financial Incentives: A Pilot Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    Korea Health Industry Development Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators are planning to conduct a pilot RCT of young obese population to evaluate the effect of smartcare with or without financial incentives for 12 weeks. Participants will be randomly assigned to a three-arm of control, smartcare, and smartcare plus financial incentives group.
    Detailed Description
    To test the feasibility and potential impact of smartcare with or without financial incentives, the study employed a three-arm, open label randomized controlled trial design: control, smartcare, and smartcare plus financial incentives. The investigators hypothesized that the 'smartcare + financial incentive' arm will show the greatest change in outcomes, followed by the 'smartcare' only arm, and lastly the control arm. Specific aims of the study are as follows: To quantify the effectiveness of a 'smartcare' intervention to promote physical activity and reduce weight over a 12 week period. To quantify the incremental effectiveness of adding financial incentives to 'smartcare' intervention

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    105 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    A standardized education material on diet, exercise, and behavior modification were provided to all participants, and each participant received a one-to-one education on diet and exercise from a trained nurse for 5 minutes each session.
    Arm Title
    smartcare
    Arm Type
    Active Comparator
    Arm Description
    Participants allocated to a smartcare arms received the Fit.life™ wireless physical activity tracker (Fit.life™, Suwon, Korea) that measures daily and weekly physical activity. It is convenient for data upload via Bluetooth on participant mobile phone or wirelessly via a personal computer, and has been validated for measurement of free-living physical activity in adults [REF]. Participants allocated to a smartcare arms were also provided a standardized education material on diet, exercise, and behavior modification.
    Arm Title
    smartcare plus financial incentives
    Arm Type
    Active Comparator
    Arm Description
    Participants in the 'smartcare plus financial incentive' arms were told that they are entitled to receive financial incentives depending on their achievement of the physical activity and weight target, and the amount they ca expect .The investigators provide financial incentives classified as process-based incentive and outcome-based incentive in addition to smartcare group intervention. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group.
    Intervention Type
    Device
    Intervention Name(s)
    smartcare
    Other Intervention Name(s)
    Fit.life™ wireless physical activity tracker
    Intervention Description
    Fit.life™ wireless physical activity tracker can measure daily physical activity including activity strength and time. It was chosen for its small size, accuracy in the measurement of physical activity, and convenient data upload via Bluetooth on participant mobile phone or wirelessly via a personal computer. Fit.life™ wireless physical activity tracker has been validated for measurement of free-living physical activity in adults [REF]. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group. The version for the latter group included the feature for the monitoring and feedback of financial incentives.
    Intervention Type
    Other
    Intervention Name(s)
    financial incentives
    Intervention Description
    Financial incentives are provided in the form of process-based and outcome-based incentive.(maximum 320,000KRW) Process-based incentives were based on daily physical activity level. Participants in the 'smart care plus financial incentive' arms could earn incentives of up to 10,000 KRW per week according to the following schedule: 1,000 KRW if a participant reached target amount of physical activity in a day / An additional 3,000 KRW if a participant reached target amount of physical activity every day in a week. Outcome-based incentives were based on achievement of weight loss target at each visit. 50,000 KRW if a participant reached weight loss target of 3% from the baseline body weight at visit 2 (4 week)/ 50,000 KRW in weight loss target of 5% from the baseline body weight at visit 3 (8 week) / 100,000 KRW in weight loss target of 7% from the baseline body weight at final visit 4 (12 week)
    Primary Outcome Measure Information:
    Title
    the amount of weight loss (kg)
    Description
    Body weight change from the baseline body weight at each visit (4, 8, 12 week)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    the level of physical activity (METs*hour/week)
    Description
    Average weekly physical activity(METs*hour/week) calculated by the IPAQ(International Physical Activity Questionnaire) at visit 4 (12 week), Physical activity change (METs*hour/week) from the baseline body weight at visit 4 (12 week)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: male students aged between 19 to 45; body mass index ≥ 27; smartphone user (either Android or iPhone); able and willing to attend a four pre-specified visit during the study period. Exclusion Criteria: any treatment involving pharmacotherapy, procedure, or surgery; use of any activity tracker device during the last three months. Those who answered positively to any Physical Activity Readiness Questionnaire (PAR-Q) question were also excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Belong Cho, MD, MPH, PhD
    Organizational Affiliation
    Depart. of Family Medicine/Center for Health Promotion and Optimal Aging, Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19066383
    Citation
    Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
    Results Reference
    background
    PubMed Identifier
    25970009
    Citation
    Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, Loewenstein G, Brennan TA, Asch DA, Volpp KG. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015 May 28;372(22):2108-17. doi: 10.1056/NEJMoa1414293. Epub 2015 May 13.
    Results Reference
    background
    PubMed Identifier
    17848854
    Citation
    Finkelstein EA, Linnan LA, Tate DF, Birken BE. A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. J Occup Environ Med. 2007 Sep;49(9):981-9. doi: 10.1097/JOM.0b013e31813c6dcb.
    Results Reference
    background
    PubMed Identifier
    24618584
    Citation
    Giles EL, Robalino S, McColl E, Sniehotta FF, Adams J. The effectiveness of financial incentives for health behaviour change: systematic review and meta-analysis. PLoS One. 2014 Mar 11;9(3):e90347. doi: 10.1371/journal.pone.0090347. eCollection 2014.
    Results Reference
    background
    PubMed Identifier
    28063226
    Citation
    Shin DW, Yun JM, Shin JH, Kwon H, Min HY, Joh HK, Chung WJ, Park JH, Jung KT, Cho B. Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial. Obesity (Silver Spring). 2017 Feb;25(2):302-310. doi: 10.1002/oby.21731. Epub 2017 Jan 7.
    Results Reference
    derived

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