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Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults

Primary Purpose

Physical Activity, Sedentary Lifestyle, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-monitoring
Incentives
Feedback
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Activity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 25 kg/m2 ≤ BMI ≤ 45 kg/m2
  • Age 18-70
  • Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week, confirmed by FitBit at baseline)
  • Able to engage in moderate amount of walking
  • Able to receive email/text messages from study staff

Exclusion Criteria:

- medical or psychiatric conditions that would make it difficult to comply with study protocols

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single-arm trial

    Arm Description

    All participants will undergo each of three conditions during the study.

    Outcomes

    Primary Outcome Measures

    Step counts
    Daily number of steps taken
    Goal attainment
    Proportion of days step goal was met

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2018
    Last Updated
    June 20, 2018
    Sponsor
    Drexel University
    Collaborators
    Psi Chi, Qualtrics, American College of Sports Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03566277
    Brief Title
    Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults
    Official Title
    Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    August 1, 2017 (Actual)
    Study Completion Date
    August 8, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Drexel University
    Collaborators
    Psi Chi, Qualtrics, American College of Sports Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to test whether deposit contracts, wherein individuals invest their own money with the study to serve as the incentive, with or without daily feedback about progress help individuals to increase step counts and more often meet a step goal compared to self-monitoring only.
    Detailed Description
    Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness. Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive. This study will last for 16 weeks. Each participant will invest $42 with the study, and be exposed to to each of three interventions. All participants will have the use of a FitBit for ongoing self-monitoring and a step-count goal of 10,000 steps per day. In one condition, these will be the only interventions you receive. In one condition, you will receive a monetary consequence for meeting or not meeting the goal. Each day during the incentive conditions, you will be eligible to lose $0.75 of your own money for not meeting the goal, or to earn back $0.75 of your money plus $0.75 from the study (i.e., a total of $1.50) for meeting the goal. In the third condition, you will have daily feedback mid-afternoon about your distance from the goal and the money you stand to gain or lose. You will be made aware of what condition you are in.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physical Activity, Sedentary Lifestyle, Obesity, Overweight

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-arm trial
    Arm Type
    Experimental
    Arm Description
    All participants will undergo each of three conditions during the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-monitoring
    Intervention Description
    Participants will have access to a wrist-worn activity monitor and have a daily step goal
    Intervention Type
    Behavioral
    Intervention Name(s)
    Incentives
    Intervention Description
    Participants will have a deposit contract, wherein they will lose money if a goal is not reached, or double their money if a goal is reached
    Intervention Type
    Behavioral
    Intervention Name(s)
    Feedback
    Intervention Description
    Participants will receive text message feedback each day about progress towards their goal
    Primary Outcome Measure Information:
    Title
    Step counts
    Description
    Daily number of steps taken
    Time Frame
    Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
    Title
    Goal attainment
    Description
    Proportion of days step goal was met
    Time Frame
    Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 25 kg/m2 ≤ BMI ≤ 45 kg/m2 Age 18-70 Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week, confirmed by FitBit at baseline) Able to engage in moderate amount of walking Able to receive email/text messages from study staff Exclusion Criteria: - medical or psychiatric conditions that would make it difficult to comply with study protocols

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31698334
    Citation
    Kerrigan SG, Forman EM, Patel M, Williams D, Zhang F, Crosby RD, Butryn ML. Evaluating the Feasibility, Acceptability, and Effects of Deposit Contracts With and Without Daily Feedback to Promote Physical Activity. J Phys Act Health. 2020 Jan 1;17(1):29-36. doi: 10.1123/jpah.2018-0589.
    Results Reference
    derived

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    Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults

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