Penn State Hershey Sitting and Health Study

October 14, 2020 updated by: Liza Rovniak, Milton S. Hershey Medical Center

Desk-Compatible Elliptical Device: Feasibility Evaluation

The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help employees to increase their daily physical activity without compromising work productivity; and (b) evaluate the effects of different types of incentives for pedaling the desk-based elliptical device on employees' pedaling quantity over a one-month intervention period. The study will involve placing a compact elliptical device (provided at no cost by the research team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data evaluating the effects of the elliptical device on work productivity will be obtained from both employees and the employees' supervisors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full time employee, employed at least 35 hours per week at Penn State Hershey
  • Able to provide documented approval from supervisor to participate
  • Age 18-70 years
  • Overweight or obese (BMI between 25-55)
  • Sit at desk at least 5 hours per day
  • Have regular working hours between 6 am and 6 pm on weekdays
  • Ability to understand written and spoken English
  • Own a smartphone (Android or iPhone) with Internet access
  • Willing to download cycling app on smartphone during one month study period

Exclusion Criteria:

  • Not present in Penn State Hershey office during study period due to personal circumstances such as travel/extended vacation or leave, relocation, or health-related circumstances
  • Advised to only do physical activity recommended by a physician
  • Chest pain during physical activity or during prior month
  • Currently has a desk-based pedaling device or treadmill workstation already installed at desk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Delayed Compensation, Money
Will receive delayed monetary compensation with Amazon gift card, non performance-contingent.
Behavioral: Desk-based pedaling device and pedaling incentives provided
Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
Active Comparator: Usual Delayed Compensation, Food
Will receive delayed compensation with food-based gift card, non performance-contingent.
Behavioral: Desk-based pedaling device and pedaling incentives provided
Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
Experimental: Individual Immediate Contingent Reward, Money
Will receive daily performance-contingent monetary compensation with Amazon gift card.
Behavioral: Desk-based pedaling device and pedaling incentives provided
Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
Experimental: Individual Immediate Contingent Reward, Food
Will receive daily performance-contingent food-based gift card.
Behavioral: Desk-based pedaling device and pedaling incentives provided
Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
Experimental: Joint Immediate Contingent Reward, Money
Will receive daily performance-contingent monetary compensation with Amazon gift card, with additional compensation contingent on pedaling activity of co-worker participant.
Behavioral: Desk-based pedaling device and pedaling incentives provided
Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
Experimental: Joint Immediate Contingent Reward, Food
Will receive daily performance-contingent monetary compensation with food gift card, with additional compensation contingent on pedaling activity of co-worker participant.
Behavioral: Desk-based pedaling device and pedaling incentives provided
Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Worker Productivity
Time Frame: Baseline (1 month period prior to program start) and post-program (immediately after program ends)
Self-report assessments of worker productivity. The assessments will ask about work productivity in the prior 4-week period.
Baseline (1 month period prior to program start) and post-program (immediately after program ends)
Elliptical Device Pedaling Quantity
Time Frame: 1 month (4 weeks) during pedaling program
Objectively-measured pedaling quantity from elliptical device
1 month (4 weeks) during pedaling program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
User satisfaction, process evaluations
Time Frame: Post-program (immediately after program ends)
Satisfaction with intervention condition
Post-program (immediately after program ends)
General (non-desk pedaling) physical activity
Time Frame: Baseline (1 month period prior to program start) and post-program (immediately after program ends)
Self-reported physical activity
Baseline (1 month period prior to program start) and post-program (immediately after program ends)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R21HL118453 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on Desk-based pedaling device and pedaling incentives provided

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings