Testing Strategies for Increasing Exercise

August 17, 2015 updated by: Michael Norton, Harvard University

The purpose of the study is to learn more about effective ways to motivate people to increase their non-exercise energy expenditure exercise. This is an important research question because obesity and weight-related issues are increasingly becoming a problem in America. This project will address this research question by testing the effect of group dynamics in motivating employees who are predominantly sedentary to use Walkstations at work. The Walkstations are treadmills that move at a very slow rate (maximum 2miles / hour) and are attached to a work station (i.e. with computer and telephone); they therefore are designed to increase energy spent not through heavy exercise, but through small changes in posture and movement associated with routines in daily life (called nonexercise activity thermogenesis or NEAT). The proposed study is designed to build upon previous research (Levine et al., 2005) suggesting the role of NEAT-enhanced behaviors in weight loss.

In this study, the investigators are interested in the impact of group dynamics on the propensity to use the Walkstations. Participants in the active arms will be asked to use the Walkstations for at least 3 hours per week. They will do so by signing up for a time slot. During their session, they will be asked to log into the scheduling system to indicate that they are using the Walkstation. Walkstation usage will be assessed by log-in data: employees will log-in to the phone and computer when they use the Walkstation. This log-in data is work-station specific; therefore the investigators will be able to tell when a given subject used the Walkstation.

Subjects will be randomly assigned to one of three conditions:

  1. Individual. In the individual condition, participants will not be part of a team. They will receive weekly email feedback on their Walkstation performance (e.g. number of time slots they signed up for, and number of times they showed up for the time slot.) Participants will also receive a wellness tip in each email. (see appendix for a sample email)
  2. Pairs. In the pair condition, participants will be randomly assigned to a partner. They will receive the same feedback as those in the individual condition, for both themselves AND their partner.
  3. Group. In the group condition, participants will be randomly assigned to a group of 5 people. They will receive the same feedback as those in the individual condition, for both themselves AND each member of their group.

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.
224

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Blue Cross Blue Shield Massachusetts

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:

  • Must pass the ParQ
  • Must be employee of BCBS Massachusetts

Exclusion Criteria:

  • Failing the ParQ
  • Not being an employee of BCBS Massachusetts

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

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.
No Intervention: Control
Participants in the control condition will be asked to refrain from using the WalkStations during the study period.
Experimental: Individual
In the individual condition, participants will not be part of a team. They will receive weekly email feedback on their Walkstation performance (e.g. number of time slots they signed up for, and number of times they showed up for the time slot.)
Behavioral: Social walking intervention
In this intervention, we are interested in the impact of group dynamics on the propensity to use the Walkstations. The intervention consists of 4 levels: control, individual, pair, and group.
Experimental: Pairs
In the pair condition, participants will be randomly assigned to a partner. They will receive the same feedback as those in the individual condition, for both themselves AND their partner.
Behavioral: Social walking intervention
In this intervention, we are interested in the impact of group dynamics on the propensity to use the Walkstations. The intervention consists of 4 levels: control, individual, pair, and group.
Experimental: Groups
In the group condition, participants will be randomly assigned to a group of 5 people. They will receive the same feedback as those in the individual condition, for both themselves AND each member of their group.
Behavioral: Social walking intervention
In this intervention, we are interested in the impact of group dynamics on the propensity to use the Walkstations. The intervention consists of 4 levels: control, individual, pair, and group.

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
WalkStation usage
Time Frame: 3 months
Frequency with which the participant uses the WalkStation
3 months

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
Creativity
Time Frame: 3 months
Creativity measured on versus off the WalkStation.
3 months
Focus
Time Frame: 3 months
Focus, as measured when person is on versus off the WalkStation.
3 months
Health Behaviors Survey
Time Frame: pre-baseline
Survey of health-related behaviors to be completed by participant.
pre-baseline
WalkStation Usage
Time Frame: 6 months
Frequency with which the participant uses the WalkStation
6 months
Health Behaviors Survey
Time Frame: baseline
Survey of health-related behaviors to be completed by participant.
baseline
Health Behaviors Survey
Time Frame: 6 months
Survey of health-related behaviors to be completed by participant.
6 months
Creativity
Time Frame: baseline
Creativity measured on versus off the WalkStation.
baseline
Focus
Time Frame: baseline
Focus, as measured when person is on versus off the WalkStation.
baseline

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.
Harvard University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Blue Cross Blue Shield

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

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.
June 1, 2010

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.
January 1, 2011

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.
January 1, 2011

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).
June 3, 2010

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.
June 7, 2010

First Posted (Estimate)

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.
June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

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.
August 19, 2015

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.
August 17, 2015

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.
August 1, 2015

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.
  • WalkStation1

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.

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