- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02109432
Short-term Behavior Change With Pedal Desk Installation (PD-ST)
March 28, 2019 updated by: Corby K. Martin, Pennington Biomedical Research Center
The purpose of this investigation is to evaluate participant use of a dedicated office pedal desk with and without behavioral support.
Study Overview
Status
Terminated
Conditions
Detailed Description
For this pilot study the investigators will identify and recruit up to 20 full time Pennington Biomedical staff members employed in sedentary jobs (i.e., report mostly sitting during working hours).
The sample size is limited by the number of pedal desks being built for this pilot study and the need for timely data generation.
Although the investigators can stagger starts as needed, all participants must intend to be on campus for the subsequent 6 weeks after they start the intervention.
Two cohorts of 10 participants will complete the three 2-week conditions in the following order: 1) SELF-DIRECTED use where participants have access to their daily recorded data but will not have any other form of feedback or goal-setting; 2) FACILITATED use where participants are provided with their daily recorded pedal desk data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount; 3) FACILITATED use with PEDOMETER where participants will be provided with their daily recorded pedal desk and step count data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount and increase their step count by 3,000 steps/day compared to baseline.
Participants will be asked to pedal at a sustainable and self-selected pace while using the pedal desk.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- 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
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research 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
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be a full-time employee at Pennington Biomedical Research Center
- Be between 21 and 65 years of age
- Primarily sit while at work
- Work from a private office/cubicle
Exclusion Criteria:
- Weigh more than 250 pounds
- Have physical limitations that prevent performance of pedaling motions
- Plan to be away from work for the 6 weeks of the intervention
- Be pregnant
- Have a pace maker and/or metal joint replacement
- Plan to be away from work for the 6 weeks of the intervention
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Pedal Desk
Participants will complete three 2-week conditions in the following order:
|
participants will have a pedal desk installed in their office and will have access to their daily recorded data but will not have any other form of feedback or goal-setting
participants are provided with their daily recorded pedal desk data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount
participants will be provided with their daily recorded pedal desk and step count data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount and increase their step count by 3,000 steps/day compared to baseline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Change (kg)
Time Frame: Baseline to 6 weeks
|
KG weight change from Baseline to 6 weeks
|
Baseline to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Corby K Martin, PhD, Pennington Biomedical Research 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
May 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 12, 2014
First Submitted That Met QC Criteria
April 4, 2014
First Posted (Estimate)
April 9, 2014
Study Record Updates
Last Update Posted (Actual)
March 29, 2019
Last Update Submitted That Met QC Criteria
March 28, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 2013-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Yes
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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