- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544867
Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes
Optimizing Sedentary Behavior Interventions to Affect Acute Physiological
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary aim: To determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day.
Secondary aim: To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior.
Exploratory aim: To establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g. decreased overall sitting time or increased number of breaks in sitting).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92093
- University of California, San Diego
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females 50 -70 years of age
- Able to attend 4 measurement visits with study staff in 3 consecutive weeks
- Spend at least 8 hours per day sitting
- Willing and able to wear study device for 21 days
- Able to read and write in English
- Able to provide written informed consent
Exclusion Criteria:
- Do not sit for at least 8 hours per day
- Unable to attend 4 visits
- Diagnosis of serious chronic condition that would limit the ability to stand
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Reduction in sitting time
Those randomized to this condition focused on reducing their overall sitting time by two hours per day (a goal achieved in similar studies [17,18] that represented approximately a 25% reduction in daily sitting time).
Participants were encouraged to reach this goal by standing in bouts of roughly 10 minutes per hour.
The purpose of this arm was to investigate whether we could replicate improvements in sitting time achieved in other worksite studies in our cohort of older adults, which included both workers and non-workers.
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Participants were randomized to either reduce their total sitting time or increase sit-to-stand transitions.
Information was provided in person, through written materials and by emails and phone calls in both conditions.
Both groups received written educational materials on the dangers of excessive sitting and reviewed a generic day to illustrate how many sitting opportunities individuals face each day.
During each session, the health educator also discussed the benefits of sitting less or increasing sit-to-stand transitions (depending on study condition) and brainstormed potential barriers to implementing the new behavior as well as strategies to overcome these barriers.
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Experimental: Increase in sit-to-stand transitions
Those randomized to the sit-to-stand condition focused on increasing the number of sit-to-stand transitions they performed throughout the day with a goal of adding 30 additional transitions per day.
Previous studies have not succeeded in increasing the number of sit-to-stand transitions in older adults, possibly because they focused on reducing overall sitting time, encouraged longer standing breaks and did not provide a specific goal for sit-to-stand transitions [26-28].
An increase in sit-to-stand transitions would not be expected with an increase standing intervention alone, as prolonged standing reduces the opportunity for sit-to-stand transitions.
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Participants were randomized to either reduce their total sitting time or increase sit-to-stand transitions.
Information was provided in person, through written materials and by emails and phone calls in both conditions.
Both groups received written educational materials on the dangers of excessive sitting and reviewed a generic day to illustrate how many sitting opportunities individuals face each day.
During each session, the health educator also discussed the benefits of sitting less or increasing sit-to-stand transitions (depending on study condition) and brainstormed potential barriers to implementing the new behavior as well as strategies to overcome these barriers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability and feasibility
Time Frame: 3 weeks
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To determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement
Time Frame: 3 weeks
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To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior.
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3 weeks
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Sedentary behavior
Time Frame: 3 weeks
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To establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g.
decreased overall sitting time or increased number of breaks in sitting).
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3 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacqueline Kerr, Phd, UCSD
Publications and helpful links
General Publications
- Takemoto M, Godbole S, Rosenberg DE, Nebeker C, Natarajan L, Madanat H, Nichols J, Kerr J. The search for the ejecting chair: a mixed-methods analysis of tool use in a sedentary behavior intervention. Transl Behav Med. 2020 Feb 3;10(1):186-194. doi: 10.1093/tbm/iby106.
- Kerr J, Takemoto M, Bolling K, Atkin A, Carlson J, Rosenberg D, Crist K, Godbole S, Lewars B, Pena C, Merchant G. Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults. PLoS One. 2016 Jan 6;11(1):e0145427. doi: 10.1371/journal.pone.0145427. eCollection 2016.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HRPP Project #130817
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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