- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609438
An Intervention to Reduce Sitting Time at Work: Effects on Metabolic Health and Inactivity (Up4Health)
The Effects of Short, Frequent Breaks in Sitting Versus Longer, Planned Breaks in Sitting on Sedentary Behavior and Metabolic Health Among Inactive Females Working Sedentary Jobs
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to determine whether varying the frequency and length of activity breaks during the workday will differentially impact sedentary behavior and health outcomes. Women aged 25-50 who work full-time in sedentary jobs and participate in less than 60 minutes of overall physical activity per week will be recruited. At the beginning of the study participants will visit the laboratory to complete baseline health assessments and meet with a research assistant to outline their plan for reducing sitting time at work. At this time they will be randomly assigned to one of two groups: 1) Group A will be asked to take two 15-minute walks during each workday, or 2) Group B will be asked to stand up and move around for 1-2 minutes every half hour throughout the workday. The total duration of this program will be eight weeks. During this time participants will be asked to keep a brief daily log of their activity breaks during the workday. At the end of the 8-week program participants will return to the laboratory to repeat the health assessments.
ASSESSMENTS:
All participants will complete the following tests and procedures:
- Metabolic blood panel. Blood will be drawn from a quick finger stick to assess total cholesterol, triglycerides, LDL, HDL, and fasting glucose.
- DEXA scan. Participants will lie down on a body scanner for about 10 minutes to assess body composition.
- Body measurements. A trained research assistant will measure height, weight, and waist circumference.
- Blood pressure. A trained research assistant will measure blood pressure using an automated blood pressure cuff.
In addition, participants will complete the following assessments outside of the laboratory:
- Questionnaires: Participants will be asked to complete a series of questionnaires. This should take 15-20 minutes.
- Accelerometer: Participants will be asked to wear a motion sensor for a total of 21 days (three 7-day periods). This small apparatus is worn around the waist during the day. Participants will complete a log indicating when they were wearing the accelerometer each day.
- Food diary: Participants will be asked to record their food intake for a total of 9 days (three 3-day periods).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Work at least 35 hours per week
- Spend at least 80% of working hours sitting (self-reported)
- Engage in less than 60 minutes per week of leisure-time exercise (self-reported)
- Not pregnant or planning to become pregnant in the next 3 months
- Not currently trying to change weight
- Speak English
- Able to attend assessments
- Willing to wear accelerometer
- No anticipated significant conflicts during 8-week intervention
Exclusion Criteria:
- Male
- Working less than 35 hours per week
- Spend >25% of working hours standing or active
- Engage in more than 60 minutes per week of leisure-time exercise
- Pregnant
- Actively dieting or attempting to change weight
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Short breaks
Participants instructed to stand/move for 1-2 minutes every half hour throughout the workday
|
Following baseline testing, participants will attend a 30-minute individual orientation session, during which they will complete a planning worksheet with a research assistant.
They will identify specific strategies they will use to accomplish the pre-specified goal (i.e., to take a 1-minute active break every 30 minutes during the workday).
They will also identify potential barriers they will face and devise strategies for overcoming them.
The intervention will officially start the Monday after the orientation session and will last for 8 weeks.
Participants will receive a weekly email containing tips related to reducing sitting time at work.
All participants will complete daily activity logs indicating the time and duration of all breaks from sitting across the 8-week intervention.
Other Names:
|
|
Active Comparator: Long breaks
Participants instructed to take two 15-minute activity breaks during each workday
|
Following baseline testing, participants will attend a 30-minute individual orientation session, during which they will complete a planning worksheet with a research assistant.
They will identify specific strategies they will use to accomplish the pre-specified goal (i.e., to take two 15-minute activity breaks during each workday).
They will also identify potential barriers they will face and devise strategies for overcoming them.
The intervention will officially start the Monday after the orientation session and will last for 8 weeks.
Participants will receive a weekly email containing tips related to reducing sitting time at work.
All participants will complete daily activity logs indicating the time and duration of all breaks from sitting across the 8-week intervention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sedentary behavior during the workday
Time Frame: Baseline - week 8
|
Measured by GT3X accelerometer
|
Baseline - week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight
Time Frame: Baseline - week 9
|
Baseline - week 9
|
|
|
Change in blood pressure
Time Frame: Baseline - week 9
|
Baseline - week 9
|
|
|
Change in resting heart rate
Time Frame: Baseline - week 9
|
Baseline - week 9
|
|
|
Change in total cholesterol, HDL cholesterol, LDL cholesterol
Time Frame: Baseline - week 9
|
Baseline - week 9
|
|
|
Change in triglycerides
Time Frame: Baseline - week 9
|
Baseline - week 9
|
|
|
Change in fasting blood glucose
Time Frame: Baseline - week 9
|
Baseline - week 9
|
|
|
Change in waist circumference
Time Frame: Baseline - week 9
|
Baseline - week 9
|
|
|
Change in body composition
Time Frame: Baseline - week 9
|
DEXA or bioelectrical impedance
|
Baseline - week 9
|
|
Change in energy, tiredness, tension, and calmness
Time Frame: Baseline - week 8
|
Activation-Deactivation Checklist
|
Baseline - week 8
|
|
Change in fatigue severity, interference, and duration
Time Frame: Baseline - week 8
|
Fatigue Symptom Inventory
|
Baseline - week 8
|
|
Change in mood
Time Frame: Baseline - week 8
|
Positive and Negative Affect Scale
|
Baseline - week 8
|
|
Change in overall self-reported physical activity
Time Frame: Baseline - week 8
|
International Physical Activity Questionnaire
|
Baseline - week 8
|
|
Change in overall objectively measured physical activity
Time Frame: Baseline - week 8
|
Measured by GT3X accelerometer
|
Baseline - week 8
|
|
Change in diet quantity
Time Frame: Baseline - week 8
|
Measured by 3-day food diary
|
Baseline - week 8
|
|
Change in diet quality
Time Frame: Baseline - week 8
|
Dietary Screener Questionnaire
|
Baseline - week 8
|
|
Adherence to assigned protocols
Time Frame: up to 8 weeks
|
Measured by activity logs
|
up to 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Casey K, Mailey EL, Rosenkranz RR, Swank A, Ablah E, Rosenkranz SK. Does dietary intake change during an intervention to reduce sedentary behavior and cardiovascular disease risk? A randomized comparative effectiveness trial. BMC Nutr. 2018 Apr 2;4:16. doi: 10.1186/s40795-018-0223-1. eCollection 2018.
- Mailey EL, Rosenkranz SK, Ablah E, Swank A, Casey K. Effects of an Intervention to Reduce Sitting at Work on Arousal, Fatigue, and Mood Among Sedentary Female Employees: A Parallel-Group Randomized Trial. J Occup Environ Med. 2017 Dec;59(12):1166-1171. doi: 10.1097/JOM.0000000000001131.
- Mailey EL, Rosenkranz SK, Casey K, Swank A. Comparing the effects of two different break strategies on occupational sedentary behavior in a real world setting: A randomized trial. Prev Med Rep. 2016 Aug 9;4:423-8. doi: 10.1016/j.pmedr.2016.08.010. eCollection 2016 Dec.
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
Keywords
Other Study ID Numbers
- USRG-3046
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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