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An Intervention to Reduce Sitting Time at Work: Effects on Metabolic Health and Inactivity (Up4Health)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609438
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Emily Mailey, Kansas State University

Brief Summary:
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. Participants will be randomly assigned to take short, frequent breaks (i.e., 1 minute every half hour) or longer, planned breaks (i.e., two 15-minute walks) from sitting during the workday. They will be instructed to follow the assigned protocols for an 8-week intervention and the effects of their participation on sedentary behavior and a variety of health outcomes will be assessed. The investigators anticipate participants in both intervention arms will demonstrate significant reductions in daily sitting time, bit do not have an a priori hypothesis regarding the relative effectiveness of each approach.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: Short breaks Behavioral: Long breaks Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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 Start Date : March 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Short breaks
Participants instructed to stand/move for 1-2 minutes every half hour throughout the workday
Behavioral: Short breaks
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 Name: Up4Health - short breaks

Active Comparator: Long breaks
Participants instructed to take two 15-minute activity breaks during each workday
Behavioral: Long breaks
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 Name: Up4Health - long breaks




Primary Outcome Measures :
  1. Change in sedentary behavior during the workday [ Time Frame: Baseline - week 8 ]
    Measured by GT3X accelerometer


Secondary Outcome Measures :
  1. Change in weight [ Time Frame: Baseline - week 9 ]
  2. Change in blood pressure [ Time Frame: Baseline - week 9 ]
  3. Change in resting heart rate [ Time Frame: Baseline - week 9 ]
  4. Change in total cholesterol, HDL cholesterol, LDL cholesterol [ Time Frame: Baseline - week 9 ]
  5. Change in triglycerides [ Time Frame: Baseline - week 9 ]
  6. Change in fasting blood glucose [ Time Frame: Baseline - week 9 ]
  7. Change in waist circumference [ Time Frame: Baseline - week 9 ]
  8. Change in body composition [ Time Frame: Baseline - week 9 ]
    DEXA or bioelectrical impedance

  9. Change in energy, tiredness, tension, and calmness [ Time Frame: Baseline - week 8 ]
    Activation-Deactivation Checklist

  10. Change in fatigue severity, interference, and duration [ Time Frame: Baseline - week 8 ]
    Fatigue Symptom Inventory

  11. Change in mood [ Time Frame: Baseline - week 8 ]
    Positive and Negative Affect Scale

  12. Change in overall self-reported physical activity [ Time Frame: Baseline - week 8 ]
    International Physical Activity Questionnaire

  13. Change in overall objectively measured physical activity [ Time Frame: Baseline - week 8 ]
    Measured by GT3X accelerometer

  14. Change in diet quantity [ Time Frame: Baseline - week 8 ]
    Measured by 3-day food diary

  15. Change in diet quality [ Time Frame: Baseline - week 8 ]
    Dietary Screener Questionnaire

  16. Adherence to assigned protocols [ Time Frame: up to 8 weeks ]
    Measured by activity logs



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Work at least 35 hours per week
  2. Spend at least 80% of working hours sitting (self-reported)
  3. Engage in less than 60 minutes per week of leisure-time exercise (self-reported)
  4. Not pregnant or planning to become pregnant in the next 3 months
  5. Not currently trying to change weight
  6. Speak English
  7. Able to attend assessments
  8. Willing to wear accelerometer
  9. No anticipated significant conflicts during 8-week intervention

Exclusion Criteria:

  1. Male
  2. Working less than 35 hours per week
  3. Spend >25% of working hours standing or active
  4. Engage in more than 60 minutes per week of leisure-time exercise
  5. Pregnant
  6. Actively dieting or attempting to change weight

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609438


Sponsors and Collaborators
Kansas State University
Investigators
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Principal Investigator: Emily L Mailey, PhD Kansas State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emily Mailey, Assistant Professor, Kansas State University
ClinicalTrials.gov Identifier: NCT02609438    
Other Study ID Numbers: USRG-3046
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Emily Mailey, Kansas State University:
worksite
intervention
sitting