Sedentary LifestyleUp4HealthNCT02609438
An Intervention to Reduce Sitting Time at Work: Effects on Metabolic Health and Inactivity
A study testing Short breaks and Long breaks in people with Sedentary Lifestyle, run by Kansas State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Short breaks and Long breaks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Able to attend assessments
- Willing to wear accelerometer
- No anticipated significant conflicts during 8-week intervention
Who cannot join
- 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
About this study
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
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.
Read the 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).
- Conditions
- Sedentary Lifestyle
- Being tested
- Short breaks, Long breaks
- Keywords
- worksite, intervention, sitting
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short breaksBehavioural
Also called Up4Health - 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.
Long breaksBehavioural
Also called Up4Health - 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.
| Study group | Role | What they receive |
|---|---|---|
| Short breaks | Active comparator | Participants instructed to stand/move for 1-2 minutes every half hour throughout the workday Receives: Behavioral: Short breaks |
| Long breaks | Active comparator | Participants instructed to take two 15-minute activity breaks during each workday Receives: Behavioral: Long breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sedentary behavior during the workday
Measured by GT3X accelerometer
Measured: Baseline - week 8
Secondary outcomes (16)
Change in weight
Measured: Baseline - week 9
Change in blood pressure
Measured: Baseline - week 9
Change in resting heart rate
Measured: Baseline - week 9
Change in total cholesterol, HDL cholesterol, LDL cholesterol
Measured: Baseline - week 9
Change in triglycerides
Measured: Baseline - week 9
Change in fasting blood glucose
Measured: Baseline - week 9
Change in waist circumference
Measured: Baseline - week 9
Change in body composition
DEXA or bioelectrical impedance
Measured: Baseline - week 9
Change in energy, tiredness, tension, and calmness
Activation-Deactivation Checklist
Measured: Baseline - week 8
Change in fatigue severity, interference, and duration
Fatigue Symptom Inventory
Measured: Baseline - week 8
Change in mood
Positive and Negative Affect Scale
Measured: Baseline - week 8
Change in overall self-reported physical activity
International Physical Activity Questionnaire
Measured: Baseline - week 8
Change in overall objectively measured physical activity
Measured by GT3X accelerometer
Measured: Baseline - week 8
Change in diet quantity
Measured by 3-day food diary
Measured: Baseline - week 8
Change in diet quality
Dietary Screener Questionnaire
Measured: Baseline - week 8
Adherence to assigned protocols
Measured by activity logs
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Mailey, Kansas State University
- Investigators
- Emily L Mailey, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609438
- Sponsor's protocol ID
- USRG-3046
- Acronym
- Up4Health
- Status last verified
- Nov 2015
- First submitted
- 16 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32153880Mailey 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.
PubMed 28816735Mailey 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.
PubMed 27583200
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02609438
- Acronym / sponsor ID
- Up4Health / USRG-3046
- Conditions
- Sedentary Lifestyle
- Keywords
- worksite, intervention, sitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short breaks | Active comparator | Behavioral: Short breaksParticipants instructed to stand/move for 1-2 minutes every half hour throughout the workday |
| Long breaks | Active comparator | Behavioral: Long breaksParticipants instructed to take two 15-minute activity breaks during each workday |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short breaksAlso: Up4Health - short breaksFollowing 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. | Behavioural | Short breaks |
| Long breaksAlso: Up4Health - long breaksFollowing 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. | Behavioural | Long breaks |
Primary outcome
Change in sedentary behavior during the workday
Time frame: Baseline - week 8
Measured by GT3X accelerometer
16 secondary outcomes
Change in weight
Time frame: Baseline - week 9
Change in blood pressure
Time frame: Baseline - week 9
Change in resting heart rate
Time frame: Baseline - week 9
Change in total cholesterol, HDL cholesterol, LDL cholesterol
Time frame: Baseline - week 9
Change in triglycerides
Time frame: Baseline - week 9
Change in fasting blood glucose
Time frame: Baseline - week 9
Change in waist circumference
Time frame: Baseline - week 9
Change in body composition
Time frame: Baseline - week 9
Change in energy, tiredness, tension, and calmness
Time frame: Baseline - week 8
Change in fatigue severity, interference, and duration
Time frame: Baseline - week 8
Change in mood
Time frame: Baseline - week 8
Change in overall self-reported physical activity
Time frame: Baseline - week 8
Change in overall objectively measured physical activity
Time frame: Baseline - week 8
Change in diet quantity
Time frame: Baseline - week 8
Change in diet quality
Time frame: Baseline - week 8
Adherence to assigned protocols
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 32153880Casey 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.
- Derived from this study: PubMed 28816735Mailey 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.
- Derived from this study: PubMed 27583200Mailey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily L Mailey, PhD principal investigator
Kansas State University
Questions about this trial
What is this clinical trial studying?
A study testing Short breaks and Long breaks in people with Sedentary Lifestyle, run by Kansas State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sedentary behavior during the workday (time frame: Baseline - week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609438, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.