MoodNCT02717377
Effect of Frequent Interruptions of Prolonged Sitting on Self-perceived Levels of Energy, Mood, Food Cravings and Cognitive Function
A study testing physical activity in people with Mood and Energy, run by University of Colorado, Denver.
Trial summary
This study is designed to test the effects of six 5 minute microbursts of physical activity spread across the day as compared to either a sedentary control condition or a single 30 minute bout of moderate intensity physical activity on cognitive function, self-reported energy levels, aspects of eating behavior and… Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood, Energy, Food Cravings
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2014
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All ethnic groups and both genders
- Age: Lower age limit: 19 years; Upper age limit: 45 years
- Body-mass Index: Lower BMI limit: 18.5 kg/m2; Upper BMI limit: 29.9 kg/m2
- Willing to adhere to caffeine restrictions of no more than two 16 ounce beverages in the morning of each study day with no caffeine intake after 12:00pm on any of the three study days
Who cannot join
- History of cardiovascular disease, including coronary artery disease, congestive heart failure, \& unstable angina, or uncontrolled hypertension (>140/90 mm Hg)
- Currently smoking or stopped smoking in the last 6 months
- Medications affecting weight, energy intake, or energy expenditure in the last 6 months
- Use of oral steroids
- History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushing's syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
- Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
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- Infectious diseases: Self-reported HIV positivity or active tuberculosis
- Inability to exercise for more than 30 minutes on a treadmill at moderate intensity
- Currently pregnant, lactating or less than 6 months post-partum
- History of a major psychiatric disorder including schizophrenia, bipolar illness or psychotic depression
- Score of >25 on Beck Depression Inventory
- No recreational drug use including marijuana in the past 1 year
About this study
This study is designed to test the effects of six 5 minute microbursts of physical activity spread across the day as compared to either a sedentary control condition or a single 30 minute bout of moderate intensity physical activity on cognitive function, self-reported energy levels, aspects of eating behavior and measures of metabolic health. The primary hypotheses are:
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function as compared to a no exercise condition.
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function more than a single 30 minute AM bout.
Read more
Secondary exploratory hypotheses include
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health as compared to a no exercise condition.
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health more than a single 30 minute AM bout.
- Conditions
- Mood, Energy, Food Cravings, Cognitive Function
- Being tested
- physical activity
- Keywords
- Micro bouts, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Uninterrupted sitting | No intervention | Subjects remained seated all day except to rise from the chair to void. |
| Sitting + one bout of activity | Active comparator | Subjects remained seated all day, except to rise from the chair to void, and to perform one bout of 30-minutes moderate-intensity walking. Physical activity was performed at 0800, after measures of vitals and basal questionnaire assessments, but before breakfast. Receives: Behavioral: physical activity |
| Sitting + microbursts of activity | Experimental | Subjects rose from the seated position every hour for 6-hours from 0910 to 1430 to complete 5-minute bouts of moderate-intensity walking, yielding a total activity time of 30-minutes. Receives: Behavioral: physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Energy and Mood level
Self-perceived energy and mood were measured by using visual analogue scales (VAS) as described below at baseline.
Measured: During each of the three separate study days energy and mood levels are assessed at (in minutes): T0, T40, T70, T80, T90, T120, T140, T230, T350, T390, T400, T405, T410, and T435
Change in Cognitive function
The flanker task is used to measure cognitive function
Measured: During each of the three separate study days cognitive function is measured at (in minutes): T410
Change in Cognitive Function
After the Flanker task, the Comprehensive Trail Making Test is used to measure cognitive function during each study day.
Measured: During each of the three separate study days cognitive function is measured at (in minutes): T425
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoodStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Hill, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717377
- Sponsor's protocol ID
- 13-2777
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This clinical trial is a small study (n=30) that received limited funding from Johnson and Johnson Company, a non-public funding company. Our data sharing plan will follow the NIH guidelines for data sharing plans of small clinical trials and not unique set of data that could benefit the community (http://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_faqs.htm#901). Following the NIH definition of "the timely release and sharing" to be no later than the acceptance for publication of the main findings from the final data set, final research data will be shared through scientific publications after peer-review.
Publications
Bergouignan A, Legget KT, De Jong N, Kealey E, Nikolovski J, Groppel JL, Jordan C, O'Day R, Hill JO, Bessesen DH. Effect of frequent interruptions of prolonged sitting on self-perceived levels of energy, mood, food cravings and cognitive function. Int J Behav Nutr Phys Act. 2016 Nov 3;13(1):113. doi: 10.1186/s12966-016-0437-z.
PubMed 27809874
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Frequent Interruptions of Prolonged Sitting on Self-perceived Levels of Energy, Mood, Food Cravings and Cognitive Function
- ClinicalTrials.gov ID
- NCT02717377
- Acronym / sponsor ID
- 13-2777
- Conditions
- Mood, Energy, Food Cravings, Cognitive Function
- Keywords
- Micro bouts, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Mar 2016 (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.
This study is designed to test the effects of six 5 minute microbursts of physical activity spread across the day as compared to either a sedentary control condition or a single 30 minute bout of moderate intensity physical activity on cognitive function, self-reported energy levels, aspects of eating behavior and measures of metabolic health. The primary hypotheses are:
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function as compared to a no exercise condition.
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function more than a single 30 minute AM bout.
Secondary exploratory hypotheses include
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health as compared to a no exercise condition.
- Hourly 5 minute bouts of moderate intensity exercise during the day will increase self-reported energy levels, reduce orexigenic appetitive measures and improve measures of metabolic health more than a single 30 minute AM bout.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uninterrupted sitting | No intervention | –Subjects remained seated all day except to rise from the chair to void. |
| Sitting + one bout of activity | Active comparator | Behavioral: physical activitySubjects remained seated all day, except to rise from the chair to void, and to perform one bout of 30-minutes moderate-intensity walking. Physical activity was performed at 0800, after measures of vitals and basal questionnaire assessments, but before breakfast. |
| Sitting + microbursts of activity | Experimental | Behavioral: physical activitySubjects rose from the seated position every hour for 6-hours from 0910 to 1430 to complete 5-minute bouts of moderate-intensity walking, yielding a total activity time of 30-minutes. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All ethnic groups and both genders
- Age: Lower age limit: 19 years; Upper age limit: 45 years
- Body-mass Index: Lower BMI limit: 18.5 kg/m2; Upper BMI limit: 29.9 kg/m2
- Willing to adhere to caffeine restrictions of no more than two 16 ounce beverages in the morning of each study day with no caffeine intake after 12:00pm on any of the three study days
Key exclusion criteria (12 listed)
- History of cardiovascular disease, including coronary artery disease, congestive heart failure, \& unstable angina, or uncontrolled hypertension (>140/90 mm Hg)
- Currently smoking or stopped smoking in the last 6 months
- Medications affecting weight, energy intake, or energy expenditure in the last 6 months
- Use of oral steroids
- History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushing's syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
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 |
|---|---|---|
| physical activity | Behavioural | Sitting + microbursts of activity, Sitting + one bout of activity |
Primary outcome
Change in Energy and Mood level
Time frame: During each of the three separate study days energy and mood levels are assessed at (in minutes): T0, T40, T70, T80, T90, T120, T140, T230, T350, T390, T400, T405, T410, and T435
Self-perceived energy and mood were measured by using visual analogue scales (VAS) as described below at baseline.
Change in Cognitive function
Time frame: During each of the three separate study days cognitive function is measured at (in minutes): T410
The flanker task is used to measure cognitive function
Change in Cognitive Function
Time frame: During each of the three separate study days cognitive function is measured at (in minutes): T425
After the Flanker task, the Comprehensive Trail Making Test is used to measure cognitive function during each study day.
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 23 Mar 2016.
- Derived from this study: PubMed 27809874Bergouignan A, Legget KT, De Jong N, Kealey E, Nikolovski J, Groppel JL, Jordan C, O'Day R, Hill JO, Bessesen DH. Effect of frequent interruptions of prolonged sitting on self-perceived levels of energy, mood, food cravings and cognitive function. Int J Behav Nutr Phys Act. 2016 Nov 3;13(1):113. doi: 10.1186/s12966-016-0437-z.
- Individual participant dataSharing planned: No. This clinical trial is a small study (n=30) that received limited funding from Johnson and Johnson Company, a non-public funding company. Our data sharing plan will follow the NIH guidelines for data sharing plans of small clinical trials and not unique set of data that could benefit the community (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm#901). Following the NIH definition of "the timely release and sharing" to be no later than the acceptance for publication of the main findings from the final data set, final research data will be shared through scientific publications after peer-review.
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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.
James Hill principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Mood and Energy, run by University of Colorado, Denver.
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 4 inclusion and 12 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 23 Mar 2016. 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 Energy and Mood level (time frame: During each of the three separate study days energy and mood levels are assessed at (in minutes): T0, T40, T70, T80, T90, T120, T140, T230, T350, T390, T400, T405, T410, and T435). The study lists 3 primary outcomes in all. 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 NCT02717377, which also lists 1 linked publication.
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 23 Mar 2016.