Effect of Frequent Interruptions of Prolonged Sitting on Self-perceived Levels of Energy, Mood, Food Cravings and Cognitive Function
1 other identifier
interventional
30
0 countries
N/A
Brief 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 measures of metabolic health. The primary hypotheses are:
- 1.Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function as compared to a no exercise condition.
- 2.Hourly 5 minute bouts of moderate intensity exercise during the day will increase afternoon cognitive function more than a single 30 minute AM bout.
- 3.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.
- 4.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedMarch 23, 2016
March 1, 2016
6 months
February 22, 2016
March 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Energy and Mood level
Self-perceived energy and mood were measured by using visual analogue scales (VAS) as described below at baseline.
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
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.
During each of the three separate study days cognitive function is measured at (in minutes): T425
Study Arms (3)
Uninterrupted sitting
NO INTERVENTIONSubjects remained seated all day except to rise from the chair to void.
Sitting + one bout of activity
ACTIVE COMPARATORSubjects 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
EXPERIMENTALSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27809874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Hill
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
March 23, 2016
Study Start
November 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 23, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share
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.