Effects of Microbouts of Activity on Metabolic Health
1 other identifier
interventional
30
1 country
1
Brief Summary
Population studies suggest that time spent in sedentary behaviors is associated with all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of time spent in exercise. Frequent interruptions to sedentary time are however beneficially associated with metabolic health outcomes, even in individuals who exercise regularly. The goal is to use integrative approach to understand the biological mechanisms that underlie these associations in a longitudinal intervention study in overweight sedentary adults. The investigators believe that the proposed study will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of activity. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches.
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 May 2017
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedStudy Start
First participant enrolled
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2021
CompletedNovember 18, 2024
November 1, 2024
4.4 years
December 2, 2016
November 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in sedentary time as measured by ActiPAL
Over each 2 week period, participants will be instructed to wear an ActiPAL (PALTechnologies: Glasgow, Scotland) activity monitor on their right leg. Participants will be instructed to wear the monitors at all times except when sleeping or participating in water-based activities. The time-stamped "event" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day.
weeks 1-2 and weeks 5-6
Changes in insulin sensitivity
Insulin sensitivity will be determined via an insulin modified frequently sampled intra-venous glucose tolerance test (IVGTT). After baseline samples, intravenous glucose (0.3 g/kg) will be infused over 1 minute, followed by insulin at 0.03 U/kg, 20 minutes after glucose administration. Blood samples will be frequently sampled over 5 hours, and insulin sensitivity will be calculated using the Bergman minimal model.
Week 2 and week 8
Postprandial glycemia
Incremental area under the curve of plasma glucose concentration measured in fasting and every hour for 14 hours.
Week 2 and week 8
Secondary Outcomes (12)
Changes in total energy expenditure (TEE)
week 1-2 and week 5-6
Changes in Moderate-to-vigorous physical activity as measured by ActiGraph
weeks 1-6
24hr substrate oxidation and energy expenditure
Week 2 and week 8
Changes in Dietary Carbohydrate Oxidation
week 2 and week 8
Changes in Dietary Fat Oxidation
week 2 and week 8
- +7 more secondary outcomes
Other Outcomes (1)
Self-perceived appetite and hunger
Week 2 and week 8
Study Arms (2)
Traditional Exercise Training
ACTIVE COMPARATORParticipants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations.
Daily Microbursts of Activity
EXPERIMENTALParticipants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks.
Interventions
Participants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations.
Participants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks.
Eligibility Criteria
You may qualify if:
- Overweight but weight stable (+/- 3kg over previous 6 months) sedentary male and female adults (n=30) will be recruited.
- Ages between 18-45 years old
- BMI of 25-35 kg/m2
- Sedentary ( self report \< 150min/wk of moderate-to-vigorous activity or less than 6,500 steps per day as measured for 5 days in free-living conditions with a pedometer).
- The use of birth pill control will be accepted
You may not qualify if:
- Any history of renal (present or past kidney failure, kidney transplant, dialysis or kidney cysts),
- Uncontrolled hypertension
- Cardiovascular (present or past atherosclerosis, heart attack, ischemic stroke, heart failure)
- Hepatic diseases (past or present hepatitis B or C, fibrosis, cirrhosis, NAFLD/NASH)
- Type 1 or 2 diabetes
- Cancer
- Smoking
- Consumption of drugs (marijuana included)
- Consumption of alcohol (\>40g/d)
- HIV positivity
- Psychiatric disorders
- Any medications known to interfere with lipid or energy metabolism
- Known physical activity contraindications
- Major illness/physical problems (acute or chronic) that may limit their ability to perform the walking activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Audrey Bergouignan, PhD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 21, 2016
Study Start
May 9, 2017
Primary Completion
October 8, 2021
Study Completion
October 8, 2021
Last Updated
November 18, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share