NCT02258438

Brief Summary

The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting. The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 8, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

October 2, 2014

Last Update Submit

April 29, 2021

Conditions

Keywords

Sedentary Behavior

Outcome Measures

Primary Outcomes (3)

  • Total substrate oxidation

    Total fat oxidation during the test day will be determined using whole-room indirect calorimetry. O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described

    1 day

  • Postprandial plasma insulin and glucose response

    Plasma glucose and insulin will be measured in fasting conditions and hourly during 12hrs following a standard meal consumption. The area under the curve will be calculated for both plasma glucose and insulin. This area will represent the postprandial response to a meal for both insulin and glucose.

    1 day

  • Dietary fat oxidation

    Subjects will collect their own hourly breath sampling for 13CO2 by blowing through a straw into two 15ml Vacutainer after the investigators will have shown them the procedure. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with Isotopic Ratio Mass Spectrometer (IRMS).

    1 day

Study Arms (3)

Uninterrupted sitting

EXPERIMENTAL

Patient will refrain from any structured activity and reduce any daily life activity. The patient will spend 24 hours in the calorimeter room. During the 24 hours the patient will remain sedentary for the 24 hours but will be able to watch TV, computer work or read.

Behavioral: Uninterrupted sitting

Sitting + 1 bout of activity

EXPERIMENTAL

The patient will be asked to perform the 45 minutes of moderate-exercise intervention in the morning once per day for two days in their daily life. This bout of exercise will be supervised by study staff on one of the treadmills On day 3 the patient will report at the Clinical and Translational Research Center (CTRC) of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, you will be asked to sit quietly in a chair, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity walking on a treadmill.

Behavioral: Sitting + 1 bout of activity

Sitting + microbursts of activity

EXPERIMENTAL

The patient will be asked to refrain from any structured exercise running, swimming, lifting weights, yoga, dancing, etc.) for two days but to walk for the 5 minute intervention each hour between 1000 and 1800. On day 3, The patient will report at the CTRC of the University Hospital of Colorado and will spend 24hr in the room calorimeter. During the day, the patient will be asked to rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5 min moderate-intensity walking on a treadmill, which represents a total of 45 min.

Behavioral: Sitting + microbursts of activity

Interventions

Subjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life. On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void.

Uninterrupted sitting

Subjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life. On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000.

Sitting + 1 bout of activity

Subjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life. On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min.

Sitting + microbursts of activity

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overweight but weight stable (less than +/- 3kg over previous 6 months) male and female adults (n=24) will be recruited.
  • age between 19-45 years old,
  • a BMI of 27-33 kg/m2,
  • inactive (≤ 1.5hr/wk of moderate-to-vigorous activity),
  • sedentary (office employees who are spending more than 6hrs/day in sitting position) and
  • English-speaking.

You may not qualify if:

  • any history of renal, cardiovascular or hepatic diseases,
  • type 1 or 2 diabetes,
  • cancer,
  • pregnancy,
  • smoking,
  • consumption of drugs or alcohol (\>40g/d),
  • any medications known to interfere with lipid or energy metabolism,
  • known physical activity contraindications, or major illness/physical problems (acute or chronic) that may limit their ability to perform the walking activities and
  • menopause (defined as no menses in the prior 6 months). The use of birth pill control will be accepted. Women are asked to avoid pregnancy until completion of Condition C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • De Jong NP, Rynders CA, Goldstrohm DA, Pan Z, Lange AH, Mendez C, Melanson EL, Bessesen DH, Bergouignan A. Effect of frequent interruptions of sedentary time on nutrient metabolism in sedentary overweight male and female adults. J Appl Physiol (1985). 2019 Apr 1;126(4):984-992. doi: 10.1152/japplphysiol.00632.2018. Epub 2019 Jan 10.

MeSH Terms

Conditions

Health BehaviorSedentary Behavior

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Audrey Bergouignan, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 7, 2014

Study Start

October 8, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations