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The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors (BPS2)

Primary Purpose

Sedentary Lifestyle, Overweight and Obesity, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Control
Breaker
Prolonger
Intermediate
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Lifestyle focused on measuring Exercise, Breaking prolonged sitting, physical activity

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Males, age 20-50 years, waist-to-height ratio ≥ 0.5 and/or waist circumference ≥ 102 cm.

Exclusion Criteria:

  • Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz & Reibold 1990), contraindications to increased levels of physical activity.

Sites / Locations

  • Center for Physical Activity Research, Copenhagen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Breaker

Intermediate

Prolonger

Arm Description

Participants will spend 8 hours sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.) Participants will only be allowed to stand or walk to go to the toilet.

Participants will spend a total of 7 hours and 12 min sedentary and a total of 48 min breaking sitting time with LPA. Sedentary time will be done in bouts of 18 min with 2 min of light walking.

Total duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 54 min with 6 min of LPA between each bout.

Total duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 108 min with 12 min of LPA between each bout.

Outcomes

Primary Outcome Measures

AUC post prandial glucose concentration

Secondary Outcome Measures

AUC post prandial insulin concentration
AUC post prandial c-peptide concentration
AUC post prandial triglyceride concentration
AUC post prandial total cholesterol concentration
AUC post prandial ldl concentration
AUC post prandial hdl concentration
AUC post prandial glucagon concentration
Mean 24 hour glucose concentration
Variation in 24 hour glucose concentration
Maximum in 24 hour glucose concentration

Full Information

First Posted
October 30, 2016
Last Updated
December 12, 2018
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02951624
Brief Title
The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors
Acronym
BPS2
Official Title
The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is to investigate the acute effect of the frequency and duration of breaks in sitting time on the metabolic risk factor profile.
Detailed Description
Fifteen (n=15) sedentary adult overweight males will be included in the study. All participants will undergo the four interventions in a randomized cross-over design. Wash out between intervention will be minimum four days. Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.), with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand or walk to go to the toilet. Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low intensity walking. Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low intensity walking Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low intensity walking All interventions will be matched for total physical activity as well as sitting. Thus, we aim for the active interventions to be iso-caloric.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Overweight and Obesity, Metabolic Disease
Keywords
Exercise, Breaking prolonged sitting, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Participants will spend 8 hours sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.) Participants will only be allowed to stand or walk to go to the toilet.
Arm Title
Breaker
Arm Type
Experimental
Arm Description
Participants will spend a total of 7 hours and 12 min sedentary and a total of 48 min breaking sitting time with LPA. Sedentary time will be done in bouts of 18 min with 2 min of light walking.
Arm Title
Intermediate
Arm Type
Experimental
Arm Description
Total duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 54 min with 6 min of LPA between each bout.
Arm Title
Prolonger
Arm Type
Experimental
Arm Description
Total duration of sedentary time and LPA time will be the same as in Breaker. Sedentary time will be done in bouts of 108 min with 12 min of LPA between each bout.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control intervention
Intervention Type
Behavioral
Intervention Name(s)
Breaker
Intervention Description
Short breaks of physical activity
Intervention Type
Behavioral
Intervention Name(s)
Prolonger
Intervention Description
longer breaks of physical activity
Intervention Type
Behavioral
Intervention Name(s)
Intermediate
Intervention Description
Intermediate breaks of physical activity
Primary Outcome Measure Information:
Title
AUC post prandial glucose concentration
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
AUC post prandial insulin concentration
Time Frame
6 hours
Title
AUC post prandial c-peptide concentration
Time Frame
6 hours
Title
AUC post prandial triglyceride concentration
Time Frame
6 hours
Title
AUC post prandial total cholesterol concentration
Time Frame
6 hours
Title
AUC post prandial ldl concentration
Time Frame
6 hours
Title
AUC post prandial hdl concentration
Time Frame
6 hours
Title
AUC post prandial glucagon concentration
Time Frame
6 hours
Title
Mean 24 hour glucose concentration
Time Frame
24 hours
Title
Variation in 24 hour glucose concentration
Time Frame
24 hours
Title
Maximum in 24 hour glucose concentration
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males, age 20-50 years, waist-to-height ratio ≥ 0.5 and/or waist circumference ≥ 102 cm. Exclusion Criteria: Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz & Reibold 1990), contraindications to increased levels of physical activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Ried, PhD
Organizational Affiliation
Group leader
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Physical Activity Research, Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data may be available after publication (fully anonymized) by contact the PI

Learn more about this trial

The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors

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