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

December 12, 2018 updated by: Mathias Ried-Larsen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Center for Physical Activity Research, Copenhagen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
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.
Behavioral: Control
Control intervention
Experimental: Breaker
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.
Behavioral: Breaker
Short breaks of physical activity
Experimental: Intermediate
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.
Behavioral: Intermediate
Intermediate breaks of physical activity
Experimental: Prolonger
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.
Behavioral: Prolonger
longer breaks of physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC post prandial glucose concentration
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC post prandial insulin concentration
Time Frame: 6 hours
6 hours
AUC post prandial c-peptide concentration
Time Frame: 6 hours
6 hours
AUC post prandial triglyceride concentration
Time Frame: 6 hours
6 hours
AUC post prandial total cholesterol concentration
Time Frame: 6 hours
6 hours
AUC post prandial ldl concentration
Time Frame: 6 hours
6 hours
AUC post prandial hdl concentration
Time Frame: 6 hours
6 hours
AUC post prandial glucagon concentration
Time Frame: 6 hours
6 hours
Mean 24 hour glucose concentration
Time Frame: 24 hours
24 hours
Variation in 24 hour glucose concentration
Time Frame: 24 hours
24 hours
Maximum in 24 hour glucose concentration
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Mathias Ried, PhD, Group Leader

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

July 15, 2018

Study Completion (Actual)

July 15, 2018

Study Registration Dates

First Submitted

October 30, 2016

First Submitted That Met QC Criteria

October 30, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data may be available after publication (fully anonymized) by contact the PI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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