NCT02951624

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

October 30, 2016

Last Update Submit

December 12, 2018

Conditions

Keywords

ExerciseBreaking prolonged sittingphysical activity

Outcome Measures

Primary Outcomes (1)

  • AUC post prandial glucose concentration

    6 hours

Secondary Outcomes (10)

  • AUC post prandial insulin concentration

    6 hours

  • AUC post prandial c-peptide concentration

    6 hours

  • AUC post prandial triglyceride concentration

    6 hours

  • AUC post prandial total cholesterol concentration

    6 hours

  • AUC post prandial ldl concentration

    6 hours

  • +5 more secondary outcomes

Study Arms (4)

Control

EXPERIMENTAL

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

Breaker

EXPERIMENTAL

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

Intermediate

EXPERIMENTAL

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

Prolonger

EXPERIMENTAL

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

Interventions

ControlBEHAVIORAL

Control intervention

Control
BreakerBEHAVIORAL

Short breaks of physical activity

Breaker
ProlongerBEHAVIORAL

longer breaks of physical activity

Prolonger
IntermediateBEHAVIORAL

Intermediate breaks of physical activity

Intermediate

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Physical Activity Research, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Sedentary BehaviorOverweightObesityMetabolic DiseasesMotor Activity

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mathias Ried, PhD

    Group leader

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader

Study Record Dates

First Submitted

October 30, 2016

First Posted

November 1, 2016

Study Start

November 1, 2016

Primary Completion

July 15, 2018

Study Completion

July 15, 2018

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations