NCT02007681

Brief Summary

The main purposes of this randomized cross-over trial are to test if a 3h/day reduction of time spent in sedentary behaviour (SB) through breaking up hourly and shifting it for standing and walking behaviours would substantially increase total (TEE) and PA energy expenditure (PAEE) compared to a week of habitual prolonged SB, in male and female overweight/obese inactive (which do not attained MVPA recommendations) and sedentary desk workers. Specifically using an experiment design our main aims are: a) to determine the impact of reducing SB on TEE and PAEE; b) to analyse the independent effects of interrupting SB through breaks and the overall reduction in SB on TEE and PAEE; c) To analyse the determinants for the overall reduction in SB; d) If the changes occurred in TEE and PAEE were dependent on specific covariates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

Same day

First QC Date

November 26, 2013

Last Update Submit

December 6, 2013

Conditions

Keywords

Sedentary Behavior; Breaks; Workplace; Energy Expenditure; Physical activity; doubly labeled water

Outcome Measures

Primary Outcomes (10)

  • Change from control week and intervention week in total energy expenditure (TEE)

    The TEE was estimated by the doubly labeled water technique

    week 1 and week 2

  • Resting energy expenditure (REE)

    REE was measured by indirect calorimetry

    Baseline (day 0)

  • Change from control week and intervention week in physical activity energy expenditure (PAEE)

    PAEE was calculated as the difference between TEE and the sum of the REE and the thermogenic effect of food (assumed to be 10% of TEE)

    week 1 and week 2

  • Change from control week and intervention week in daily time spent in sedentary (SB)

    PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart)

    week 1 and week 2

  • Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities

    PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart)

    week 1 and week 2

  • Change from control week and intervention week in number of breaks in sedentary time (BST)

    PA variables were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart), and an inclinometer (activpal)

    week 1 and week 2

  • Change from control week and intervention week in time spent sitting (TSS)

    An inclinometer (activpal)

    week 1 and week 2

  • Change from control week and intervention week in time spent standing (TSst)

    An inclinometer (activpal)

    week 1 and week 2

  • Change from control week and intervention week in time spent walking (TSW)

    An inclinometer (activpal)

    week 1 and week 2

  • Change from control week and intervention week in number of steps

    Steps were assessed using an accelerometer, a combined device that measures accelerometry and heart rate (actiheart), an inclinometer (activpal) and a pedometer.

    week 1 and week 2

Secondary Outcomes (1)

  • Change from baseline and intervention week in body composition

    Baseline (day 0) and final day of intervention week

Study Arms (2)

Lifestyle change

EXPERIMENTAL

One 5-10 minute break per hour during the work day using a software that alert the participant, and perform 6000 steps above the baseline number of steps/day (previously evaluated), by adopting several domain specific strategies, during 7 days.

Behavioral: Reduction of sedentary time by breaking it with low intensity physical activity

Control

NO INTERVENTION

Regular free week with no changes performed

Interventions

One 5-10 minute break per hour during the work day using a software that alert the participant, and perform 6000 steps above the baseline number of steps/day (previously evaluated), by adopting several domain specific strategies, during 7 days.

Also known as: LIPA, breaks
Lifestyle change

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were required to be sedentary, between 18-65 years old, have a BMI above 25.0 kg/m2 and physical inactive (not meeting the MVPA recommendations and not exceed 6000 steps/day). In addition subjects had to be free of any major disease with a general healthy status warranted.

You may not qualify if:

  • Taking any medication or dietary supplements that may interfere with body composition or energy expenditure regulation, performing more than 5000 steps/day and meeting actual MVPA recommendations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Health Laboratory, Faculty of Human Kinetics, University of Lisboa

Cruz Quebrada, Lisbon District, 1495, Portugal

Location

Related Publications (3)

  • Judice PB, Teixeira L, Silva AM, Sardinha LB. Accuracy of Actigraph inclinometer to classify free-living postures and motion in adults with overweight and obesity. J Sports Sci. 2019 Aug;37(15):1708-1716. doi: 10.1080/02640414.2019.1586281. Epub 2019 Mar 7.

  • Judice PB, Hamilton MT, Sardinha LB, Silva AM. Randomized controlled pilot of an intervention to reduce and break-up overweight/obese adults' overall sitting-time. Trials. 2015 Nov 2;16:490. doi: 10.1186/s13063-015-1015-4.

  • Judice PB, Santos DA, Hamilton MT, Sardinha LB, Silva AM. Validity of GT3X and Actiheart to estimate sedentary time and breaks using ActivPAL as the reference in free-living conditions. Gait Posture. 2015 May;41(4):917-22. doi: 10.1016/j.gaitpost.2015.03.326. Epub 2015 Mar 30.

MeSH Terms

Conditions

Risk Reduction BehaviorSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Analiza M Silva, PhD

    Faculty of Human Kinetics, University of Lisboa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Analiza M Silva

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 11, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations