NCT03138187

Brief Summary

This study is a randomized controlled trial, designed to evaluate the effect of structured physical exercise sessions on the spontaneous physical activity energy expenditure and caloric intake in overweight adults. The design employs a parallel three-group experimental arms: (1) a moderate exercise group (MEG); (2) a vigorous exercise group (VEG); and a control group (CG) without physical exercise sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

April 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

April 30, 2017

Last Update Submit

September 16, 2019

Conditions

Physical Activity

Keywords

spontaneous physical activitycaloric intake

Outcome Measures

Primary Outcomes (1)

  • spontaneous physical activity energy expenditure

    Physical activity energy expenditure will be assessed by a triaxial accelerometers (ActiGraph GT3x-BT, Pensacola, FL, USA). The device will be positioned at the anterior axillary line of the non-dominant hip, for 15 consecutive days

    15 days

Secondary Outcomes (3)

  • appetite sensations

    15 days

  • energy intake

    15 days

  • laboratorial biomarkers

    15 days

Study Arms (3)

control

NO INTERVENTION

without physical exercise sessions

Moderate exercise group

EXPERIMENTAL

The training phase of the moderate exercise group (MEG) will consist of 4 sets of 10 minutes walking/running at moderate intensity, with 5 minutes walking at low intensity for recovery between sets

Behavioral: Moderate exercise

Vigorous exercise group

EXPERIMENTAL

The training phase of the vigorous exercise group (VEG) will consist of 4 sets of 10 minutes running at vigorous intensity, with 5 minutes walking at low intensity for recovery between sets

Behavioral: Vigorous exercise

Interventions

Moderate exerciseBEHAVIORAL

The training phase of the moderate exercise group (MEG) will consist of 4 sets of 10 minutes walking/running at moderate intensity, with 5 minutes walking at low intensity for recovery between sets

Moderate exercise group
Vigorous exerciseBEHAVIORAL

The training phase of the vigorous exercise group (VEG) will consist of 4 sets of 10 minutes running at vigorous intensity, with 5 minutes walking at low intensity for recovery between sets

Vigorous exercise group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsonly male
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • overweight

You may not qualify if:

  • diabetes mellitus
  • cardiovascular diseases
  • musculoskeletal injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Academy

Rio de Janeiro, 20021-010, Brazil

Location

Related Publications (2)

  • Paravidino VB, Mediano MFF, Crochemore-Silva I, da Cruz VL, Antunes MML, Beaulieu K, Gibbons C, Finlayson G, Blundell JE, Sichieri R. The compensatory effect of exercise on physical activity and energy intake in young men with overweight: The EFECT randomised controlled trial. Physiol Behav. 2021 Feb 1;229:113249. doi: 10.1016/j.physbeh.2020.113249. Epub 2020 Nov 20.

    PMID: 33221391DERIVED

  • Paravidino VB, Mediano MFF, Silva ICM, Wendt A, Del Vecchio FB, Neves FA, Terra BS, Gomes EAC, Moura AS, Sichieri R. Effect of physical exercise on spontaneous physical activity energy expenditure and energy intake in overweight adults (the EFECT study): a study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):167. doi: 10.1186/s13063-018-2445-6.

    PMID: 29514690DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and physical trainer blinding will not be feasible due to the characteristics of prescribed exercise sessions. However, the evaluators will be blinded to the following endpoints: weight, body composition, appetite, energy intake and laboratorial biomarkers.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

April 30, 2017

First Posted

May 3, 2017

Study Start

June 1, 2017

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)