Physical ActivityNCT03138187
Physical Exercise and Energy Balance
A study testing Moderate exercise and Vigorous exercise in people with Physical Activity, run by Rio de Janeiro State University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men only
- Conditions the study is for
- Physical Activity
- What is being tested?
- Moderate exercise and Vigorous exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male
- overweight
Who cannot join
- diabetes mellitus
- cardiovascular diseases
- musculoskeletal injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Physical Exercise Intensity on Spontaneous Physical Activity Energy Expenditure and Energy Intake in Overweight Adults: a Study Protocol for a Randomized Controlled Trial.
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.
- Conditions
- Physical Activity
- Being tested
- Moderate exercise, Vigorous exercise
- Keywords
- spontaneous physical activity, caloric intake
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate exerciseBehavioural
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
Vigorous exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Vigorous exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Secondary outcomes (3)
appetite sensations
Subjective hunger and satiety sensations will be measured through the visual analog scale (VAS) proposed by Flint et al. (2000).
Measured: 15 days
energy intake
Food and beverages consumption will be assessed by 24-h food recalls (REC24h). Nutritionists will conduct a face-to-face interview in four different moments during the intervention period: at the 2nd and 5th days (Tuesday and Friday) in the first week; and at the 11th and 15th days (Thursday and Monday) in the second week, including weekdays and weekend.
Measured: 15 days
laboratorial biomarkers
To investigate the physiological mechanisms involved in energy expenditure and food consumption regulation, blood and salivary samples will be collected to biochemical and hormonal analyses at the 1st (baseline) and the 15th days of the intervention period, in the morning, after at least 10 hours of fasting.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jun 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosely Sichieri, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138187
- Sponsor's protocol ID
- exercise and obesity
- Status last verified
- Sep 2019
- First submitted
- 30 Apr 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33221391Paravidino 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.
PubMed 29514690
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Exercise Intensity on Spontaneous Physical Activity Energy Expenditure and Energy Intake in Overweight Adults: a Study Protocol for a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03138187
- Acronym / sponsor ID
- exercise and obesity
- Conditions
- Physical Activity
- Keywords
- spontaneous physical activity, caloric intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –without physical exercise sessions |
| Moderate exercise group | Experimental | Behavioral: Moderate exerciseThe 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 |
| Vigorous exercise group | Experimental | Behavioral: Vigorous exerciseThe 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male
- overweight
Key exclusion criteria (3 listed)
- diabetes mellitus
- cardiovascular diseases
- musculoskeletal injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate exerciseThe 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 | Behavioural | Moderate exercise group |
| Vigorous exerciseThe 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 | Behavioural | Vigorous exercise group |
Primary outcome
spontaneous physical activity energy expenditure
Time frame: 15 days
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
3 secondary outcomes
appetite sensations
Time frame: 15 days
energy intake
Time frame: 15 days
laboratorial biomarkers
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 33221391Paravidino 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.
- Derived from this study: PubMed 29514690Paravidino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate exercise and Vigorous exercise in people with Physical Activity, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spontaneous physical activity energy expenditure (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.