Energy IntakeNCT02119208
Effects of the Intensity and the Timing of the Physical Activity in a Primary School
A study testing Intensity and timing of exercise in people with Energy Intake, run by Université de Montréal at 1 site in Canada.
Trial summary
1. In natural environment, the moderate-intensity break will allow a reduction of the caloric intake at the dinner more important than for the light-intensity break 2. In natural environment, the break taken juste before dinner will allow a reduction of the caloric intake at the diner more important than earlier in… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Intake
- What is being tested?
- Intensity and timing of exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to May 2014
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged of approximately 5 years old of a of a nursery class of the school Jacques-Barclay, St-Mathieu
Who cannot join
- Present allergy of the foods in the lunch
- having a handicap or a limitation that avoid walking, running or tkaing part of the physcial activity courses at the school.
- Having a potential surgery
- Having a metabolic disease or taking drugs that could have an impact on the results of the study
- Be vegetarian
- Having intestinal disorders
Trial locations and contacts
1 site in 1 country.
About this study
- In natural environment, the moderate-intensity break will allow a reduction of the caloric intake at the dinner more important than for the light-intensity break
- In natural environment, the break taken juste before dinner will allow a reduction of the caloric intake at the diner more important than earlier in the day.
- Conditions
- Energy Intake
- Being tested
- Intensity and timing of exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity and timing of exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Intensity and timing of exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric intake at the breakfast, lunch and diner (kj)
Measured: 3 days per condition
Secondary outcomes (1)
Anthropometric measures
Measured: At preliminary visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy IntakeStudies 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Ève Mathieu, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119208
- Sponsor's protocol ID
- 13-135-CERES-P
- Status last verified
- Apr 2014
- First submitted
- 23 Feb 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Intensity and the Timing of the Physical Activity in a Primary School
- ClinicalTrials.gov ID
- NCT02119208
- Acronym / sponsor ID
- 13-135-CERES-P
- Conditions
- Energy Intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- 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.
- In natural environment, the moderate-intensity break will allow a reduction of the caloric intake at the dinner more important than for the light-intensity break
- In natural environment, the break taken juste before dinner will allow a reduction of the caloric intake at the diner more important than earlier in the day.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Intensity and timing of exercise |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged of approximately 5 years old of a of a nursery class of the school Jacques-Barclay, St-Mathieu
Key exclusion criteria (6 listed)
- Present allergy of the foods in the lunch
- having a handicap or a limitation that avoid walking, running or tkaing part of the physcial activity courses at the school.
- Having a potential surgery
- Having a metabolic disease or taking drugs that could have an impact on the results of the study
- Be vegetarian
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 |
|---|---|---|
| Intensity and timing of exercise | Behavioural | Lifestyle counseling |
Primary outcome
Caloric intake at the breakfast, lunch and diner (kj)
Time frame: 3 days per condition
1 secondary outcome
Anthropometric measures
Time frame: At preliminary visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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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 Intensity and timing of exercise in people with Energy Intake, run by Université de Montréal at 1 site in Canada.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Apr 2014. 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 Canada. 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?
Results are not available in the source record.
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?
Caloric intake at the breakfast, lunch and diner (kj) (time frame: 3 days per condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2014.