Cardiovascular Diseases RiskNCT03479658
Dose-effect of HIIT on Cardiovascular Health of Children
A study testing High intensity interval training and Nutritional education in people with Cardiovascular Diseases Risk and Adiposity, run by Universidad Pública de Navarra at 1 site in Spain.
Trial summary
An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases Risk, Adiposity
- What is being tested?
- High intensity interval training and Nutritional education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 27 Feb 2018to 30 Sep 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All school children able to attend the physical education sessions of the school
- -
Who cannot join
- Children with medical condition that limits physical activity
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Health Sciences, Universidad Pública de Navarra
Pamplona, Navarre, 31008
About this study
Official title: Dose-effect of HIIT on Cardiovascular Health of Children Aged 9 to 10 Years Old Participating in a School Based Multidisciplinary Intervention Program: a Pilot Study
An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children.
The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases.
School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.
- Conditions
- Cardiovascular Diseases Risk, Adiposity
- Being tested
- High intensity interval training, Nutritional education
- Keywords
- HIIT, nutritional education, Dose-effect, school, children, cardiovascular, adiposity, blood pressure, fitness
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old). One of them has two physical education (PE) sessions per week and the other has only one PE session per week. In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group. Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup. Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools. The duration of the intervention will be of eight weeks.
Nutritional educationBehavioural
School-based nutritional education on healthy dietary habits
| Study group | Role | What they receive |
|---|---|---|
| HIIT two sessions | Experimental | Two sessions per week of HIIT + nutritional education (1 session/week) Receives: Behavioral: High intensity interval training; Behavioral: Nutritional education |
| HIIT one session | Experimental | One session per week of HIIT + nutritional education (1 session/week) Receives: Behavioral: High intensity interval training; Behavioral: Nutritional education |
| Nutritional education | Active comparator | Nutritional education (1 session/week) Receives: Behavioral: Nutritional education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness
20m shuttle run test (Alpha battery)
Measured: Change from baseline cardiorespiratory fitness at eight weeks
Secondary outcomes (5)
Change in Body fat
Body fat percent measured by bioimpedance
Measured: Change from baseline body fat at eight weeks
Change in Ankle-brachial index
Automated simultaneous blood pressure measurement
Measured: Change from baseline Ankle-brachial index at eight weeks
Change in Dietary habits
Food frequency questionnaire and 24h recall
Measured: Change from baseline Dietary habits at eight weeks
Change in Muscular strength
Handgrip strength and long jump (Alpha battery)
Measured: Change from baseline Muscular strength at eight weeks
Change in speed-agility
4x10m speed agility test (Alpha battery)
Measured: Change from baseline speed agility at eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start27 Feb 2018
- Primary completion20 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases RiskStudies 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
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idoia Labayen, Universidad Pública de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479658
- Sponsor's protocol ID
- PI-018/17
- Status last verified
- Oct 2018
- First submitted
- 20 Feb 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-effect of HIIT on Cardiovascular Health of Children Aged 9 to 10 Years Old Participating in a School Based Multidisciplinary Intervention Program: a Pilot Study
- ClinicalTrials.gov ID
- NCT03479658
- Acronym / sponsor ID
- PI-018/17
- Conditions
- Cardiovascular Diseases Risk, Adiposity
- Keywords
- HIIT, nutritional education, Dose-effect, school, children, cardiovascular, adiposity, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 27 Mar 2018 (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.
An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children.
The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases.
School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIIT two sessions | Experimental | Behavioral: High intensity interval training, Behavioral: Nutritional educationTwo sessions per week of HIIT + nutritional education (1 session/week) |
| HIIT one session | Experimental | Behavioral: High intensity interval training, Behavioral: Nutritional educationOne session per week of HIIT + nutritional education (1 session/week) |
| Nutritional education | Active comparator | Behavioral: Nutritional educationNutritional education (1 session/week) |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All school children able to attend the physical education sessions of the school
- -
Key exclusion criteria (1 listed)
- Children with medical condition that limits physical activity
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 |
|---|---|---|
| High intensity interval trainingTwo schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old). One of them has two physical education (PE) sessions per week and the other has only one PE session per week. In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group. Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup. Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools. The duration of the intervention will be of eight weeks. | Behavioural | HIIT one session, HIIT two sessions |
| Nutritional educationSchool-based nutritional education on healthy dietary habits | Behavioural | HIIT one session, HIIT two sessions, Nutritional education |
Primary outcome
Change in cardiorespiratory fitness
Time frame: Change from baseline cardiorespiratory fitness at eight weeks
20m shuttle run test (Alpha battery)
5 secondary outcomes
Change in Body fat
Time frame: Change from baseline body fat at eight weeks
Change in Ankle-brachial index
Time frame: Change from baseline Ankle-brachial index at eight weeks
Change in Dietary habits
Time frame: Change from baseline Dietary habits at eight weeks
Change in Muscular strength
Time frame: Change from baseline Muscular strength at eight weeks
Change in speed-agility
Time frame: Change from baseline speed agility at eight weeks
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 3 Oct 2018.
- 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 High intensity interval training and Nutritional education in people with Cardiovascular Diseases Risk and Adiposity, run by Universidad Pública de Navarra at 1 site in Spain.
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 1 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 3 Oct 2018. 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 Spain. 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?
Change in cardiorespiratory fitness (time frame: Change from baseline cardiorespiratory fitness at eight weeks). 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 3 Oct 2018.