NCT03479658

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

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

First Submitted

Initial submission to the registry

February 20, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

February 20, 2018

Last Update Submit

October 2, 2018

Conditions

Keywords

HIITnutritional educationDose-effectschoolchildrencardiovascularadiposityblood pressurefitness

Outcome Measures

Primary Outcomes (1)

  • Change in cardiorespiratory fitness

    20m shuttle run test (Alpha battery)

    Change from baseline cardiorespiratory fitness at eight weeks

Secondary Outcomes (5)

  • Change in Body fat

    Change from baseline body fat at eight weeks

  • Change in Ankle-brachial index

    Change from baseline Ankle-brachial index at eight weeks

  • Change in Dietary habits

    Change from baseline Dietary habits at eight weeks

  • Change in Muscular strength

    Change from baseline Muscular strength at eight weeks

  • Change in speed-agility

    Change from baseline speed agility at eight weeks

Study Arms (3)

HIIT two sessions

EXPERIMENTAL

Two sessions per week of HIIT + nutritional education (1 session/week)

Behavioral: High intensity interval trainingBehavioral: Nutritional education

HIIT one session

EXPERIMENTAL

One session per week of HIIT + nutritional education (1 session/week)

Behavioral: High intensity interval trainingBehavioral: Nutritional education

Nutritional education

ACTIVE COMPARATOR

Nutritional education (1 session/week)

Behavioral: Nutritional education

Interventions

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.

HIIT one sessionHIIT two sessions

School-based nutritional education on healthy dietary habits

HIIT one sessionHIIT two sessionsNutritional education

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All school children able to attend the physical education sessions of the school

You may not qualify if:

  • Children with medical condition that limits physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health Sciences, Universidad Pública de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 27, 2018

Study Start

February 27, 2018

Primary Completion

June 20, 2018

Study Completion

September 30, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations