Dose-effect of HIIT on Cardiovascular Health of Children
1 other identifier
interventional
180
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
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
February 20, 2018
CompletedStudy Start
First participant enrolled
February 27, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedOctober 3, 2018
October 1, 2018
4 months
February 20, 2018
October 2, 2018
Conditions
Keywords
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
EXPERIMENTALTwo sessions per week of HIIT + nutritional education (1 session/week)
HIIT one session
EXPERIMENTALOne session per week of HIIT + nutritional education (1 session/week)
Nutritional education
ACTIVE COMPARATORNutritional education (1 session/week)
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.
School-based nutritional education on healthy dietary habits
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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