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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03479658
Other study ID # PI-018/17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 27, 2018
Est. completion date September 30, 2018

Study information

Verified date October 2018
Source Universidad Pública de Navarra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date September 30, 2018
Est. primary completion date June 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 10 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Children with medical condition that limits physical activity

Study Design


Intervention

Behavioral:
High intensity interval training
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 education
School-based nutritional education on healthy dietary habits

Locations

Country Name City State
Spain Department of Health Sciences, Universidad Pública de Navarra Pamplona Navarra

Sponsors (1)

Lead Sponsor Collaborator
Universidad Pública de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cardiorespiratory fitness 20m shuttle run test (Alpha battery) Change from baseline cardiorespiratory fitness at eight weeks
Secondary Change in Body fat Body fat percent measured by bioimpedance Change from baseline body fat at eight weeks
Secondary Change in Ankle-brachial index Automated simultaneous blood pressure measurement Change from baseline Ankle-brachial index at eight weeks
Secondary Change in Dietary habits Food frequency questionnaire and 24h recall Change from baseline Dietary habits at eight weeks
Secondary Change in Muscular strength Handgrip strength and long jump (Alpha battery) Change from baseline Muscular strength at eight weeks
Secondary Change in speed-agility 4x10m speed agility test (Alpha battery) Change from baseline speed agility at eight weeks
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