The MOVI-HIIT Pilot Trial: The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers

NCT05243784 | Completed DMC

• 1 other identifier: PID2019-104160RB-I00-Pilot
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study to test the acceptability and feasibility of an intervention aimed to test the effectiveness, in preschool children, of an integrated physical activity intervention in the classroom based on intervallic training (MOVI-HIIT) on improving executive function, body composition and cardiorespiratory fitness.

Conditions

Physical Activity; Obesity, Childhood; Cardiovascular Diseases; High Intensity Interval Training; Cognition

Keywords

Children; obesity; High Intensity Interval Training; cognition; cardiorespiratory fitness; Aerobic capacity; Preschool; Adiposity; Physical Activity

Outcome Measures

Primary Outcomes (5)

• Evaluation of the perceived effort and exercise enjoyment within the use of the MOVI-HIIT platform by questionnaires.

  The schoolchildren's exercise enjoyment will be measured with the short version of the Physical Activity Enjoyment Scale, PACES-S \[10.3390/ijerph182111035\]), (range from 4 to 12, where the highest rate indicates more satisfaction); and the schoolchildren's perceived effort will be assessed with the Children's Effort Rating Table, Pictorial-CERT \[10.1111/j.1365-2214.2007.00767.x.\], with a range from 1 to 10 (where 10 indicates the highest perceived effort).

  4 months

• Acceptance rate and adverse effects of the MOVI-HIIT intervention.

  The acceptability of the exercise program will be assessed recording adherence (rate of school's session attendance recorded in the online platform) and safety of the exercise programme (number and type of adverse events recorded by the teacher everyday after the session).

  4 months

• Evaluation of schoolchildren's compliance with the MOVI-HIIT intervention.

  These trial feasibility outcomes will include: (1) recruitment (percentage achieved of the targeted study sample), (2) retention (drop-out rate and reasons for withdrawal), (3) outcome completion (percentage of children with both measurements at the end of the study).

  4 months

• Participant's satisfaction with the MOVI-HIIT program by questionnaire

  An ad-hoc questionnarie will ask participants' about their satisfaction with the program (5-item pictorial scale questions, where the higher rate indicates higher satisfaction).

  4 months

• Teacher's perception about the suitability of the MOVI-HIIT platform by interviews.

  It will be assessed with teachers feedback via interviews on the use of the exercise platform (user-friendliness, connectivity, attractiveness, practicality) and the barriers and facilitators to implementing the programme.

  4 months

Secondary Outcomes (9)

• VO2max

  4 months

• Inhibition/Attention (Executive Function)

  4 months

• Working memory (Executive Function)

  4 months

• Cognitive flexibility (Executive Function)

  4 months

• Percentage of body fat

  4 months

Study Arms (2)

Intervention

EXPERIMENTAL

The design of the MOVI-HIIT intervention is framed within the socio-ecological model of behavior modification, in such a way that it will be designed to intervene in the individual, family and school environment. It will have a duration of 8 weeks and will consist of two 5-minute daily physical activity breaks based on intervallic training, five days a week.

Behavioral: MOVI-HIIT intervention

Control

NO INTERVENTION

Students in the control group (CG) will receive mandatory lessons on Spain (one 45-minute session of Psychomotor/Physical Education), and the usual classroom teaching methodology. Teachers in the CG schools will be asked not to make any changes to their methodology during the time of the study, with the promise by the research team to share and explain the MOVI-HIIT program once the interventions are completed.

Interventions

MOVI-HIIT intervention BEHAVIORAL

Each HIIT break will last approximately 5 minutes and will not require any specific materials. The structure of the HIIT-Rest will be as follows: 1' to describe the work to be done; 3' of work following the HIIT protocol: 6 repetitions of a functional movement such as squats, Jumping Jack or running on site for 20" at high intensity (85-90% of HR -heart rate- max) followed by 10" of recovery (65-75% of HR max); and 1' to perform a return to calm in order to lower the activation and prepare the student body to return to class activities.

Intervention

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The participating schoolchildren must belong to the 2nd and 3rd year of preschool education, not have any malformation that prevents them from learning the Spanish language (or Spanish sign language), not have any type of physical or mental disorder that parents and/or teachers have identified that prevents the performance of physical activities, not suffer from any chronic disease such as heart disease, diabetes or asthma that, according to the criteria of their pediatrician - after analysis of the program of activities - prevents their participation in the measurements and/or the intervention.
• As this is an intervention in the classroom, the school faculty will include the active breaks proposed in the center's programming, for which reason the intervention will be received by all the children in the intervention group school. However, the investigators will consider school participants to be those who have the consent of the parent or guardian for participation in the study. In addition, schoolchildren must verbally express their willingness to participate in the baseline and final physical examinations.

You may not qualify if:

• Children with severe Spanish language learning difficulties.
• Children with serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities.
• Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-HIIT)

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (1)

Social and Health Research Center. Universidad de Castilla-La Mancha

Cuenca, 16071, Spain

Location

MeSH Terms

Conditions

Motor Activity; Pediatric Obesity; Cardiovascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 17, 2022
• Study Start: January 27, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)