Obesity Clinical Trial
— MOVI-HIITOfficial title:
The Impact of a Classroom-based Physical Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschool Children (MOVI-HIIT)
Verified date | June 2024 |
Source | University of Castilla-La Mancha |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Project which objective is a) 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, cardiorespiratory fitness and b) to evaluate teachers' perceptions of barriers and facilitating elements for the implementation and monitoring of MOVI-HIIT interventions in the classroom.
Status | Completed |
Enrollment | 522 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 6 Years |
Eligibility | Inclusion Criteria: - Schools in the province of Ciudad Real with at least one class (classroom) at each level (2nd and 3rd of preschool education), and in which the School Board gives its approval to the interventions and to the basal and final evaluations. - 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 them. - 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 each IG school. However, we 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. Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Spain | Social and Health Research Center. Universidad de Castilla-La Mancha | Cuenca |
Lead Sponsor | Collaborator |
---|---|
University of Castilla-La Mancha | Ministerio de Ciencia e Innovación, Spain |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VO2max | Cardiorespiratory fitness, with the Course Navette or 20-m shuttle run test, validated to measure maximum aerobic capacity in children. It will be carried out according to the Léger protocol. This battery adapts the Course Navette test to children under the age of 6. | One year | |
Primary | Executive function | NIH toolbox battery.
Inhibition/Attention by means of the Flanker Inhibitory Control and Attention test. Working memory with the List Sorting Working Memory test. Cognitive flexibility through the DCCS (Dimensional Change Card Sort) test. |
One year | |
Primary | Body fat percent | Body fat percentage measured by Bioimpedance analysis | One year | |
Secondary | Health-related quality of life - Parents | Kiddy-KINDL-R questionnaire version for parents, which has a 0-100 score scale. | One year | |
Secondary | Health-related quality of life - Children | Kiddy-KINDL-R questionnaire version for children, which has a 0-100 score scale. | One year | |
Secondary | Mothers' breastfeeding | Parents are going to be ask about what type of feeding had been chosen during their children's first 24 months of life. In each month, systematically, mothers can indicate if their children had been fed by breast milk, artificial milk, both and/or complementary feeding. Mothers can mark one or several options from all those indicated. | Baseline measurements | |
Secondary | Questionnaire ad-hoc about pregnancy | birth weight of their child (Kgr.); maternal weight gain during pregnancy (Kgr.); and parental weight (Kgr.) via direct written questions. | Baseline measurements | |
Secondary | Eating habits | Children's Eating Habits Questionnaire, which has a 0-30 score scale. | One year | |
Secondary | Motor competence | Movement Assessment Battery for Children - Second Edition (MABC-2). Red zone below 5th percentile which denotes significant movement difficulty; amber zone below or equial to 15th percentile which suggests child at risk of motor problems; green zone, above 15th percentile which indicates no movement problems detected. | One year | |
Secondary | Physical activity | Physical activity will be objectively measured in a subsample of 300 children randomly selected. GENEActive® accelerometers (ActivInsights) will be worn for seven consecutive days, with a fixed frequency of 85.7Hz to collect raw acceleration data measured in "g" for each axis of motion (x,y,z). The data shall be stored directly in the memory of the device and expressed in milli-g units (1000mg =1 g =9.81 m/s2). | One year | |
Secondary | Sleep quality | Sleep quality via acelerometer will be objectively measured in a subsample of 300 children randomly selected. GENEActive® accelerometers (ActivInsights) will be worn for seven consecutive days during nights, with a fixed frequency of 85.7Hz to collect raw acceleration data measured in "g" for each axis of motion (x,y,z). The data shall be stored directly in the memory of the device and expressed in milli-g units (1000mg =1 g =9.81 m/s2). | One year | |
Secondary | Energy expenditure from MOVI-HIIIT breaks | 40 schoolchildren of an IG school will be estimated from the oxygen consumption measured with a portable gas analyzer (COSMED® k4b2). | One year | |
Secondary | The acute effect of physical exercise on the brain's electrical activity | 40 schoolchildren (20 from the CG and 20 from the IG) will be estimated from the brain activity measured with a portable electroencephalogram (EMOTIV EPOC X).
14-channel EEG - for whole brain sensing (AF3, AF4, F3, F4, F7, F8, T7, T8, P3, P4, P7, P8, O1, O2) |
One year |
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