Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10! (MOVI-da10!)

Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!

Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.

Study Overview

• Status: Completed
• Conditions: Obesity; Physical Activity; Children; Cardiorespiratory Fitness; Cardiovascular
• Intervention / Treatment: Behavioral: MOVI-da10! active breaks; Behavioral: MOVI-da10! integrated physical activity

Detailed Description

In the last decade, this research group has tested the effectiveness of three interventions following after-school intervention model. The first one (MOVI) was carried out in peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a moderate effect in reducing the adiposity of schoolchildren with higher BMI, an improvement of the lipid profile, without significantly improving the global cardiometabolic risk because it did not produce a reduction in insulinemia.

The second edition (MOVI-2), carried out at schoolchildren of the same age range, increased the duration and intensity of the sessions, and was focused on the development of muscular strength in order to improve insulinemia levels. The intervention showed proved effectiveness; in addition, the data from this intervention showed a modest improvement in girls' aerobic capacity, but not in boys.

The last edition (MOVI-KIDS) was aimed at children aged 4 to 7 years to test the hypotheses that vigorous physical activity at early ages could produce lifelong cardio-metabolic benefits. Data submitted for publication in this study show that, as in the case of the IDEFICS study in children of similar age, the intervention was not effective in improving fitness.

This new edition (MOVI-da10!) has been designed following integrated physical activity intervention and active breaks designs, and as a controlled cluster-randomized trial including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third grade preschool children (about 5 years old), using two different design. Three of them will receive an active breaks intervention, in which twice a day a 10 minutes breaks standard physical activity will be developed, and the other three will receive twice a day a 10 minutes of enriched physical activity integrated in the curriculum. The other three schools will be allocated to the control group (CG).

During an academic year the MOVIda10! interventions will consist of: i) an integrated across the curriculum cognitive demanding physical activity program including two active breaks lasting 10 min, five days/week; and ii) an active breaks physical activity program including two active breaks lasting 10 min, five days/week. In the CG regular physical activity will continue.

At the end of the school year the researchers will determine main outcome variables: changes in VO2max, body fat by bioimpedance and executive function.

The hypotheses of this new edition will be that: the MOVI-da10 intervention! based on physical activity integrated in the curriculum for third grade preschool children, will be:

1. Moderately increase the executive function and academic performance in the IGs versus the CG (effect size 0.5).
2. Increase aerobic capacity (VO2max) in IGs versus CG by 3%.
3. Reduced body fat in IGs versus CG by 3%

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cuenca, Spain, 16071
    • Social and Health Research Center. Universidad de Castilla-La Mancha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Schools must have at least one full classrooms for the 3rd year of preschool.
• The approval of boards of governors will be necessary to participate in the intervention and in the measurements at the beginning and end of academic year.
• Children's parents or legal representatives will sign an informed consent to participate.
• Children's parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.

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-da10!).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: MOVI-da 10! active breaks; It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children	Behavioral: MOVI-da10! active breaks; MOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
Experimental: MOVI-da10! integrated physical activity; It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children	Behavioral: MOVI-da10! integrated physical activity; MOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive function	Executive function will be measured by standardized test using the NIH toolbox	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max	It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children.	One year
Motor skills	By using the Movement Assessment Battery for Children 2 (M-ABC 2)	One year
Body fat%	Body fat percentage measured by Bioimpedance analysis	One year
Health-related quality of life	By using the validated version in Spanish of KIDL for children of 4-7 years and their parents.	One year

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Carlos III Health Institute
• Investigators: Principal Investigator: Vicente Martínez-Vizcaíno, PhD, MD, Social and Health Care Research Center, University of Castilla-La Mancha

Publications and helpful links

General Publications

• Sanchez-Lopez M, Ruiz-Hermosa A, Redondo-Tebar A, Visier-Alfonso ME, Jimenez-Lopez E, Martinez-Andres M, Solera-Martinez M, Soriano-Cano A, Martinez-Vizcaino V; MOVI group. Rationale and methods of the MOVI-da10! Study -a cluster-randomized controlled trial of the impact of classroom-based physical activity programs on children's adiposity, cognition and motor competence. BMC Public Health. 2019 Apr 18;19(1):417. doi: 10.1186/s12889-019-6742-0.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Children; Physical activity; Cognitive function; Aerobic capacity; Cardiorespiratory fitness; Adiposity; Academic achievement; Cardiovascular fitness
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PI16b/01919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No