Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance

NCT01971827 | Unknown DMC

• 1 other identifier: PI12/00761
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD)

Conditions

Physical Activity; Obesity; Children; Academic Underachievement Disorder; Attention Deficit Hyperactivity Disorder

Keywords

Physical activity; Obesity; Adiposity rebound period; Children with ADHD; Children without ADHD; Academic performance; Motor skills; Health related-quality of life; Sleep

Outcome Measures

Primary Outcomes (1)

• Body fat percentage

  Reduce body fat percentage in the intervention group versus the control group in 2% in children adiposity rebound age (4-7 years). Body fat percentage is estimated with an eight-electrode BC-418 MA bioimpedance analysis system (Tanita Corp. Tokyo, Japan) using the mean of two readings made under controlled temperature and humidity conditions.

  One year (interim analysis)

Secondary Outcomes (5)

• Academic achievement

  One year (interim analysis)

• Motor skills

  One year (interim analysis)

• Health-related quality of life

  One year (interim analysis)

• Sleep quality

  One year (interim analysis)

• Attention-deficit/hyperactivity disorder risk

  One year (interim analysis)

Study Arms (2)

Control

NO INTERVENTION

No intervention

MOVI-KIDS Program

EXPERIMENTAL

Intervention group

Behavioral: MOVI-KIDS

Interventions

MOVI-KIDS BEHAVIORAL

MOVI-KIDS is a multidimensional intervention that consist of: a) for children, 4.5 h/week of a standardized recreative, non-competitive physical activity extracurricular program; b) informative sessions to parents and teachers about how schoolchildren can became more active, and c) interventions in the playground (environmental changes: equipment, facilities, painting, etc.) aimed to promote physical activity during recess (MOVI-Playground).

MOVI-KIDS Program

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Schools with at least one full course of 3rd of early childhood education and one of 1st primary school.
• The Boards of Governors (community participatory organ in each school) give its approval to the intervention and measurements at the beginning and end of the course.
• Children 4 to 7 years old.
• Children's parents/caregivers will give their written consent to the children's participation.
• Collaboration in the family to respond to questionnaires on family leisure habits, sleeping, eating, getting around town, etc., included in the measurement protocol of this project.

You may not qualify if:

• Have a malformation that prevents learning of the Spanish language (or Spanish sign language).
• Have some kind of physical or mental disorder identified by parents or teachers that prevent physical activity.
• Have a chronic illness such as heart disease, diabetes or asthma, as determined by their pediatrician/family doctor -after analysis of the activities program- prevents participation in them.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Carlos III Health Institute: collaborator

Study Sites (1)

Health and Social Research Centre, University of Castilla-La Mancha

Cuenca, Cuenca, 16071, Spain

Location

Related Publications (1)

• Sanchez-Lopez M, Pardo-Guijarro MJ, Del Campo DG, Silva P, Martinez-Andres M, Gulias-Gonzalez R, Diez-Fernandez A, Franquelo-Morales P, Martinez-Vizcaino V; Movi-Kids group. Physical activity intervention (Movi-Kids) on improving academic achievement and adiposity in preschoolers with or without attention deficit hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:456. doi: 10.1186/s13063-015-0992-7.

  PMID: 26458986 DERIVED

Related Links

• Information and results of the first and second edition of the MOVI Program

MeSH Terms

Conditions

Motor Activity; Obesity; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mairena Sánchez-López, PhD

  Health and social Research Centre, University of Castilla-La Mancha, Cuenca, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 29, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2015
• Last Updated: December 24, 2013

Record last verified: 2013-10

Locations

ES (1)