Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.

NCT01971840 | Unknown DMC

• 1 other identifier: PI12/02400
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Coordinated project whose objectives are: a) to assess the effectiveness of a physical activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the carotid intima-media thickness.

Conditions

Physical Activity; Adiposity; Children; Obesity; Cardiovascular Disease

Keywords

Physical activity; Physical fitness; Obesity; Adiposity; Adiposity rebound period; Children; Blood pressure; Randomized controlled trials; Barriers and facilitators of the environment

Outcome Measures

Primary Outcomes (1)

• Body fat percentage

  To reduce body fat percentage in the intervention group versus the control group in 2% in children during the adiposity rebound 4-7 years). Mean of two measurements of body fat percentage using an eight-electrode BC-418 MA bioimpedance analysis system (Tanita Corp. Tokyo, Japan).

  One year (interim analysis)

Secondary Outcomes (4)

• Physical fitness

  One year (interim analysis)

• Waist circumference

  One year (interim analysis)

• Tricipital skinfold thickness

  one year (interim analysis)

• Blood pressure

  one year (interim analysis)

Other Outcomes (1)

• Prior assessment of barriers and facilitators

  One year

Study Arms (2)

MOVI-KIDS Program

EXPERIMENTAL

Intervention group

Behavioral: MOVI-KIDS

Control

NO INTERVENTION

No intervention

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 your 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 (3)

• Martinez-Vizcaino V, Pozuelo-Carrascosa DP, Garcia-Prieto JC, Cavero-Redondo I, Solera-Martinez M, Garrido-Miguel M, Diez-Fernandez A, Ruiz-Hermosa A, Sanchez-Lopez M. Effectiveness of a school-based physical activity intervention on adiposity, fitness and blood pressure: MOVI-KIDS study. Br J Sports Med. 2020 Mar;54(5):279-285. doi: 10.1136/bjsports-2018-099655. Epub 2019 Jan 9.

  PMID: 30626597 DERIVED

• Pozuelo-Carrascosa DP, Sanchez-Lopez M, Cavero-Redondo I, Torres-Costoso A, Bermejo-Cantarero A, Martinez-Vizcaino V. Obesity as a Mediator between Cardiorespiratory Fitness and Blood Pressure in Preschoolers. J Pediatr. 2017 Mar;182:114-119.e2. doi: 10.1016/j.jpeds.2016.11.005. Epub 2016 Nov 29.

  PMID: 27912924 DERIVED

• Martinez-Vizcaino V, Mota J, Solera-Martinez M, Notario-Pacheco B, Arias-Palencia N, Garcia-Prieto JC, Gonzalez-Garcia A, Alvarez-Bueno C, Sanchez-Lopez M; MOVI-KIDS group. Rationale and methods of a randomised cross-over cluster trial to assess the effectiveness of MOVI-KIDS on preventing obesity in pre-schoolers. BMC Public Health. 2015 Feb 22;15:176. doi: 10.1186/s12889-015-1512-0.

  PMID: 25884885 DERIVED

Related Links

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

MeSH Terms

Conditions

Motor Activity; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Vicente Martínez-Vizcaíno, 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: Proffesor / 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)