NCT01277224

Brief Summary

The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention (RPAI) for reducing the prevalence of overweight/obesity and other cardiovascular risk factors

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 27, 2013

Status Verified

May 1, 2013

Enrollment Period

1.1 years

First QC Date

January 12, 2011

Last Update Submit

May 24, 2013

Conditions

Physical ActivityObesityChildren

Keywords

physical activityobesityadipositychildrenblood lipidsblood pressurerandomized controlled trials

Outcome Measures

Primary Outcomes (1)

  • Skin-fold thickness

    Over 1 years, the Movi program will reduce the prevalence of excess weight in schoolchildren and improve other cardiovascular risk factors.

    1 year

Secondary Outcomes (1)

  • Physical activity, physical fitness, sleep, and quality of life

    1 year

Study Arms (2)

Movi2 Program

EXPERIMENTAL
Behavioral: Movi2 Program

Control

NO INTERVENTION

Interventions

Movi2 ProgramBEHAVIORAL

In the Movi2 program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors. It consisted of two 90-min after school sessions per week on school days and one 150-minute session on Saturday morning.

Movi2 Program

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
The Boards of Governors (community participatory organ in each school) and the children's parents will inform of the study's aims and methods, and give their written consent to the children's participation. Similarly, the study will present classroom-by-classroom to the children, and their oral consent will obtain. Participant children will be free of serious learning difficulties, or physical or mental disorders, that could impede participation in the scheduled physical activities.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Nystrom CD, Henriksson P, Martinez-Vizcaino V, Medrano M, Cadenas-Sanchez C, Arias-Palencia NM, Lof M, Ruiz JR, Labayen I, Sanchez-Lopez M, Ortega FB. Does Cardiorespiratory Fitness Attenuate the Adverse Effects of Severe/Morbid Obesity on Cardiometabolic Risk and Insulin Resistance in Children? A Pooled Analysis. Diabetes Care. 2017 Nov;40(11):1580-1587. doi: 10.2337/dc17-1334. Epub 2017 Sep 22.

    PMID: 28939688DERIVED

  • Martinez-Vizcaino V, Sanchez-Lopez M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martinez M, Franquelo-Morales P, Lopez-Martinez S, Garcia-Prieto JC, Arias-Palencia N, Torrijos-Nino C, Mora-Rodriguez R, Rodriguez-Artalejo F. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial. Int J Behav Nutr Phys Act. 2014 Dec 10;11:154. doi: 10.1186/s12966-014-0154-4.

    PMID: 25491026DERIVED

  • Martinez-Vizcaino V, Sanchez-Lopez M, Salcedo-Aguilar F, Notario-Pacheco B, Solera-Martinez M, Moya-Martinez P, Franquelo-Morales P, Lopez-Martinez S, Rodriguez-Artalejo F; MOVI-2 group. Protocol of a randomized cluster trial to assess the effectiveness of the MOVI-2 program on overweight prevention in schoolchildren. Rev Esp Cardiol (Engl Ed). 2012 May;65(5):427-33. doi: 10.1016/j.recesp.2011.12.008. Epub 2012 Mar 10. English, Spanish.

    PMID: 22410389DERIVED

MeSH Terms

Conditions

Motor ActivityObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vicente Martinez-Vizcaíno, PhD

    Health and Social Research Centre, Universidad de Castilla-La Mancha, Cuenca, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 14, 2011

Study Start

September 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 27, 2013

Record last verified: 2013-05