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Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period. (MOVI-KIDS)

22 december 2013 uppdaterad av: FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha

Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.

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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The prevalence of overweight in Spanish children in the puberty age is among the highest in the world and increasing quickly. Our group has done so far two interventions based on after-school programs of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children (8-to-11 years)in Cuenca, Spain.

The first edition, called MOVI, showed moderate effect in reducing adiposity and improving the lipid profile, but did not significantly improve overall cardiometabolic risk, mainly because of did not reduce blood insulin levels. A second edition (MOVI-2), increased duration and intensity of the sessions and was more focused on increased muscle strength. Preliminary analysis also show a decrease in body fat, a reduction of global cardiometabolic because of decreased insulin levels.

Our project integrates a multidimensional intervention to promote physical activity, with a mixed design (cross-over randomized trial, and a qualitative study) and consist of two sub-projects that share the same study population: "Effectiveness of an intervention of physical activity promotion in schoolchildren on preventing obesity during the adiposity rebound period: a cross-over randomized cluster trial" and "Effectiveness of physical activity intervention to prevent obesity and improve academic performance in children with and without ADHD risk".

The two interventions are based on a cross-over randomized trial aimed to test the effectiveness of an intervention to promote physical activity in the school environment (MOVI-KIDS) during two-years in 22 schools (20 public and two private schools) in the provinces of Cuenca and Ciudad Real, Spain.

This principal subproject consisted of a mixed study including both the trial cited above and a nested qualitative study aimed to identify barriers and facilitators to physical activity in children in the school environment (social and family factors, urban planning, etc.), and produce knowledge about the perceptions of children, parents and teachers on how you can improve conditions of physical and social environment to facilitate physical activity.

The hypotheses of this third edition are that a multidimensional intervention promoting physical activity in children at the adiposity rebound period (4-7 years),in the school environment (MOVI-KIDS), lasting two-years, will to:

  1. Reduce the body fat percentage in the intervention group versus the control group in 2%.
  2. Improve the several components of fitness: aerobic capacity, strength, speed and agility.
  3. Reduce the carotid intima-media thickness and
  4. Reduce fat, increase fat free mass, and reduce sedentary behavior.

Studietyp

Interventionell

Inskrivning (Förväntat)

1600

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
      • Cuenca, Spanien, 16071
        • Health and Social Research Centre, University of Castilla-La Mancha

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 7 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollera
Inget ingripande
Experimentell: MOVI-KIDS-program
Insatsgrupp
Beteende: MOVI-KIDS
MOVI-KIDS är en multidimensionell intervention som består av: a) för barn, 4,5 timmar/vecka av ett standardiserat rekreativt, icke-konkurrensutsatt fysisk aktivitet extracurricular program; b) informativa sessioner för föräldrar och lärare om hur skolbarn kan bli mer aktiva, och c) insatser på lekplatsen (miljöförändringar: utrustning, lokaler, målning etc.) som syftar till att främja fysisk aktivitet under rasten (MOVI-Lekplats).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Body fat percentage
Tidsram: One year (interim analysis)

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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physical fitness
Tidsram: One year (interim analysis)
It will be assessed the main components of fitness: a) muscle strength by using standing long jump test b) Flexibility by using the sit and reach test c) speed-agility (The 4x10 meters shuttle run test), d) aerobic capacity, by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years.
One year (interim analysis)
Waist circumference
Tidsram: One year (interim analysis)
Waist circumference will be measured 3 times at the midpoint between the last rib and the iliac crest at the end of a normal expiration and using a flexible tape.
One year (interim analysis)
Tricipital skinfold thickness
Tidsram: one year (interim analysis)
Skinfold thickness will be measured 3 times at the triceps using a Holtain Ltd. caliper (0.2 mm accuracy and consistent 10 g/mm2 pressure between valves)
one year (interim analysis)
Blood pressure
Tidsram: one year (interim analysis)
Blood pressure will be measured twice, with a 5-min interval between measurements. The first measurement will be made after at least 5 min rest. The child will be seated, in relaxing conditions, with the right arm semi-flexed at heart level. Blood pressure will be measured with an Omron M5-I monitor (Omron Healthcare UK Ltd.) using one of 3 different cuff sizes according to arm circumference.
one year (interim analysis)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prior assessment of barriers and facilitators
Tidsram: One year
Nested qualitative study aimed to understand the barriers and limitations perceived by children, parents, and teachers for the physical activity of schoolchildren, using focus groups under a phenomenologic framework.
One year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Castilla-La Mancha

Samarbetspartners

Carlos III Health Institute

Utredare

  • Huvudutredare: Vicente Martínez-Vizcaíno, PhD, Health and Social Research Centre, University of Castilla-La Mancha, Cuenca, Spain

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2013

Primärt slutförande (Faktisk)

1 oktober 2013

Avslutad studie (Förväntat)

1 juni 2015

Studieregistreringsdatum

Först inskickad

7 oktober 2013

Först inskickad som uppfyllde QC-kriterierna

23 oktober 2013

Första postat (Uppskatta)

29 oktober 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 december 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 december 2013

Senast verifierad

1 oktober 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PI12/02400

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