Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period. (MOVI-KIDS)
Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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:
- Reduce the body fat percentage in the intervention group versus the control group in 2%.
- Improve the several components of fitness: aerobic capacity, strength, speed and agility.
- Reduce the carotid intima-media thickness and
- Reduce fat, increase fat free mass, and reduce sedentary behavior.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Cuenca, Espanja, 16071
- Health and Social Research Centre, University of Castilla-La Mancha
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Ei väliintuloa: Ohjaus
Ei väliintuloa
|
|
|
Kokeellinen: MOVI-KIDS-ohjelma
Interventioryhmä
|
MOVI-KIDS on moniulotteinen interventio, joka koostuu: a) lapsille 4,5 h/viikko standardoitua virkistävää, ei-kilpailevaa fyysistä aktiviteettiohjelmaa; b) vanhemmille ja opettajille suunnatut tiedotustilaisuudet siitä, miten koululaiset voivat aktivoitua, ja c) leikkikentällä tapahtuvat interventiot (ympäristömuutokset: laitteet, tilat, maalaus jne.), joiden tarkoituksena on edistää fyysistä aktiivisuutta välitunnin aikana (MOVI-Playground).
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Body fat percentage
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Physical fitness
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Prior assessment of barriers and facilitators
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Vicente Martínez-Vizcaíno, PhD, Health and Social Research Centre, University of Castilla-La Mancha, Cuenca, Spain
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- PI12/02400
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset MOVI-KIDS
-
University of Castilla-La ManchaCarlos III Health InstituteTuntematonLihavuus | Liikunta | Lapset | Tarkkaavaisuus-ja ylivilkkaushäiriö | Akateeminen alimenestyshäiriöEspanja
-
University of Castilla-La ManchaCarlos III Health InstituteValmisLihavuus | Liikunta | Lapset | Cardiorespiratory Fitness | KardiovaskulaarinenEspanja
-
University of Castilla-La ManchaCarlos III Health InstituteValmisLihavuus | Liikunta | Lapset | Cardiorespiratory Fitness | KardiovaskulaarinenEspanja
-
University of Castilla-La ManchaMinisterio de Ciencia e Innovación, SpainValmisSydän-ja verisuonitaudit | Korkean intensiteetin intervalliharjoittelu | Liikunta | Lihavuus, Lapsuus | KognitioEspanja
-
Gobiquity Mobile HealthValmis
-
University of VirginiaVirginia Polytechnic Institute and State UniversityIlmoittautuminen kutsustaSokeripitoiset juomatYhdysvallat
-
Cynthia GerhardtOhio State UniversityLopetettu
-
University of CopenhagenValmisHampaiden kariesRuotsi
-
Pennington Biomedical Research CenterAmerican Diabetes Association; Louisiana State University, Baton Rouge; American...ValmisElämänlaatu | Lihavuus, Lapsuus | Painonmuutos, vartaloYhdysvallat
-
University of California, DavisValmisAutismispektrihäiriöYhdysvallat