Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!
NCT ID: NCT03236337
Last Updated: 2018-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
570 participants
INTERVENTIONAL
2017-09-19
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!
NCT03236363
The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers
NCT04863040
Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance
NCT01971827
The MOVI-HIIT Pilot Trial: The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers
NCT05243784
Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
NCT01971840
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The second edition (MOVI-2), carried out at schoolchildren of the same age range, increased the duration and intensity of the sessions, and was focused on the development of muscular strength in order to improve insulinemia levels. The intervention showed proved effectiveness; in addition, the data from this intervention showed a modest improvement in girls' aerobic capacity, but not in boys.
The last edition (MOVI-KIDS) was aimed at children aged 4 to 7 years to test the hypotheses that vigorous physical activity at early ages could produce lifelong cardio-metabolic benefits. Data submitted for publication in this study show that, as in the case of the IDEFICS study in children of similar age, the intervention was not effective in improving fitness.
This new edition (MOVI-daFit!) has been designed as controlled cluster-randomized trial including 10 schools from Cuenca province, Spain. Five schools will be randomized to intervention group (IG), in which the intervention MOVI-daFit! will be conducted for children in fourth and fifth school grades (9-11 years old). The other five schools will be allocated to the control group (CG).
During an academic year the 4th and 5th schoolchildren allocated to IG will be carry out, in out of school hours, four times by week, one hour sessions of a standardized recreative, non competitive, physical activity intervention based on games adapted to high intensity interval training methodology (MOVI-daFit!). In the CG regular physical activity will continue.
At the end of the school year the researchers will determine main outcome variables: changes in VO2max, body fat by bioimpedance, reactive hyperemia index, academic achievement, executive function, and biochemical analytic procedures including lipid profile, insulin, HbA1, C ultrasensitive reactive protein and BDNF.
The hypotheses of this new edition will be that the MOVI-daFit! based on high intensity interval training (HITT) adapted for the 4th and 5th schoolchildren, will:
1. Increase the aerobic capacity (VO2max).
2. Reduce the percentage of body fat in the GI versus the GC by 6%.
3. Improve executive function and academic performance.
4. Improve subclinical markers of atherosclerosis (endothelial function and carotid intima-media thickness).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
No intervention
No interventions assigned to this group
MOVI intervention
\- MOVI-da Fit! is a high intensity interval training intervention that consists on: a) 4 h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.
MOVI intervention
MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MOVI intervention
MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The approval of boards of governors will be necessary.
* Children's parents or legal representatives will sign an informed consent to participate.
* Parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.
Exclusion Criteria
* Serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities.
* Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-daFit!).
8 Years
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Carlos III Health Institute
OTHER_GOV
University of Castilla-La Mancha
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vicente Martínez-Vizcaíno, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Social and Health Care Research Center, University of Castilla-La Mancha
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health and Social Research Centre, University of Castilla-La Mancha
Cuenca, , Spain
Mairena Sánchez-López
Cuenca, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Visier-Alfonso ME, Jimenez-Lopez E, Rodriguez-Gutierrez E, Mesas AE, Nunez de Arenas-Arroyo S, Diaz-Goni V, Alvarez-Bueno C, Martinez-Vizcaino V. Internal Consistency and Validity of a Short Spanish Version (10-Items) of the Center for Epidemiological Studies Depression Scale for Children and Adolescents (CES-DC). Depress Anxiety. 2024 Sep 25;2024:5409747. doi: 10.1155/2024/5409747. eCollection 2024.
Pozuelo-Carrascosa DP, Martinez-Vizcaino V, Torres-Costoso A, Martinez MS, Rodriguez-Gutierrez E, Garrido-Miguel M. "Fat but Fit" Paradox and Cardiometabolic Risk in Children: The Role of Physical Activity. Child Obes. 2023 Jun;19(4):282-291. doi: 10.1089/chi.2022.0073. Epub 2022 Jul 26.
Martinez-Vizcaino V, Garrido-Miguel M, Redondo-Tebar A, Notario-Pacheco B, Rodriguez-Martin B, Sanchez-Lopez M. The "Fat but Fit" Paradigm from a Children's Health-Related Quality of Life Perspective. Child Obes. 2021 Oct;17(7):449-456. doi: 10.1089/chi.2021.0041. Epub 2021 May 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI16/01919
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.