Clinical Trials Logo
NCT number NCT03236363
Study type Interventional
Source University of Castilla-La Mancha
Contact Vicente Martinez-Vizcaino, PhD, MD
Phone 0034 969179100
Email Vicente.Martinez@uclm.es
Status Not yet recruiting
Phase N/A
Start date September 2017
Completion date December 2019

Clinical Trial Summary

Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.


Clinical Trial Description

In the last decade, this research group has tested the effectiveness of three interventions following after-school intervention model. The first one (MOVI) was carried out in peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a moderate effect in reducing the adiposity of schoolchildren with higher BMI, an improvement of the lipid profile, without significantly improving the global cardiometabolic risk because it did not produce a reduction in insulinemia.

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-da10!) has been designed following integrated physical activity intervention and active breaks designs, and as a controlled cluster-randomized trial including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third grade preschool children (about 5 years old), using two different design. Three of them will receive an active breaks intervention, in which twice a day a 10 minutes breaks standard physical activity will be developed, and the other three will receive twice a day a 10 minutes of enriched physical activity integrated in the curriculum. The other three schools will be allocated to the control group (CG).

During an academic year the MOVIda10! interventions will consist of: i) an integrated across the curriculum cognitive demanding physical activity program including two active breaks lasting 10 min, five days/week; and ii) an active breaks physical activity program including two active breaks lasting 10 min, five days/week. 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 and executive function.

The hypotheses of this new edition will be that: the MOVI-da10 intervention! based on physical activity integrated in the curriculum for third grade preschool children, will be:

1. Moderately increase the executive function and academic performance in the IGs versus the CG (effect size 0.5).

2. Increase aerobic capacity (VO2max) in IGs versus CG by 3%.

3. Reduced body fat in IGs versus CG by 3%


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Completed NCT02235961 - Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects Phase 1
Completed NCT03195712 - Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers N/A
Recruiting NCT00341406 - Fat Cell Size in Insulin Resistance N/A
Recruiting NCT02918279 - Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity Phase 3
Completed NCT00494767 - Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs Phase 1
Completed NCT01222793 - Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia N/A
Completed NCT01967563 - Study of the Effect of a Very-Low-Carbohydrate Diet on Energy Expenditure N/A
Completed NCT00976105 - Effects of Repeat Dosing of GSK1521498 Phase 1
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin N/A
Not yet recruiting NCT03104205 - MOWI Home-Based Pilot N/A
Recruiting NCT03130244 - Endoscopic Procedure for Jejunal to Ileal Diversion to Treat Type 2 Diabetes N/A
Recruiting NCT03104192 - MOWI Research Pilot N/A
Not yet recruiting NCT02924636 - Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery N/A
Not yet recruiting NCT03251833 - The Impact of Obesity on Maternal and Perinatal Outcomes N/A
Not yet recruiting NCT03112824 - Functional Assessment of Ashwagandaha Root Extract During Weight Loss Phase 3
Not yet recruiting NCT03047018 - Open Trial Obesity CHANGE Program ASD N/A
Not yet recruiting NCT03236337 - Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit! N/A
Not yet recruiting NCT03232762 - Effects of Diet on Pregnancy Outcome and Child Obesity N/A
Not yet recruiting NCT02621086 - Cellodextrin Tolerability Study N/A