Obesity Clinical Trial
Official title:
Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!
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.
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%
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |