Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03236337
Other study ID # PI16/01919
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 19, 2017
Est. completion date June 30, 2018

Study information

Verified date July 2018
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Project which objective is to test the effectiveness of an extracurricular physical activity intervention based on high intensity interval training (MOVI-daFit!) on improving cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic performance.


Description:

In the last decade, this research group has tested the effectiveness of three interventions following this 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-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).


Recruitment information / eligibility

Status Completed
Enrollment 570
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 11 Years
Eligibility Inclusion criteria:

- Schools must have at least one full classrooms for both the 4th and 5th grade of primary school.

- 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:

- Severe Spanish language learning difficulties.

- 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!).

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
Spain Health and Social Research Centre, University of Castilla-La Mancha Cuenca
Spain Mairena Sánchez-López Cuenca

Sponsors (2)

Lead Sponsor Collaborator
University of Castilla-La Mancha Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary VO2 max It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years. One year
Secondary BDNF blood determination Biochemical determinations will be performed in order to determine Brain-derived neurotrophic factor. It is a protein that, in humans, is encoded by the BDNF gene. BDNF acts on certain neurons of the central nervous system and the peripheral nervous system, helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. In the brain, it is active in the hippocampus, cortex, and basal forebrain—areas vital to learning, memory, and higher thinking. One year
Secondary Health-related quality of life By using the KIDSCREEN-27 for children from 8 years. One year
Secondary Sleep behaviors and sleep problems by questionnaire By using the Spanish version of the Children's Sleep Habits Questionnaire (CSHQ) completed by parents. Four questions will be added in order to ask about bedtime, waking up, getting up, and total number of hours of sleep. One year
Secondary Sleep quality by accelerometry The latency, quantity, duration of sleep and the number of awakenings will also be measured by accelerometry in a subsample of 242 school children.
Actigraphy (ACT) is a non-invasive method used to study sleep-wake patterns and circadian rhythms by assessing movement. The GENEActive (ActivInsights) monitor will be used, a wristwatch device that monitors activity levels for extended continuous periods.
One year
Secondary Motor skills By using the Movement Assessment Battery for Children 2 (M-ABC 2) One year
Secondary Physical activity In a sub-sample of 242 randomly selected school children will be measured objectively by GENEActive (ActivInsights) accelerometers during seven consecutive days (including nights), with a fixed frequency of 85.7Hz to collect raw acceleration data measured in g for each axis of motion (x, y, z). One year
Secondary Body fat% Body fat percentage measured by Bioimpedance analysis One year
Secondary Academic achievement Children´s mean scores on mathematics and language will be considered One year
Secondary Arterial Stiffness Carotid intima-media thickness measurement through Sonosite Micromax ultrasound (Sonosite Inc., Bothell, Washington, USA). One year
Secondary Pulse wave velocity Pulse wave velocity measurement through SphymgoCor System (AtCor Medical Pty Ltd Head Office, West Ryde, Australia) One year
Secondary Subclinical atherosclerosis Reactive Hyperemia index measurement through ENDO- PAT (Moerland et al. Int J Vasc Med, 2012; 17; 682-86) One year
Secondary Executive function Executive function will be measured by standardized tests using the NIH toolbox One year
Secondary Glucose profile Glucose (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics One year
Secondary Lipid profile Apolipoproteins (mg/dl) level will be determined by using a system Cobas 8000 of Roche Diagnostics. One year
Secondary Insulin profile Insulin (µU/L) level will be determined by using the Architect platform of Abbott ® One year
Secondary Ultrasensitive protein profile C-reactive protein ultrasensitive (mg/l) level will be determined by using a system Cobas 8000 of Roche Diagnostics One year
See also
  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