Physical ActivityMOVI-KIDSNCT01971827
Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance
A study testing MOVI-KIDS in people with Physical Activity and Obesity, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD) Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Obesity, Children
- What is being tested?
- MOVI-KIDS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 their pediatrician/family doctor -after analysis of the activities program- prevents participation in them.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Health and Social Research Centre, University of Castilla-La Mancha
Cuenca, Cuenca, 16071
About this study
Official title: Effectiveness of Physical Activity Intervention to Prevent Obesity and Improve Academic Performance in Children With and Without Attention Deficit Hyperactivity Disorder (ADHD) Risk
Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD)
Read the detailed description
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 program of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children (8-to-11 years) in Cuenca.
This intervention, in its first edition showed moderate effect in reducing adiposity and improving the lipid profile, but did not significantly improve overall cardiometabolic risk by not reduce blood insulin. In a second edition (MOVI-2), increased duration and intensity of the sessions and worked over the development of muscle strength. Preliminary analysis also show a decrease in body fat, a reduction of global cardiometabolic because of decreasing 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 two sub-projects 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 cross-over randomized trial to test the effectiveness of an intervention to promote physical activity in the school environment (MOVI-KIDS), two-year in 22 schools (20 public and two private schools) in the provinces of Cuenca and Ciudad Real, Spain.
This subproject (subproject-2) will assess the effectiveness of the intervention of the MOVI-KIDS Program in improving attention and cognition in students at risk for ADHD. Furthermore, this project will evaluate the effectiveness of MOVI-KIDS Program in improving motor skills and academic achievement in the overall sample, and the impact that changes in the year have on the amount of physical activity that the students in the sample performed during recess.
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 body fat percentage in the intervention group versus the control group in 2% in children adiposity rebound age (4-7 years),
- Improve academic performance and motor skills in children with and without attention deficit hyperactivity disorder (ADHD),
- Reduce adiposity and sedentary time, improve academic performance, quality of life and the duration and quality of sleep in children with and without ADHD.
- Conditions
- Physical Activity, Obesity, Children, Academic Underachievement Disorder, Attention Deficit Hyperactivity Disorder
- Being tested
- MOVI-KIDS
- Keywords
- Physical activity, Obesity, Adiposity rebound period, Children with ADHD, Children without ADHD, Academic performance, Motor skills, Health related-quality of life, Sleep
- Medical subject headings
- Motor Activity, Obesity, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVI-KIDSBehavioural
MOVI-KIDS is a multidimensional intervention that consist of: a) for children, 4.5 h/week of a standardized recreative, non-competitive physical activity extracurricular program; b) informative sessions to parents and teachers about how schoolchildren can became more active, and c) interventions in the playground (environmental changes: equipment, facilities, painting, etc.) aimed to promote physical activity during recess (MOVI-Playground).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| MOVI-KIDS Program | Experimental | Intervention group Receives: Behavioral: MOVI-KIDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat percentage
Reduce body fat percentage in the intervention group versus the control group in 2% in children adiposity rebound age (4-7 years).
Body fat percentage is estimated with an eight-electrode BC-418 MA bioimpedance analysis system (Tanita Corp. Tokyo, Japan) using the mean of two readings made under controlled temperature and humidity conditions.
Measured: One year (interim analysis)
Secondary outcomes (5)
Academic achievement
It will assess the different basic psychological processes involved in learning (intelligence, cognition, memory, attention, and perception) by using the Differential Aptitude Battery-BADyG-I General scale for children aged 3-6 years (Yuste C, 2008) and the E1 BADY scale for children 6-to-8 years old (Yuste C, 2008). Both scales include a) global academic predictors (eg general intelligence), b) non-verbal tests (eg reasoning and logical puzzle figures), c) verbal tests (eg numerical quantitative concepts), and d) additional tests (eg auditory perception).
Measured: One year (interim analysis)
Motor skills
Motor Skills will be assessed by the Movement Assessment Battery for Children - Second Edition [Movement Assessment Battery for Children 2 (M-ABC 2)]. This battery has been validated to identify and describe deficiencies in motor performance in children and adolescents aged 3-to-16 years old. It consists of eight tests for each age group (3-6, 7-10, and 11-16) measuring three dimensions: manual skills, throws and catches and equilibrium (static and dynamic). Children can score between 0 and 5 in each of the tests. The total score is obtained as the sum of the scores of all tests (range 0-40). A lower score indicates better motor performance. It allows classifying: children with motor problems, children with motor risk and children with normal motor development
Measured: One year (interim analysis)
Health-related quality of life
Quality of life related to health: Kiddy-KINDL, this questionnaire has been validated in Castilian version for children ages 4-7 and parents (Rajmil L, 2004). The KINDL is a generic HRQOL instrument for children and adolescents developed in Germany for use both in clinical practice and in healthy children. Kiddy-KINDL questionnaire contains 12 questions (with 3 response options; range of 1-3, where 1 = never, 2 = sometimes and 3 = many times) in six dimensions: physical, emotional, self-esteem, family, friends and school. The children's version will be administered by interview, and parents will be self-administered version.
Measured: One year (interim analysis)
Sleep quality
It will be assessed by using the Spanish version of the Children's Sleep Habits Questionnaire ( CSHQ ) ( Owens JA . 2000 ) completed by parents. The CSHQ is focused on common sleep disorders for children 4-to-10 years old. The questionnaire allows parents indicate on each item if they consider sleep habits are a problem for their child. It will also four questions about the time to go to bed, wake up, get up , and total number of hours of sleep. Finally, latency, amount, duration of sleep and number of awakenings will also be measured by accelerometer in the subsample of 200 schoolchildren. During a week, children will completed a sleep diary.
Measured: One year (interim analysis)
Attention-deficit/hyperactivity disorder risk
The ADHD risk will be assessed by using the Magallanes scales, which has been validated in Spanish for detect ADHD risk and other developmental problems: EMA-DDA in its versions for parents and teachers (Scales detection Magallanes attention deficit: EMA-DDA, Bilbao, ALBOR-COHS Group, 2006).
Measured: One year (interim analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, FRANCISCO QUILES VICECHANCELLOR OF RESEARCH, University of Castilla-La Mancha
- Investigators
- Mairena Sánchez-López, PhD, Principal investigator, Health and social Research Centre, University of Castilla-La Mancha, Cuenca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971827
- Sponsor's protocol ID
- PI12/00761
- Acronym
- MOVI-KIDS
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanchez-Lopez M, Pardo-Guijarro MJ, Del Campo DG, Silva P, Martinez-Andres M, Gulias-Gonzalez R, Diez-Fernandez A, Franquelo-Morales P, Martinez-Vizcaino V; Movi-Kids group. Physical activity intervention (Movi-Kids) on improving academic achievement and adiposity in preschoolers with or without attention deficit hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:456. doi: 10.1186/s13063-015-0992-7.
PubMed 26458986
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Activity Intervention to Prevent Obesity and Improve Academic Performance in Children With and Without Attention Deficit Hyperactivity Disorder (ADHD) Risk
- ClinicalTrials.gov ID
- NCT01971827
- Acronym / sponsor ID
- MOVI-KIDS / PI12/00761
- Conditions
- Physical Activity, Obesity, Children, Academic Underachievement Disorder, Attention Deficit Hyperactivity Disorder
- Keywords
- Physical activity, Obesity, Adiposity rebound period, Children with ADHD, Children without ADHD, Academic performance, Motor skills, Health related-quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD)
Detailed description
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 program of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children (8-to-11 years) in Cuenca.
This intervention, in its first edition showed moderate effect in reducing adiposity and improving the lipid profile, but did not significantly improve overall cardiometabolic risk by not reduce blood insulin. In a second edition (MOVI-2), increased duration and intensity of the sessions and worked over the development of muscle strength. Preliminary analysis also show a decrease in body fat, a reduction of global cardiometabolic because of decreasing 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 two sub-projects 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 cross-over randomized trial to test the effectiveness of an intervention to promote physical activity in the school environment (MOVI-KIDS), two-year in 22 schools (20 public and two private schools) in the provinces of Cuenca and Ciudad Real, Spain.
This subproject (subproject-2) will assess the effectiveness of the intervention of the MOVI-KIDS Program in improving attention and cognition in students at risk for ADHD. Furthermore, this project will evaluate the effectiveness of MOVI-KIDS Program in improving motor skills and academic achievement in the overall sample, and the impact that changes in the year have on the amount of physical activity that the students in the sample performed during recess.
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 body fat percentage in the intervention group versus the control group in 2% in children adiposity rebound age (4-7 years),
- Improve academic performance and motor skills in children with and without attention deficit hyperactivity disorder (ADHD),
- Reduce adiposity and sedentary time, improve academic performance, quality of life and the duration and quality of sleep in children with and without ADHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| MOVI-KIDS Program | Experimental | Behavioral: MOVI-KIDSIntervention group |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 their pediatrician/family doctor -after analysis of the activities program- prevents participation in them.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVI-KIDSMOVI-KIDS is a multidimensional intervention that consist of: a) for children, 4.5 h/week of a standardized recreative, non-competitive physical activity extracurricular program; b) informative sessions to parents and teachers about how schoolchildren can became more active, and c) interventions in the playground (environmental changes: equipment, facilities, painting, etc.) aimed to promote physical activity during recess (MOVI-Playground). | Behavioural | MOVI-KIDS Program |
Primary outcome
Body fat percentage
Time frame: One year (interim analysis)
Reduce body fat percentage in the intervention group versus the control group in 2% in children adiposity rebound age (4-7 years). Body fat percentage is estimated with an eight-electrode BC-418 MA bioimpedance analysis system (Tanita Corp. Tokyo, Japan) using the mean of two readings made under controlled temperature and humidity conditions.
5 secondary outcomes
Academic achievement
Time frame: One year (interim analysis)
Motor skills
Time frame: One year (interim analysis)
Health-related quality of life
Time frame: One year (interim analysis)
Sleep quality
Time frame: One year (interim analysis)
Attention-deficit/hyperactivity disorder risk
Time frame: One year (interim analysis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Derived from this study: PubMed 26458986Sanchez-Lopez M, Pardo-Guijarro MJ, Del Campo DG, Silva P, Martinez-Andres M, Gulias-Gonzalez R, Diez-Fernandez A, Franquelo-Morales P, Martinez-Vizcaino V; Movi-Kids group. Physical activity intervention (Movi-Kids) on improving academic achievement and adiposity in preschoolers with or without attention deficit hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:456. doi: 10.1186/s13063-015-0992-7.
- Information and results of the first and second edition of the MOVI ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mairena Sánchez-López, PhD principal investigator
Health and social Research Centre, University of Castilla-La Mancha, Cuenca, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVI-KIDS in people with Physical Activity and Obesity, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat percentage (time frame: One year (interim analysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.