AzTrials
AzTrials

Motor ActivityPREVIENENCT03185338

A School-based Physical Activity Promotion Intervention in Children. PREVIENE Project

A study testing Active commuting to/from school, Active Physical Education lessons and Active school recess in people with Motor Activity, run by Universidad de Granada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Background:The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost,easy-to-implement school-based interventions to increase physical activity among children. Read more about this study

Who is it for?
Ages 8 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Motor Activity
What is being tested?
Active commuting to/from school, Active Physical Education lessons and Active school recess
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
9 Jan 2018to 22 Oct 2019
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 8 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Schools with at least two groups of students
  • Each group with at least 25 students

Who cannot join

  • None

Trial locations and contacts

No sites are listed yet.

Pablo Terdedor, PhD contact

034958246636

tercedor@ugr.es

Pablo Tercedor, PhD contact

034958246636

tercedor@ugr.es

About this study

Official title: A School-based Physical Activity Promotion Intervention in Children: Rationale and Study Protocol for the PREVIENE Project

Background:The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost,easy-to-implement school-based interventions to increase physical activity among children. The PREVIENE Project will evaluate the effectiveness of five innovative, simple, and feasible interventions(active commuting to school, Physical Education lessons, active school recess physical activity, sleep health promotion, and an integrated program incorporating all 4 interventions) to improve physical activity, fitness, anthropometry, sleep health, academic achievement,and health-related quality of life in primary school children.

Methods:A total of 350 children (grade 3; 8-9 years of age) from six schools in Granada (Spain) will be enrolled in one of the 8-week interventions (one intervention per school; 50 children per school) or a control group (no intervention school; 50 children). Outcomes will include physical activity (measured by accelerometry), physical fitness (assessed using the ALPHA fitness battery), anthropometry (height, weight and waist circumference), sleep health (measured by accelerometers, a sleep diary, and sleep health questionnaires), academic achievement (grades from the official school's records), and health-related quality of life (child and parental questionnaires).To assess the effectiveness of the different interventions on objectively measured PA and the other outcomes, the generalized linear model will be used.

Read more

Discussion: The PREVIENE Project will provide the information about the effectiveness and implementation of different school-based interventions for physical activity promotion in primary schoolchildren.

Keywords:children, physical activity, school,active commuting, Physical Education, school recess, sleep health, fitness, academic achievement, health-related quality of life.

Read the detailed description

Background

The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost,easy-to-implement school-based interventions to increase physical activity among children. The PREVIENE Project will evaluate the effectiveness of five innovative, simple, and feasible interventions (active commuting to school, Physical Education lessons, active school recess physical activity, sleep health promotion, and an integrated program incorporating all 4 interventions) to improve physical activity, fitness, anthropometry, sleep health, academic achievement,and health-related quality of life in primary school children.

Methods

The PREVIENE Project uses a quasi-experimental approach with a convenience sample size of 300 children (grade 3, 8-9 years old) from six primary schools in Granada (Spain) (2 classes per school x 6 schools = 12classesin total). With the average class size of 25 children and the expected recruitment rate is 90%, two classes will be selected in each participating school. All 79 primary schools in Granada will be invited to participate in this study. The schools will initially be contacted by email followed by a phone call. Research team will arrange a meeting with the interested schools and their staff (principal, physical education teacher and other relevant teachers). At this meeting, the researchers will explain the main objective of this study and the inclusion criteria for schools' participation: 1) At least 2 classes of grade 3 children at school, 2) the average class size has to be 25 or more children. Once determined the schools that satisfy the inclusion criteria and express their willingness to participate, a total of six schools will be randomly selected.

The Regional Ministry of Education will endorse the participation of each selected school in the study. At the beginning of the study, families of all children in the selected classes will receive an invitation to an initial meeting at school to receive information about the study. Both children and parents will be encouraged to participate in the study. Parents will sign an informed consent which include the participation of them and their child. The study protocol has been approved by the University of Granada Human Research EthicsCommittee (Reference: 57/CEIH/2015).

Five schools will be randomly assigned to an intervention schools, four of them will apply a single intervention (n=50 children per intervention/school) and one school will implement the integrated program (all four interventions simultaneously;n=50 children).The sixth school will serve as a control school and will not receive any intervention (n=50 children). In schools assigned to the active PE lesson and integrated intervention, standard PE lessons will be replaced for the Active Didactics Unit. In all other schools, children will be exposed to the usual PE session's structure according to the National Education Program in Spain (i.e. 45 min sessions twice per week).

Interventions

Active commuting to/from school

This intervention will include a range of school-, family- and community-based activities. These activities will be focused on children and their families following the ecological model proposed by Sallis et al., targeting mainly individual factors such as children's perceptions (safety perception on the way to school) and attitudes (independence or motivation to walk). A total of six 1-hour activities will be conducted at the classroom and two activities in the school neighborhood designed based on previous literature. Taken together, these activities will emphasize the benefits of active commuting to/from school and promote active commuting to/from school using phrases such as "If you rides a bike for 1.200 km, the medium number of disease days will be reduced by one" for families.Moreover, supporting information will be sent to families on four occasions during the intervention to encourage families to use active modes of commuting to/from school. The supporting information will consist of sending messages by whatsapp and advices (text and images) explaining the most important ideas related active commuting and benefits of active commuting on academic achievements and children´s mental and physical health.

Finally, throughout the intervention period, the teacher will ask children their mode of transport to school of that day twice a week by raising their hand and encourage possible changes in mode of commuting as motivational strategy by using positive reinforcement (as reinforce when some children accompanied each other in the way to school). The objective of this reinforcement is to remind children to active commute to and from school.

Active PE lessons

This intervention has been developed by the Spanish Ministry of Health, Social Services and Equality and the Ministry of Education, Culture and Sport to increase the amount of children's PA during PE lessons in primary schools. At the time of this study, any school in Spain could choose to adopt this programme. This intervention includes two sets of eight active PE lessons specifically developed for third grade of primary school. These lessons will replace the original PE lessons in schools assigned to Active PE lesson intervention and integrated intervention. Additionally, this intervention provides some methodological advices to increase the PA time during the PE lesson (i.e. different ways to take attendance or deciding on the most suitable activity given the availability of resources).

Active school recess

This intervention has been designed based on previous research. The teacher will prepare the school playground offering adequate space and games to encourage children to be active. A sheet placed on the wall as a reminder will help teacher to remind children to participate and motivate them. On this sheet, each child will write the activity completed during the school recess every day during the intervention period.

Sleep health promotion

This intervention will aim to raise the awareness of the importance of having a good quality sleep at night and to teach healthy sleep behaviours that will contribute to improving sleep hygiene. As a part of this intervention, eight activities will be carried out at home and at school. During the first activity, parents and children will attend a general talk about sleep and health and will sign a contract for a "healthy sleep at home". Signing "the contract" will enable participants to have an active role in the sleep intervention. Also, with help of their parents at home, children will complete a diary in which they will keep a record of their activities prior to going to bed and after waking up in the morning. The objective of this activity is to strengthen the importance of a routine before going to sleep and its benefits on the adequate sleep behaviour. Parents will be given a manual to help children use an adequate sleep routine and reinforce children's achievements. At school, several teachers assisted by the researchers will implement the activities. The first classroom-based activity will be based on the educational program "I have a dream" (Spanish adaptation of the SimplyHealthy@Schools International Program; Philips Ibérica, S.A., Madrid, Spain). The remaining classroom-based activities will include with a group art project with questions and answers about sleep, children's calculation of their own sleep parameters from the sleep log data, and discussion groups about the sleep diary completed at home and other sleep issues, as well as strategies to achieve the commitments included in the "signed contract". In addition, the class teacher will introduce the concept of relaxation and its benefits at bedtime and will teach an abbreviated version of the Jacobson's progressive relaxation technique every morning after the recess.

School global intervention

Also, a simultaneous implementation of all four interventions (see the others arms) will be examined in one of the intervention schools.

Data analysis

Demographic characteristics will be analysed using descriptive statistics. Data will be presented using the mean and standard deviation or median and interquartile range, where appropriate for continuous variables, and frequency and percentage for categorical variables. To assess the effectiveness of the different interventions on objectively measured PA and the other outcomes, the generalized linear model will be used with the outcome measures as dependent variables in separate models, the intervention as an independent variable and controlling for potential confounders (such as gender, body mass index, socioeconomic status, and baseline PA). Statistical significance will be set at p<0.05.

Conditions
Motor Activity
Being tested
Active commuting to/from school, Active Physical Education lessons, Active school recess, Sleep health promotion, School global intervention
Keywords
physical activity, promotion, school
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active commuting to/from schoolBehavioural

    Active transport to/from school on foot or by bike will be promoted

  • Active Physical Education lessonsBehavioural

    Specific lessons designed for increasing moderate to vigorous physical activity in Physical Education will be applied

  • Active school recessBehavioural

    Teachers will design games and activities and will encourage children for being active

  • Sleep health promotionBehavioural

    This intervention will aim to raise the awareness of the importance of having a good quality sleep at night and to teach healthy sleep behaviours that will contribute to improving sleep hygiene

  • School global interventionBehavioural

    A simultaneous implementation of all four interventions (see the others arms) will be examined in one of the intervention schools.

Study groups in NCT03185338
Study groupRoleWhat they receive
Active commuting to/from schoolExperimentalThis intervention will be focused on children and their families following the ecological model proposed by Sallis et al., targeting mainly individual factors such as children's perceptions (safety perception on the way to school) and attitudes (independence or motivation to walk). A total of six 1-hour activities will be conducted at the classroom and two activities in the school neighborhood designed based on previous literature. Taken together, these activities will emphasize the benefits of active commuting to/from school and promote active commuting to/from school.Moreover, supporting information will be sent to families on four occasions during the intervention to encourage families to use active modes of commuting to/from school.
Receives: Behavioral: Active commuting to/from school
Active Physical Education lessonsExperimentalThis intervention has been developed by the Spanish Ministry of Health, Social Services and Equality and the Ministry of Education, Culture and Sport to increase the amount of children's PA during PE lessons in primary schools. At the time of this study, any school in Spain could choose to adopt this programme. This intervention includes two sets of eight active PE lessons specifically developed for third grade of primary school. These lessons will replace the original PE lessons in schools assigned to Active PE lesson intervention and integrated intervention.Additionally, this intervention provides some methodological advices to increase the PA time during the PE lesson (i.e. different ways to take attendance or deciding on the most suitable activity given the availability of resources).
Receives: Behavioral: Active Physical Education lessons
Active school recessExperimentalThis intervention has been designed based on previous research. The teacher will prepare the school playground offering adequate space and games to encourage children to be active. A sheet placed on the wall as a reminder will help teacher to remind children to participate and motivate them. On this sheet, each child will write the activity completed during the school recess every day during the intervention period.
Receives: Behavioral: Active school recess
Sleep health promotionExperimentalEight activities will be carried out at home and at school. During the first activity, parents and children will attend a general talk about sleep and health and will sign a contract for a "healthy sleep at home". Also, children will complete a diary in which they will keep a record of their activities prior to going to bed and after waking up in the morning. At school, the first classroom-based activity will be based on the educational program "I have a dream" (Spanish adaptation of the SimplyHealthy@Schools International Program). The remaining classroom-based activities will include with a group art project with questions and answers about sleep, discussion groups about the sleep diary completed at home, and an abbreviated version of the Jacobson's progressive relaxation technique.
Receives: Behavioral: Sleep health promotion
School global interventionExperimentalAlso, a simultaneous implementation of all four interventions (see the others arms) will be examined in one of the intervention schools.
Receives: Behavioral: Active commuting to/from school; Behavioral: Active Physical Education lessons; Behavioral: Active school recess; Behavioral: Sleep health promotion; Behavioral: School global intervention
Control schoolNo interventionControl school will be evaluate but will not receive any intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sedentary time

    Sedentary time will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  2. Light physical activity

    Light physical activity will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  3. Moderate physical activity

    Moderate physical activity will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  4. Vigorous physical activity

    Vigorous physical activity will be measured using a tri-axial accelerometer (Actigraph wGT3X-BT, Pensacola, FL, USA) on 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. Children will take it off only while water-based activities.Children will also complete a log to record the time when they take off the accelerometer. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  5. Moderate-to-vigorous physical activity

    Moderate and vigorous physical activity will be combined to report moderate-to-vigorous physical activity

    Measured: Change from baseline to week 8 and 5 months later

Secondary outcomes (19)
  1. Sociodemographic characteristics and health status

    Parents will complete a questionnaire about child's sociodemographic characteristics including date of birth and gender, household factors,family's socioeconomic characteristics (family income, parental education and parental employment status) and child's health status (reporting medical conditions and medications, if any).

    Measured: Change from baseline to week 8 and 5 months later

  2. Weight

    Weight will be assessed wearing PE clothes (shorts and a short sleeve shirt) and bare feet. Weight will be measured with a 0.1 kg approximation using a Seca 876 weighing system (Seca, Ltd., Hamburg, Germany).

    Measured: Change from baseline to week 8 and 5 months later

  3. Height

    Height will be assessed wearing PE clothes (shorts and a short sleeve shirt) and bare feet. Height will be measured in the Frankfort plane, with an approximation of 0.1 cm using a Seca 2013 stadiometer (Seca, Ltd., Hamburg, Germany).

    Measured: Change from baseline to week 8 and 5 months

  4. Body Mass Index

    Weight and height will be combined to report body mass index in kg/m^2

    Measured: Change from baseline to week 8 and 5 months later

  5. Waist circumference

    Waist circumference will be assessed in a horizontal plane, at the level of the natural waist, by the measuring tape Seca 201 (Seca, Ltd., Hamburg, Germany)

    Measured: Change from baseline to week 8 and 5 months

  6. Handgrip strength

    Handgrip strength will be assessed using the handgrip strength test included in ALPHA fitness test battery. The result will be registered in kilograms.

    Measured: Change from baseline to week 8 and 5 months later

  7. Explosive power of the legs

    Explosive power of the legs will be assessed using the standing long jump test included in ALPHA fitness test battery. The result will be registered in centimeters.

    Measured: Change from baseline to week 8 and 5 months later

  8. Speed-agility

    Speed-agility will be assessed using the 10-meter shuttle run test included in ALPHA fitness test battery. The result will be registered in centimeters.

    Measured: Change from baseline to week 8 and 5 months later

  9. Cardiorespiratory fitness

    Cardiorespiratory fitness will be assessed using the 20-meters shuttle run test included in ALPHA fitness test battery. The result will be registered in seconds.

    Measured: Change from baseline to week 8 and 5 months later

  10. Commuting to school behaviour

    Children will complete the questionnaire Pedalea y Anda al COlegio [ride a bike and go on foot to school] (PACO) with the help of the teacher and researcher at school. The Spanish and English versions of the questionnaire is available at http://profith.ugr.es/pages/investigacion/recursos/paco

    Measured: Change from baseline to week 8 and 5 months later

  11. Total sleep time

    Total sleep time will be assessed using accelerometry (ActigraphwGT3X-BT, Pensacola, FL, USA) 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  12. Sleep onset latency

    Sleep onset latency will be assessed using accelerometry (ActigraphwGT3X-BT, Pensacola, FL, USA) 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  13. Sleep efficiency

    Sleep efficiency will be assessed using accelerometry (ActigraphwGT3X-BT, Pensacola, FL, USA) 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  14. Wake after sleep onset

    Wake after sleep onset will be assessed using accelerometry (ActigraphwGT3X-BT, Pensacola, FL, USA) 7 consecutive days, 24 hours/day. Children will be instructed to wear an accelerometer attached to the non-dominant wrist. The results will be registered in minutes.

    Measured: Change from baseline to week 8 and 5 months later

  15. Sleep knowledge and hygiene

    Children's sleep knowledge will be assessed using the Sleep Knowledge and Sleep Hygiene questionnaire developed by Philips as part of the educational program "I have a dream" (Spanish adaptation of the SimplyHealthy@Schools International Program; Philips Ibérica, S.A., Madrid, España). This questionnaire includes six questions about sleep knowledge and sleep-related behaviours (sleep hygiene, and bed time routine).

    Measured: Change from baseline to week 8 and 5 months later

  16. Pediatric Sleep Questionnaire

    Parents will complete the Pediatric Sleep Questionnaire to report general children's sleep behaviour, symptoms related to sleep disorders (especially, sleep apnea, enuresis, and parasomnias), and daytime behaviour hypersomnolence, inattention, hyperactivity). The questionnaire contains 71 items with response categories "yes", "no" and "don't know" and 18 four-point Likert-type items. This questionnaire has been validated in Spanish children

    Measured: Change from baseline to week 8 and 5 months later

  17. Pediatric Daytime Sleepiness Scale

    Parents will complete the Pediatric Daytime Sleepiness Scale to assesses daytime sleepiness-related behaviour. The scale contains 8 items answered by parents and scored from 0 to 4, using a 5-point Likert-scale. The questionnaire was translated into Spanish and has been tested for comprehension in Spanish children

    Measured: Change from baseline to week 8 and 5 months later

  18. Academic achievement

    Academic achievement will be determined from the final grades from the official school's records at the end of each trimester of the academic year in which data are collected. The academic indicators will be the grades (ranging from 0 to 10) from selected subjects (Natural Science, Social Sciences, Language (Spanish), Foreign language (English), Music, Arts and PE) and the medium grade (sum of the grade obtained in each of the subjects divided by the total of subjects).

    Measured: Change from baseline to week 8 and 5 months later

  19. Health-Related Quality of Life

    Health-related quality of life will be assessed using the Revidierter KINDer Lebensqualitätsfragebogen (KINDL-R), validated for 4 to 16 years old Spanish children.The KINDL-R consists of 24 items associated with 6 dimensions of health-related quality of life: physical well-being (e.g., illness, pain, fatigue), emotional well-being (e.g., boredom, loneliness, scared), self-esteem (e.g., pride, feeling on top of the world), family (e.g., relationship with parents, conflict at home), friends (e.g., getting along, feeling different from others), everyday functioning in school (e.g., enjoying class, worrying about the future) and disease (e.g., illness uncertainty, parent overprotection, missing school).Both children and parents will complete the respective versions of the KINDL-R questionnaires.The total score of both child and parental questionnaires will be transformed to a scale of 0 to 100, where higher scores indicate better health-related quality of life.

    Measured: Change from baseline to week 8 and 5 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start9 Jan 2018 (estimated)
  3. Primary completion17 Jan 2018 (estimated)
  4. Study completion22 Oct 2019 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03185338
Sponsor's protocol ID
DEP2015-63988-R
Acronym
PREVIENE
Status last verified
Jun 2017
First submitted
7 Jun 2017
Last updated
14 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Active commuting to/from school, Active Physical Education lessons and Active school recess in people with Motor Activity, run by Universidad de Granada.

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 2 inclusion and 1 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Pablo Terdedor, PhD (034958246636, tercedor@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedentary time (time frame: Change from baseline to week 8 and 5 months later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Jun 2017.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in