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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03185338
Recruitment Status : Unknown
Verified June 2017 by Pablo Tercedor, Universidad de Granada.
Recruitment status was:  Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Pablo Tercedor, Universidad de Granada

Brief 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. 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.

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.


Condition or disease Intervention/treatment Phase
Motor Activity Behavioral: Active commuting to/from school Behavioral: Active Physical Education lessons Behavioral: Active school recess Behavioral: Sleep health promotion Behavioral: School global intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A School-based Physical Activity Promotion Intervention in Children: Rationale and Study Protocol for the PREVIENE Project
Estimated Study Start Date : January 9, 2018
Estimated Primary Completion Date : January 17, 2018
Estimated Study Completion Date : October 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active commuting to/from school
This 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.
Behavioral: Active commuting to/from school
Active transport to/from school on foot or by bike will be promoted

Experimental: Active Physical Education 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).
Behavioral: Active Physical Education lessons
Specific lessons designed for increasing moderate to vigorous physical activity in Physical Education will be applied

Experimental: 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.
Behavioral: Active school recess
Teachers will design games and activities and will encourage children for being active

Experimental: Sleep health promotion
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". 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.
Behavioral: 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

Experimental: School global intervention
Also, a simultaneous implementation of all four interventions (see the others arms) will be examined in one of the intervention schools.
Behavioral: Active commuting to/from school
Active transport to/from school on foot or by bike will be promoted

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

Behavioral: Active school recess
Teachers will design games and activities and will encourage children for being active

Behavioral: 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

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

No Intervention: Control school
Control school will be evaluate but will not receive any intervention



Primary Outcome Measures :
  1. Sedentary time [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  2. Light physical activity [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  3. Moderate physical activity [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  4. Vigorous physical activity [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  5. Moderate-to-vigorous physical activity [ Time Frame: Change from baseline to week 8 and 5 months later ]
    Moderate and vigorous physical activity will be combined to report moderate-to-vigorous physical activity


Secondary Outcome Measures :
  1. Sociodemographic characteristics and health status [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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).

  2. Weight [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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).

  3. Height [ Time Frame: Change from baseline to week 8 and 5 months ]
    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).

  4. Body Mass Index [ Time Frame: Change from baseline to week 8 and 5 months later ]
    Weight and height will be combined to report body mass index in kg/m^2

  5. Waist circumference [ Time Frame: Change from baseline to week 8 and 5 months ]
    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)

  6. Handgrip strength [ Time Frame: Change from baseline to week 8 and 5 months later ]
    Handgrip strength will be assessed using the handgrip strength test included in ALPHA fitness test battery. The result will be registered in kilograms.

  7. Explosive power of the legs [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  8. Speed-agility [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  9. Cardiorespiratory fitness [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  10. Commuting to school behaviour [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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

  11. Total sleep time [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  12. Sleep onset latency [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  13. Sleep efficiency [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  14. Wake after sleep onset [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.

  15. Sleep knowledge and hygiene [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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).

  16. Pediatric Sleep Questionnaire [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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

  17. Pediatric Daytime Sleepiness Scale [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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

  18. Academic achievement [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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).

  19. Health-Related Quality of Life [ Time Frame: Change from baseline to week 8 and 5 months later ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185338


Contacts
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Contact: Pablo Terdedor, PhD 034958246636 tercedor@ugr.es
Contact: Pablo Tercedor, PhD 034958246636 tercedor@ugr.es

Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Pablo Tercedor, PhD Universidad de Granada
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Responsible Party: Pablo Tercedor, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03185338    
Other Study ID Numbers: DEP2015-63988-R
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pablo Tercedor, Universidad de Granada:
physical activity, promotion, school