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

NCT03185338 | Unknown

• 1 other identifier: DEP2015-63988-R
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Motor Activity

Keywords

physical activity, promotion, school

Outcome Measures

Primary Outcomes (5)

• 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.

  Change from baseline to week 8 and 5 months later

• 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.

  Change from baseline to week 8 and 5 months later

• 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.

  Change from baseline to week 8 and 5 months later

• 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.

  Change from baseline to week 8 and 5 months later

• Moderate-to-vigorous physical activity

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

  Change from baseline to week 8 and 5 months later

Secondary Outcomes (19)

• Sociodemographic characteristics and health status

  Change from baseline to week 8 and 5 months later

• Weight

  Change from baseline to week 8 and 5 months later

• Height

  Change from baseline to week 8 and 5 months

• Body Mass Index

  Change from baseline to week 8 and 5 months later

• Waist circumference

  Change from baseline to week 8 and 5 months

Study Arms (6)

Active commuting to/from school

EXPERIMENTAL

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 Physical Education lessons

EXPERIMENTAL

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

Active school recess

EXPERIMENTAL

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

Sleep health promotion

EXPERIMENTAL

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

School global intervention

EXPERIMENTAL

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; Behavioral: Active Physical Education lessons; Behavioral: Active school recess; Behavioral: Sleep health promotion; Behavioral: School global intervention

Control school

NO INTERVENTION

Control school will be evaluate but will not receive any intervention

Interventions

Active commuting to/from school BEHAVIORAL

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

Active commuting to/from school; School global intervention

Active Physical Education lessons BEHAVIORAL

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

Active Physical Education lessons; School global intervention

Active school recess BEHAVIORAL

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

Active school recess; School global intervention

Sleep health promotion BEHAVIORAL

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 intervention; Sleep health promotion

School global intervention BEHAVIORAL

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

School global intervention

Eligibility Criteria

• Age: 8 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Universidad de Granada: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Pablo Tercedor, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Terdedor, PhD

CONTACT

034958246636; tercedor@ugr.es

Pablo Tercedor, PhD

CONTACT

034958246636; tercedor@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: January 9, 2018
• Primary Completion: January 17, 2018
• Study Completion: October 22, 2019
• Last Updated: June 14, 2017

Record last verified: 2017-06