Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000076673
Ethics application status
Approved
Date submitted
13/12/2022
Date registered
23/01/2023
Date last updated
23/01/2023
Date data sharing statement initially provided
23/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of promoting health-enhancing physical activity and health education in the local community families: the Promoting Health and Access to Sport Equipment (PHASE) project
Scientific title
Efficacy of promoting health-enhancing physical activity and health education in the local community families: the Promoting Health and Access to Sport Equipment (PHASE) project
Secondary ID [1] 308574 0
ERASMUS + funding number: 622288-EPP-1-2020-1-PT-SPO-SCP
Universal Trial Number (UTN)
Trial acronym
PHASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 328512 0
Condition category
Condition code
Public Health 325537 325537 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Promoting Health and Access to Sport Equipment (PHASE) is a school-based family centred health education program focused on physical activity.
To promote physical activity within the local community families and primary school children a physically active game-based approach will be used, including formal and informal team games. The following contents will be explored in the various sessions of the PHASE intervention: (a) line ball games; (b) dodgeball; (c) throwball; (d) adapted basketball; (e) tag rugby; (f) free play. The sessions will all have a similar structure: 10 minutes warm up, 20 minutes informal team games and rule learning, 25 minutes formal team game and 5 minutes relaxation.
The PHASE intervention will be evaluated using a controlled trial, selecting two primary schools from the same area in each Portuguese (n=4), Spanish (n=2), Polish (n=2), Latvian (n=2) and Czech (n=2) partner.
PHASE will be implemented in two phases: (I) controlled intervention of the health education program; (II) open the health education program to the control group, using an experimental design approach. In the intervention group the program will last 20 weeks, with two 60-minutes sessions per week. The sessions will take place inside the school using the school sports facilities up to a total of 50 participants (25 parents and 25 children).
A focus group with parents and other one with children were previously conducted to evaluate the feasibility and the receptiveness for the implementation of the project, namely the involvement of parents in the school to practice physical activity with children and their availability for the sessions. Based on the focus groups, one session will occur during the week in the afternoon after school. Ideally, the other will take place during the weekend in the morning or afternoon. Sessions will be held on non-consecutive days and at least two days (e.g., one session on Wednesday and the other on Saturday). Sessions will be performed by qualified professionals in the field of Physical Activity/Physical Education with, at least, a Bachelor’s level degree.
To assess the adherence to the program, participation will be registered in each session.
Intervention code [1] 325067 0
Lifestyle
Intervention code [2] 325070 0
Behaviour
Comparator / control treatment
PHASE will be implemented in two phases: (I) controlled intervention of the health education program; (II) open the health education program to the control group, using an experimental design approach.
For the control group, the school will be open for 10 weeks providing the school's sports facilities for parents and children to practice physical activity. To monitor participation, parents and children should enrol in the program up to a total of 50 participants (25 parents and 25 children).
After 10 weeks, the physical activity sessions will be opened to the control group. This phase II will last 10 weeks and will have the same characteristics as the experimental group: two 60-minutes sessions per week with (a) line ball games; (b) dodgeball; (c) throwball; (d) adapted basketball; (e) tag rugby; (f) free play. The 20 sessions will all have a similar structure: 10 minutes warm up, 20 minutes informal team games and rule learning, 25 minutes formal team game and 5 minutes relaxation.
Control group
Active

Outcomes
Primary outcome [1] 333379 0
Physical activity levels as assessed by self-report for children (instrument: Child Physical Activity Questionnaire (CPAQ))
Timepoint [1] 333379 0
Baseline (before starting the health education program), 10 weeks (at the middle), 20 weeks (last session; primary endpoint).
Primary outcome [2] 333521 0
Physical activity levels as assessed by self-report for adults (instrument: International Physical Activity Questionnaire (IPAQ))
Timepoint [2] 333521 0
Baseline (before starting the health education program), 10 weeks (at the middle), 20 weeks (last session; primary endpoint).
Primary outcome [3] 333612 0
Physical activity levels as measured by accelerometers
Timepoint [3] 333612 0
Baseline (during one week before starting the health education program), during 9th week (at the middle), during 19th week (last week of the program; primary endpoint).
Secondary outcome [1] 416849 0
Family cohesion as assessed by questionnaires (instrument: Family Adaptability and Cohesion Evaluation Scales (FACES III))
Timepoint [1] 416849 0
Baseline, 10 weeks (at the middle), 20 weeks (last session)
Secondary outcome [2] 416850 0
Body mass index: height and weight objectively measured (height measured by stadiometer and weight measured by digital scale),
Timepoint [2] 416850 0
Baseline, 10 weeks (at the middle), 20 weeks (last session)
Secondary outcome [3] 416851 0
Sedentary behaviour levels as assessed by self-report for children (instrument: Child Physical Activity Questionnaire (CPAQ))
Timepoint [3] 416851 0
Baseline (before starting the health education program), 10 weeks (at the middle), 20 weeks (last session).
Secondary outcome [4] 417417 0
Sedentary behaviour levels as assessed by self-report for adults (instrument: International Physical Activity Questionnaire (IPAQ))
Timepoint [4] 417417 0
Baseline (before starting the health education program), 10 weeks (at the middle), 20 weeks (last session).
Secondary outcome [5] 417755 0
Sedentary behaviour levels as measured by accelerometers
Timepoint [5] 417755 0
Baseline (during one week before starting the health education program), during 9th week (at the middle), during 19th week (last week of the program).

Eligibility
Key inclusion criteria
Children aged 6 to 10 attending schools where the PHASE intervention will be developed.
Parents, relatives (e.g. grandparents, uncles, older brothers) or responsible persons of the children participating in PHASE.
Availability to participate in the sessions.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Having medical impediment for practising physical activity or sports activities.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 25180 0
Portugal
State/province [1] 25180 0
Lisbon
Country [2] 25181 0
Portugal
State/province [2] 25181 0
Madeira
Country [3] 25182 0
Czech Republic
State/province [3] 25182 0
Olomouc
Country [4] 25183 0
Latvia
State/province [4] 25183 0
Riga
Country [5] 25184 0
Spain
State/province [5] 25184 0
Burgos
Country [6] 25185 0
Poland
State/province [6] 25185 0
Wroclaw

Funding & Sponsors
Funding source category [1] 312821 0
Other
Name [1] 312821 0
EACAE Erasmus+ Sport
Country [1] 312821 0
Belgium
Primary sponsor type
University
Name
University of Lisbon
Address
Estrada da Costa
1499-002 Cruz Quebrada - Dafundo
Portugal
Country
Portugal
Secondary sponsor category [1] 314464 0
None
Name [1] 314464 0
Address [1] 314464 0
Country [1] 314464 0
Other collaborator category [1] 282502 0
University
Name [1] 282502 0
University of Madeira
Address [1] 282502 0
Campus Universitário da Penteada, 9020-105 Funchal, Portugal
Country [1] 282502 0
Portugal
Other collaborator category [2] 282503 0
University
Name [2] 282503 0
University of Latvia
Address [2] 282503 0
Raina blvd. 19, Riga, Latvia, LV-1586
Country [2] 282503 0
Latvia
Other collaborator category [3] 282504 0
University
Name [3] 282504 0
Palacky University Olomouc
Address [3] 282504 0
Krizkovskeho 511/8, Olomouc, 771 47, Czech Republic
Country [3] 282504 0
Czech Republic
Other collaborator category [4] 282505 0
University
Name [4] 282505 0
Universidad Isabel I
Address [4] 282505 0
Calle Fernán González, 76, 09003, Burgos
Country [4] 282505 0
Spain
Other collaborator category [5] 282506 0
University
Name [5] 282506 0
University School of Physical Education
Address [5] 282506 0
I. J. Paderewskiego 35, 51-612 Wroclaw
Country [5] 282506 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312101 0
Conselho de Ética para a Investigação da Faculdade de Motricidade Humana, Universidade de Lisboa (CEIFMH)
Ethics committee address [1] 312101 0
Ethics committee country [1] 312101 0
Portugal
Date submitted for ethics approval [1] 312101 0
Approval date [1] 312101 0
03/05/2022
Ethics approval number [1] 312101 0
Parecer CEIFMH N.º: 12/2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123478 0
Prof Adilson Marques
Address 123478 0
University of Lisbon
Estrada da Costa
1499-002 Cruz Quebrada - Dafundo
Portugal
Country 123478 0
Portugal
Phone 123478 0
+351962843264
Fax 123478 0
Email 123478 0
[email protected]
Contact person for public queries
Name 123479 0
Adilson Marques
Address 123479 0
University of Lisbon
Estrada da Costa
1499-002 Cruz Quebrada - Dafundo
Portugal
Country 123479 0
Portugal
Phone 123479 0
+351962843264
Fax 123479 0
Email 123479 0
[email protected]
Contact person for scientific queries
Name 123480 0
Adilson Marques
Address 123480 0
University of Lisbon
Estrada da Costa
1499-002 Cruz Quebrada - Dafundo
Portugal
Country 123480 0
Portugal
Phone 123480 0
+351962843264
Fax 123480 0
Email 123480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data privacy reasons.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17862Study protocol  [email protected] It will be insert after its publication.
17863Ethical approval  [email protected]
17864Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.