Physical ActivityNCT05382975
Adapted Comprehensive School Physical Activity Program
A study testing CSPAP in people with Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Investigators will conduct a hybrid implementation-effectiveness trial of an adapted Comprehensive School Physical Activity Program (CSPAP) intervention. A clustered stepped wedge design will be used, with the duration of the trial being 3 years. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- CSPAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,637 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 30 Jun 2025
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Adolescent Inclusion Criteria:
- Age 11-14 (inclusive)
- Attend one of the participating schools during the study period
Teacher/Staff Inclusion Criteria:
- Age 18 or older
- Work at one of the participating schools during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98101
About this study
Investigators will conduct a hybrid implementation-effectiveness trial of an adapted Comprehensive School Physical Activity Program (CSPAP) intervention. A clustered stepped wedge design will be used, with the duration of the trial being 3 years.
Read the detailed description
The Comprehensive School Physical Activity Program (CSPAP) is a multi-component approach by which schools use all opportunities for students to be physically active in 5 domains: physical education; physical activity during school; physical activity before and after school; staff involvement; and family and community engagement. Overall, CSPAP-based interventions have had small effect sizes in impacting youth PA, with larger effect sizes seen when more CSPAP domains are included. CSPAP-based interventions may be particularly beneficial for students attending schools located in communities with the fewest out of school resources for PA. There is thus a critical need to effectively support schools in increasing PA opportunities with an emphasis on meeting the PA-related needs of youth who have limited access to opportunities for physical activity, sports, and outdoor recreation.
The effectiveness and implementation of a flexible, systems-level intervention to increase opportunities for PA in middle schools will be studied. The intervention seeks to support middle schools in increasing opportunities for PA practices in all CSPAP domains-addressing two core systems-level barriers to such implementation (staffing and teacher/staff training) and building in flexibility for setting-specific needs assessment and action planning. Core components include (1) provision of a dedicated staff member (via Americorps or other organization) to support school PA (via direct staffing and capacity building), (2) setting-specific needs assessment and action planning, and (3) professional development opportunities for teachers, staff, and coaches related to the provision of PA across CSPAP domains.
The study will use a stepped wedge design with a total of 7 middle schools, in which each school will be randomized to start the intervention at different time points. All schools will provide baseline data and will later switch to the intervention phase in random order and in 3 waves. Based on feasibility considerations, 2 schools will switch from control phase to intervention phase in wedge 1, 3 schools will be in wedge 2, and 2 schools will be in wedge 3. Each 2-year intervention phase will be followed by a year when data will be collected to assess sustainability of the intervention. In total, there will be approximately 15 control phase data collections, 20 intervention phase data collections, for a total of 1800 student-assessments. This study will:
- Assess how intervention exposure is associated with student (accelerometer-measured) PA
- Assess how intervention exposure is associated with student depression and anxiety
- Assess how intervention exposure is associated with change in PA opportunities at the school level
- Explore systems-level barriers and facilitators to successful intervention implementation and maintenance.
- Conditions
- Physical Activity
- Being tested
- CSPAP
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSPAPBehavioural
Adapted CSPAP delivery:
- Staffing support
- Professional development for teachers and staff
- Setting specific needs assessment and action planning
| Study group | Role | What they receive |
|---|---|---|
| Wedge 1 includes Schools 1 and 2. | Other | Not described Receives: Behavioral: CSPAP |
| Wedge 2 includes Schools 3, 4, and 5. | Other | Not described Receives: Behavioral: CSPAP |
| Wedge 3 includes Schools 6 and 7. | Other | Not described Receives: Behavioral: CSPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity - Accelerometer measured.
This is the primary outcome for this study and will be collected from a gender stratified random subset of at least 45 students per school, at each time point. Physical activity will be objectively measured using the ActiGraph GT3X worn at the hip for 5 day periods (x 10 hour wear) at each of the data collection timepoints (i.e., fall and spring of each school year).
Measured: 2 times per year (Fall, Spring) up to 3 years
Anxiety and Depression
Mental health symptomatology will be measured using the Patient Health Questionnaire for Depression and Anxiety (the PHQ-4), a brief behavioral screening questionnaire. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). This will be asked in surveys digitally distributed to all students in the fall and spring of each school year. Higher scores indicate worse outcomes.
Measured: 2 times per year (Fall, Spring) up to 3 years
Secondary outcomes (1)
Resilient psychosocial functioning
Psychological aspects of adolescent resilience will be measured using the positive future orientation domain of the 21-item Adolescent Resilience Scale. This will be asked in surveys digitally distributed to all students in the fall and spring of each school year.
Measured: 2 times per year (Fall, Spring) up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Aug 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- Schools will be randomized to start the intervention at different time points
- Masking
- None (open label)
- Enrolment
- 5,637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pooja Tandon, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382975
- Sponsor's protocol ID
- STUDY00003419
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Comprehensive School Physical Activity Program
- ClinicalTrials.gov ID
- NCT05382975
- Acronym / sponsor ID
- STUDY00003419
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,637 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 May 2022 (actual)
- 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.
Investigators will conduct a hybrid implementation-effectiveness trial of an adapted Comprehensive School Physical Activity Program (CSPAP) intervention. A clustered stepped wedge design will be used, with the duration of the trial being 3 years.
Detailed description
The Comprehensive School Physical Activity Program (CSPAP) is a multi-component approach by which schools use all opportunities for students to be physically active in 5 domains: physical education; physical activity during school; physical activity before and after school; staff involvement; and family and community engagement. Overall, CSPAP-based interventions have had small effect sizes in impacting youth PA, with larger effect sizes seen when more CSPAP domains are included. CSPAP-based interventions may be particularly beneficial for students attending schools located in communities with the fewest out of school resources for PA. There is thus a critical need to effectively support schools in increasing PA opportunities with an emphasis on meeting the PA-related needs of youth who have limited access to opportunities for physical activity, sports, and outdoor recreation.
The effectiveness and implementation of a flexible, systems-level intervention to increase opportunities for PA in middle schools will be studied. The intervention seeks to support middle schools in increasing opportunities for PA practices in all CSPAP domains-addressing two core systems-level barriers to such implementation (staffing and teacher/staff training) and building in flexibility for setting-specific needs assessment and action planning. Core components include (1) provision of a dedicated staff member (via Americorps or other organization) to support school PA (via direct staffing and capacity building), (2) setting-specific needs assessment and action planning, and (3) professional development opportunities for teachers, staff, and coaches related to the provision of PA across CSPAP domains.
The study will use a stepped wedge design with a total of 7 middle schools, in which each school will be randomized to start the intervention at different time points. All schools will provide baseline data and will later switch to the intervention phase in random order and in 3 waves. Based on feasibility considerations, 2 schools will switch from control phase to intervention phase in wedge 1, 3 schools will be in wedge 2, and 2 schools will be in wedge 3. Each 2-year intervention phase will be followed by a year when data will be collected to assess sustainability of the intervention. In total, there will be approximately 15 control phase data collections, 20 intervention phase data collections, for a total of 1800 student-assessments. This study will:
- Assess how intervention exposure is associated with student (accelerometer-measured) PA
- Assess how intervention exposure is associated with student depression and anxiety
- Assess how intervention exposure is associated with change in PA opportunities at the school level
- Explore systems-level barriers and facilitators to successful intervention implementation and maintenance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Schools will be randomized to start the intervention at different time points
| Arm | Type | Receives |
|---|---|---|
| Wedge 1 includes Schools 1 and 2. | Other | Behavioral: CSPAP |
| Wedge 2 includes Schools 3, 4, and 5. | Other | Behavioral: CSPAP |
| Wedge 3 includes Schools 6 and 7. | Other | Behavioral: CSPAP |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CSPAPAdapted CSPAP delivery: * Staffing support * Professional development for teachers and staff * Setting specific needs assessment and action planning | Behavioural | Wedge 1 includes Schools 1 and 2., Wedge 2 includes Schools 3, 4, and 5., Wedge 3 includes Schools 6 and 7. |
Primary outcome
Physical Activity - Accelerometer measured.
Time frame: 2 times per year (Fall, Spring) up to 3 years
This is the primary outcome for this study and will be collected from a gender stratified random subset of at least 45 students per school, at each time point. Physical activity will be objectively measured using the ActiGraph GT3X worn at the hip for 5 day periods (x 10 hour wear) at each of the data collection timepoints (i.e., fall and spring of each school year).
Anxiety and Depression
Time frame: 2 times per year (Fall, Spring) up to 3 years
Mental health symptomatology will be measured using the Patient Health Questionnaire for Depression and Anxiety (the PHQ-4), a brief behavioral screening questionnaire. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). This will be asked in surveys digitally distributed to all students in the fall and spring of each school year. Higher scores indicate worse outcomes.
1 secondary outcome
Resilient psychosocial functioning
Time frame: 2 times per year (Fall, Spring) up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Related trials for Physical Activity
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Recruiting
Stress Modulation and Dynamic Balance
Stress
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSPAP in people with Physical Activity, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 30 Jun 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical Activity - Accelerometer measured. (time frame: 2 times per year (Fall, Spring) up to 3 years). The study lists 2 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 30 Jun 2026.