Healthy LifestyleNCT04675658
Stay Active Physical Activity Program
A study testing CBPA + family support and CBPA in people with Healthy Lifestyle and Sedentary Behavior, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Sedentary Behavior
- What is being tested?
- CBPA + family support and CBPA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 31 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Classrooms
- Teacher of a 4th or 5th grade class in the Kansas City area.
- English speaking only
- Students
- Any student in the selected classrooms
- A parent or guardian of the student
- English speaking only
Who cannot join
- Does not meet the required criteria above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stay Active Physical Activity Program for Teachers, Students, and Families
The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic.
Read the detailed description
This study will compare the impact of two physical activity interventions on student's physical activity.
- Conditions
- Healthy Lifestyle, Sedentary Behavior
- Being tested
- CBPA + family support, CBPA
- Keywords
- Physical Activity, Exercise
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBPA + family supportBehavioural
Classroom Based Physical Activity + family support as described in the Arm
CBPABehavioural
Classroom Based Physical Activity
| Study group | Role | What they receive |
|---|---|---|
| Classroom Intervention | Active comparator | Physical activity support is provided by integrating daily structured activities in the classroom delivered by physical activity leaders through a video conferencing platform in partnership with the classroom teacher. Activities last about 10 minutes or less and have the flexibility of being integrated with academic lessons or serving as a break from academics.
The activities are simple and get kids moving in place. The activities will be delivered by a research staff member via video conferencing (using the schools preferred platform). A combination of live activities led by the research team and pre-recorded videos will be used (see example below). If live videos do not work for the teacher, they will have the option to only use the pre-recorded videos or receive a list of resources to promote CBPA in their classrooms. Receives: Behavioral: CBPA |
| Classroom Intervention plus family support | Experimental | Same components as the Classroom Intervention Arm plus the following:
Family Component: A newsletter will be sent to parents or guardians once every two weeks over the semester and posted on the study website. The newsletters include physical activity information related to safety/protection, skills building, motivation, overcoming barriers, and goal setting and monitoring (all newsletters are included as an appendix). As part of the program, children also receive a Garmin wearable physical activity monitor. Parents or guardians will receive text messages with behavior change messages based on the Garmin data (text message content is included as an appendix). Text messages also contain links to website materials.
Texts will be sent out using the Twilio platform. Receives: Behavioral: CBPA + family support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily minutes of PA (physical activity)
Measured by Garmin device
Measured: 3 months
Daily step count
Measured by Garmin device
Measured: 3 months
Secondary outcomes (2)
Parent perceptions of interventions
Measured via satisfaction surveys
Measured: 3 months
Teacher perceptions of interventions
Measured via satisfaction interviews
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start5 Oct 2020
- Primary completion20 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Carlson, PhD, Principal investigator, Research Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675658
- Sponsor's protocol ID
- STUDY00001495
- Status last verified
- Jun 2021
- First submitted
- 8 Dec 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stay Active Physical Activity Program for Teachers, Students, and Families
- ClinicalTrials.gov ID
- NCT04675658
- Acronym / sponsor ID
- STUDY00001495
- Conditions
- Healthy Lifestyle, Sedentary Behavior
- Keywords
- Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Dec 2020 (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.
The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic.
Detailed description
This study will compare the impact of two physical activity interventions on student's physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classroom Intervention | Active comparator | Behavioral: CBPAPhysical activity support is provided by integrating daily structured activities in the classroom delivered by physical activity leaders through a video conferencing platform in partnership with the classroom teacher. Activities last about 10 minutes or less and have the flexibility of being integrated with academic lessons or serving as a break from academics. The activities are simple and get kids moving in place. The activities will be delivered by a research staff member via video conferencing (using the schools preferred platform). A combination of live activities led by the research team and pre-recorded videos will be used (see example below). If live videos do not work for the teacher, they will have the option to only use the pre-recorded videos or receive a list of resources to promote CBPA in their classrooms. |
| Classroom Intervention plus family support | Experimental | Behavioral: CBPA + family supportSame components as the Classroom Intervention Arm plus the following: Family Component: A newsletter will be sent to parents or guardians once every two weeks over the semester and posted on the study website. The newsletters include physical activity information related to safety/protection, skills building, motivation, overcoming barriers, and goal setting and monitoring (all newsletters are included as an appendix). As part of the program, children also receive a Garmin wearable physical activity monitor. Parents or guardians will receive text messages with behavior change messages based on the Garmin data (text message content is included as an appendix). Text messages also contain links to website materials. Texts will be sent out using the Twilio platform. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Classrooms
- Teacher of a 4th or 5th grade class in the Kansas City area.
- English speaking only
- Students
- Any student in the selected classrooms
Key exclusion criteria (1 listed)
- Does not meet the required criteria above.
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 |
|---|---|---|
| CBPA + family supportClassroom Based Physical Activity + family support as described in the Arm | Behavioural | Classroom Intervention plus family support |
| CBPAClassroom Based Physical Activity | Behavioural | Classroom Intervention |
Primary outcome
Daily minutes of PA (physical activity)
Time frame: 3 months
Measured by Garmin device
Daily step count
Time frame: 3 months
Measured by Garmin device
2 secondary outcomes
Parent perceptions of interventions
Time frame: 3 months
Teacher perceptions of interventions
Time frame: 3 months
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 14 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Jordan Carlson, PhD principal investigator
Research Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBPA + family support and CBPA in people with Healthy Lifestyle and Sedentary Behavior, run by Children's Mercy Hospital Kansas City 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?
The sponsor lists 7 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: finished, as of the sponsor's last update on 14 Jun 2021. 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?
Daily minutes of PA (physical activity) (time frame: 3 months). 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 14 Jun 2021; AzTrials last refreshed its copy on 2 Nov 2026.