Physical ActivityAMSCNCT06970067
Co-Creating Active Middle School Communities to Increase Student Physical Activity
A study testing Active Middle School Communities in people with Physical Activity, run by Deanna Hoelscher at 1 site in United States.
Trial summary
The purpose of this study is to identify community-level barriers and facilitators for active transport and leisure physical activity and to co-create and test the effectiveness and longer-term sustainability of community-based physical activity intervention strategies in middle schools. Read more about this study
- Who is it for?
- Ages 11 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Active Middle School Communities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent/guardian and child/adolescent dyads
- Child/adolescent must be enrolled in the 6th grade at participating schools at baseline
- Parent/guardian and child/adolescent must reside in the same household
- Parent/guardian and child/adolescent must reside within the school catchment area (school community)
- Parent/guardian must speak English or Spanish
- Child/adolescent must speak English
Who cannot join
- Child/adolescent has a condition that precludes or decreases participation in physical activity
- Child/adolescent cannot complete a written survey
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Austin, Texas, 78701
Deanna M Hoelscher, PhD, 5123912510, Deanna.M.Hoelscher@uth.tmc.edu
Sarah S Bentley, MPH, +1 (512) 482 6152, Sarah.S.Bentley@uth.tmc.edu
About this study
Official title: Co-Creating and Implementing Contextually Responsive Physical Activity Interventions With Middle School Adolescents
The purpose of this study is to identify community-level barriers and facilitators for active transport and leisure physical activity and to co-create and test the effectiveness and longer-term sustainability of community-based physical activity intervention strategies in middle schools. Participation in this study may help the investigators and scientific community better understand and address child physical activity and health. This study will collect information about middle school children's physical activity behaviors, habits, knowledge, and activity. The UTHealth School of Public Health is leading the study together with the University of Texas at Austin.
Read the detailed description
Early adolescence is a critical window of opportunity for establishing lifelong physically active lifestyles. During this stage, youth seek autonomy and experience independent mobility. However, steep declines in physical activity occur in adolescence, a trend that continues into adulthood. This is partly due to reduced opportunities for structured exercise and sports in later life relative to childhood. Despite this, most school-based interventions heavily focus on physical education, sports participation, and active recess strategies (i.e., leisure), with less emphasis on promoting utilitarian (transport-based) physical activity.
Interventions prioritizing the entire school community (including students, their families, and school neighborhood residents), and focused on increasing active transport and leisure, might have a more significant and sustainable impact over the lifespan. To be effective and contextually responsive, however, intervention development, implementation, and evaluation must be collaboratively conducted with and through local community members.
This project proposes to conduct a comprehensive and community-engaged mixed methods study to design and test strategies for improving community-wide and individual-level physical activity outcomes in middle school neighborhoods. The specific aims of this study are:
Aim 1. To identify community-level barriers and facilitators for physical activity in middle school communities using a comprehensive mixed methods approach (Delphi method with Group Concept Mapping, geospatial analysis, participatory GIS).
Aim 2. To engage multi-sectoral and multi-generational community actors for co-creating contextually-responsive intervention strategies to improve access to active transport and leisure in middle school communities.
Aim 3. To conduct a first-generation, controlled trial testing the effectiveness of the co-created intervention strategies for improving physical activity outcomes in middle school communities.
Hypothesis 3.1. 12-month pre-post change in daily minutes of moderate- to vigorous-intensity physical activity (MVPA) will be higher among middle school students (grades 6-7) in school communities that implement co-created strategies relative to comparison school communities.
Hypothesis 3.2 (exploratory). Community-based physical activity levels will improve at 12 months in intervention school communities, relative to comparison school communities.
Hypothesis 3.3. (exploratory). The intervention will improve community-level outcomes, including enhanced community norms regarding active travel, collective efficacy for physical activity, and perceived neighborhood traffic and crime safety.
If successful, these strategies can be scaled up to help increase physical activity among middle school children and communities in the U.S. Increased physical activity among middle school youth can lead to higher levels of physical activity throughout the lifespan, potentially decreasing or attenuating chronic diseases.
- Conditions
- Physical Activity
- Being tested
- Active Middle School Communities
- Keywords
- physical activity, adolescent health, active transport, active leisure, middle school
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Middle School CommunitiesBehavioural
This intervention will engage multi-sectoral and multi-generational community members and middle school students to co-produce (co-design, co-implementation, and co-evaluation) contextually-responsive intervention strategies to improve access to active transport and leisure, resulting in increased physical activity and decreased risk for chronic disease in middle school communities. This intervention will use community-based participatory methods, with resources provided for changes in the built environment around the school catchment area.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention co-produced by the community and investigators | Experimental | This intervention will engage multi-sectoral and multi-generational community members and middle school students for co-producing (co-design, co-implementation, and co-evaluation) contextually-responsive intervention strategies to improve access to active transport and leisure in three middle school communities. Receives: Behavioral: Active Middle School Communities |
| Usual environmental and programmatic programs | No intervention | During the trial, three comparison school communities will not receive the intervention and will engage in usual environmental and programmatic programs. After the trial is completed, these schools will receive a modified version of the programs and strategies developed in the intervention arm (delayed intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child/adolescent physical activity
Measured using Accelerometry to determine minutes of moderate-to-vigorous physical activity (MVPA)
Measured: Baseline, 12 months (initial effectiveness), and 24 months (sustainability)
Secondary outcomes (1)
Percentage of children/adolescents using active transport to/from school
Measured using Active Commuting to School Tallies to obtain counts of children/adolescents who walk or bike to or from school compared to all children/adolescents
Measured: Data will be collected for 4 years in both fall and spring each year (Years 2-5) for 8 data points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start2 Mar 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be conducted in three middle school catchment areas, with three additional middle school catchment areas with usual programs used as comparison.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deanna Hoelscher
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor-investigator, Deanna Hoelscher, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970067
- Sponsor's protocol ID
- HSC-SPH-23-1139
- Other IDs
- 1R01MD019423
- Acronym
- AMSC
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2025
- Last updated
- 11 May 2026
- Results posted
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Creating and Implementing Contextually Responsive Physical Activity Interventions With Middle School Adolescents
- ClinicalTrials.gov ID
- NCT06970067
- Acronym / sponsor ID
- AMSC / HSC-SPH-23-1139
- Conditions
- Physical Activity
- Keywords
- physical activity, adolescent health, active transport, active leisure, middle school
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Deanna HoelscherUniversity, hospital or other
- Collaborators
- University of Texas at Austin, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 May 2025 (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 purpose of this study is to identify community-level barriers and facilitators for active transport and leisure physical activity and to co-create and test the effectiveness and longer-term sustainability of community-based physical activity intervention strategies in middle schools. Participation in this study may help the investigators and scientific community better understand and address child physical activity and health. This study will collect information about middle school children's physical activity behaviors, habits, knowledge, and activity. The UTHealth School of Public Health is leading the study together with the University of Texas at Austin.
Detailed description
Early adolescence is a critical window of opportunity for establishing lifelong physically active lifestyles. During this stage, youth seek autonomy and experience independent mobility. However, steep declines in physical activity occur in adolescence, a trend that continues into adulthood. This is partly due to reduced opportunities for structured exercise and sports in later life relative to childhood. Despite this, most school-based interventions heavily focus on physical education, sports participation, and active recess strategies (i.e., leisure), with less emphasis on promoting utilitarian (transport-based) physical activity.
Interventions prioritizing the entire school community (including students, their families, and school neighborhood residents), and focused on increasing active transport and leisure, might have a more significant and sustainable impact over the lifespan. To be effective and contextually responsive, however, intervention development, implementation, and evaluation must be collaboratively conducted with and through local community members.
This project proposes to conduct a comprehensive and community-engaged mixed methods study to design and test strategies for improving community-wide and individual-level physical activity outcomes in middle school neighborhoods. The specific aims of this study are:
Aim 1. To identify community-level barriers and facilitators for physical activity in middle school communities using a comprehensive mixed methods approach (Delphi method with Group Concept Mapping, geospatial analysis, participatory GIS).
Aim 2. To engage multi-sectoral and multi-generational community actors for co-creating contextually-responsive intervention strategies to improve access to active transport and leisure in middle school communities.
Aim 3. To conduct a first-generation, controlled trial testing the effectiveness of the co-created intervention strategies for improving physical activity outcomes in middle school communities.
Hypothesis 3.1. 12-month pre-post change in daily minutes of moderate- to vigorous-intensity physical activity (MVPA) will be higher among middle school students (grades 6-7) in school communities that implement co-created strategies relative to comparison school communities.
Hypothesis 3.2 (exploratory). Community-based physical activity levels will improve at 12 months in intervention school communities, relative to comparison school communities.
Hypothesis 3.3. (exploratory). The intervention will improve community-level outcomes, including enhanced community norms regarding active travel, collective efficacy for physical activity, and perceived neighborhood traffic and crime safety.
If successful, these strategies can be scaled up to help increase physical activity among middle school children and communities in the U.S. Increased physical activity among middle school youth can lead to higher levels of physical activity throughout the lifespan, potentially decreasing or attenuating chronic diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be conducted in three middle school catchment areas, with three additional middle school catchment areas with usual programs used as comparison.
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention co-produced by the community and investigators | Experimental | Behavioral: Active Middle School CommunitiesThis intervention will engage multi-sectoral and multi-generational community members and middle school students for co-producing (co-design, co-implementation, and co-evaluation) contextually-responsive intervention strategies to improve access to active transport and leisure in three middle school communities. |
| Usual environmental and programmatic programs | No intervention | –During the trial, three comparison school communities will not receive the intervention and will engage in usual environmental and programmatic programs. After the trial is completed, these schools will receive a modified version of the programs and strategies developed in the intervention arm (delayed intervention). |
Who may qualify
- Ages
- 11 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Parent/guardian and child/adolescent dyads
- Child/adolescent must be enrolled in the 6th grade at participating schools at baseline
- Parent/guardian and child/adolescent must reside in the same household
- Parent/guardian and child/adolescent must reside within the school catchment area (school community)
- Parent/guardian must speak English or Spanish
Key exclusion criteria (2 listed)
- Child/adolescent has a condition that precludes or decreases participation in physical activity
- Child/adolescent cannot complete a written survey
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 |
|---|---|---|
| Active Middle School CommunitiesThis intervention will engage multi-sectoral and multi-generational community members and middle school students to co-produce (co-design, co-implementation, and co-evaluation) contextually-responsive intervention strategies to improve access to active transport and leisure, resulting in increased physical activity and decreased risk for chronic disease in middle school communities. This intervention will use community-based participatory methods, with resources provided for changes in the built environment around the school catchment area. | Behavioural | Physical activity intervention co-produced by the community and investigators |
Primary outcome
Child/adolescent physical activity
Time frame: Baseline, 12 months (initial effectiveness), and 24 months (sustainability)
Measured using Accelerometry to determine minutes of moderate-to-vigorous physical activity (MVPA)
1 secondary outcome
Percentage of children/adolescents using active transport to/from school
Time frame: Data will be collected for 4 years in both fall and spring each year (Years 2-5) for 8 data points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Middle School Communities in people with Physical Activity, run by Deanna Hoelscher 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deanna M Hoelscher, PhD ((512) 391-2510, Deanna.M.Hoelscher@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child/adolescent physical activity (time frame: Baseline, 12 months (initial effectiveness), and 24 months (sustainability)). 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 11 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.