Co-Creating Active Middle School Communities to Increase Student Physical Activity

NCT ID: NCT06970067

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Physical Activity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The intervention will be conducted in three middle school catchment areas, with three additional middle school catchment areas with usual programs used as comparison.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Physical activity intervention co-produced by the community and investigators

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.

Group Type EXPERIMENTAL

Active Middle School Communities

Intervention Type BEHAVIORAL

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.

Usual environmental and programmatic programs

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active Middle School Communities

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Child/adolescent has a condition that precludes or decreases participation in physical activity
* Child/adolescent cannot complete a written survey
Minimum Eligible Age

11 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Deanna Hoelscher

OTHER

Sponsor Role lead

Responsible Party

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Deanna Hoelscher

Regional Dean, Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The University of Texas Health Science Center at Houston

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Deanna M Hoelscher, PhD

Role: CONTACT

(512) 391-2510

Deborah Salvo, PhD

Role: CONTACT

408-386-5614

Facility Contacts

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Deanna M Hoelscher, PhD

Role: primary

5123912510

Sarah S Bentley, MPH

Role: backup

+1 (512) 482 6152

Other Identifiers

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1R01MD019423

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SPH-23-1139

Identifier Type: -

Identifier Source: org_study_id

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