Clinical trial NCT06970067: Co-Creating Active Middle School Communities to Increase Student Physical Activity
Official title: Co-Creating and Implementing Contextually Responsive Physical Activity Interventions With Middle School Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
adolescent health
active transport
active leisure
middle school
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-05-14
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Child/adolescent physical activity
timeFrame: Baseline, 12 months (initial effectiveness), and 24 months (sustainability)
Secondary outcomes:
measure: Percentage of children/adolescents using active transport to/from school
timeFrame: Data will be collected for 4 years in both fall and spring each year (Years 2-5) for 8 data points.
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas Health Science Center at Houston School of Public Health in Austin
state: Texas
Study officials:
References: