NCT06970067

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

March 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 11, 2026

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

March 11, 2025

Last Update Submit

May 7, 2026

Conditions

Keywords

physical activityadolescent healthactive transportactive leisuremiddle school

Outcome Measures

Primary Outcomes (1)

  • Child/adolescent physical activity

    Measured using Accelerometry to determine minutes of moderate-to-vigorous physical activity (MVPA)

    Baseline, 12 months (initial effectiveness), and 24 months (sustainability)

Secondary Outcomes (1)

  • Percentage of children/adolescents using active transport to/from school

    Data will be collected for 4 years in both fall and spring each year (Years 2-5) for 8 data points.

Study Arms (2)

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.

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).

Interventions

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.

Physical activity intervention co-produced by the community and investigators

Eligibility Criteria

Age11 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Child/adolescent has a condition that precludes or decreases participation in physical activity
  • Child/adolescent cannot complete a written survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Austin, Texas, 78701, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Deanna M Hoelscher, PhD

CONTACT

Deborah Salvo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The intervention will be conducted in three middle school catchment areas, with three additional middle school catchment areas with usual programs used as comparison.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Regional Dean, Professor

Study Record Dates

First Submitted

March 11, 2025

First Posted

May 14, 2025

Study Start

March 2, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 11, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations