NCT06229457

Brief Summary

The goal of this study is to examine the impact of a 12-week sports sampling and physical literacy program on rural girls' physical activity.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
30mo left

Started May 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
May 2024Nov 2028

First Submitted

Initial submission to the registry

January 11, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 28, 2024

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

4.4 years

First QC Date

January 11, 2024

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Recruitment capability

    Feasibility metric: successfully enroll 30 participants

    Weeks 10-12

  • Study assessments completed

    Feasibility metric: ≥75% participants complete time 1 and time 2 assessments

    Weeks 10-12

  • Intervention acceptability and appropriateness

    Feasibility metric: Mean score ≥3 on the Acceptability of Intervention Measure; mean score ≥3 on the Intervention Appropriateness Measure

    Weeks 10-12

  • Intervention feasibility and participant attendance

    Feasibility metric: Mean score ≥3 on the Feasibility of Intervention Measure

    Weeks 10-12

  • Participant attendance

    Attend ≥75% of in-person sessions (on average)

    Weeks 10-12

Secondary Outcomes (7)

  • Change from baseline in physical activity levels at 10-12 weeks measured via Actigraph GT3X+

    Week 0-1; Week 10-12

  • Change from baseline in physical literacy at 10-12 weeks measured via the Canadian Assessment for Physical Literacy, Second Edition (CAPL-2)

    Week 0-1; Week 10-12

  • Change from baseline in autonomy at 10-12 weeks

    Week 0-1; Week 10-12

  • Change in sport engagement at 10-12 weeks

    Week 0-1; Week 10-12

  • Change in sport enjoyment at 10-12 weeks

    Week 0-1; Week 10-12

  • +2 more secondary outcomes

Study Arms (1)

Girls PLAY program

EXPERIMENTAL
Behavioral: Girls PLAY program

Interventions

Girls PLAY program (8-12 weeks) will include 1) a series of in-person sessions, led by Boys and Girls Clubs staff at the Boys and Girls Club sites, and 2) take-home activities. In-person sessions (60-75 min; 2-3x/week) will center around a different developmentally appropriate sport each week. Lesson plans will outline games/activities in which youth engage in fundamental, sport-specific movement skills. Lesson plans will be delivered by Boys and Girls Club leaders using acts of instruction derived from Self-Determination Theory. Take home activities will 1) summarize and add on to the week's in-person sessions and 2) be adapted for delivery by parents and/or self-guided participation by youth. Take-home activities will provide information for engaging in the past week's activities as well as additional activities that parents and youth can participate in together.

Girls PLAY program

Eligibility Criteria

Age8 Years - 10 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • living in Imperial County, California
  • identify as female
  • aged 8-10 years old
  • enrolled at a participating Boys \& Girls Club site

You may not qualify if:

  • has a sibling enrolled in the study
  • physical or mental impairment that would preclude physical activity or protocol compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (1)

  • Johnson A, Bocarro J, Kroshus-Havril E, Arredondo E. Development and testing of a sports intervention (Girls PLAY)to promote physical activity among rural girls: a feasibility study protocol. Pilot Feasibility Stud. 2026 Feb 2. doi: 10.1186/s40814-026-01765-2. Online ahead of print.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 29, 2024

Study Start

May 28, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations