HealthyGirlsPLAYNCT06229457
Development and Testing of a Sports Intervention to Promote Physical Activity in Rural Girls
A study testing Girls PLAY program in people with Healthy, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Girls PLAY program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to Nov 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 8 to 10 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- living in Imperial County, California
- identify as female
- aged 8-10 years old
- enrolled at a participating Boys \& Girls Club site
Who cannot join
- has a sibling enrolled in the study
- physical or mental impairment that would preclude physical activity or protocol compliance
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
San Diego State University
San Diego, California, 92182
About this study
Official title: Development and Feasibility Testing of a Boys & Girls Clubs' Sports Intervention to Promote Physical Activity in Rural Girls: Girls PLAY
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.
Read the detailed description
Fewer than 30% of elementary-aged youth meet physical activity guidelines, with lower activity levels found among girls, racial minorities, and those living in rural areas. Sport is one of the best strategies for promoting physical activity, yet girls, Hispanics, and rural populations participate in youth sport at lower numbers and drop out at a higher rate. In line with Self-Determination Theory, commonly cited barriers include lack of competence, autonomy, and relatedness. Physical literacy and sport sampling have also been identified as key determinants of youth sport participation. Developing interventions around physical literacy and sport sampling, with intervention delivery grounded in Self-Determination Theory principles, is a promising strategy for promoting youth sport. However, the few existing interventions aimed to promote girls' physical activity through sport were developed outside the United States, focused on adolescent (versus younger) girls, and/or conducted among urban or suburban youth, limiting generalizability. Rural, Hispanic girls face unique challenges around sport that should be identified and addressed, yet there remains a paucity of information on determinants of sport participation among this population.
This study aims to to develop, tailor, and examine the impact of a tailored Boys \& Girls Clubs (BGC) sport sampling and physical literacy program on rural girls' physical activity levels. BGC is an organization that provides learning and leadership programs to millions of rural youth nationwide, about half of whom are girls.
This study will enroll Hispanic girls ages 8-10 living in rural Imperial County, California. The first aims are to develop and refine a 12-week sport sampling and physical literacy intervention entitled "Girls Positive Learning Activities for Youth", or "Girls PLAY". The Girls PLAY intervention will be delivered as Boys \& Girls Clubs programming, and intervention delivery will be grounded in Self-Determination Theory. We will then examine the feasibility of the 12-week Girls PLAY intervention. Secondary outcomes of physical activity levels, physical literacy, Self-Determination Theory constructs, and sports participation will also be assessed.
- Conditions
- Healthy
- Being tested
- Girls PLAY program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girls PLAY programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Girls PLAY program | Experimental | Not described Receives: Behavioral: Girls PLAY program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment capability
Feasibility metric: successfully enroll 30 participants
Measured: Weeks 10-12
Study assessments completed
Feasibility metric: ≥75% participants complete time 1 and time 2 assessments
Measured: 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
Measured: Weeks 10-12
Intervention feasibility and participant attendance
Feasibility metric: Mean score ≥3 on the Feasibility of Intervention Measure
Measured: Weeks 10-12
Participant attendance
Attend ≥75% of in-person sessions (on average)
Measured: Weeks 10-12
Secondary outcomes (7)
Change from baseline in physical activity levels at 10-12 weeks measured via Actigraph GT3X+
We will use Actigraph GT3X+ (ActiGraph LLC, Pensacola, FL) to obtain a valid, objective measure of physical activity. Data will be collected over 7 days (sample frequency of 30 Hz; 15-sec epochs).
Measured: 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)
Physical literacy changes will be assessed using the Canadian Assessment for Physical Literacy, Second Edition (CAPL-2). This includes the plank, Progressive Aerobic Cardiovascular Endurance Run, Canadian Agility \& Movement Skill Assessment, and 22-item questionnaire.
Measured: Week 0-1; Week 10-12
Change from baseline in autonomy at 10-12 weeks
Autonomy will be measured using the 9-item Autonomy-Supportive Coaching Questionnaire.
Measured: Week 0-1; Week 10-12
Change in sport engagement at 10-12 weeks
Engagement will be assessed via child survey examining current sport involvement (length of involvement, primary and secondary sport) and behavioral intention (e.g., "I intend to play sports this year") adapted from items used in studies among similar age groups.
Measured: Week 0-1; Week 10-12
Change in sport enjoyment at 10-12 weeks
Enjoyment will be assessed using an adapted 5-item Enjoyment subscale of the Sport Commitment Questionnaire-2.
Measured: Week 0-1; Week 10-12
Change from baseline in competence at 10-12 weeks
Competence will be measured using an adapted version of the Perceived Competence Scale (4-item).
Measured: Week 0-1; Week 10-12
Change from baseline in relatedness at 10-12 weeks
Relatedness will be measured using a 5-item acceptance subscale of the Need for Relatedness Scale.
Measured: Week 0-1; Week 10-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start28 May 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Boys and Girls Clubs of Imperial Valley, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229457
- Sponsor's protocol ID
- HS-2023-0186
- Other IDs
- 1K01HL171860-01
- Acronym
- GirlsPLAY
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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;12(1):34. doi: 10.1186/s40814-026-01765-2.
PubMed 41630110
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of a Boys & Girls Clubs' Sports Intervention to Promote Physical Activity in Rural Girls: Girls PLAY
- ClinicalTrials.gov ID
- NCT06229457
- Acronym / sponsor ID
- GirlsPLAY / HS-2023-0186
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Boys and Girls Clubs of Imperial Valley, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 May 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 29 Jan 2024 (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 goal of this study is to examine the impact of a 12-week sports sampling and physical literacy program on rural girls' physical activity.
Detailed description
Fewer than 30% of elementary-aged youth meet physical activity guidelines, with lower activity levels found among girls, racial minorities, and those living in rural areas. Sport is one of the best strategies for promoting physical activity, yet girls, Hispanics, and rural populations participate in youth sport at lower numbers and drop out at a higher rate. In line with Self-Determination Theory, commonly cited barriers include lack of competence, autonomy, and relatedness. Physical literacy and sport sampling have also been identified as key determinants of youth sport participation. Developing interventions around physical literacy and sport sampling, with intervention delivery grounded in Self-Determination Theory principles, is a promising strategy for promoting youth sport. However, the few existing interventions aimed to promote girls' physical activity through sport were developed outside the United States, focused on adolescent (versus younger) girls, and/or conducted among urban or suburban youth, limiting generalizability. Rural, Hispanic girls face unique challenges around sport that should be identified and addressed, yet there remains a paucity of information on determinants of sport participation among this population.
This study aims to to develop, tailor, and examine the impact of a tailored Boys \& Girls Clubs (BGC) sport sampling and physical literacy program on rural girls' physical activity levels. BGC is an organization that provides learning and leadership programs to millions of rural youth nationwide, about half of whom are girls.
This study will enroll Hispanic girls ages 8-10 living in rural Imperial County, California. The first aims are to develop and refine a 12-week sport sampling and physical literacy intervention entitled "Girls Positive Learning Activities for Youth", or "Girls PLAY". The Girls PLAY intervention will be delivered as Boys \& Girls Clubs programming, and intervention delivery will be grounded in Self-Determination Theory. We will then examine the feasibility of the 12-week Girls PLAY intervention. Secondary outcomes of physical activity levels, physical literacy, Self-Determination Theory constructs, and sports participation will also be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Girls PLAY program | Experimental | Behavioral: Girls PLAY program |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- living in Imperial County, California
- identify as female
- aged 8-10 years old
- enrolled at a participating Boys \& Girls Club site
Key exclusion criteria (2 listed)
- has a sibling enrolled in the study
- physical or mental impairment that would preclude physical activity or protocol compliance
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 |
|---|---|---|
| Girls PLAY programGirls 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. | Behavioural | Girls PLAY program |
Primary outcome
Recruitment capability
Time frame: Weeks 10-12
Feasibility metric: successfully enroll 30 participants
Study assessments completed
Time frame: Weeks 10-12
Feasibility metric: ≥75% participants complete time 1 and time 2 assessments
Intervention acceptability and appropriateness
Time frame: Weeks 10-12
Feasibility metric: Mean score ≥3 on the Acceptability of Intervention Measure; mean score ≥3 on the Intervention Appropriateness Measure
Intervention feasibility and participant attendance
Time frame: Weeks 10-12
Feasibility metric: Mean score ≥3 on the Feasibility of Intervention Measure
Participant attendance
Time frame: Weeks 10-12
Attend ≥75% of in-person sessions (on average)
7 secondary outcomes
Change from baseline in physical activity levels at 10-12 weeks measured via Actigraph GT3X+
Time frame: 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)
Time frame: Week 0-1; Week 10-12
Change from baseline in autonomy at 10-12 weeks
Time frame: Week 0-1; Week 10-12
Change in sport engagement at 10-12 weeks
Time frame: Week 0-1; Week 10-12
Change in sport enjoyment at 10-12 weeks
Time frame: Week 0-1; Week 10-12
Change from baseline in competence at 10-12 weeks
Time frame: Week 0-1; Week 10-12
Change from baseline in relatedness at 10-12 weeks
Time frame: Week 0-1; Week 10-12
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 10 Sep 2026.
- Derived from this study: PubMed 41630110Johnson 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;12(1):34. doi: 10.1186/s40814-026-01765-2.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Girls PLAY program in people with Healthy, run by San Diego State University 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 4 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: enrolling by invitation, as of the sponsor's last update on 10 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment capability (time frame: Weeks 10-12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06229457, which also lists 1 linked publication.
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 10 Sep 2026.