Physical InactivityNCT05241808
Girls Can...Move! Testing the Feasibility of a Community-based Physical Activity Intervention for Adolescent Girls
A study testing Girls Can...Move! in people with Physical Inactivity, run by Deirdre Dlugonski at 1 site in United States.
Trial summary
The purpose of this research is to learn about how to promote physical activity among adolescent girls by testing the feasibility and initial effectiveness of the Girls Can...Move! intervention. Read more about this study
- Who is it for?
- Ages 11 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Girls Can...Move!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female
- Enrolled in 6th, 7th, or 8th grade at target school
Who cannot join
- Engage in 60 minutes of moderate-to-vigorous physical activity on more than 3 days per week
- Doctor has told child/parent that there are certain types of activities that the child should not do
- Preexisting injuries or health conditions that limit physical activity
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to learn about how to promote physical activity among adolescent girls by testing the feasibility and initial effectiveness of the Girls Can...Move! intervention. Girls Can...Move! will target each component of physical literacy by providing opportunities for adolescent girls to gain knowledge about their own physical activity level, to explore and practice different types of physical activities, and to learn from active female role models. Female participants (n = 30) from one middle school will be randomly assigned to the Girls Can...Move! intervention group or a control group at a 1:1 ratio. The primary outcome variables, physical activity and physical literacy, will be assessed before and after the 8-week Girls Can...Move! intervention using accelerometers and online surveys.
- Conditions
- Physical Inactivity
- Being tested
- Girls Can...Move!
- Keywords
- physical literacy, female, accelerometer, exercise
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girls Can...Move!Behavioural
Girls Can...Move! is an 8-week intervention designed to increase physical literacy and physical activity among middle school aged girls. One-hour, in-person sessions will be held twice per week for a total of 16 sessions. Each session involves: a brief educational lesson related to physical activity participation, a 30-minute group physical activity session, and a take-home challenge. The physical activities will prioritize enjoyment of physical activity and promote the development of movement competence. These activities may include: yoga; Zumba; Pilates; strength training; kick boxing; circuit training; etc.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No-treatment group that only participates in pre- and post-testing. |
| Experimental | Experimental | Experimental group participants will receive the 8-week Girls Can...Move! program. Receives: Behavioral: Girls Can...Move! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Girls Can...Move! intervention
The number of participants enrolled, intervention session attendance (experimental group only), and participant satisfaction with intervention (experimental group only) will be included as feasibility measures.
Measured: pre-intervention (week 0)
Change in physical activity
Participants will wear an Actigraph accelerometer to measure change in physical activity from pre- to post- intervention for the experimental compared to control group.
Measured: pre-intervention immediately following 8-week intervention period (week 9)
Change in physical literacy
Participants will complete measures of self-reported physical literacy (PLAYself survey) at pre- and post-intervention to measure change in perceived physical literacy between experimental and control groups.
Measured: pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
Secondary outcomes (2)
Change in peer social support
Participants will complete measures of self-reported peer social support at pre- and post-intervention to measure change in perceived social support between experimental and control groups.
Measured: pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
Change in parental social support
Participants will complete measures of self-reported parental social support at pre- and post-intervention to measure change in perceived social support between experimental and control groups.
Measured: pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start2 Dec 2021
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deirdre Dlugonski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deirdre Dlugonski, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241808
- Sponsor's protocol ID
- 59680
- Status last verified
- Jun 2022
- First submitted
- 5 Jan 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girls Can...Move! Testing the Feasibility of a Community-based Physical Activity Intervention for Adolescent Girls
- ClinicalTrials.gov ID
- NCT05241808
- Acronym / sponsor ID
- 59680
- Conditions
- Physical Inactivity
- Keywords
- physical literacy, female, accelerometer, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Deirdre DlugonskiUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 16 Feb 2022 (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 purpose of this research is to learn about how to promote physical activity among adolescent girls by testing the feasibility and initial effectiveness of the Girls Can...Move! intervention. Girls Can...Move! will target each component of physical literacy by providing opportunities for adolescent girls to gain knowledge about their own physical activity level, to explore and practice different types of physical activities, and to learn from active female role models. Female participants (n = 30) from one middle school will be randomly assigned to the Girls Can...Move! intervention group or a control group at a 1:1 ratio. The primary outcome variables, physical activity and physical literacy, will be assessed before and after the 8-week Girls Can...Move! intervention using accelerometers and online surveys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No-treatment group that only participates in pre- and post-testing. |
| Experimental | Experimental | Behavioral: Girls Can...Move!Experimental group participants will receive the 8-week Girls Can...Move! program. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Female
- Enrolled in 6th, 7th, or 8th grade at target school
Key exclusion criteria (3 listed)
- Engage in 60 minutes of moderate-to-vigorous physical activity on more than 3 days per week
- Doctor has told child/parent that there are certain types of activities that the child should not do
- Preexisting injuries or health conditions that limit physical activity
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 Can...Move!Girls Can...Move! is an 8-week intervention designed to increase physical literacy and physical activity among middle school aged girls. One-hour, in-person sessions will be held twice per week for a total of 16 sessions. Each session involves: a brief educational lesson related to physical activity participation, a 30-minute group physical activity session, and a take-home challenge. The physical activities will prioritize enjoyment of physical activity and promote the development of movement competence. These activities may include: yoga; Zumba; Pilates; strength training; kick boxing; circuit training; etc. | Behavioural | Experimental |
Primary outcome
Feasibility of the Girls Can...Move! intervention
Time frame: pre-intervention (week 0)
The number of participants enrolled, intervention session attendance (experimental group only), and participant satisfaction with intervention (experimental group only) will be included as feasibility measures.
Change in physical activity
Time frame: pre-intervention immediately following 8-week intervention period (week 9)
Participants will wear an Actigraph accelerometer to measure change in physical activity from pre- to post- intervention for the experimental compared to control group.
Change in physical literacy
Time frame: pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
Participants will complete measures of self-reported physical literacy (PLAYself survey) at pre- and post-intervention to measure change in perceived physical literacy between experimental and control groups.
2 secondary outcomes
Change in peer social support
Time frame: pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
Change in parental social support
Time frame: pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Can...Move! in people with Physical Inactivity, run by Deirdre Dlugonski 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the Girls Can...Move! intervention (time frame: pre-intervention (week 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2022.