- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05241808
Girls Can...Move! Testing the Feasibility of a Community-based Physical Activity Intervention for Adolescent Girls
June 23, 2022 updated by: Deirdre Dlugonski
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University of Kentucky
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Enrolled in 6th, 7th, or 8th grade at target school
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
pre-intervention (week 0)
|
|
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.
|
pre-intervention immediately following 8-week intervention period (week 9)
|
|
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.
|
pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in peer social support
Time Frame: pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
|
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.
|
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)
|
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.
|
pre-intervention (week 0) and immediately following 8-week intervention period (week 9)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2021
Primary Completion (Actual)
April 26, 2022
Study Completion (Actual)
April 26, 2022
Study Registration Dates
First Submitted
January 5, 2022
First Submitted That Met QC Criteria
February 4, 2022
First Posted (Actual)
February 16, 2022
Study Record Updates
Last Update Posted (Actual)
June 29, 2022
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 59680
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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