NCT05241808

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 2, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

January 5, 2022

Last Update Submit

June 23, 2022

Conditions

Physical Inactivity

Keywords

physical literacyfemaleaccelerometerexercise

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    pre-intervention (week 0) and immediately following 8-week intervention period (week 9)

Secondary Outcomes (2)

  • Change in peer social support

    pre-intervention (week 0) and immediately following 8-week intervention period (week 9)

  • Change in parental social support

    pre-intervention (week 0) and immediately following 8-week intervention period (week 9)

Study Arms (2)

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.

Behavioral: Girls Can...Move!

Interventions

Girls Can...Move!BEHAVIORAL

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.

Experimental

Eligibility Criteria

Age11 Years - 15 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must identify as female.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Female
  • Enrolled in 6th, 7th, or 8th grade at target school

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 5, 2022

First Posted

February 16, 2022

Study Start

December 2, 2021

Primary Completion

April 26, 2022

Study Completion

April 26, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)