Stay Active Physical Activity Program

NCT ID: NCT04675658

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2020-12-31

Brief Summary

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The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic.

Detailed Description

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This study will compare the impact of two physical activity interventions on student's physical activity.

Conditions

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Healthy Lifestyle Sedentary Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
Care provider/study staff will be masked to the arm the participant is assigned.

Study Groups

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Classroom Intervention

Physical activity support is provided by integrating daily structured activities in the classroom delivered by physical activity leaders through a video conferencing platform in partnership with the classroom teacher. Activities last about 10 minutes or less and have the flexibility of being integrated with academic lessons or serving as a break from academics.

The activities are simple and get kids moving in place. The activities will be delivered by a research staff member via video conferencing (using the schools preferred platform). A combination of live activities led by the research team and pre-recorded videos will be used (see example below). If live videos do not work for the teacher, they will have the option to only use the pre-recorded videos or receive a list of resources to promote CBPA in their classrooms.

Group Type ACTIVE_COMPARATOR

CBPA

Intervention Type BEHAVIORAL

Classroom Based Physical Activity

Classroom Intervention plus family support

Same components as the Classroom Intervention Arm plus the following:

Family Component: A newsletter will be sent to parents or guardians once every two weeks over the semester and posted on the study website. The newsletters include physical activity information related to safety/protection, skills building, motivation, overcoming barriers, and goal setting and monitoring (all newsletters are included as an appendix). As part of the program, children also receive a Garmin wearable physical activity monitor. Parents or guardians will receive text messages with behavior change messages based on the Garmin data (text message content is included as an appendix). Text messages also contain links to website materials.

Texts will be sent out using the Twilio platform.

Group Type EXPERIMENTAL

CBPA + family support

Intervention Type BEHAVIORAL

Classroom Based Physical Activity + family support as described in the Arm

Interventions

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CBPA + family support

Classroom Based Physical Activity + family support as described in the Arm

Intervention Type BEHAVIORAL

CBPA

Classroom Based Physical Activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Classrooms

* Teacher of a 4th or 5th grade class in the Kansas City area.
* English speaking only

Students

* Any student in the selected classrooms
* A parent or guardian of the student
* English speaking only

Exclusion Criteria

* Does not meet the required criteria above.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordan Carlson, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Faculty

Locations

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Children's Mercy

Kansas City, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00001495

Identifier Type: -

Identifier Source: org_study_id

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