Stay Active Physical Activity Program

NCT04675658 | Completed

• 1 other identifier: STUDY00001495
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Lifestyle; Sedentary Behavior

Keywords

Physical Activity; Exercise

Outcome Measures

Primary Outcomes (2)

• Daily minutes of PA (physical activity)

  Measured by Garmin device

  3 months

• Daily step count

  Measured by Garmin device

  3 months

Secondary Outcomes (2)

• Parent perceptions of interventions

  3 months

• Teacher perceptions of interventions

  3 months

Study Arms (2)

Classroom Intervention

ACTIVE COMPARATOR

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.

Behavioral: CBPA

Classroom Intervention plus family support

EXPERIMENTAL

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.

Behavioral: CBPA + family support

Interventions

CBPA + family support BEHAVIORAL

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

Classroom Intervention plus family support

CBPA BEHAVIORAL

Classroom Based Physical Activity

Classroom Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Does not meet the required criteria above.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jordan Carlson, PhD

  Research Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider/study staff will be masked to the arm the participant is assigned.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 19, 2020
• Study Start: October 5, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 31, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)