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Walking to School Supports

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089020
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
University of Kansas Medical Center
University of Kansas
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:
This pilot study will test the feasibility and acceptability of an enhanced individual-level intervention delivered to 4th-6th graders to increase rates of walking to/from school. Up to 8 youth who do not already walk to school will be enrolled into the intervention. The theoretically-based intervention content will be delivered over 5 weeks through family-based telephone coaching sessions, ongoing short message service (SMS) text messaging, and activities and content on the study website.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Support for walking to school Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Psychosocial Supports for Walking to School Paired With a Walking School Bus
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: Psychosocial intervention
Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 5 weeks.
Behavioral: Support for walking to school
5 modules that address psychosocial skills, with ongoing text messaging.




Primary Outcome Measures :
  1. Acceptability of Intervention: "satisfaction questionnaire" [ Time Frame: at 6 weeks, immediately after completion of the intervention ]
    Acceptability and preferences related to intervention content will be measured using a questionnaire developed for this study ("satisfaction questionnaire"). Both parent and child will respond to 5 items asking about satisfaction with the intervention components. Items are rated on a 10-pt scale, with higher values indicating greater satisfaction. Parent and child will respond to two additional open-ended questions asking which aspects of the intervention they liked most and least. These qualitative items will be summarized.


Secondary Outcome Measures :
  1. Frequency of walking to school [ Time Frame: up to 6 weeks ]
    Number of walking trips to/from school per week (0 to 10) will be assessed using a daily (Mon-Fri) tracking questionnaire completed through RedCap.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children who report currently walking to school for no more than 4 trips per week.

Exclusion Criteria:

  • Children with mobility impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089020


Contacts
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Contact: Jordan Carlson, PhD 816-234-9240 jacarlson@cmh.edu

Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Contact: Jordan Carlson, PhD    816-234-9240    jacarlson@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of Kansas Medical Center
University of Kansas

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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT04089020    
Other Study ID Numbers: STUDY00000851
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified information may be available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No