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Walking to School Supports

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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

Tracking Information
First Submitted Date  ICMJE September 10, 2019
First Posted Date  ICMJE September 13, 2019
Last Update Posted Date September 16, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
Acceptability of Intervention: 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.
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Walking to School Supports
Official Title  ICMJE Psychosocial Supports for Walking to School Paired With a Walking School Bus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Health Behavior
Intervention  ICMJE Behavioral: Support for walking to school
5 modules that address psychosocial skills, with ongoing text messaging.
Study Arms  ICMJE 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.
Intervention: Behavioral: Support for walking to school
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Children with mobility impairment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jordan Carlson, PhD 816-234-9240 jacarlson@cmh.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04089020
Other Study ID Numbers  ICMJE STUDY00000851
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: De-identified information may be available upon request.
Responsible Party Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE
  • University of Kansas Medical Center
  • University of Kansas
Investigators  ICMJE Not Provided
PRS Account Children's Mercy Hospital Kansas City
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP