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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04089020
Other study ID # STUDY00000851
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2019
Est. completion date January 31, 2020

Study information

Verified date October 2022
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 6 weeks through family-based telephone coaching sessions, ongoing short message service (SMS) text messaging, and activities and content on the study website.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 13 Years
Eligibility Inclusion Criteria: - Parents of children enrolled at Benjamin Banneker school - Parents/child dyads who completed the Phase 1 survey OR respond to recruitment attempts and express interest in walking to school. Included parent/child dyads will be: Those who do not participate in LINC program both before and after school 4+ days per week (child); Those who live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off). Exclusion Criteria: - Children not enrolled at Benjamin Banneker school - Those who participate in LINC program both before and after school 4+ days per week (child); Those who do not live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are not willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off). - We will exclude each of the following special populations: Adults unable to consent Prisoners Wards of the state Pregnant women may be included, but only in such capacity as parents of other children enrolled at Benjamin Banneker school

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Support for walking to school
5 modules that address psychosocial skills, with ongoing text messaging.

Locations

Country Name City State
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (3)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City University of Kansas, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of Intervention: "Satisfaction Questionnaire" Acceptability and preferences related to intervention content will be measured using a questionnaire developed for this study ("satisfaction questionnaire"). Families (both parent and child responding together) will respond to 5 items asking about satisfaction with the intervention components. Items are rated on a 10-pt scale (minimum:1- maximum:10), with higher values indicating greater satisfaction. They 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. at 6 weeks, immediately after completion of the intervention
Secondary Frequency of Walking to School 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. up to 6 weeks
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