NCT04089020

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

September 10, 2019

Results QC Date

January 26, 2022

Last Update Submit

October 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Frequency of Walking to School

    up to 6 weeks

Study Arms (1)

Psychosocial intervention

EXPERIMENTAL

Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.

Behavioral: Support for walking to school

Interventions

5 modules that address psychosocial skills, with ongoing text messaging.

Psychosocial intervention

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Jordan Carlson, PhD.
Organization
Children's Mercy Kansas City

Study Officials

  • Jordan Carlson, PhD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Doctoral Research Faculty

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 13, 2019

Study Start

September 25, 2019

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

August 18, 2023

Results First Posted

August 18, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

De-identified information may be available upon request.

Locations