Health BehaviorNCT04089020

Walking to School Supports

A study testing Support for walking to school in people with Health Behavior, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 13 yearsHealthy volunteers can take part
Conditions the study is for: Health Behavior
What is being tested?: Support for walking to school
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 25 Sep 2019to 31 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 13 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy Hospital
Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Psychosocial Supports for Walking to School Paired With a Walking School Bus

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.

Conditions: Health Behavior
Being tested: Support for walking to school
Medical subject headings: Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04089020
Study group	Role	What they receive
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. Receives: Behavioral: Support for walking to school

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: at 6 weeks, immediately after completion of the intervention

Secondary outcomes (1)

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.
Measured: up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201931 Jan 2020

First posted13 Sep 2019
Study start25 Sep 2019
Primary completion31 Dec 2019
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Health BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04089020
Sponsor's protocol ID: STUDY00000851
Status last verified: Oct 2022
First submitted: 10 Sep 2019
Last updated: 18 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified information may be available upon request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Psychosocial Supports for Walking to School Paired With a Walking School Bus
ClinicalTrials.gov ID: NCT04089020
Acronym / sponsor ID: STUDY00000851
Conditions: Health Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Collaborators: University of Kansas Medical Center, University of Kansas
Study start: 25 Sep 2019 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 13 Sep 2019 (actual)
Results: Posted 18 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Psychosocial intervention	Experimental	Behavioral: Support for walking to schoolText messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.

Who may qualify

Ages: 5 to 13 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Support for walking to school5 modules that address psychosocial skills, with ongoing text messaging.	Behavioural	Psychosocial intervention

Primary outcome

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"). 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.

1 secondary outcome

Frequency of Walking to School
Time frame: up to 6 weeks

Results and safety

Results posted to the registry on 18 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Psychosocial Intervention	32	31

Primary outcome: Acceptability of Intervention: "Satisfaction Questionnaire"

Time frame: at 6 weeks, immediately after completion of the intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychosocial Intervention n = 13
Did you like the text messages?	9.83 (0.58)
How did you like the materials?	9.33 (1.0)
How did you like the calls?	9.33 (1.16)
How did you like the program overall?	9.82 (0.6)

Population analysed: The satisfaction questionnaire was completed by the families (parent and child responding together). Of the 14 participant families, 13 were successfully contacted to complete the questionnaire.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Psychosocial Intervention	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. De-identified information may be available upon request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jordan Carlson, PhD principal investigator

Children's Mercy Hospital Kansas City

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Support for walking to school in people with Health Behavior, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Intervention: "Satisfaction Questionnaire" (time frame: at 6 weeks, immediately after completion of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.