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| Name | Class |
|---|---|
| University of Kansas Medical Center | OTHER |
| University of Kansas | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support for walking to school | Behavioral | 5 modules that address psychosocial skills, with ongoing text messaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Carlson, PhD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
De-identified information may be available upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Psychosocial Intervention | Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks. Support for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study included parent/child dyads, however no data was collected at baseline for parents.
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| ID | Title | Description |
|---|---|---|
| BG000 | Psychosocial Intervention | Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks. Support for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | at 6 weeks, immediately after completion of the intervention |
|
6 weeks
Adverse events were only monitored for child participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psychosocial Intervention | Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks. Support for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Carlson, PhD. | Children's Mercy Kansas City | 816-234-9240 | jacarlson@cmh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2019 | Jan 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks. Support for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging. |
|
|
| 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. | Posted | Mean | Standard Deviation | walking trips | up to 6 weeks |
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| 0 |
| 18 |
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| 18 |
| 0 |
| 18 |
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