Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-22 @ 9:56 AM
Study NCT ID:
NCT04089020
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Walking to School Supports
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jacarlson@cmh.edu', 'phone': '816-234-9240', 'title': 'Jordan Carlson, PhD.', 'organization': "Children's Mercy Kansas City"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'Adverse events were only monitored for child participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Psychosocial Intervention', 'description': 'Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.\n\nSupport for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability of Intervention: "Satisfaction Questionnaire"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Psychosocial Intervention', 'description': 'Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.\n\nSupport for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging.'}], 'classes': [{'title': 'Did you like the text messages?', 'categories': [{'measurements': [{'value': '9.83', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'How did you like the materials?', 'categories': [{'measurements': [{'value': '9.33', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'How did you like the calls?', 'categories': [{'measurements': [{'value': '9.33', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'How did you like the program overall?', 'categories': [{'measurements': [{'value': '9.82', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 6 weeks, immediately after completion of the intervention', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Frequency of Walking to School', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Psychosocial Intervention', 'description': 'Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.\n\nSupport for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.10', 'spread': '2.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 weeks', 'description': '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.', 'unitOfMeasure': 'walking trips', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Psychosocial Intervention', 'description': 'Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.\n\nSupport for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '18 youth participants 14 parent participants', 'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '18 youth participants 13 parent participants', 'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Psychosocial Intervention', 'description': 'Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.\n\nSupport for walking to school: 5 modules that address psychosocial skills, with ongoing text messaging.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This study included parent/child dyads, however no data was collected at baseline for parents.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-01', 'size': 295138, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-24T15:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2019-09-10', 'resultsFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-14', 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Intervention: "Satisfaction Questionnaire"', 'timeFrame': 'at 6 weeks, immediately after completion of the intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Walking to School', 'timeFrame': 'up to 6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Behavior']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of children enrolled at Benjamin Banneker school\n* 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:\n\nThose 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).\n\nExclusion Criteria:\n\n* Children not enrolled at Benjamin Banneker school\n* 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).\n* We will exclude each of the following special populations:\n\nAdults 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'}, 'identificationModule': {'nctId': 'NCT04089020', 'briefTitle': 'Walking to School Supports', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Psychosocial Supports for Walking to School Paired With a Walking School Bus', 'orgStudyIdInfo': {'id': 'STUDY00000851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychosocial intervention', 'description': 'Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.', 'interventionNames': ['Behavioral: Support for walking to school']}], 'interventions': [{'name': 'Support for walking to school', 'type': 'BEHAVIORAL', 'description': '5 modules that address psychosocial skills, with ongoing text messaging.', 'armGroupLabels': ['Psychosocial intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Jordan Carlson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified information may be available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, {'name': 'University of Kansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Doctoral Research Faculty', 'investigatorFullName': 'Jordan Carlson', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}