Trial Outcomes & Findings for Walking to School Supports (NCT NCT04089020)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

at 6 weeks, immediately after completion of the intervention

Results posted on

2023-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	32
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psychosocial Intervention n=18 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.
Age, Categorical <=18 years	18 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants
Sex: Female, Male Female	6 Participants n=18 Participants
Sex: Female, Male Male	12 Participants n=18 Participants
Region of Enrollment United States	18 participants n=18 Participants

PRIMARY outcome

Timeframe: at 6 weeks, immediately after completion of the intervention

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=13 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.
Acceptability of Intervention: "Satisfaction Questionnaire" Did you like the text messages?	9.83 score on a scale Standard Deviation 0.58
Acceptability of Intervention: "Satisfaction Questionnaire" How did you like the materials?	9.33 score on a scale Standard Deviation 1.0
Acceptability of Intervention: "Satisfaction Questionnaire" How did you like the calls?	9.33 score on a scale Standard Deviation 1.16
Acceptability of Intervention: "Satisfaction Questionnaire" How did you like the program overall?	9.82 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: up to 6 weeks

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.

Outcome measures

Outcome measures
Measure	Psychosocial Intervention n=18 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.
Frequency of Walking to School	4.10 walking trips Standard Deviation 2.15

Adverse Events

Psychosocial Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jordan Carlson, PhD.

Children's Mercy Kansas City

Phone: 816-234-9240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place