Development and Feasibility of an Incentive Scheme to Promote Walking/Cycling to School

Physical Activity Clinical Trial

— RIGHT_TRACKS  

Official title:

The RIGHT TRACKS Study - Development and Feasibility of an Incentive Scheme to Promote Active School Travel in Year 5 Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282631
• Other study ID #: AST-00759
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: March 29, 2017
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2017
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether an incentive scheme is a feasible approach to increase walking/cycling to school.

Description:

This will be a feasibility study using a two-arm cluster randomised controlled design; the Year 5 group (and respective school) will be the unit of randomisation. Participants will be Year 5 pupils, aged 9-10.

Data will be collected throughout approximately three months. In total, assessments will be carried out over a nine week period, which excludes an interval week between baseline and the first intervention week, and half-term (school holidays).

All children in Year 5's in the selected schools will be approached to participate and will be allocated randomly (according to the school they attend) to the two arms: (i) intervention group taking part in the incentive scheme and (ii) control group receiving ongoing curricular advice on active travel.

Parents' participation consists in completing a socio-demographic questionnaire and consent form, and in completing a daily form (or answering daily text messages) reporting whether child has actively traveled to school (AST report) .

A number of schools will be invited to participate by email. A reply by post, phone or email to the lead researcher will be requested within two weeks, at the end of which pending schools will be contacted by phone to confirm their decision. Of those interested, two schools will be selected, ideally matched for characteristics such as location, free school meals and AST rates.

Once the two participating schools have been identified, a meeting in person will be arranged with each head teacher at a time/place of their choice.

The researcher will then visit the schools and introduce the RIGHT TRACKS study to the Year 5 class. After the study has been presented and questions answered, an information pack will be sent home in the pupil's school folder. This pack will include an information leaflet for child, an information leaflet for the parent/carer, a parent questionnaire, a participant information sheet and a consent form. Two of the points stressed are confidentiality and the freedom to drop out of the study at any time without giving justification. After reading and having the chance of asking questions (by phone/email to the lead researcher), parents will be required to formally consent (opt in procedure) to their and to their child's participation.

Parental questionnaires and consent forms are expected to be filled in at home but phone or email inquiries may be made to the researcher during working hours. Within one week after delivery, parents will be requested to return completed and signed documents to the researcher. Specific methods of distribution and collection will be decided with the school beforehand to accommodate local circumstances and preferences.

Questionnaire completion will be requested of parents, however only return of the signed consent form will be essential to determine the child's participation. In addition, participating children will complete an assent form in the classroom.

Baseline assessment Following the identification of participants, children in both schools will be given and instructed to wear an accelerometer on a waist band above the lateral hip over the ensuing seven days, from the moment they get up until they go to bed, except for water-based activities and certain sports.

Together with the accelerometer, the child will be given the parent AST report form, which he/she must take home and return at the end of the seven day period, completed by the parent, together with the accelerometer. Four questions will be asked to parents in the parent AST report form, in relation to each day of the week: e.g. "On Monday did your child walk or cycle to school, all or part of the journey?", "At what time did your child leave home?", "At what time did your child arrive at school?", "Did your child stop anywhere on the way? If yes, how long was the stop for? ____ minutes".

Upon collection of the accelerometer and completed parents AST report forms, children's AST form will be filled out in the classroom retrospectively in relation to the five previous school days (mornings). The only question to be asked to children in relation to the five days is: e.g. "On Monday did you walk or cycle to school, all or part of the journey?" At the end of the baseline week, those complying with the study protocol will be rewarded, as stated in advance on the information materials: a prompt return of the completed parent AST report form and undamaged accelerometer, and completed child AST report form in the classroom, will be essential requisites for receiving a £5 thank you voucher.

Intervention phase The next stage of the RIGHT TRACKS consists in testing the feasibility of the incentive scheme. Similar to baseline, the quality of data from the three sources - accelerometry, parental AST report and child self-report of AST - will be examined. In particular, the validity of parental and child-reported AST will be assessed vis-à-vis accelerometry, currently considered to be one of the gold-standards. However, parental report of AST will be used as the basis of the incentive scheme. Once again, in both intervention and control conditions, there will be a £5 thanks voucher for every child taking part in the measurement procedures, in compliance with the protocol. At the end of the study, a debrief sheet will be handed to all participants, including parents and children, and to the two head teachers.

Intervention group - incentive scheme The incentive scheme will be explained to the intervention group in an introductory session. Partway active trips will be given particular emphasis. Each subsequent session is anticipated to take no more than 25 minutes per week of the classroom time.

The incentive scheme run in the intervention school consists of a prize draw taking place once a week. The prize is a £5 shopping gift voucher valid in a number of high street shops. Chances of winning depend entirely on the number of "points": the number of active trips to school reported exclusively by the parent on the AST report form, through the same questions used at baseline. For each week day that they travel to school the child gets one point. This point is the equivalent to a ticket with the child's ID number that will then be entering the draw. Each child can earn between zero and five tickets per week, depending on the number of active travel trips to school reported by the parent. Discrepant numbers between parental reports and those reported by the child or recorded on the accelerometer are of great interest for measurement, but will be disregarded for the purposes of the draw. In the absence of the parent AST report, the child report may be use for point count, but the child will be reminded that the parental report will be necessary for the next draw.

A difference between baseline and intervention phase concerns the format of the parent AST report form, which may now be completed in writing as before, or by SMS text messages on the weeks the child is not wearing the accelerometer. Preference for either of the options can be stated in advance in the consent form. Parents will be asked to keep them, fill in and return on time every week (personally or via the child), as the programme proceeds. Mobile phone respondents will be notified daily by SMS, to which they can reply directly. Questions asked will be the same in the paper version and mobile phone. However, on the two weeks the child wears the accelerometer, all participants will be asked to use the parent AST report. When the child is not wearing the accelerometer, the only question asked on the parental form or text messages is whether the child walked/cycled to school all or part of the journey. For those wearing the accelerometer in the intervention school, the point will be credited as long as the first question is answered (i.e. if parent indicated whether child actively traveled but failed to complete questions on times).

During the intervention phase, three tasks will be expected from children: (1) wearing an accelerometer for another seven-day period, which they must return to the classroom, together with the parent AST report form, (2) returning the parent AST report form in the remaining weeks (if applicable) and (3) complete an AST report form in the classroom each day of the draw.

Thank you vouchers (£5) will be issued on timely receipt of the accelerometer (together with AST forms), even if the accelerometer turns out to not have been worn for the requested time (i.e. at least four days, including at least one weekend day, and 10 hours each day).

The researcher will retire to a different room (or section of the school) and based on the parent AST report form only, points relative to the five previous days will be calculated. In the case of SMS, responses will be gathered in the evening, at the researcher's workplace, and next day's point will only be credited if received before 12noon (this will be stated in every text message that parents receive on a draw day). Class scores will be anonymously displayed on a graphic/chart week-after-week, in a printed version if possible or by hand if necessary. Depending on the school's preferences and availability, the logistics of counting points and producing tickets may be slightly different. For example, a teacher may agree to return all the completed parent AST reports to the school office in the morning, in which case the researcher could collect them and prepare the tickets in advance.

After producing all the tickets, the researcher will return to the classroom to distribute the accelerometers to the next batch of users. Once the thank you vouchers and accelerometers have been sorted out, the draw will finally take place in the classroom. A ticket will be picked out of a black string bag, probably by a school staff member of by the researcher. Depending on parental choice specified on the consent form, the incentive scheme voucher will be provided to the winner straight away, or will be left in the school office for later collection by the parent. The class score graphic/chart will be put on display on the wall.

Control group - normal curricular AST advice With the exception of the incentive scheme, identical procedures will be followed in both intervention and control groups. Each week, new groups of participants (e.g. the next five on the list) will be requested to wear the accelerometer, return the parent AST report form (if applicable) and complete their own AST report form.

Qualitative study One component of this study consists of semi-structured interviews with children, parents/carers and stakeholders, both from experimental and control groups, to explore different perspectives associated with the proposed intervention and trial procedures and to help refine both. Willingness to be interviewed will be expressed in the consent form before baseline in the case of parents (in addition to assent form in the case of children), from which a purposive sample will be selected based on the socio-demographic variables assessed in the questionnaire. The researcher will directly invite teachers and head teachers, who in turn will suggest other stakeholders for interview among their acquaintances (snowball sampling).

The aim will be to interview dropout participants throughout the intervention phase (as soon as they leave the study), and full participants immediately after the study has ended (January 2015). Sessions are expected to last between 30-45 minutes for adults and 15-30 minutes for children. Verbal consent to take part and to have the session audio-taped will be requested at the onset (in the case of children, to parents first and then by verbal assent), and the confidential nature of all records will be reiterated. Data will be securely stored in compliance with Newcastle University's regulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 10 Years

Eligibility

Inclusion Criteria:

• Year 5 children in any of the selected schools

• Consent from parent and assent from child

Exclusion Criteria:

• No consent/assent

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Incentive scheme
Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent.

Locations

Country	Name	City	State
United Kingdom	Newcastle University, Institute of Health and Society, Baddiley-Clark Building	Newcastle upon Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schools Who Accepted to Take Part	Percentage of schools who accepted to take part in this study	May 2014 to June 2014
Primary	School Retention	% of schools who were retained for the whole duration of the study (out of the two who took part)	September 2014 to December 2014
Primary	Recruitment of Participants	Number of participants recruited in this study.	Sep 2014 to December 2014
Primary	Retention of Participants	Number of participants who remained in the study until the end.	September 2014 to December 2014
Primary	Number of Participants Who Returned Their Accelerometers on Time at the End of the Baseline Week	Number of participants who returned their accelerometer to the researcher on the designated day, at end of baseline week (all children wore the accelerometer at the same time)	1 week
Primary	Number of Participants Who Returned Their Accelerometers on Time at the End of the Post-baseline Week	Number of participants who returned their accelerometer on time to the researcher (myself) on the designated day, at end of post-baseline week. This was the second week of wear for participants. Whereas all participants were assessed concurrently at baseline, different subsamples were assessed every week at post-baseline.	8 weeks after baseline
Primary	Accelerometers Lost or Damaged	Number of accelerometers lost or damaged in this study	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Parental ATS Paper Reports Returned	N parental ATS* paper reports returned to researcher(me); *Active Travel to School; Paper reports with at least 1 box had been ticked out of the five boxes on the form (there was 1 box for each day of the week).; ATS reports were collected weekly, i.e. on the baseline week and on each of the eight post-baseline weeks. Accelerometers were only used twice; once at baseline (1week) and once at post-baseline (1week).; Parental paper ATS reports were preferred by 6 families, but on the 2 accelerometer weeks all participants had to use a paper reports including usual SMS respondents. In contr. group: all used paper reports at baseline (1st accel. week) (n=14), 6 usual paper respondents at post-baseline (6x8 weeks = 48), 6 SMS respondents who had to paper-report on the 2nd accel.week (both dropouts were SMS respondents & left too early for a 2nd accel.), so total N possible paper reports 14 + 48 + 6=68. Int. school: 15 participants & 8 usual paper respondents, total=15 + (8 x 8) + 7=86	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Child ATS Reports Returned	Number of child ATS* reports returned to the researcher (myself) throughout the study. Child ATS reports were always on paper.; *Active Travel to School	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Agreement Between Parent and Child Reports	Inter-rater agreement between parent and child ATS* reports; *Active Travel to School	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Active Travel to School Based on Parental Report	Active travel to school (ATS) refers to the behaviour of travelling to school by human-powered means as opposed to motorised transportation, for example by walking or cycling. This was based on parental ATS reports.	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Active Travel to School Based on Child Report	Percentage of active trips to school based on child report. This data is from all the trips reported by children, whether parental reports exist for the same day or not. For that reason, this differs from the number of trips reported in 'Agreement Between Parent and Child Reports' because in that case, both parent and child reports were required for the same day.	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Differences in MVPA During the Times Reported by the Parent, Based on Parental Report	differences in minutes of moderate-to-vigorous physical activity (MVPA) between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on parental report (i.e. parent reported whether the trip was ATS or non-ATS)	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Differences in MVPA During the Hour Before the Classes, Based on Parental Report	differences in MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on parental report (i.e. parent reported whether trip was ATS or non-ATS)	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Differences in MVPA During the Times Reported by the Parent, Based on Child Report	differences in minutes of MVPA between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on child report (i.e. child reported whether trip was ATS or non-ATS)	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Differences in MVPA During the Hour Before the Classes, Based on Child Report	differences in minutes of MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on child report (i.e. child reported whether trip was ATS or non-ATS)	9 weeks (one week at baseline plus eight weeks after baseline)
Primary	Parental ATS Reports by SMS	Number of parental ATS reports by SMS.; In this case, for comparability with data from paper reports, one SMS reports refers to a week in which at least one SMS report was received from the parent.; Parental SMS reports were only possible in those weeks when the child was not wearing the accelerometer. Parents who had chosen to report ATS by SMS were requested to report by paper on the weeks when the child wore the accelerometer (once at baseline, and once at post-baseline), and could report ATS by SMS in all other weeks.	8 weeks after baseline
Secondary	Number of Participants Who Met Physical Activity Guidelines	Number of participants who met physical activity guidelines, i.e. at least 60 minutes of moderate-to-vigorous physical activity (MVPA) a day, measured by accelerometer (ActiGraph GT3X+); cut points of intensity by Evenson et al (2008) (sedentary <100 counts per minute (cpm); light >100cpm; moderate >=2296cpm; vigorous >=4012cmp), epoch 10 seconds. Valid wear was at least 6h/day on at least 3 days (weekdays or weekends).; NOTE: the above criterion of 10h/day for at least 5 days was changed before the start of the fieldwork, although not on this website. We found studies which suggested that wearing the accelerometer 6h/day on at least three days, with or without weekend days, were sufficient to assess overall levels of physical activity. Consistent with these findings, this new minimum wear criterion was adopted in the present study.	9 weeks