Physical ActivityRIGHT_TRACKSNCT02282631
Development and Feasibility of an Incentive Scheme to Promote Walking/Cycling to School
A study testing Incentive scheme in people with Physical Activity, run by Newcastle University at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate whether an incentive scheme is a feasible approach to increase walking/cycling to school. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Incentive scheme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Feb 2015
- 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Year 5 children in any of the selected schools
- Consent from parent and assent from child
Who cannot join
- No consent/assent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle University, Institute of Health and Society, Baddiley-Clark Building
Newcastle upon Tyne, Tyne and Wear, NE2 4AX
About this study
Official title: The RIGHT TRACKS Study - Development and Feasibility of an Incentive Scheme to Promote Active School Travel in Year 5 Children
The aim of this study is to investigate whether an incentive scheme is a feasible approach to increase walking/cycling to school.
Read the detailed 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.
- Conditions
- Physical Activity
- Being tested
- Incentive scheme
- Keywords
- active school travel, active travel, incentive scheme, children, school, behaviour change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive schemeBehavioural
Also called Incentive-scheme, lottery-based scheme, intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group school | Experimental | School where the incentive scheme will be run. Receives: Behavioral: Incentive scheme |
| Control group school | No intervention | School with no intervention; ongoing advice on active school travel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schools Who Accepted to Take Part
Percentage of schools who accepted to take part in this study
Measured: May 2014 to June 2014
School Retention
% of schools who were retained for the whole duration of the study (out of the two who took part)
Measured: September 2014 to December 2014
Recruitment of Participants
Number of participants recruited in this study.
Measured: Sep 2014 to December 2014
Retention of Participants
Number of participants who remained in the study until the end.
Measured: September 2014 to December 2014
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)
Measured: 1 week
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.
Measured: 8 weeks after baseline
Accelerometers Lost or Damaged
Number of accelerometers lost or damaged in this study
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
Agreement Between Parent and Child Reports
Inter-rater agreement between parent and child ATS* reports
*Active Travel to School
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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.
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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.
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Measured: 9 weeks (one week at baseline plus eight weeks after baseline)
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.
Measured: 8 weeks after baseline
Secondary outcomes (1)
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.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionFeb 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Ginja, Newcastle University
- Investigators
- Elaine McColl, PhD, Study director, Newcastle UniversityBronia Arnott, PhD, Study director, Newcastle UniversityVera Araujo-Soares, PhD, Study director, Newcastle UniversityAnil Namdeo, PhD, Study director, Newcastle UniversitySamuel Ginja, MSc, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282631
- Sponsor's protocol ID
- AST-00759
- Acronym
- RIGHT_TRACKS
- Status last verified
- Mar 2017
- First submitted
- 5 Sep 2014
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ginja S, Arnott B, Araujo-Soares V, Namdeo A, McColl E. Feasibility of an incentive scheme to promote active travel to school: a pilot cluster randomised trial. Pilot Feasibility Stud. 2017 Nov 14;3:57. doi: 10.1186/s40814-017-0197-9. eCollection 2017.
PubMed 29167744
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RIGHT TRACKS Study - Development and Feasibility of an Incentive Scheme to Promote Active School Travel in Year 5 Children
- ClinicalTrials.gov ID
- NCT02282631
- Acronym / sponsor ID
- RIGHT_TRACKS / AST-00759
- Conditions
- Physical Activity
- Keywords
- active school travel, active travel, incentive scheme, children, school, behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate whether an incentive scheme is a feasible approach to increase walking/cycling to school.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group school | Experimental | Behavioral: Incentive schemeSchool where the incentive scheme will be run. |
| Control group school | No intervention | –School with no intervention; ongoing advice on active school travel. |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Year 5 children in any of the selected schools
- Consent from parent and assent from child
Key exclusion criteria (1 listed)
- No consent/assent
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 |
|---|---|---|
| Incentive schemeAlso: Incentive-scheme, lottery-based scheme, interventionChildren 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. | Behavioural | Intervention group school |
Primary outcome
Schools Who Accepted to Take Part
Time frame: May 2014 to June 2014
Percentage of schools who accepted to take part in this study
School Retention
Time frame: September 2014 to December 2014
% of schools who were retained for the whole duration of the study (out of the two who took part)
Recruitment of Participants
Time frame: Sep 2014 to December 2014
Number of participants recruited in this study.
Retention of Participants
Time frame: September 2014 to December 2014
Number of participants who remained in the study until the end.
Number of Participants Who Returned Their Accelerometers on Time at the End of the Baseline Week
Time frame: 1 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)
Number of Participants Who Returned Their Accelerometers on Time at the End of the Post-baseline Week
Time frame: 8 weeks after baseline
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.
Accelerometers Lost or Damaged
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
Number of accelerometers lost or damaged in this study
Parental ATS Paper Reports Returned
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
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
Child ATS Reports Returned
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
Number of child ATS* reports returned to the researcher (myself) throughout the study. Child ATS reports were always on paper. *Active Travel to School
Agreement Between Parent and Child Reports
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
Inter-rater agreement between parent and child ATS* reports *Active Travel to School
Active Travel to School Based on Parental Report
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
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.
Active Travel to School Based on Child Report
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
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.
Differences in MVPA During the Times Reported by the Parent, Based on Parental Report
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Differences in MVPA During the Hour Before the Classes, Based on Parental Report
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Differences in MVPA During the Times Reported by the Parent, Based on Child Report
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Differences in MVPA During the Hour Before the Classes, Based on Child Report
Time frame: 9 weeks (one week at baseline plus eight weeks after baseline)
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)
Parental ATS Reports by SMS
Time frame: 8 weeks after baseline
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.
1 secondary outcome
Number of Participants Who Met Physical Activity Guidelines
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29167744Ginja S, Arnott B, Araujo-Soares V, Namdeo A, McColl E. Feasibility of an incentive scheme to promote active travel to school: a pilot cluster randomised trial. Pilot Feasibility Stud. 2017 Nov 14;3:57. doi: 10.1186/s40814-017-0197-9. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Elaine McColl, PhD study director
Newcastle University
Bronia Arnott, PhD study director
Newcastle University
Vera Araujo-Soares, PhD study director
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive scheme in people with Physical Activity, run by Newcastle University at 1 site in United Kingdom.
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 2 inclusion and 1 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 4 Apr 2017. 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 Kingdom. 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 4 Apr 2017). 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?
Schools Who Accepted to Take Part (time frame: May 2014 to June 2014). The study lists 17 primary outcomes in all. 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 NCT02282631, which also lists 1 linked publication.
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 4 Apr 2017.