Physical ActivityPhase 1NCT02455986
The StepSmart Project: A Pedometer Based Phased Intervention to Encourage Physical Activity in Schools
A Phase 1 study testing The StepSmart Challenge in people with Physical Activity and Health Behavior, run by Queen's University, Belfast.
Trial summary
A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote physical activity (PA). Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Behavior, Competitive Behavior
- What is being tested?
- The StepSmart Challenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 12-14 years
- enrolled in participating school
Who cannot join
- Unable to give informed consent
- Presence of an underlying medical conditions
- Already enrolled in a physical activity intervention
About this study
Official title: A Randomised Controlled Trial of a Pedometer Based Phased Intervention to Encourage Physical Activity in Schools: A Feasibility Study.
A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote physical activity (PA).
Read the detailed description
The intervention is separated into three main phases.
Phase One: A 10-week school competition using pedometers and a range of non-financial incentives e.g. t-shirts, pens, badges etc. (April - June 2015).
Phase Two: End of school competition but participants will still keep the pedometers. We will set them various challenges over the summer to keep active (July - Oct 2015).
Phase Three: Removal of all extrinsically motivation factors. Focus on PA maintenance.
- Conditions
- Physical Activity, Health Behavior, Competitive Behavior, Incentives
- Being tested
- The StepSmart Challenge
- Medical subject headings
- Motor Activity, Health Behavior, Competitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The StepSmart ChallengeBehavioural
A six month pedometer based intervention designed to increase Physical Activity in school children
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group includes 150 participants aged 12-14 across three schools. Each participant has been given a Fitbit Zip pedometer to wear for a six month period and enrolled on the StepSmart challenge. Participants within the intervention group will take part in two competitions during this period.
1. School and team based competition. 27/05/15 - 22/06/15 (8 weeks)
2. Individually focused competition. 22/06/15 - 26/10/15 (18 weeks)
Prizes of low monetary value will be given to participants based on competition performance Receives: Behavioral: The StepSmart Challenge |
| Control | No intervention | The control group for the study involves approximately 90 participants aged 12 - 14. across two schools. Participants within the control group will complete the same measures as the intervention group including wearing an actigraph GT3X accelerometer for a seven day period and completing all questionnaires at the same time points as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in physical activity as assessed by Actigraph accelerometer
Actigraph accelerometer counts per minute and minutes of moderate and vigorous physical activity
Measured: Baseline, 6 months and 1 year
Secondary outcomes (3)
Change in mental wellbeing measured by the Warwick Edinburgh Mental Well-being Scale
Warwick Edinburgh Mental Well-being Scale is a validated, self-report instrument assessing mental wellbeing. Possible scores range from range from 14-70, with higher scores indicating higher mental well-being
Measured: Baseline, 6 months and 1 year
Change in social support for physical activity measured by the social support for physical activity scale
Social support for physical activity scale is a validated 5-item scale. Social support is measured as tghe sum of responses to four sub-scales including parental social support (3 items), parental encouragement (2 items), peer support (3 items), and teacher support (3 items). Each question is answered with a 4-point response format ranging from 1 (hardly ever or never) to 4 (every day).
Measured: Baseline, 6 months and 1 year
Change in future orientation and impulsivity measured using 8-item time preference scale
A previously validated 8-item time preference scale is included. Responses are summed to obtain a a future orientation and impulsivity score. High scores reflect future time orientation and greater impulsivity in decision making.
Measured: Baseline, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mark Tully, Queen's University, Belfast
- Investigators
- Mark A Tully, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455986
- Sponsor's protocol ID
- StepSmart
- Status last verified
- Aug 2017
- First submitted
- 21 May 2015
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Corepal R, Best P, O'Neill R, Kee F, Badham J, Dunne L, Miller S, Connolly P, Cupples ME, van Sluijs EMF, Tully MA, Hunter RF. A feasibility study of 'The StepSmart Challenge' to promote physical activity in adolescents. Pilot Feasibility Stud. 2019 Nov 17;5:132. doi: 10.1186/s40814-019-0523-5. eCollection 2019.
PubMed 31832227Corepal R, Best P, O'Neill R, Tully MA, Edwards M, Jago R, Miller SJ, Kee F, Hunter RF. Exploring the use of a gamified intervention for encouraging physical activity in adolescents: a qualitative longitudinal study in Northern Ireland. BMJ Open. 2018 Apr 20;8(4):e019663. doi: 10.1136/bmjopen-2017-019663.
PubMed 29678971Best P, Badham J, Corepal R, O'Neill RF, Tully MA, Kee F, Hunter RF. Network methods to support user involvement in qualitative data analyses: an introduction to Participatory Theme Elicitation. Trials. 2017 Nov 23;18(1):559. doi: 10.1186/s13063-017-2289-5.
PubMed 29169378
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Pedometer Based Phased Intervention to Encourage Physical Activity in Schools: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT02455986
- Acronym / sponsor ID
- StepSmart
- Conditions
- Physical Activity, Health Behavior, Competitive Behavior, Incentives
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote physical activity (PA).
Detailed description
The intervention is separated into three main phases.
Phase One: A 10-week school competition using pedometers and a range of non-financial incentives e.g. t-shirts, pens, badges etc. (April - June 2015).
Phase Two: End of school competition but participants will still keep the pedometers. We will set them various challenges over the summer to keep active (July - Oct 2015).
Phase Three: Removal of all extrinsically motivation factors. Focus on PA maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The StepSmart ChallengeThe intervention group includes 150 participants aged 12-14 across three schools. Each participant has been given a Fitbit Zip pedometer to wear for a six month period and enrolled on the StepSmart challenge. Participants within the intervention group will take part in two competitions during this period. 1. School and team based competition. 27/05/15 - 22/06/15 (8 weeks) 2. Individually focused competition. 22/06/15 - 26/10/15 (18 weeks) Prizes of low monetary value will be given to participants based on competition performance |
| Control | No intervention | –The control group for the study involves approximately 90 participants aged 12 - 14. across two schools. Participants within the control group will complete the same measures as the intervention group including wearing an actigraph GT3X accelerometer for a seven day period and completing all questionnaires at the same time points as the intervention group. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 12-14 years
- enrolled in participating school
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Presence of an underlying medical conditions
- Already enrolled in a physical activity intervention
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 |
|---|---|---|
| The StepSmart ChallengeA six month pedometer based intervention designed to increase Physical Activity in school children | Behavioural | Intervention |
Primary outcome
Change from baseline in physical activity as assessed by Actigraph accelerometer
Time frame: Baseline, 6 months and 1 year
Actigraph accelerometer counts per minute and minutes of moderate and vigorous physical activity
3 secondary outcomes
Change in mental wellbeing measured by the Warwick Edinburgh Mental Well-being Scale
Time frame: Baseline, 6 months and 1 year
Change in social support for physical activity measured by the social support for physical activity scale
Time frame: Baseline, 6 months and 1 year
Change in future orientation and impulsivity measured using 8-item time preference scale
Time frame: Baseline, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Derived from this study: PubMed 31832227Corepal R, Best P, O'Neill R, Kee F, Badham J, Dunne L, Miller S, Connolly P, Cupples ME, van Sluijs EMF, Tully MA, Hunter RF. A feasibility study of 'The StepSmart Challenge' to promote physical activity in adolescents. Pilot Feasibility Stud. 2019 Nov 17;5:132. doi: 10.1186/s40814-019-0523-5. eCollection 2019.
- Derived from this study: PubMed 29678971Corepal R, Best P, O'Neill R, Tully MA, Edwards M, Jago R, Miller SJ, Kee F, Hunter RF. Exploring the use of a gamified intervention for encouraging physical activity in adolescents: a qualitative longitudinal study in Northern Ireland. BMJ Open. 2018 Apr 20;8(4):e019663. doi: 10.1136/bmjopen-2017-019663.
- Derived from this study: PubMed 29169378Best P, Badham J, Corepal R, O'Neill RF, Tully MA, Kee F, Hunter RF. Network methods to support user involvement in qualitative data analyses: an introduction to Participatory Theme Elicitation. Trials. 2017 Nov 23;18(1):559. doi: 10.1186/s13063-017-2289-5.
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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.
Mark A Tully, PhD principal investigator
Queen's University, Belfast
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The StepSmart Challenge in people with Physical Activity and Health Behavior, run by Queen's University, Belfast.
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 3 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in physical activity as assessed by Actigraph accelerometer (time frame: Baseline, 6 months and 1 year). 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 NCT02455986, which also lists 3 linked publications.
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 17 Aug 2017.