- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455986
The StepSmart Project: A Pedometer Based Phased Intervention to Encourage Physical Activity in Schools
A Randomised Controlled Trial of a Pedometer Based Phased Intervention to Encourage Physical Activity in Schools: A Feasibility Study.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- aged 12-14 years
- enrolled in participating school
Exclusion Criteria
- Unable to give informed consent
- Presence of an underlying medical conditions
- Already enrolled in a physical activity intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
Prizes of low monetary value will be given to participants based on competition performance |
A six month pedometer based intervention designed to increase Physical Activity in school children
|
No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 6 months and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mental wellbeing measured by the Warwick Edinburgh Mental Well-being Scale
Time Frame: Baseline, 6 months and 1 year
|
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
|
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
|
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).
|
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
|
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.
|
Baseline, 6 months and 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark A Tully, PhD, Queen's University, Belfast
Publications and helpful links
General 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.
- Corepal 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.
- Best 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- StepSmart
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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