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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455986
Other study ID # StepSmart
Secondary ID
Status Completed
Phase Phase 1
First received May 21, 2015
Last updated August 14, 2017
Start date April 2015
Est. completion date October 2016

Study information

Verified date August 2017
Source Queen's University, Belfast
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote physical activity (PA).


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 14 Years
Eligibility 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 Design


Intervention

Behavioral:
The StepSmart Challenge
A six month pedometer based intervention designed to increase Physical Activity in school children

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Queen's University, Belfast

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in physical activity as assessed by Actigraph accelerometer Actigraph accelerometer counts per minute and minutes of moderate and vigorous physical activity Baseline, 6 months and 1 year
Secondary 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 Baseline, 6 months and 1 year
Secondary 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). Baseline, 6 months and 1 year
Secondary 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. Baseline, 6 months and 1 year
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