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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02871830
Other study ID # REC/11/0236
Secondary ID
Status Completed
Phase N/A
First received August 10, 2016
Last updated August 15, 2016
Start date January 2014
Est. completion date October 2015

Study information

Verified date August 2016
Source University of Ulster
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Children and young people are recommended to undertake at least 60 minutes of moderate to vigorous intensity physical activity each day. However recent findings have indicated that only 51% of children aged 7 years were meeting these guidelines. Previous research has also highlighted girls are significantly less active than. Furthermore, children living in Northern Ireland are least likely to meet the guidelines, with only 43.4% of children here reaching the recommended ≥ 60 minutes a day. The development of interventions which can successfully increase levels of physical activity in adolescent girls in Northern Ireland is of key importance. The aim of this intervention is to investigate whether or not girls (aged 11-13 years) can increase their daily levels of physical activity over a 12 week period by taking part in a school-based brisk walking intervention. The impact of participating in a school-based brisk walking intervention on a range of other outcome measures will also be investigated. A total sample of 200 adolescent females will be recruited onto the study, with recruitment of participants taking place at the school level. Following written consent from parents/guardians and assent from participants, participants will be randomised at the school level to either participate in the walking intervention or to act as controls. Objective physical activity will be assessed at 3 time points using an Actigraph accelerometer. At baseline, post-intervention (12 weeks) and follow up (4 months post-intervention) participants will also undergo measurements of height, weight, waist and hip circumference, bloody pressure, and cardiorespiratory fitness. Participants will also complete questionnaires assessing levels of physical activity and a number of psychosocial variables at each time point. Following completion of follow up measurements, a sub-sample of participants (n=45) will be invited to take part in focus groups to evaluate their experiences of the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 13 Years
Eligibility Inclusion Criteria:

- 11-13 years old

- Female

- Attend a school selected to take part in the study

- Healthy and free from any medical condition that limits their participation in a brisk walking intervention, for example, a musculoskeletal injury

Exclusion Criteria:

- Male pupils

- Those who are unable to walk or for whom walking is contraindicated will not be eligible for inclusion

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
15 mins physical activity per day within the school setting.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Ulster

Outcome

Type Measure Description Time frame Safety issue
Primary Total daily physical activity Measured for 7 consecutive days using Actigraph accelerometer at each time-point Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Physical activity intensity Measured for 7 consecutive days using Actigraph accelerometer at each time-point Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Self-reported physical activity Measured using Physical Activity Questionnaire for children Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Weight Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Blood pressure Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Cardiorespiratory fitness Measured using the Queens College Step test Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Self-efficacy for physical activity Psychosocial questionnaire - Children's physical activity self-efficacy scale Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Self-efficacy for walking Psychosocial questionnaire - adapted walking self-efficacy scale Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Social support for physical activity and walking Social support for physical activity and walking from male and female parents/guardians and friends scale Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Attitude to exercise Psychosocial questionnaire - perceived benefits and barriers to exercise scale Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
Secondary Waist hip ratio Change between baseline and post-intervention (12 weeks) and 4-months post-intervention No
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