Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cardiovascular Disease and the Effects of a Cross-curricular Physical Activity Intervention

This study has been completed.
Sponsor:
Collaborators:
Sports Council Wales
University of Wales Institute Cardiff
Information provided by:
University of Glamorgan
ClinicalTrials.gov Identifier:
NCT00998478
First received: October 19, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The purpose of this study is to investigate the effects of a cross-curricular physical activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null hypothesis states that the intervention will have no effect on cardiovascular disease risk factors.


Condition Intervention
Cardiovascular Disease
Other: Activity Knowledge Circuits

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cardiovascular Disease Risk Factors and the Effects of a Cross-curricular Physical Activity Intervention in 11-14 Year Olds. Activity Knowledge Circuit

Further study details as provided by University of Glamorgan:

Primary Outcome Measures:
  • Cardiovascular disease risk factors (obesity, blood pressure, blood lipid & lipoprotein) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity behaviour and aerobic fitness profile [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • 7 day diet assessment [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Maturation status [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Motivation to exercise [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Psychological well-being, self concept, and cognitive performance [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Activity prescription Other: Activity Knowledge Circuits
The activity knowledge circuits were implemented, where in addition to regular physical education (PE) activity was increased by two hours a week over an 18-week period. Participants briskly walked 3200 m twice weekly during curriculum lessons (60 min). Short tasks, in line with current curriculum, were provided by subject teachers for participants to complete at stations set every 400 or 800 m. Crucially participants continued to follow national curriculum whilst exercising. Tasks designed by teachers lasted no longer than 60 seconds at each station. With the exception of PE, each curriculum subject delivered a total of four intervention lessons. Circuits were performed outdoors on school premises, with an indoor course of equal distance used during adverse weather conditions.
No Intervention: Normal Curriculum
Followed normal curriculum including physical education

Detailed Description:

Cardiovascular disease is the leading cause of mortality worldwide. Risk factors associated with cardiovascular disease including obesity, blood pressure and blood lipids have been shown to track from childhood through to adulthood. The prevalence of overweight and obesity for children (4-18 years) in the UK is reported to be 15 % and 4 % respectively. Furthermore, in comparison to England (2.9 %) obesity is more prevalent for those living in Scotland (7.6 %) and Wales (6.5 %). Previous research from two Welsh secondary schools indicate overweight and obesity rates for boys and girls aged 12-13 to be even greater at 26 % and 38 % respectively. Further to this, 19 % were identified as having elevated total cholesterol (≥5.2 mmol/L).

For many, overweight and obesity is the result of the combined effect of excess energy consumption and inadequate physical activity. Previous school-based physical activity interventions have demonstrated modest improvements to cardiovascular disease risk factors by implementing extra-curricular activities or improving current physical education curriculum. Few have attempted to increase physical activity using normally, class-room taught curriculum subjects. This study examines the impact of activity knowledge circuits to combat cardiovascular disease risk factors in 11-14 year old children.

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any pupil attending years 7, 8, and 9 of a secondary comprehensive school in South Wales

Exclusion Criteria:

  • Any pupil with an injury or illness that prevented them from taking part in any form of physical activity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998478

Locations
United Kingdom
Porth County Community School
Porth, Rhondda Cynon Taff, United Kingdom, CF39 0BS
Sponsors and Collaborators
University of Glamorgan
Sports Council Wales
University of Wales Institute Cardiff
Investigators
Principal Investigator: Gareth J Knox, MSc University of Wales Institute Cardiff
  More Information

No publications provided by University of Glamorgan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gareth Knox, University of Wales Institute Cardiff
ClinicalTrials.gov Identifier: NCT00998478     History of Changes
Other Study ID Numbers: AKC01
Study First Received: October 19, 2009
Last Updated: October 19, 2009
Health Authority: United Kingdom: National Research Ethics Service

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014