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Changing Lifestyle in Children (ALLChange)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005186
First Posted: October 30, 2009
Last Update Posted: January 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of St Andrews
Information provided by (Responsible Party):
University of Dundee
  Purpose
A lifestyle intervention aimed at improving exercise levels in primary school children.

Condition Intervention Phase
Cardiovascular Risk Behavioral: Eating habits, diet and exercise Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Can an acceptable strategy, based on social cultural factors that influence adherence to the strategy and designed for altering lifestyle associated with CV risk (ALL CHANGE) be developed for school aged children?

Secondary Outcome Measures:
  • Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?

Enrollment: 92
Study Start Date: July 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Active
Behavioral: Eating habits, diet and exercise
Programme of change to eating habits, diet and exercise
Experimental: Active 2
Active
Behavioral: Eating habits, diet and exercise
Programme of change to eating habits, diet and exercise

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Children 9-11 yrs

Exclusion Criteria:

  • Children <9 yrs and >12 yrs
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT01005186     History of Changes
Other Study ID Numbers: 2003CV40
First Submitted: October 29, 2009
First Posted: October 30, 2009
Last Update Posted: January 8, 2016
Last Verified: January 2016


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