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Changing Lifestyle in Children (ALLChange)

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ClinicalTrials.gov Identifier: NCT01005186
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
University of St Andrews
Information provided by (Responsible Party):
University of Dundee

Brief Summary:
A lifestyle intervention aimed at improving exercise levels in primary school children.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Behavioral: Eating habits, diet and exercise Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
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?
Study Start Date : July 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?


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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

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