Changing Lifestyle in Children (ALLChange)

This study has been completed.
Sponsor:
Collaborator:
University of St Andrews
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT01005186
First received: October 29, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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: Open Label
Primary Purpose: Prevention
Official Title: Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?

Resource links provided by NLM:


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? [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum? [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: July 2006
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

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Children 9-11 yrs

Exclusion Criteria:

  • Children <9 yrs and >12 yrs
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Jill Belch, University of Dundee
ClinicalTrials.gov Identifier: NCT01005186     History of Changes
Other Study ID Numbers: 2003CV40
Study First Received: October 29, 2009
Last Updated: October 29, 2009
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on July 23, 2014