Changing Lifestyle in Children

Cardiovascular Risk Clinical Trial

— ALLChange  

Official title:

Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005186
• Other study ID #: 2003CV40
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2009
• Last updated: January 7, 2016
• Start date: July 2006
• Est. completion date: July 2007

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

Inclusion Criteria

• Children 9-11 yrs

Exclusion Criteria:

• Children <9 yrs and >12 yrs

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Risk

Intervention

Behavioral:
• Eating habits, diet and exercise
Programme of change to eating habits, diet and exercise

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	University of St Andrews

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?			No
Secondary	Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?			No