ALLChange: Changing Lifestyle in Children

• Sponsor: University of Dundee (Other)
• Overall Status: Completed
• CT.gov ID: NCT01005186
• Collaborator: University of St Andrews (Other)
• Enrollment: 92
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jul 1, 2006
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

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

Outcome Measures

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? []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Children 9-11 yrs

Exclusion Criteria:

• Children <9 yrs and >12 yrs

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Dundee
• University of St Andrews

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Dundee
• ClinicalTrials.gov Identifier: NCT01005186
• Other Study ID Numbers: 2003CV40
• First Posted: Oct 30, 2009
• Last Update Posted: Jan 8, 2016
• Last Verified: Jan 1, 2016

Study Results

No Results Posted as of Jan 8, 2016