NCT01005186

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

October 29, 2009

Last Update Submit

January 7, 2016

Conditions

Cardiovascular Risk

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Study Arms (2)

Active

EXPERIMENTAL

Active

Behavioral: Eating habits, diet and exercise

Active 2

EXPERIMENTAL

Active

Behavioral: Eating habits, diet and exercise

Interventions

Eating habits, diet and exerciseBEHAVIORAL

Programme of change to eating habits, diet and exercise

ActiveActive 2

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 9-11 yrs

You may not qualify if:

  • Children \<9 yrs and \>12 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DietExercise

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

July 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 8, 2016

Record last verified: 2016-01