NCT01156805

Brief Summary

The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable obesity

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

December 13, 2019

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

July 2, 2010

Results QC Date

August 11, 2017

Last Update Submit

August 6, 2020

Conditions

Keywords

ChildrenSchool-based programObesity

Outcome Measures

Primary Outcomes (1)

  • Anthropometric Variables

    BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity.

    every two years

Secondary Outcomes (3)

  • Height

    every two years

  • Father's Height

    every two years

  • Mother's Height

    every two years

Study Arms (2)

Educational intervention, Control

EXPERIMENTAL

Experimental, intervention group has received specific educational training to improve food habits and physical activity during the period of the study.

Other: Educational program

Educational program

NO INTERVENTION

No intervention has been made.

Interventions

The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test

Educational intervention, Control

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children born in 2000 who attended schools in Granollers City

You may not qualify if:

  • Schoolchildren who need special diet for metabolic or digestive disorder, physical activity incapacity, no family acceptance or attendance to school was discontinued

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Recasens MA, Xicola-Coromina E, Manresa JM, Ullmo PA, Jensen BB, Franco R, Suarez A, Nadal A, Vila M, Recasens I, Perez MJ, Castell C, Llargues E. Impact of school-based nutrition and physical activity intervention on body mass index eight years after cessation of randomized controlled trial (AVall study). Clin Nutr. 2019 Dec;38(6):2592-2598. doi: 10.1016/j.clnu.2018.12.029. Epub 2019 Jan 24.

  • Llargues E, Recasens MA, Manresa JM, Jensen BB, Franco R, Nadal A, Vila M, Recasens I, Perez MJ, Castell C. Four-year outcomes of an educational intervention in healthy habits in schoolchildren: the Avall 3 Trial. Eur J Public Health. 2017 Feb 1;27(1):42-47. doi: 10.1093/eurpub/ckw199. No abstract available.

MeSH Terms

Conditions

ObesityFeeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Results Point of Contact

Title
Dr. Esteve Llargues
Organization
Hospital General de Granollers

Study Officials

  • Assumpta Recasens, MD

    Hospital de Granollers

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 5, 2010

Study Start

September 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2012

Last Updated

August 17, 2020

Results First Posted

December 13, 2019

Record last verified: 2017-08