NCT02104973

Brief Summary

The purpose of this study is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of Mexico city.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 7, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

January 23, 2014

Last Update Submit

April 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    We will evaluate the change in body mass index

    0, 12 months

Secondary Outcomes (1)

  • Change in vegetal and fruit consumption

    0, 12 months

Other Outcomes (2)

  • Adiposity

    0, 12 months

  • Physical activity

    0, 12 months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

After obtaining the approval of schools and parents, will be established in schools, units in which individual attention is given to children, parents and teachers that request: the advice is aimed at training users on healthy diet and constant physical activity. Workshops with children, in which selected topics will be discussed based on the analysis of depth interviews with children, parents and teachers, and information on habits and resources gathered through questionnaires will be conducted. The intervention included the provision of information and feedback with the population through a website. The work will include participation in the selection of foods sold in schools.

Behavioral: Lifestyle counseling

Control

NO INTERVENTION

Usual care

Interventions

We will intent to modify the diet of the children. The intervention is designed to promote the increase the intake of fruits and vegetables and to reduce the high density foods consumption.

Lifestyle counseling

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children students in selected schools
  • Anthropometric diagnostic of normality or overweight
  • Informed consent of parents

You may not qualify if:

  • Children with special diet or children with limited motor functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marco A González, Master

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2014

First Posted

April 7, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2015

Last Updated

April 7, 2014

Record last verified: 2014-01

Locations