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Trial registered on ANZCTR


Registration number
ACTRN12611000883910
Ethics application status
Approved
Date submitted
17/08/2011
Date registered
18/08/2011
Date last updated
18/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
School based program to promote lifestyle changes to prevent overweight in elementary school children.
Scientific title
Randomized school intervention to reduce BMI and prevent childhood obesity in Mexican elementary schools.
Secondary ID [1] 262860 0
nil
Universal Trial Number (UTN)
U1111-1123-1957
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity prevention 270575 0
Weight maintenance 270576 0
Condition category
Condition code
Diet and Nutrition 270743 270743 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was a quasi-experimental randomized cluster controlled trial during a period of 2 years.
The intervention group (group1) was conformed by 1 public and 1 private school, with 7 class groups in total, the control group (group 2) was conformed by 1 public and 1 private school with 6 class groups in total. There were no statistical differences between the two groups in BMI, BMIz-score.
During the first phase, all components of the intervention were developed and implemented to the intervention group (group1).
The study’s intervention consisted of three components: 1) school board and teachers, 2) classroom curriculum, and 3) parent involvement.
The intervention approach was based in the Bronfenbrenner’s Ecological Model. The educational component was designed to be interdisciplinary. Nutrition and physical activity professionals interacted with parents, children, and teachers. Its purpose was to show how food choices and physical activity depend on personal behavior, individual health and school and family environment.
The classroom curricula for 2nd and 3rd grades were designed to promote healthful eating behaviors and to increase physical activity. One 30-min interactive lesson was delivered by nutrition graduate students each week for 8 weeks during the academic year. The objective of the interactive children sessions was to encourage children to increase fruit and vegetable consumption, to enroll in sports and play activities, to reduce the consumption of soda and snacks with a high fat and sugar content, and to lower the number of hours of TV viewing. This component also included the assessment of dietary intake and physical activity.
Four 60-minute sessions were delivered to school board and teachers by nutrition and PA professionals to discuss healthy lifestyles. Several meetings took place to discuss how to improve school meals and snacks offered in the cafeteria, and also on how to improve PA installations and offer PA activities during and after school.
The aim of the parents’ involvement component was to introduce them to the intervention program and to receive nutrition education and extend their knowledge on healthy lifestyle and eating behaviors. The parents’ component consisted of a 60-minute session delivered by nutrition professionals each month for 4 months during the academic year.
After the six months the control group Group 2 received the intervention program.
In phase 2 :For the intervention and control group a follow-up program was continued for another 18 and 12 months respectively. The follow-up program consisted in a 30 min weekly session for the semester with classroom activities to promote fruit and vegetable consumption and PA and decresease soda and non healthy snack consumption.
Intervention code [1] 269207 0
Lifestyle
Intervention code [2] 269217 0
Prevention
Comparator / control treatment
For the control group (group 2) three 60-minute sessions were delivered to school board, teachers, and parents by medical professionals to discuss health issues (diabetes, hipertension, and blood lipid problems).
After the initial six month period, the control group received the intervention due to the benefits observed in the intervention group in the first six months.
Control group
Active

Outcomes
Primary outcome [1] 269439 0
BMI and z-score BMI changes between control and intervention groups and pre- and post-intervention.
Timepoint [1] 269439 0
at 6, 12, 18, 24 months after randomization
Secondary outcome [1] 287645 0
Changes in waist circumference (WC). The wast circunference will be measured using a flexible and retractable measuring tape (SECA) at the midpoint between the lower rib and the top of the iliac crest at the end of a gentle expiration. Abdominal obesity was defined as WC> 90th of NHANESIII.
Timepoint [1] 287645 0
12,and 24 months after randomization
Secondary outcome [2] 287646 0
Overweight and obesity prevalence.
Height will be measured (without shoes) to the nearest 0.1 cm using a portable stadiometer (Model 214 Road Rod, Seca Corp, Hanover, MD, USA). Weight will be measured (in light clothing) to the nearest 0.1 kg using previously calibrated electronic scales (Model 2001; Tanita Corp. Tokyo, Japan). BMI (kg/m2) and z-scores will be calculated using the WHO (2007) LMS parameters for sex and age. Cut-off points for overweight are greater than 1DS, and obesity greater than 2 DS.
The percentage of children with overweight or obese will be calculated.
Timepoint [2] 287646 0
12, and 24 months after randomization
Secondary outcome [3] 287647 0
remission (percentage of children who were overweight or obese at baseline but were not overweight or obese at follow-up)
Timepoint [3] 287647 0
12, and 24 months after randomization
Secondary outcome [4] 287648 0
incidence (percentage of children with normal weight at baseline who became overweight or obese at follow-up).
Timepoint [4] 287648 0
12, and 24 months after randomization
Secondary outcome [5] 287649 0
Fruit and vegetables, soda and sweetened and high fat snack consumption and availability.
Dietary registry of food consumption: Children will be ask to complete a dietary registry on a randomly selected weekday. The registry will be analyzed based on portions of food groups targeted in the intervention: number of servings of cereals and grains, meat, milk, fruits, vegetables, sweetened beverages, candies and snacks. The dietary registry will be recorded with the support of trained teachers.
Food inventory: children will complete a questionnaire on food inventory, which included number of portions of: fruits, vegetables, cookies, candies, snacks and sweetened beverages they had available in their homes or that they bought on the day of the inventory. The inventory will be recorded with the support of trained teachers, as a homework assignment.
Timepoint [5] 287649 0
24 months after randomization
Secondary outcome [6] 287650 0
Changes in physical activity and sedentary behavior.
Physical activity: A self-report questionnaire developed and validated in Chile (INTA PA questionnaire) will be used to assess physical activity levels in children. Children will complete the PA questionnaire with their teacher assistance and a trained student.
The reproducibility and validity, in a group of 45 children in this study, with an accelerometer ActiGraph was assessed.
Timepoint [6] 287650 0
24 months after randomization

Eligibility
Key inclusion criteria
Children of 2nd and 3rd grade from public and private elementary schools of Tijuana
Minimum age
7 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Physical and mental disability

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
From four Elementary Schools (two public and two private) with13 class groups from 2nd and 3rd grade two groups were formed. Group 1: two schools (1 public and 1 private with 7 class groroups); group 2: and two schools (1 public and 1 private with 6 class groups from 2nd and 3rd grade). The composition of group 1 and 2 were put a sealed envelop with a label on it.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A person not involved in the intervention label with number 1 or 2 on either side of a coin and tossed the coin.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3794 0
Mexico
State/province [1] 3794 0
Baja California

Funding & Sponsors
Funding source category [1] 269672 0
University
Name [1] 269672 0
Universidad Autonoma de Baja California
Address [1] 269672 0
Julian Carrillo/Alvaro Obregon s/n
Colonia Nueva CP 21100
Mexicali
Baja California
Country [1] 269672 0
Mexico
Primary sponsor type
Individual
Name
Montserrat Bacardi-Gascon
Address
Circuito Miraluna 1822A
Fracc. Altabrisa CP 22390
Tijuana
Baja California
Country
Mexico
Secondary sponsor category [1] 266707 0
Other Collaborative groups
Name [1] 266707 0
Colegio Familia School
Address [1] 266707 0
Avda de las Brisas s/n
Fracc. Altabrisa
Tijuana
Baja California
Country [1] 266707 0
Mexico
Other collaborator category [1] 252203 0
Individual
Name [1] 252203 0
Maria Eugenia Perez- Morales
Address [1] 252203 0
14418 Avda Tecnologico
Parque Industrial Internacional
Mesa de Otay
Tijuana
Baja California
Country [1] 252203 0
Mexico
Other collaborator category [2] 252204 0
Individual
Name [2] 252204 0
Arturo Jimenez- Cruz
Address [2] 252204 0
14418 Avda Tecnologico
Parque Industrial Internacional
Mesa de Otay
Tijuana
Baja California
Country [2] 252204 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271624 0
Comite de Etica de Ciencias de la Salud
Ethics committee address [1] 271624 0
Facultad de Ciencias Quimicas e Ingenierias
14418 Avda Tecnologico
Parque Industrial Internacional
Tijuana
Baja california
Ethics committee country [1] 271624 0
Mexico
Date submitted for ethics approval [1] 271624 0
15/12/2008
Approval date [1] 271624 0
25/03/2009
Ethics approval number [1] 271624 0
1/09/0031

Summary
Brief summary
The objective of this study, focused on parents and children to reduce sedentary behavior, consumption of soft drinks and high-fat containing snacks, and increase the consumption of fruits and vegetables, is to assess the effect of a six month intervention and an 18 months follow up on the body mass index, food consumption and physical activity of 2nd and 3rd grade elementary school children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33033 0
Address 33033 0
Country 33033 0
Phone 33033 0
Fax 33033 0
Email 33033 0
Contact person for public queries
Name 16280 0
Arturo Jimenez-Cruz
Address 16280 0
Circuito Miraluna 1822
Altabrisa
Tijuana
BC
Country 16280 0
Mexico
Phone 16280 0
52-664-9736638
Fax 16280 0
52-664-6821233
Email 16280 0
arturojimenezc@yahoo.com
Contact person for scientific queries
Name 7208 0
Montserrat Bacardi-Gascon
Address 7208 0
Facultad de Medicina y Psicologia
14418 Avda. Tecnologico
Edificio 4
Parque Industrial Internacional
Country 7208 0
Mexico
Phone 7208 0
52-6646821233
Fax 7208 0
52-6646821233
Email 7208 0
montserrat.bacardi@uabc.edu.mx

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary