Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000620628
Ethics application status
Approved
Date submitted
14/05/2014
Date registered
11/06/2014
Date last updated
11/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of an intervention program to improve the nutritional quality of lunchboxes in elementary school children
Scientific title
Comparison of an intervention program to improve the nutritional quality of home prepared lunchboxes in second and sixth grade elementary school children
Secondary ID [1] 284433 0
none
Universal Trial Number (UTN)
U1111-1155-6935
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
food and nutrient consumption 291637 0
Condition category
Condition code
Diet and Nutrition 292022 292022 0 0
Other diet and nutrition disorders
Public Health 292284 292284 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be based on information about healthy food and nutrients that should be included in the lunchbox. This will be implemented during an eight week period.
At the beginning of the study the food and nutrient content of the lunchboxes will be assessed. Posters for children and parents with information to improve the content of school lunchbox will be displayed at the school and leaflets will be distributed to the parents and their children.
During the first week, the importance of drinking water will be emphasized; in the second week, it will be focused on the inclusion of fruits and vegetables, in the third week, how to prepare healthy foods will be showed, and in the fourth week, information about prepared dishes and unhealthy foods will be given.
The following four weeks letters with menus for breakfast, lunchbox contents and healthy food will be sent home.
After the eight weeks of intervention the food and nutrient content of the lunchboxes will be assessed.
Intervention code [1] 289183 0
Prevention
Intervention code [2] 289403 0
Lifestyle
Comparator / control treatment

The control group receives no intervention.
Control group
Active

Outcomes
Primary outcome [1] 291909 0
Reduce the number of unhealthy lunchboxes.
Unhealthy lunchboxes that does not meet the guidelines of school snack recommend the Health Secretary in Mexico.
Do not included; A) plain water, b) a portion of fruit or natural vegetable, c) prepared or commercial food containing approximately less than 250 kcal.
For the data analysis of the information will be used the programs Excel 2010 and SPSS version 19.0 for Windows.
Chi-square test will be used to see if there are differences between percentages of unhealthy and healthy Lunchbox, fruits, vegetables and unhealthy food, water between the control group and group intervention, pre-and post-intervention and by sex and age groups.
Timepoint [1] 291909 0
Eight weeks
Secondary outcome [1] 307795 0
Reduce the calorie content of lunchboxes
For the analysis of lunch box contents using a food program Nutritionist Pro v 5.2
Timepoint [1] 307795 0
Eight weeks
Secondary outcome [2] 307796 0
Increase the number fruits and vegetables, and plain water
With a checklist will be registered the kind of food in the lunch box
Timepoint [2] 307796 0
Eight weeks

Eligibility
Key inclusion criteria
second and sixth grade elementary school children
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
children with mental or physical disabilities, metabolic problems or cancer

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/10/2013
Actual
4/11/2013
Date of last participant enrolment
Anticipated
13/12/2013
Actual
13/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment outside Australia
Country [1] 6002 0
Mexico
State/province [1] 6002 0
Baja California

Funding & Sponsors
Funding source category [1] 289084 0
University
Name [1] 289084 0
Universidad Autonoma de Baja California
Country [1] 289084 0
Mexico
Primary sponsor type
University
Name
Universidad Autonoma de Baja California
Address
Av. Universidad 14418, Otay. Unidad Universitaria,. Tijuana, Baja California, 22390
Country
Mexico
Secondary sponsor category [1] 287745 0
None
Name [1] 287745 0
Address [1] 287745 0
Country [1] 287745 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The objective of this project is to design and implement a program of nutritional educational guidance for parents, to modify the type and quality of food that sent to lunchbox at their children. At the same time reduce the number of unhealthy lunchboxes, calorie content, increase the number fruits and vegetables, and plain water.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47706 0
Dr Motnserrat Bacardi Gascon
Address 47706 0
Universidad Autonoma de Baja California
Av. Universidad 14418, Otay. Unidad Universitaria,. Tijuana, Baja California, 22390
Country 47706 0
Mexico
Phone 47706 0
52-664-682-1233
Fax 47706 0
Email 47706 0
[email protected]
Contact person for public queries
Name 47707 0
Glenda Diaz Ramirez
Address 47707 0
Universidad Autonoma de Baja California
Av. Universidad 14418, Otay. Unidad Universitaria,. Tijuana, Baja California, 22390
Country 47707 0
Mexico
Phone 47707 0
52 664 6936847
Fax 47707 0
Email 47707 0
[email protected]
Contact person for scientific queries
Name 47708 0
Arturo Jimenez Cruz
Address 47708 0
Universidad Autonoma de Baja California
Av. Universidad 14418, Otay. Unidad Universitaria,. Tijuana, Baja California, 22390
Country 47708 0
Mexico
Phone 47708 0
52-664-682-1233
Fax 47708 0
Email 47708 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.