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Trial registered on ANZCTR


Registration number
ACTRN12618001550291
Ethics application status
Approved
Date submitted
11/09/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Educational intervention to increase water consumption in school children from Zapopan, Mexico.
Scientific title
Educational intervention based on the Theory of Planned Behavior, designed to increase water consumption in Zapopan schoolchildren.
Secondary ID [1] 296052 0
Nil known
Universal Trial Number (UTN)
U1111-1220-2245
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 309604 0
Obesity 309632 0
Condition category
Condition code
Diet and Nutrition 308422 308422 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intervention based on the Theory of Planned Behavior in the intervention group (IG) will be carried out, in the control group (CG) informative posters will be given to the principals.
The intervention in the IC will consist of six biweekly sessions of 45 minutes each, the agenda was built with the findings of a qualitative exploratory study, using the Theory of Social Representations. Sessions will be held at school facilities: classrooms and playground. The qualitative exploratory study was part of the first phase of the project, entitled Project Gotita de Agua, the present investigation, will be the second phase. The main themes if the agenda will be; water sources in the world, water and my body, positive effects of water consumption on health, adequate hydration during physical activity and finally, a healthy beverage preparation workshop was held, with the objective of offering children Healthy and delicious beverage options.
Each session will be guided by a PhD student, as well as 5 nutrition students as support: It will be used for each sessions; sheets of paper, colored pencils, cutouts of magazines, computer, project, as well as toys for the realization of physical activity.
The water consumption will be evaluated at the beginning of the intervention, at the end and finally, three months after concluding the intervention.
Intervention code [1] 312390 0
Behaviour
Comparator / control treatment
In the control group (CG), only information will be provided through posters with the same topics as IG intervention sessions.
The educational intervention will be replicated in the CG once the data collections are finished.
Control group
Active

Outcomes
Primary outcome [1] 307385 0
First outcome: Water consumption will be assessed with 24 hours beverage reminder, according to the method proposed by Ferrari-Mariela (2013) and Drewnowski, Rehm and Constant (2013).

The data collection instrument will be applied before the intervention begins, immediately after the end and three months after the end.
Timepoint [1] 307385 0
The data will be collected before the start of the intervention, at the end and three months after the end of the intervention
The data collection tool was designed specifically for the research project. Consists of a 24-hour food and beverage reminder, as well as elements to evaluate the change in the constructs of the theory of planned behavior
Secondary outcome [1] 351765 0
Secondary outcome: Sugar Sweetned beverages consumption will be assessed with 24 hours beverage reminder, according to the method proposed by Ferrari-Mariela (2013) and Drewnowski, Rehm and Constant (2013).
The data collection instrument will be applied before the intervention begins, immediately after the end and three months after the end.
Timepoint [1] 351765 0
The data will be collected before the start of the intervention, at the end and three months after the end of the intervention

Eligibility
Key inclusion criteria
*Schools must have spaces for physical activity, as well as facilities for the consumption of water at free demand.

*Students must be enrolled in the selected schools.
* Signed parental consent
* Verbal assent of the children
Minimum age
10 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Kidney desease

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
The calculation of the sample size will be made in Open Epi, in its section of difference of means, considering the water intake and the standard deviation of the CG and IG in an intervention (Garipaaoulo, 2008). With a confidence level of 95% and a power of 80%, considering a mean consumption of the CG of 470 ml and a standard deviation of 165 ml, and an average consumption of the IG of 504 ml and a standard deviation of 150 ml, it is necessary to include:
676 children in total
• Control of the Group: 338 students.
• Intervention Group: 338 students

A descriptive analysis of the sociodemographic variables will be carried out: the qualitative variables will be expressed as frequencies and percentages, while the quantitative variables will be expressed as mean and standard deviation or as median and percentiles, depending on the distribution of the variables.
The frequencies of consumption of beverages will be analyzed descriptively according to the nature of the variables, in addition the test Xi2 and Mc Nemar will be used, to compare the results between groups and intra group, in each measurement time
For dietary data, the comparison of the consumption of each study group (baseline-post and post-intervention measurement) will be made, comparing the GC with the IG, for this analysis the paired student's T test or Wilcoxon will be used (intra comparison groups) and student T or U Mann Whitney for independent samples (comparison between groups). In addition, the Friedman test will be used to determine the change in consumption through the measurement times.


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] 20836 0
Mexico
State/province [1] 20836 0
Jalisco

Funding & Sponsors
Funding source category [1] 300640 0
Government body
Name [1] 300640 0
Consejo Nacional de Ciencia y Tecnología
Address [1] 300640 0
Av. Insurgentes Sur 1582, Col. Crédito Constructor • Del. Benito Juárez C.P.: 03940, Ciudad de México.
Country [1] 300640 0
Mexico
Primary sponsor type
Individual
Name
Barbara Vizmanos Lamotte
Address
Sierra Mojada 950, Col. Independencia, C.P. 44340, Guadalajara, Jalisco, México
Country
Mexico
Secondary sponsor category [1] 300153 0
None
Name [1] 300153 0
Address [1] 300153 0
Country [1] 300153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301428 0
Committee of Research, Ethics in Research and Biosecurity of the University Center of Health Sciences of the University of Guadalajara
Ethics committee address [1] 301428 0
Sierra Mojada 950, Independencia Oriente, 44340 Guadalajara, Jal.
Ethics committee country [1] 301428 0
Mexico
Date submitted for ethics approval [1] 301428 0
02/01/2017
Approval date [1] 301428 0
05/06/2017
Ethics approval number [1] 301428 0
008/15

Summary
Brief summary
In Mexico, there has been an increase in the consumption of sugary beverages, and as a result a decrease in water consumption; which seems to have an effect on the prevalence of overweight and obesity.
The design of an educational intervention with a mixed methodological model, based on an exploratory qualitative study using the Theory of Social Representations as a theoretical framework and, later, in a second stage, designed based on the Theory of Planned Behavior, to achieve greater effectiveness in the desired behavior change; it will contribute to increase the consumption of water and decrease the consumption of sugary drinks.
The educational intervention will increase water consumption by 20% in schoolchildren in Jalisco, Mexico, compared to an informative intervention.
Finally, the goal of this study is to propose an intervention model, where the importance of cultural relevance in the design of interventions for behavior change is considered.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86962 0
Dr Alejandra María Corona Romero
Address 86962 0
Doctorate in Public Health Sciences, University Center of Health Sciences, University of Guadalajara
Sierra Mojada 950, Independencia Oriente, 44340 Guadalajara, Jal.
Country 86962 0
Mexico
Phone 86962 0
+51 443313531545
Fax 86962 0
Email 86962 0
lnalejandra.coronaromero@gmail.com
Contact person for public queries
Name 86963 0
Dr Alejandra Corona Romero
Address 86963 0
Doctorate in Public Health Sciences, University Center of Health Sciences, University of Guadalajara
Sierra Mojada 950, Independencia Oriente, 44340 Guadalajara, Jal.
Country 86963 0
Mexico
Phone 86963 0
013313531545
Fax 86963 0
+51 443313531545
Email 86963 0
lnalejandra.coronaromero@gmail.com
Contact person for scientific queries
Name 86964 0
Dr Alejandra Corona Romero
Address 86964 0
Doctorate in Public Health Sciences, University Center of Health Sciences, University of Guadalajara
Sierra Mojada 950, Independencia Oriente, 44340 Guadalajara, Jal.
Country 86964 0
Mexico
Phone 86964 0
013313531545
Fax 86964 0
+51 443313531545
Email 86964 0
lnalejandra.coronaromero@gmail.com

No data has been provided for results reporting
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