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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03904992
Other study ID # 102342
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2018
Est. completion date November 12, 2018

Study information

Verified date April 2019
Source Universidad Peruana Cayetano Heredia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The preschool stage has been identified as an important moment for the study of factors associated with obesity. The worrying national situation of overweight in children from 3 to 5 years old, the increase in consumption of ultra-processed foods nationwide that is associated with the increase of the body mass index at the national level, the reduced national scientific evidence regarding the effectiveness of interventions in promoting healthy habits, as well as the lack of tools for mothers of preschool children in nutrition and physical activity, make interventions necessary in this area. On the other hand, currently, users worldwide are installing fewer applications and, although they spend more time using mobile applications, they are limited to a handful. Therefore, developing a native mobile application that is highly consumed is very difficult and expensive. For this reason, progressive web apps emerge as an attractive alternative for users given its attractive features, cross-platform interface, lower development cost and a growing demand for such applications. Thus, this research seeks to explore a novel way to promote healthy habits in preschoolers and check their effectiveness. In this way, a precedent could be set in the use of technologies in health promotion that could be extended to other age groups.


Description:

SAMPLE SIZE The sample size was calculated using OpenEpi (www.openepi.com), with the sample size formula to compare two means, considering a confidence interval of 95%, power of 80%, ratio of sample size (group 2 / group 1) equal to 1, a minimum expected mean difference of 5 points and a standard deviation of 9.5 points for both groups. Thus, the required sample size is 114 participants (57 intervened and 57 not intervened).

TECHNIQUES AND PROCEDURES FOR DATA COLLECTION

First stage: Design of the progressive web app

In this phase, the profile of the users will be defined through a focus group. Among the information gathered is socio-demographic data, use of technology, current situation of the feeding and physical activity of the preschool, and expectations of the functions of the computer tool. In addition, a complementary bibliographic search will be carried out on the subject to expand the information necessary for the design of the PWA.

Based on the information collected, the alpha version of the application will be developed. It will undergo a validation process and based on the feedback, the application will be improved until a beta version is developed.

Second stage: intervention with the progressive web app (PWA)

ANALYSIS PLAN

The data was collected using the Magpi software. To verify the comparability of the two randomization groups based on the sociodemographic covariates through a descriptive analysis, a frequency and percentage table was constructed, which were compared by statistical tests.

In addition, the variation of the ration consumption of the food groups, the score in each component of the feeding behavior and the activity of the preschool was analyzed; the variation of the nutritional status and quality of the components of the lunch box in the control and intervention group was identified; and the variation of the Z score for the indicator of BMI for age and the consumption of the lunch box was plotted through a chart of boxes.

To determine the effect of the intervention, the differences of the measurements (post-pre) of the control and intervention groups were compared. For this, the Student t test was used for independent samples. The variables analyzed were:

- Variation of the dietetic quality of the preschool

- Variation in the nutritional status of children

- Variation of preschool feeding behavior

- Variation of the composition of the lunchbox

- Variation of the consumption of the lunchbox

- Variation of physical activity Finally, a satisfaction survey was applied to the intervention group and the results were presented using descriptive statistics.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date November 12, 2018
Est. primary completion date November 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Caregivers of children from 3 to 6 years old that currently attend school

- People who have access to a mid-range or high-end Smartphone with Android 6.0 operating system or higher, with Internet access, in which the application will be installed

Exclusion Criteria:

- Caregivers of children with hormonal diseases that affect the nutritional status (referred by caregiver or caregiver): hypothyroidism, hyperthyroidism, Cushing's syndrome, growth hormone deficiency, diabetes

- Caregivers of children with heart disease, kidney disease or cancer (referred by caregiver or caregiver)

- Caregivers of children with paraplegia, tetraplegia or some degree of paralysis

- Caregivers of children who are beneficiaries of the Qali Warma Program

- People who are illiterate or who have great difficulties in the operation of smartphones

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Progressive web app
Access to a progressive web app for the promotion of healthy habits in preescholers through the participant's smatphone

Locations

Country Name City State
Peru I.E.I. Juan Pablo Peregrino San Martín De Porres Lima

Sponsors (1)

Lead Sponsor Collaborator
Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

References & Publications (21)

Ater T. Building Progressive Web Apps: Bringing the Power of Native to the Browser. 1ed ed. EE.UU.: O`Reilly Media; 2017. 288 p.

Camargo DM, Santisteban S, Paredes E, Flórez MA, Bueno D. [Reliability of a questionnaire for measuring physical activity and sedentary behavior in children from preschool to fourth grade]. Biomedica. 2015 Jul-Sep;35(3):347-56. doi: 10.7705/biomedica.v35i3.2502. Spanish. — View Citation

Carbajal I. Estado nutricional y consumo de energía y nutrientes en un grupo de adolescentes de Lima y Callao. Universidad Nacional Mayor de San Marcos; 2001.

Carnell S, Wardle J. Measuring behavioural susceptibility to obesity: validation of the child eating behaviour questionnaire. Appetite. 2007 Jan;48(1):104-13. Epub 2006 Sep 7. — View Citation

Cortina LS. Protocolos de nutrición. Protoc la AEP [Internet]. 2010;297-305. Available from: http://www.aeped.es/documentos/protocolos-nutricion

Gmbh GG, Steiner T. What is in a Web View ? An Analysis of Progressive Web App Features When the Means of Web Access is not a Web Browser. In: Companion of the The Web Conference 2018 on The Web Conference 2018. Ginebra, Suiza: International World Wide Web Conferences Steering Committee; 2018. p. 789-96.

Instituto Nacional de Salud. Situación Nutricional - Obsevatorio de Nutrición y el Estudio del Sobrepeso y Obesidad [Internet]. [cited 2018 Apr 18]. Available from: http://www.observateperu.ins.gob.pe/sala-situacional/situacion-nutricional

Leal KK, Schneider BC, França GV, Gigante DP, dos Santos I, Assunção MC. [Diet quality of preschool children aged 2 to 5 years living in the urban area of Pelotas, Brazil]. Rev Paul Pediatr. 2015 Jul-Sep;33(3):311-8. doi: 10.1016/j.rpped.2015.05.002. Epub 2015 Jun 10. Portuguese. — View Citation

OPS. Alimentos y bebidas ultraprocesados en América Latina: tendencias, efecto sobre la obesidad e implicaciones para las políticas públicas [Internet]. Washington D.C.: Organización Panamericana de la Salud; 2015 [cited 2018 Apr 30]. Available from: http://iris.paho.org/xmlui/bitstream/handle/123456789/7698/9789275318645_esp.pdf

Organización Mundial de la Salud. Interpretando los Indicadores de Crecimiento Interpretando los Indicadores [Internet]. Curso de Capacitación sobre la Evaluación del Crecimiento del Niño. 2008. 56 p. Available from: http://www.who.int/childgrowth/training/c_interpretando.pdf

Pediatría C de N de la SU de. Guías de alimentación del niño preescolar y escolar. Arch Pediatr Urug. 2004;75(2):159-13.

Rauber F, da Costa Louzada ML, Vitolo MR. Healthy eating index measures diet quality of Brazilian children of low socioeconomic status. J Am Coll Nutr. 2014;33(1):26-31. doi: 10.1080/07315724.2014.869979. — View Citation

Revilla L, Alvarado C, Álvarez D, Tarqui C, Gómez G, Jacoby E, et al. Un gordo problema: Sobrepeso y Obesidad en el Perú. Editor Imprenta Sanchez SRL [Internet]. 2012;1-24. Available from: http://bvs.minsa.gob.pe/local/MINSA/1830.pdf

Rojas A, León M, Sánchez O. Formación de hábitos alimentarios y de estilos de vida saludables. Curric Educ Inicial [Internet]. 2003;1-36. Available from: http://www.unicef.org/venezuela/spanish/educinic9.pdf

Ruiz EF, Proaño Á, Ponce OJ, Curioso WH. [Mobile health for public health in Peru: lessons learned]. Rev Peru Med Exp Salud Publica. 2015 Apr-Jun;32(2):364-72. Spanish. — View Citation

Santiago MA, Fernández RN, Esquirol JRL, Sánchez IP. La edad preescolar como momento singular del desarrollo humano. Rev Cubana Pediatr. 2007;79(4) Available from: http://www.aeped.es/documentos/protocolos-nutricion

Sheppard D (Computer software developer). Beginning progressive web app development creating a native app experience on the web [Internet]. EE.UU.: Apress Media LLC; 2017. Available from: https://books.google.mu/books?id=9_RADwAAQBAJ&dq=progressive+web+apps&source=gbs_navlinks_s

Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422. — View Citation

Tarqui C, Sánchez J, Alvarez D, Gómez G, Valdivia S. Tendencia del sobrepeso, obesidad y exceso de peso en el Perú. La Rev Peru Epidemiol [Internet]. 2013;17(3):7. Available from: http://ateneo.unmsm.edu.pe/ateneo/bitstream/123456789/3132/3/rev_peru_epidemiol04v17n3_2013.pdf%5Cnhttp://rpe.epiredperu.net/rpe_ediciones/2013_v17_n03/Original tendencia del sobrepeso y obesidad en Peru RPE 17_3.pdf

Trost SG, Sirard JR, Dowda M, Pfeiffer KA, Pate RR. Physical activity in overweight and nonoverweight preschool children. Int J Obes Relat Metab Disord. 2003 Jul;27(7):834-9. — View Citation

Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Variation of the dietary diversity of the preescholer The difference between the scores obtained in the baseline and the evaluation using the Healthy Eating Index score 60 days after the instalation of the Progressive Web App
Secondary Variation in preescholer's nutritional status The difference between the Z-point values of the BMI for age pattern. 60 days after the instalation of the Progressive Web App
Secondary Variation of the preescholer's eating behavior The difference between the scores obtained for child's eating behavior that will be evaluated through the Children Eating Behaviour Questionnaire 60 days after the instalation of the Progressive Web App
Secondary Variation of the composition of the lunch box Change in the score obtained for the composition of the preescholer's lunch boxes 60 days after the instalation of the Progressive Web App
Secondary Variation of the refreshment consumption The change in the consumption of the refreshments (lunch box) will be determined using a food scale (grams). 60 days after the instalation of the Progressive Web App
Secondary Variation of physical activity A difference in the number of minutes of physical activity of the preschoolers reported by the parents using a validated questionnaire 60 days after the instalation of the Progressive Web App
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