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Intervention With a Progressive Web App for the Promotion of Healthy Habits in Preschoolers

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ClinicalTrials.gov Identifier: NCT03904992
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief 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.

Condition or disease Intervention/treatment Phase
Health Behavior Other: Progressive web app Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

First, a baseline evaluation will be made to the participants, based on the indicators of interest.

During a period of 60 days, the caregivers of the intervention group had free access to the progressive web app "Nutrinidos" and received training for its use. On the other hand, nutritional counseling was available every 30 days for the participants assigned to the control group. They consisted of personalized sessions with a duration of 20 minutes in which parents and caregivers could resolve their doubts regarding the feeding of their children. In addition, they were offered physical education materials designed and adapted with content used in this study. The educational material addressed contains information about lunch boxes, eating habits, consumption of fruits and vegetables, prevention of anemia, and physical activity.

After 60 days of follow-up, the evaluation of results will be carried out.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intervention With a Progressive Web App for the Promotion of Healthy Habits in Preschoolers
Actual Study Start Date : September 7, 2018
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
No Intervention: Non-exposed
Subjects with access to nutritional counseling sessions every 30 days
Experimental: Exposed
Subjects with access to the progressive web app in their smartphones.
Other: Progressive web app
Access to a progressive web app for the promotion of healthy habits in preescholers through the participant's smatphone




Primary Outcome Measures :
  1. Variation of the dietary diversity of the preescholer [ Time Frame: 60 days after the instalation of the Progressive Web App ]
    The difference between the scores obtained in the baseline and the evaluation using the Healthy Eating Index score


Secondary Outcome Measures :
  1. Variation in preescholer's nutritional status [ Time Frame: 60 days after the instalation of the Progressive Web App ]
    The difference between the Z-point values of the BMI for age pattern.

  2. Variation of the preescholer's eating behavior [ Time Frame: 60 days after the instalation of the Progressive Web App ]
    The difference between the scores obtained for child's eating behavior that will be evaluated through the Children Eating Behaviour Questionnaire

  3. Variation of the composition of the lunch box [ Time Frame: 60 days after the instalation of the Progressive Web App ]
    Change in the score obtained for the composition of the preescholer's lunch boxes

  4. Variation of the refreshment consumption [ Time Frame: 60 days after the instalation of the Progressive Web App ]
    The change in the consumption of the refreshments (lunch box) will be determined using a food scale (grams).

  5. Variation of physical activity [ Time Frame: 60 days after the instalation of the Progressive Web App ]
    A difference in the number of minutes of physical activity of the preschoolers reported by the parents using a validated questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904992


Locations
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Peru
I.E.I. Juan Pablo Peregrino
San Martín De Porres, Lima, Peru, 15109
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Investigators
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Principal Investigator: Oscar J Calvo Torres, BS

Publications:
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
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
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
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
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
Pediatría C de N de la SU de. Guías de alimentación del niño preescolar y escolar. Arch Pediatr Urug. 2004;75(2):159-13.
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.
Ater T. Building Progressive Web Apps: Bringing the Power of Native to the Browser. 1ed ed. EE.UU.: O`Reilly Media; 2017. 288 p.
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
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
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.
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

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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT03904992     History of Changes
Other Study ID Numbers: 102342
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad Peruana Cayetano Heredia:
Nutrtition
Physical activity
Preescholer
Informatics