NCT03904992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 3, 2019

Last Update Submit

April 3, 2019

Conditions

Keywords

NutrtitionPhysical activityPreescholerInformatics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Variation in preescholer's nutritional status

    60 days after the instalation of the Progressive Web App

  • Variation of the preescholer's eating behavior

    60 days after the instalation of the Progressive Web App

  • Variation of the composition of the lunch box

    60 days after the instalation of the Progressive Web App

  • Variation of the refreshment consumption

    60 days after the instalation of the Progressive Web App

  • Variation of physical activity

    60 days after the instalation of the Progressive Web App

Study Arms (2)

Non-exposed

NO INTERVENTION

Subjects with access to nutritional counseling sessions every 30 days

Exposed

EXPERIMENTAL

Subjects with access to the progressive web app in their smartphones.

Other: Progressive web app

Interventions

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

Exposed

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.E.I. Juan Pablo Peregrino

San Martín de Porres, Lima region, 15109, Peru

Location

Related Publications (21)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Ruiz EF, Proano A, 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.

    PMID: 26338384BACKGROUND
  • 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

    BACKGROUND
  • 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

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

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

    BACKGROUND
  • 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. doi: 10.1038/sj.ijo.0802311.

    PMID: 12821970BACKGROUND
  • 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.

    BACKGROUND
  • Ater T. Building Progressive Web Apps: Bringing the Power of Native to the Browser. 1ed ed. EE.UU.: O'Reilly Media; 2017. 288 p.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Leal KK, Schneider BC, Franca GV, Gigante DP, dos Santos I, Assuncao 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.

    PMID: 26122208BACKGROUND
  • 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.

    PMID: 24533605BACKGROUND
  • 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.

    PMID: 25760773BACKGROUND
  • 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.

    BACKGROUND
  • 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. doi: 10.1111/1469-7610.00792.

    PMID: 11693591BACKGROUND
  • Carnell S, Wardle J. Measuring behavioural susceptibility to obesity: validation of the child eating behaviour questionnaire. Appetite. 2007 Jan;48(1):104-13. doi: 10.1016/j.appet.2006.07.075. Epub 2006 Sep 7.

    PMID: 16962207BACKGROUND
  • Camargo DM, Santisteban S, Paredes E, Florez 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.

    PMID: 26849696BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Oscar J Calvo Torres, BS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

September 7, 2018

Primary Completion

November 12, 2018

Study Completion

November 12, 2018

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations