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

April 3, 2019 updated by: Universidad Peruana Cayetano Heredia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
    • Lima
      • San Martín De Porres, Lima, Peru, 15109
        • I.E.I. Juan Pablo Peregrino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 days after the instalation of the Progressive Web App

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days after the instalation of the Progressive Web App
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
60 days after the instalation of the Progressive Web App
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
60 days after the instalation of the Progressive Web App
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).
60 days after the instalation of the Progressive Web App
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
60 days after the instalation of the Progressive Web App

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Peruana Cayetano Heredia

Investigators

  • Principal Investigator: Oscar J Calvo Torres, BS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 7, 2018

Primary Completion (ACTUAL)

November 12, 2018

Study Completion (ACTUAL)

November 12, 2018

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (ACTUAL)

April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 102342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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