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
|Condition or disease||Intervention/treatment||Phase|
|Health Behavior||Other: Progressive web app||Not Applicable|
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)
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 (Clinical Trial)|
|Actual Enrollment :||114 participants|
|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)|
|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|
No Intervention: Non-exposed
Subjects with access to nutritional counseling sessions every 30 days
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
- 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
- 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.
- 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
- 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
- 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).
- 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
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
|I.E.I. Juan Pablo Peregrino|
|San Martín De Porres, Lima, Peru, 15109|
|Principal Investigator:||Oscar J Calvo Torres, BS|