NCT07376252

Brief Summary

Background. Lifestyles that promote a positive energy balance increase the prevalence of obesity. Due to the magnitude of this problem, community-level strategies are required on how to provide families with useful information to prevent it. Electronic media such as the Internet and mobile health applications are tools that have opened a new audience to send information, they are accessible and powerful, as well as the capacity to reduce associated costs, their access to information is uninterrupted, support , and personalized feedback. There is a need to develop and evaluate mobile health applications to establish consistent and effective methods to produce changes in health behavior in the population. Aim. To evaluate the impact of a mobile health application in nutrition and physical activity on nutritional status in school children. Methods. Community essay. Children from 4 primary schools in Mexico City will participate in the educational intervention. The schools were randomly assigned to one of two groups: 1) Apply for your health! group and 2) Control group. The educational intervention through the application will last 12 months and will focus on promoting healthy eating habits and physical activity, empowering parents to change habits. In the second year, the control group will be given access to the mobile application. At baseline, 6, 12, 18 and 24 months, children in both groups will have their nutritional status (anthropometry) and breakfast and school snack habits measured. Statistic analysis. Mixed effects models will be used to evaluate changes in BMI z-score within and between groups.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for not_applicable obesity

Timeline
4mo left

Started Apr 2024

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Apr 2024Aug 2026

Study Start

First participant enrolled

April 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 22, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

ObesityOverweightschoolchildrenmobile applicationeHealth

Outcome Measures

Primary Outcomes (1)

  • BMI Z-score

    The BMI Z-score variable will be assessed continuously. To evaluate the change in the BMI Z-score, the difference between the corresponding measurements at 6, 12, 18, and 24 months versus the baseline measurement will be calculated. A minimum and maximum of -5 to +5 SD will be considered. Likewise, a value closer to zero will be considered the best nutritional condition.

    Anthropometric evaluations to obtain the BMI Z score are performed at baseline, 6, 12, 18 and 24 months.

Secondary Outcomes (2)

  • Improvement in the quality of food consumed at breakfast

    Information on school breakfasts is collected at baseline, 6, 12, 18 and 24 months

  • Improvement in the quality of food consumed at school lunch

    Information on school lunch is collected at baseline, 6, 12, 18 and 24 months within schools

Study Arms (2)

Intervention with the mobile application

EXPERIMENTAL

The educational intervention was implemented through the mobile application "Applícate por tu salud" (Get Healthy), with the goal of sending information to parents on how to improve eating habits at breakfast and school lunch. To this end, recipes, text messages, and infographics related to these topics were developed.

Behavioral: Applícate por tu salud

Control group

NO INTERVENTION

The control group received no educational intervention. Only anthropometric measurements and data collection on diet and physical activity were carried out. However, the results of the anthropometric measurements were given to the parents at different times.

Interventions

The educational intervention using the mobile application "Applícate por tu salud" aims to promote, improve, and reinforce families' eating habits, focusing on breakfast and school lunches, in order to prevent overweight and obesity in schoolchildren. Through the application, using push notifications, tips in the form of text messages, infographics, videos, and recipes are sent four times a week, encouraging positive changes in eating habits related to breakfast and school snacks. The information was formatted as follows: no more than 30 words, suggesting activities that families could implement at home. Eighty-four messages were generated for breakfast and 104 messages for school snacks, including detailed information on planning, selecting, and comparing foods, as well as their preparation and consumption. The information was generated by three nutrition experts to standardize the language, and a designer created the infographics, videos, and recipes.

Intervention with the mobile application

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • School-aged children of both sexes, 5-11 years old, enrolled in the selected primary schools.
  • Children and parents who sign the written informed consent and assent form.

You may not qualify if:

  • Children participating in any weight loss program, with or without pharmacological treatment.
  • Children with a rheumatological disease, diabetes, thyroid disorder, or any condition that compromises their nutritional status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infantil de México Federico Gómez

Mexico City, Mexico City, 06720, Mexico

Location

Related Links

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: In this crossover study, the four schools were randomly assigned to receive the intervention or to be part of the control group. In the second period, the group initially assigned as the control received the intervention, while the group that had received the intervention in the first period did not receive it during this second phase.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

April 8, 2024

Primary Completion

June 14, 2024

Study Completion (Estimated)

August 30, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations