Empowering Healthy Lifestyle Behaviour Through Personalised Intervention Portfolios to Prevent and Control Obesity in Children - UEV Pilot Study (UEVCh_HW8)

This study is being performed under the European Consortium HealthyW8 that has the main objective of developing a digital tool for personalized recommendations for healthy lifestyle and prevention of obesity. This human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on children (age 5 to 12 y) and parents. The main purpose is to study whether the healthy lifestyle recommender solution, reflecting a multi-portfolio intervention and developed within this project, is well accepted by the participants, has a decent adherence (i.e. user time of the app), and whether the overall design is well suited to the participants, in order that they will improve dietary habits. This study will be of longitudinal design without a control group.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Device: Digital twin for personalized recommendations

Detailed Description

At present, numbers of persons with overweight and obesity continue to grow in most countries worldwide. Children and young adults are at risk for different reasons: in the case of children, dietary habits and lifestyle is starting to be developed and if, at this phase, children do not acquire healthy habits, it will be probable that they will have a higher potential to develop obesity and the associated co-morbidities. It is at this stage that food preferences develop. Moreover, children obesity is increasing and it is known that an obese or pre-obese children will have a higher propensity to be an obese adult. For young adults, the risks and concerns are different. Is in this period of life that most people starts an independent life, and consequently decide their food and lifestyle choices, with an increase in irregularity of meals and unhealthy food choices, together with changes in physical activity habits and social or individual pressures. It is essential to give them tools that will allow them to make healthy choices and to have healthy habits, since they will be the future adult population that will raise and inspire the next generation. As solutions to combat the trend toward increasing overweight and obesity are much in need, the present study aims to intervene with the developed healthy lifestyle recommender solution to address various factors known to constitute a risk for developing obesity, including socio-demographic aspects, psychological/behavioural ones, physical activity, dietary patterns, among other. Such a multi-dimensional portfolio approach is believed to be very much needed for the prevention of obesity and co-morbidities, and the personalization of the solution, as well as the nudging/gamification aspects will strive to ensure a high long-term adherence to the developed solution.

The primary objective of the study is to determine whether the developed healthy-lifestyle recommender solution can be successfully applied to the target population (children and their parents), and whether they adhere to using it frequently during the duration of the study.

This will be assessed by adherence time to the lifestyle recommender solution and questionnaires addressing the user-friendliness and limitation or problems encountered. Secondly, the investigators will study whether the assessment of endpoints required for the ensuing long-term study can be well assessed within the study and if despite the limited time of the intervention duration, the intervention will be able to improve some markers related to the risk of obesity and associated co-morbidities.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elsa Lamy, PhD; Phone Number: +351266780800; Email: ecsl@uevora.pt
• Study Contact Backup: Name: Maria Perez-Jimenez, PhD; Phone Number: +351266780800; Email: maria.jimenez@uevora.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children (age 5-12 y) and, at least, one of their parents
• To reside in Portugal (for logistic reasons)
• To be overweight (BMI percentile > 85%)
• Both boys and girls

Exclusion Criteria:

• To have manifest chronic diseases (e.g. cancer)
• To be already in energy restriction or following a specific diet (on their own or advised by their physician)
• To have eating behaviour pathologies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Digital intervention group; Group of individuals that will have access to the digital tool and that will be followed for their used and efficacy.

Device: Digital twin for personalized recommendations; The intervention is the developed eHealth solution, i.e. the healthy lifestyle recommender system. It is based on a previously developed meal recommender system, but will be much extended, resulting in a multilevel portfolio intervention regarding: Suggesting personalized meal recommendations,; Proposing physical activities tailored to the individuals' capabilities and preferences,; Measuring and considering emotional and psychological parameters,; Proposing additional healthy life-style patterns regarding e.g. sleeping patterns, alcohol and tobacco consumption, engaging in social activities etc. The detailed nature of the interventions will first be developed during co-creation and then targeted to the participating individual. Moreover, particular attention will be given, since this needs to be a eHealth solution easy to be used by children. The intervention will include collecting urine and saliva samples, as well as measuring anthropometrics and collecting data (persona

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to digital tool	Adherence time to the lifestyle recommender solution and questionnaires addressing the user-friendliness and limitation or problems encountered. This will be quantified according to the scale of the questionnaires.	At the end of the study, after 3-month intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in BMI	we will study whether the assessment of endpoints required for the ensuing long-term study can be well assessed within the study and if despite the limited time of the intervention duration, the intervention will be able to improve some markers related to the risk of obesity and associated co-morbidities. Toward this end, change of BMI, relatively to the beginning of the intervention will be assessed.	3-months
Salivary biomarkers of stress	The investigators will study how the intervention will be able to change salivary cortisol and alpha-amylase concentrations.	3-months
Salivary biomarkers of physiology and metabolism	The levels of different salivary molecules will be measured in the periods before and after intervention, namely: salivary glucose and insulin, salivary C-reactive protein - CRP concentrations.	3-months
Dietary habits	The dietary habits of children, at the beginning of the study, will be determined through validated Food Frequency Questionnaires, which will allow to quantify the average amount of each food type consumed per day, as well as the amounts of macro- and micronutrients consumed per day.	At the beginning of the study

Collaborators and Investigators

• Sponsor: University of Évora

Publications and helpful links

Helpful Links

• Website of HealthyW8 project, with detailed description about aims, consortium and project.

Study record dates

Study Major Dates

• Study Start (Estimated): April 14, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Prevention; Lifestyle; Digital-twin
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: UEVHeightW8Children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will be not shared. Data will be treated and only treated data will be available. Only the PI of the study will be access to the correspondence between participant identification and codification that will be given to each participant. There is no need of having identification of participants to reach the conclusions about the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No