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

NCT06933121 | Not Yet Recruiting

• 1 other identifier: UEVHeightW8Children
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

Obesity; Overweight; Prevention; Digital-twin; Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in BMI

  3-months

• Salivary biomarkers of stress

  3-months

• Salivary biomarkers of physiology and metabolism

  3-months

• Dietary habits

  At the beginning of the study

Study Arms (1)

Digital intervention group

EXPERIMENTAL

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

Interventions

Digital twin for personalized recommendations DEVICE

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: 1. Suggesting personalized meal recommendations, 2. Proposing physical activities tailored to the individuals' capabilities and preferences, 3. Measuring and considering emotional and psychological parameters, 4. 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

Digital intervention group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Évora: lead

Related Links

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

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elsa Lamy, PhD

CONTACT

+351266780800; ecsl@uevora.pt

Maria Perez-Jimenez, PhD

CONTACT

+351266780800; maria.jimenez@uevora.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of the Laboratory of Oral Biology and Salivary Proteomics

Model Details: In this short-term study, the intervention with a digital solution, with personalized recommendations about lifestyle aspects, will be used to all participants. Data collection will be made at the beginning and at the end of the study.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: April 18, 2025
• Study Start: April 14, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 31, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share