Empowering Healthy Lifestyle Behavior to Prevent and Control Obesity in Young Adults

NCT06943651 | Not Yet Recruiting DMC

• 2 other identifiers: UEVHealthyW8YAdultsGA - 101080645
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This human study will be a pilot trial that will precede a planned more long-term intervention trial. It will focus on young adults (age 18 to 25 y). 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. At present, numbers of persons with overweight and obesity continue to grow in most countries worldwide. Young adults are at risk since in in this period of life most people start to be independent from their families, with the consequent decisions about their food and lifestyle choices. It is frequent that at this time an increase in irregularity of meals and unhealthy food choices, occurs, together with changes in physical activity habits and social or individual pressures. Because of this, it is essential to give tools to these individuals 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.

Conditions

Obese; Overweight

Keywords

Obesity; Overweight; Digital twin; Obesity prevention; Lifestyle

Outcome Measures

Primary Outcomes (2)

• Adherence to digital tool

  Adherence time to the lifestyle recommender solution, in order to determine the success of application of the healthy-lifestyle recommender solution to the target population (the young adults).

  3-month

• Satisfaction relative to the digital solution

  The satisfaction for the use of the digital solution will be assessed through questionnaires addressing the user-friendliness and limitation or problems encountered. Scales will be used, where higher scores mean higher satisfaction.

  3 months

Secondary Outcomes (8)

• Anthropometry

  3-month

• Fat Mass

  3-months

• Blood Pressure

  3-month

• Salivary biomarkers

  3-month

• Salivary markers of stress

  3-month

Other Outcomes (1)

• Antropometric data

  3-month

Study Arms (1)

Test of healthyW8 Digital Twin of healthy lifestyle recommendations

EXPERIMENTAL

Individuals will have access to a digital tool, putting together nutrition, physical activity and emotional aspects. Participant interaction with the tool, through registration collected or inputed by the individual will allow personalized recommendations.

Device: HealthyW8 Digital Twin of healthy lifestyle recommendations

Interventions

HealthyW8 Digital Twin of healthy lifestyle recommendations DEVICE

The applied intervention with the developed healthy lifestyle recommender system will be unique and is not used in any other clinical study. However, a large number of intervention studies on young adults' obesity, considering nudging (e.g. 60 in www.clinical.trials.gov), were found. Among the registered clinical trials in the referred database, 3 considered young adults obesity and saliva salivary analysis, but with a different purpose. Moreover, the type of digital solution that will be tested will put together different aspects that are not usually to see together in the same application. These different lifestyle aspects will be used for personalized recommendations.

Test of healthyW8 Digital Twin of healthy lifestyle recommendations

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be young adult (age 18-25 y)
• To reside in Portugal
• To be overweight (BMI between 25-30 kg/m2)
• Women and men

You may not qualify if:

• To have a 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 behavior pathologies.

Sponsors & Collaborators

• University of Évora: lead

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: OTHER
• 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 of MED, University of Evora

Model Details: This is a longitudinal study, non-controlled. Participants will receive the developed healthy life-style recommender solution for the duration of the study, and endpoints within subjects will be compared before and after.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: April 24, 2025
• Study Start: April 21, 2025
• Primary Completion: June 20, 2025
• Study Completion: July 31, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From the beginning until the final of HealthyW8 project (from 2025-2028)
• Access Criteria: Only the researcher responsible for the study will have access to the correspondence between identification and codification. All the other researchers will have access only to codified individual data. Individual data will be shared only with the researchers responsible for statistical analysis and not public presented.