Empowering Healthy Lifestyle Personalised Intervention to Prevent and Control Obesity: The HealthyW8 Project

NCT07011368 | Not Yet Recruiting

• 2 other identifiers: HealthyW8-Pilot-and-Long-Trial101080645
• Study Type: interventional
• Target: 2,720
• Locations: 8 countries
• Sites: 13

Brief Summary

The goal of the HealthyW8 study (an intervention study) is: To assess the usefulness and effects of a digital-based healthy lifestyle recommender system (HRLS) on the prevention of obesity in the following propulations: schoolchildren (5-10 y) and their parents, young adults (18-25 y) and elders (\>65 y). The main questions it aims to answer are: Outcome 1: To select and validate a tool-assisted 3-mo intervention (mostly digital) by iteratively testing the HLRS on reducing risk of overweight/obesity among the described age groups. Outcome 2: To assess the effect of 1-y interventions (mostly digital) with the HLRS described and further iteratively improved previously (outcome 1) on reducing risk of overweight/obesity at described ages. Researchers will compare the intervention group before the intervention (baseline) and after it (3-mo intervention trial), or control group (standard care) vs. Intervention group (1-y intervention) to see changes on changes in overweight/obesity, and related parameters (body composition and biomarkers). Participants will follow the HLRS recommendations (meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural/psychological aspects, and motivational features through digital devices), which will be assessed by means of measurement of body weight, body composition, and biomarkers.

Conditions

Obesity Prevention; Obesity and Overweight; Obesity and Obesity-related Medical Conditions; Digital Health; Behavioural Science Interventions to Improve Health Equity

Keywords

Healthy lifestyle recommender system; digital empowerment; health literacy; personalised prevention; pre-obesity biomarkers; mHealth; Human Digital Twin; behavior change techniques; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in BMI

  The Primary Outcome (to be measured every 3 months) will be the change of BMI (kg/m\^2) measuring body weight in kilograms and height in meters\^2 as combined to obtain BMI data (kg/m\^2) after the 12-month intervention of healthy lifestyle recommender solutions (HLRS) in the selected age groups (5-12 y.o. children and families; 18-25 y.o. young adults; and \>65 y.o. elderly people).

  Baseline and every 3 months up to 12 months

Secondary Outcomes (2)

• Change of visceral body fat

  Baseline and every 3 months up to 12 months

• Body composition and biomarkers

  Baseline and every 6 months up to 12 months

Study Arms (3)

School-children (including families)

EXPERIMENTAL

HLRS intervention on 5-12 year-old school-children (including families) adapted to the countries in which they will be deployed (e.g.: adaptation to cultural food habits, translation into national languages).

Behavioral: Intervention Group

Young adults

EXPERIMENTAL

HLRS intervention on 18-25-year-old young adults adapted to the countries in which they will be deployed (e.g.: adaptation to cultural food habits, translation into national languages).

Behavioral: Intervention Group

Elderly people

EXPERIMENTAL

HLRS intervention on \>65-year-old elderly people adapted to the countries in which they will be deployed (e.g.: adaptation to cultural food habits, translation into national languages).

Behavioral: Intervention Group

Interventions

Intervention Group BEHAVIORAL

Healthy Lifestyle Recommender Solution (HLRS) will be developed as intervention tool for the trials. It integrates tools (mostly digital): a meal recommender to propose balanced and individually adapted meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural/psychological aspects, and motivational features for sustained engagement and adherence. Within our multi-disciplinary portfolio approach, a set of predominantly eHealth solutions applied during the intervention trials for overweight/obesity prevention, developed in a participatory design approach with relevant stakeholders. This will include the HLRS, thus combining motivational features (nudging, gamification), targeted psychological support, dietary and physical activity advice, though also additional recommendations (healthy eating guidelines...) or education materials will be provided. Intervention trials/studies.

Elderly people; School-children (including families); Young adults

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight (BMI between 25-30 kg/m\^2)
• To have a smart phone

You may not qualify if:

• Individuals with manifest chronic diseases
• Individuals with cognitive diseases
• Individuas not able to lead an independent life

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead
• Luxembourg Institute of Health: collaborator
• University of Évora: collaborator
• University of Coimbra: collaborator
• Eindhoven University of Technology: collaborator
• Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH: collaborator
• Deutsches Forschungszentrum für Künstliche Intelligenz (DFKI): collaborator
• Technical University of Denmark: collaborator

Study Sites (13)

Virtech Ood

Sofia, 1784, Bulgaria

Location

Regional Cluster North-East

Varna, 9002, Bulgaria

Location

Danmarks Tekniske Universitet

Kongens Lyngby, 2800, Denmark

Location

Leibniz-Institut Fur Praventionsforschung Und Epidemiologie - Bips Gmbh

Bremen, 28359, Germany

Location

Deutsches Forschungszentrum Fur Kunstliche Intelligenz Gmbh

Kaiserslautern, 67663, Germany

Location

Universita Degli Studi Di Scienze Gastronomiche

Bra, 12042, Italy

Location

Luxembourg Institute of Health

Luxembourg, 1526, Luxembourg

Location

Technische Universiteit Eindhoven

Eindhoven, 5612 AE, Netherlands

Location

Universidade de Coimbra

Coimbra, 3004-531, Portugal

Location

Universidade de Evora

Evora, 7000 803, Portugal

Location

Fundacio Institut D'Investigacio Sanitaria Illes Balears (Idisba)

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Centre de Recerca En Economia I Desenvolupament Agroalimentari-Upc-Irta

Castelldefels, 08860, Spain

Location

Centro de Investigacion Y Tecnologia Agroalimentaria de Aragon

Zaragoza, 50059, Spain

Location

Related Publications (1)

• Vahid F, Dessenne C, Tur JA, Bouzas C, Devaux Y, Malisoux L, Monserrat-Mesquida M, Sureda A, Desai MS, Turner JD, Lamy E, Perez-Jimenez M, Ravn-Haren G, Andersen R, Forberger S, Nagrani R, Ouzzahra Y, Fontefrancesco MF, Onorati MG, Bonetti GG, de-Magistris T, Bohn T. Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol. BMJ Open. 2024 Mar 8;14(3):e083558. doi: 10.1136/bmjopen-2023-083558.

  PMID: 38458803 BACKGROUND

Related Links

• HealthyW8: Empowering Healthy Lifestyle Behaviour

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Torsten Bohn, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep A Tur, PhD

CONTACT

+34971173146; pep.tur@uib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Intervention: 1. Pilot studies: Main objective is to validate the selected tool-assisted interventions by iteratively testing the HLRS and other health intervention tools among different end-user groups within different contexts (e.g. cultural, economic, social, physical). Pilot trials (\<3 months; n=30 per each age group: children, young adults, and elders) will assess their efficacy considering psychological/emotional states, adherence to dietary suggestions, technology acceptance, efficacy of nudges/gamification, user-friendliness of the tools, and actual usage and engagement. Outcomes will provide feedback for HLRS, including input for the HDT, and a roadmap for long-term intervention studies. 2. Long-trials: Main objective is to assess the effect of 1-y interventions with the HLRS described and further iteratively improved in Pilot trial on reducing risk of overweight/obesity at described life-stages n=55 per control \& intervention group, and described ages).

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: June 8, 2025
• Study Start: July 1, 2025
• Primary Completion: July 15, 2025
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (3); LU (1); PT (2); DK (1); NL (1); DE (2); BU (2)