MELIORA Data Collection Campaigns

NCT07190066 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-30

No results posted yet for this study

Summary

To support the development of the MELIORA digital app for the MELIORA main intervention, an initial pilot study (Data Collection Campaign, DCC) is being conducted with the three target participant groups: healthy women at increased risk of developing breast cancer (BC), BC patients, and BC survivors across the four intervention countries (Spain, Greece, Lithuania, Sweden). The planned sample size for each group is 156 healthy women at risk (defined as not meeting recommendations for a healthy lifestyle), 58 BC patients, and 86 BC survivors. Each participant is asked to test and evaluate a preliminary version of the MELIORA app over a 14-day period. The DCC takes place in the early stages of the project, as part of the intervention development phase, to inform the technical refinement and preliminary evaluation of the MELIORA digital app.

Conditions

  • Breast Cancer Prevention

Interventions

OTHER

Data Collection campaign

Participants will be asked to download the MELIROA app, compatible with iOS and Android, to their smartphones and test it for 14 days. The app will prompt the user to set a weekly goal on physical activity and support daily self-monitoring and step count tracking. Τhe app will also offer culturally adapted educational material through mini-courses, motivational and practical tips and an embedded library of materials relevant to physical activity, healthy diet and alcohol consumption. To boost motivation, it will also include reminders and gamification features like badges and points.

Sponsors & Collaborators

  • BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN

    collaborator UNKNOWN
  • FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA

    collaborator UNKNOWN
  • Instituto de Investigacion Sanitaria INCLIVA

    collaborator INDUSTRY
  • LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS

    collaborator UNKNOWN
  • PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA

    collaborator UNKNOWN
  • SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY

    collaborator UNKNOWN
  • EUROPEAN FOOD INFORMATION COUNCIL

    collaborator UNKNOWN
  • ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS

    collaborator UNKNOWN
  • EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS

    collaborator UNKNOWN
  • RISA SICHERHEITSANALYSEN GMBH

    collaborator UNKNOWN
  • BIOASSIST SA

    collaborator UNKNOWN
  • EUROPEAN HEALTH MANAGEMENT ASSOCIATION

    collaborator UNKNOWN
  • ETICAS DATA SOCIETY

    collaborator UNKNOWN
  • Karolinska Institutet

    collaborator OTHER
  • PREDICTBY RESEARCH AND CONSULTING S.L.

    collaborator UNKNOWN
  • Harokopio University

    lead OTHER

Principal Investigators

  • Yannis Manios, Professor · Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Greece
  • Lithuania
  • Spain
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07190066 on ClinicalTrials.gov