Breast Cancer PreventionMELIORANCT07200427
MELIORA Virtual Coach Intervention for Breast Cancer Prevention
A study testing MELIORA Virtual Coach Intervention in people with Breast Cancer Prevention, run by Harokopio University at 7 sites in 4 countries.
Trial summary
Breast cancer (BC) is the most commonly diagnosed cancer in women worldwide, with early-onset cases increasing due to genetic and lifestyle factors. Traditional prevention strategies have shown limited effectiveness, creating the need for innovative approaches. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Prevention
- What is being tested?
- MELIORA Virtual Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,080 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Mar 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MELIORA-HEALTHY study participants must meet all of the following criteria in order to be deemed eligible for study participation:
- Reside in Greece, Lithuania, or Spain.
- Be female and at least 18 years of age.
- Have access to and be able to use a smartphone (iOS or Android) compatible with the MELIORA app.
- Be willing and able to use the MELIORA app for the entire study duration.
- Willing to provide informed consent to participate in the study.
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- Have at least one of the following behavioural or metabolic risk factors for BC, assessed in a random order (each site may determine the order that is most convenient for them) until eligibility is confirmed. If a risk factor is identified, the subsequent assessments can be skipped:
- Increased alcohol consumption: More than 1 drink per day.
- Increased body mass index (BMI): BMI ≥ 25 kg/m² or waist circumference ≥80 cm for normal weight individuals.
- Physical inactivity: Not meeting World Health Organization (WHO) guidelines of at least 150 minutes of moderate-intensity or 75 minutes of high-intensity aerobic exercise per week during the last month.
- Suboptimal diet: Low diet quality based on the rapid Prime Diet Quality Score Screener (rPDQS).
- MELIORA-PATIENTS study participants must meet all of the following criteria in order to be deemed eligible for study participation:
- Reside in Spain or Lithuania.
- Be female and at least 18 years old.
- Have access to and be able to use a smartphone (iOS or Android) compatible with the MELIORA app.
- Be willing and able to use the MELIORA app for the entire study duration.
- Willing to provide informed consent to participate in the study.
- Have been diagnosed with breast cancer (BC) within the last 6 months and/or currently undergoing treatment (chemotherapy, radiotherapy, immunotherapy, hormone therapy) and/or in active follow-up.
- Have at least one of the following behavioural or metabolic risk factors for BC, assessed in a random order (each site may determine the order that is most convenient for them) until eligibility is confirmed. If a risk factor is identified, the subsequent assessments can be skipped:
- Increased alcohol consumption: More than 1 drink per day.
- Increased body mass index (BMI): BMI ≥ 25 kg/m² or waist circumference ≥80 cm for normal weight individuals.
- Physical inactivity: Not meeting World Health Organization (WHO) guidelines of at least 150 minutes of moderate-intensity or 75 minutes of high-intensity aerobic exercise per week during the last month.
- Suboptimal diet: Low diet quality based on the rapid Prime Diet Quality Score Screener (rPDQS).
- MELIORA-SURVIVORS study participants must meet all of the following criteria in order to be deemed eligible for study participation:
- Reside in Spain, Lithuania, or Sweden.
- Be female and at least 18 years old.
- Have access to and be able to use a smartphone (iOS or Android) compatible with the MELIORA app.
- Be willing and able to use the MELIORA app for the entire study duration.
- Willing to provide informed consent to participate in the study.
- Have completed primary treatment for breast cancer (surgery, chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.) and currently be in remission.
- Be considered "cancer-free" according to their treating physician and may enter the study immediately following this diagnosis.
- Ongoing adjuvant hormone therapy is permitted.
- Have at least one of the following behavioural or metabolic risk factors for BC, assessed in a random order (each site may determine the order that is most convenient for them) until eligibility is confirmed. If a risk factor is identified, the subsequent assessments can be skipped:
- Increased alcohol consumption: More than 1 drink per day.
- Increased body mass index (BMI): BMI ≥ 25 kg/m² or waist circumference ≥80 cm for normal weight individuals.
- Physical inactivity: Not meeting World Health Organization (WHO) guidelines of at least 150 minutes of moderate-intensity or 75 minutes of high-intensity aerobic exercise per week during the past month.
- Suboptimal diet: Low diet quality based on the rapid Prime Diet Quality Score Screener (rPDQS).
Who cannot join
- MELIORA-HEALTHY study participants will be excluded from study participation if they meet any of the following criteria:
- Inability to provide fully informed consent.
- Inability to understand or communicate in the local language i.e. Greek in Greece, Lithuanian in Lithuania, Spanish in Spain.
- Current or past diagnosis of cancer or other uncontrolled chronic diseases (e.g., cardiovascular disease, diabetes) that affect lifestyle, dietary habits, or communication skills.
- Mental illness or disorders that affect lifestyle, dietary habits, or communication skills.
- Use of medication that affects lifestyle, dietary habits, or communication skills.
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- Recreational drug use.
- Pregnancy, lactation, or intention to become pregnant shortly before, during, or after the intervention.
- Participation in another clinical trial or program aimed at promoting behavioural changes or weight loss at the time of recruitment. If subjects already use health-related apps that affect their weight and lifestyle, including dietary habits and physical activity, the research team will ask them to pause their use until the end of the 12-month study period. However, the use of these applications by the participants cannot be controlled.
- MELIORA PATIENTS and MELIORA SURVIVORS study participants will be excluded from study participation if they meet any of the following criteria:
- Inability to provide fully informed consent.
- Inability to understand or communicate in the local language (i.e., Lithuanian in Lithuania, Spanish in Spain, Swedish in Sweden), unless appropriate translation support is available to ensure full understanding of study procedures and informed consent.
- Current or past diagnosis of cancer (other than breast cancer, except skin cancer treated with surgery only) or other uncontrolled chronic diseases (e.g., cardiovascular diseases, diabetes) that affect lifestyle, dietary habits, or communication skills.
- Mental illness or disorders that affect lifestyle, dietary habits, and communication skills.
- Use of medication that affects lifestyle, dietary habits, or communication skills.
- Recreational drug use.
- Pregnancy, lactation, or intention to become pregnant shortly before, during, or after the intervention.
- Participation in another clinical trial or program to promote behavioural changes or weight loss during recruitment. Suppose participants are already using health-related apps affecting their weight and lifestyle, including dietary habits and physical activity. In that case, they will be asked to suspend their use until the end of the 12-month study period. However, the research team cannot control the use of these applications by the participants.
- Severe adherence issues with previous treatments that may interfere with compliance with study tasks (subject to the investigator's assessment).
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
Lithuania2 sites, 2 recruiting
- Recruiting
Lietuvos Sveikatos Mokslų Universitetas (Lsmu)
Kaunas
Gintare Kaliniene, +370868409708, gintare.kaliniene@lsmu.lt
- Recruiting
Pagalbos Onkologiniams Ligoniams Asociacija (Pola L T)
Kaunas
Neringa Ciakiene, 9999999999, neringa@pola.lt
Spain2 sites, 2 recruiting
- Recruiting
Fundación Para El Fomento de La Investigación Sanitaria Y Biomédica de La Comunitat Valenciana (Fisabio)
Valencia
Ana Molina Barceló, 9999999999, ana.molina@fisabio.es
- Recruiting
INCLIVA - Instituto de Investigación Sanitaria
Valencia
Juan Miguel Cejalvo Andújar, 9999999999, juanmitch5@hotmail.com
Sweden2 sites, 2 recruiting
- Recruiting
Bröstcancerföreningen Amazona I Stockholms Län (Amazona)
Stockholm
Linda Engström, +46730620826, linda.engstrom@amazona.se
- Recruiting
Karolinska Institutet
Stockholm
Ioannis Ioakeimidis, 9999999999, ioannis.ioakimidis@ki.se
Greece1 site, 1 recruiting
- Recruiting
Harokopio University
Athens
Yannis Manios, Professor, +302109549156, manios@hua.gr
About this study
Official title: Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence
Breast cancer (BC) is the most commonly diagnosed cancer in women worldwide, with early-onset cases increasing due to genetic and lifestyle factors. Traditional prevention strategies have shown limited effectiveness, creating the need for innovative approaches. The MELIORA project develops an AI-driven digital tool, the Virtual Coach (VC), to promote sustainable behaviour change in physical activity, diet, and alcohol use. Three randomized-controlled studies will be conducted: MELIORA-HEALTHY (women at risk, n=1080 in Greece, Lithuania, Spain), MELIORA-PATIENTS (women undergoing treatment, n=400 in Lithuania, Spain), and MELIORA-SURVIVORS (post-treatment survivors, n=600 in Lithuania, Spain, Sweden). Participants across diverse regions and backgrounds will be randomized to standard lifestyle advice or the same advice plus the MELIORA VC app. Each study lasts 12 months, with outcomes assessed at baseline, 6, and 12 months. The primary outcome is physical activity, with secondary outcomes including sedentary behaviour, diet, alcohol use, and quality of life. If effective, the MELIORA VC could offer a scalable, cost-effective model for BC prevention and survivorship care, providing valuable evidence to guide public health strategies.
Read the detailed description
Breast cancer (BC) is the most commonly diagnosed cancer among women worldwide, with early-onset cases rising rapidly due to interactions between genetics and lifestyle behaviours. Traditional efforts to modify these behaviours have had limited success, highlighting the need for innovative, multifaceted approaches. The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses this gap by promoting sustainable behaviour change through an innovative intervention using artificial intelligence (AI). The project will develop and evaluate an AI-driven behaviour change digital solution, the MELIORA virtual coach (VC), designed to enhance awareness, motivation, and promote healthier lifestyle choices related to physical activity, diet, and alcohol consumption, while addressing potential implementation barriers.
The MELIORA VC intervention consists of three separate studies: 1) the MELIORA-HEALTHY Study targeting healthy women at risk of BC (conducted in Greece, Lithuania, Spain), 2) the MELIORA-PATIENTS Study targeting BC patients (conducted in Lithuania, Spain), and 3) the MELIORA-SURVIVORS Study targeting BC survivors (conducted in Lithuania, Spain, Sweden), involving a total of 2,080 participants. The studies will encompass both urban and rural regions and will include participants across the socioeconomic spectrum and/or ethnic minority groups, allowing for the evaluation of how these factors moderate the effectiveness of the MELIORA behavioural change intervention. The studies will follow a randomized-controlled design. For the MELIORA-HEALTHY study, a total of 1080 adult women (360 per site), free of cancer and with at least one behavioural (i.e. low levels of physical activity, unhealthy diet, increased alcohol consumption) or metabolic (i.e. increased BMI) risk factor will be recruited. For the MELIORA-PATIENTS study, a total of 400 adult women diagnosed with BC and currently undergoing treatment (200 per site) will be recruited. For the MELIORA-SURVIVORS study, a total of 600 adult women diagnosed with BC and have completed primary therapy (200 per site) will be recruited.
Participants at each site will be randomly assigned (1:1 allocation) to either the intervention group or the control group. The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. The intervention group will receive the same generic advice along with the MELIORA VC intervention app. The total study duration for each participant will be 12 months, divided into two six-month periods: the intervention period and the follow-up period. Targeted behaviours will be assessed at three time points: baseline (0 months), end of the six-month intervention period (6 months), and end of the six-month follow-up period (12 months). The primary outcome that will be assessed is physical activity while secondary outcomes include sedentary behaviours, diet, alcohol consumption and health-related quality of life.
The MELIORA project represents an innovative approach to BC prevention by integrating an AI-driven digital health solution into real-world settings. The MELIORA studies highlight the role of technology in promoting sustainable behaviour change to prevent the onset or recurrence of BC. The VC tool that will be developed, tested and evaluated is a key outcome of the MELIORA project and aims to support preventive policies and health promotion guidelines for BC prevention. If successful, the MELIORA VC model could be expanded to other at-risk populations, reinforcing the potential of AI-driven, cost-effective health interventions in cancer prevention. Findings will provide valuable insights for policymakers and healthcare professionals on the feasibility, effectiveness, and cost-effectiveness of AI-supported lifestyle interventions, shaping future public health strategies.
- Conditions
- Breast Cancer Prevention
- Being tested
- MELIORA Virtual Coach Intervention, Control (generic advice)
- Keywords
- Behavior change, Disease prevention, Health behaviour, Primary prevention, Public and environmental health, Breast cancer, Cancer prevention, Sustainable intervention, Nutrition, Diet, Physical activity, Exercise, Lifestyle, Public health, Cancer risk factors, Health communication, Digital health, Health technologies, Artificial intelligence, randomized controlled trial
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELIORA Virtual Coach InterventionBehavioural
Based on baseline assessments, the MELIORA VCI app will prompt intervention group participants to set weekly goals on lifestyle behaviours such as physical activity, diet, alcohol use, and sedentary time, and support daily self-monitoring and step count tracking. Goals will be dynamically adjusted by the virtual coach or the participant to remain realistic and achievable. Τhe app will also offer culturally adapted educational, motivational, and instructional support through mini-courses, tips, recommendations and an embedded library of relevant materials to ensure high adoption rates among women from diverse countries, socioeconomic backgrounds and minority groups. To boost motivation, it will include reminders, gamification features like badges and points, as well as personalized techniques such as action planning, problem solving, social reward, and positive self-talk.
Control (generic advice)Other
The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. A 'light' version of the MELIORA VCI app will be developed to host the control group materials, track participants' step counts, send reminders, and allow scheduling of follow-up visits. No other features will be available in this version of the app.
| Study group | Role | What they receive |
|---|---|---|
| MELIORA Virtual Coach Intervention (VCI) Group | Experimental | The intervention group will receive generic advice on a healthy lifestyle and breast cancer (BC) prevention plus access to the full MELIORA VCI app. Receives: Behavioral: MELIORA Virtual Coach Intervention |
| Control Group | Placebo comparator | The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. Receives: Other: Control (generic advice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity levels - MVPA minutes
The primary outcome will be the mean change in physical activity levels as measured by MVPA minutes from baseline at the end of the six-month intervention period between the intervention and the control group.
Measured: From baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - Step count
The primary outcome will be the mean change in physical activity levels as measured by step count from baseline at the end of the six-month intervention period between the intervention and the control group.
Measured: From baseline (T0) until the end of the six-month intervention period (T1)
Secondary outcomes (30)
Physical activity levels - MVPA minutes
Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month intervention period, within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - MVPA minutes
Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month follow-up period between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - MVPA minutes
Mean changes in physical activity levels as measured by MVPA minutes, from baseline until the end of the 6-month follow-up period within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - Step count
Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month intervention period, within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - Step count
Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month follow-up period, between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - Step count
Mean changes in physical activity levels as measured by step count, from baseline until the end of the 6-month follow-up period, within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month intervention period between groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month intervention period, within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month follow-up period, between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Aerobic exercise minutes
Mean changes in aerobic exercise minutes, from baseline until the end of the 6-month follow-up period, within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month intervention period within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month intervention period between groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month follow-up period, within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Muscle strengthening minutes
Mean changes in muscle strengthening minutes, from baseline until the end of the 6-month follow-up period, between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month intervention period between groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month intervention period within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month follow-up period, within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Sedentary minutes
Mean changes in sedentary minutes, from baseline until the end of the 6-month follow-up period, between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month intervention period within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month intervention period between groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month follow-up period, within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Αlcohol consumption
Mean changes in alcohol consumption (servings/week), from baseline until the end of the 6-month follow-up period, between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Diet quality
Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month intervention period within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Diet quality
Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month intervention period between groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Diet quality
Mean changes in rapid Prime Diet Quality Score Screener (rPDQS) diet score (0-26 points with higher scores meaning a better diet quality) and individual dietary components, from baseline until the end of the 6-month follow-up period, within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Diet quality
Mean changes in diet score and individual dietary components, from baseline until the end of the 6-month follow-up period, between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Health-related quality of life
Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)] , from baseline until the end of the 6-month intervention period within groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Health-related quality of life
Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)], from baseline until the end of the 6-month intervention period between groups.
Measured: From Baseline (T0) until the end of the six-month intervention period (T1)
Health-related quality of life
Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)], from baseline until the end of the 6-month follow-up period, within groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Health-related quality of life
Mean changes in quality of life [EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L, scale 1-5 with greatest values meaning worst outcomes)], from baseline until the end of the 6-month follow-up period between groups.
Measured: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The MELIORA RCTs will employ a parallel-group, randomized controlled design with two groups: an intervention group and a control group. The study follows a superiority design, with individual-level randomization and a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN, Karolinska Institutet, Instituto de Investigacion Sanitaria INCLIVA, FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA, LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS, PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA, SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY, EUROPEAN FOOD INFORMATION COUNCIL, PredictBy Research and Consulting, S.L, ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS, EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS, RISA SICHERHEITSANALYSEN GMBH, BioAssist, EUROPEAN HEALTH MANAGEMENT ASSOCIATION, ETICAS DATA SOCIETY
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
- Investigators
- Yannis Manios, Professor, Principal investigator, Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200427
- Sponsor's protocol ID
- 101136791
- Acronym
- MELIORA
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07200427
- Acronym / sponsor ID
- MELIORA / 101136791
- Conditions
- Breast Cancer Prevention
- Keywords
- Behavior change, Disease prevention, Health behaviour, Primary prevention, Public and environmental health, Breast cancer, Cancer prevention, Sustainable intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,080 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- BROSTCANCERFORENINGEN AMAZONA I STOCKHOLMS LAN, Karolinska Institutet, Instituto de Investigacion Sanitaria INCLIVA, FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA, LIETUVOS SVEIKATOS MOKSLU UNIVERSITETAS, PAGALBOS ONKOLOGINIAMS LIGONIAMS ASOCIACIJA, SWPS UNIWERSYTET HUMANISTYCZNOSPOLECZNY, EUROPEAN FOOD INFORMATION COUNCIL, PredictBy Research and Consulting, S.L, ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS, EXUS SOFTWARE MONOPROSOPI ETAIRIA PERIORISMENIS EVTHINIS, RISA SICHERHEITSANALYSEN GMBH, BioAssist, EUROPEAN HEALTH MANAGEMENT ASSOCIATION, ETICAS DATA SOCIETY
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer (BC) is the most commonly diagnosed cancer in women worldwide, with early-onset cases increasing due to genetic and lifestyle factors. Traditional prevention strategies have shown limited effectiveness, creating the need for innovative approaches. The MELIORA project develops an AI-driven digital tool, the Virtual Coach (VC), to promote sustainable behaviour change in physical activity, diet, and alcohol use. Three randomized-controlled studies will be conducted: MELIORA-HEALTHY (women at risk, n=1080 in Greece, Lithuania, Spain), MELIORA-PATIENTS (women undergoing treatment, n=400 in Lithuania, Spain), and MELIORA-SURVIVORS (post-treatment survivors, n=600 in Lithuania, Spain, Sweden). Participants across diverse regions and backgrounds will be randomized to standard lifestyle advice or the same advice plus the MELIORA VC app. Each study lasts 12 months, with outcomes assessed at baseline, 6, and 12 months. The primary outcome is physical activity, with secondary outcomes including sedentary behaviour, diet, alcohol use, and quality of life. If effective, the MELIORA VC could offer a scalable, cost-effective model for BC prevention and survivorship care, providing valuable evidence to guide public health strategies.
Detailed description
Breast cancer (BC) is the most commonly diagnosed cancer among women worldwide, with early-onset cases rising rapidly due to interactions between genetics and lifestyle behaviours. Traditional efforts to modify these behaviours have had limited success, highlighting the need for innovative, multifaceted approaches. The Multimodal Engagement and Sustainable Lifestyle Interventions Optimizing Breast Cancer Risk Reduction Supported by Artificial Intelligence (MELIORA) project addresses this gap by promoting sustainable behaviour change through an innovative intervention using artificial intelligence (AI). The project will develop and evaluate an AI-driven behaviour change digital solution, the MELIORA virtual coach (VC), designed to enhance awareness, motivation, and promote healthier lifestyle choices related to physical activity, diet, and alcohol consumption, while addressing potential implementation barriers.
The MELIORA VC intervention consists of three separate studies: 1) the MELIORA-HEALTHY Study targeting healthy women at risk of BC (conducted in Greece, Lithuania, Spain), 2) the MELIORA-PATIENTS Study targeting BC patients (conducted in Lithuania, Spain), and 3) the MELIORA-SURVIVORS Study targeting BC survivors (conducted in Lithuania, Spain, Sweden), involving a total of 2,080 participants. The studies will encompass both urban and rural regions and will include participants across the socioeconomic spectrum and/or ethnic minority groups, allowing for the evaluation of how these factors moderate the effectiveness of the MELIORA behavioural change intervention. The studies will follow a randomized-controlled design. For the MELIORA-HEALTHY study, a total of 1080 adult women (360 per site), free of cancer and with at least one behavioural (i.e. low levels of physical activity, unhealthy diet, increased alcohol consumption) or metabolic (i.e. increased BMI) risk factor will be recruited. For the MELIORA-PATIENTS study, a total of 400 adult women diagnosed with BC and currently undergoing treatment (200 per site) will be recruited. For the MELIORA-SURVIVORS study, a total of 600 adult women diagnosed with BC and have completed primary therapy (200 per site) will be recruited.
Participants at each site will be randomly assigned (1:1 allocation) to either the intervention group or the control group. The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. The intervention group will receive the same generic advice along with the MELIORA VC intervention app. The total study duration for each participant will be 12 months, divided into two six-month periods: the intervention period and the follow-up period. Targeted behaviours will be assessed at three time points: baseline (0 months), end of the six-month intervention period (6 months), and end of the six-month follow-up period (12 months). The primary outcome that will be assessed is physical activity while secondary outcomes include sedentary behaviours, diet, alcohol consumption and health-related quality of life.
The MELIORA project represents an innovative approach to BC prevention by integrating an AI-driven digital health solution into real-world settings. The MELIORA studies highlight the role of technology in promoting sustainable behaviour change to prevent the onset or recurrence of BC. The VC tool that will be developed, tested and evaluated is a key outcome of the MELIORA project and aims to support preventive policies and health promotion guidelines for BC prevention. If successful, the MELIORA VC model could be expanded to other at-risk populations, reinforcing the potential of AI-driven, cost-effective health interventions in cancer prevention. Findings will provide valuable insights for policymakers and healthcare professionals on the feasibility, effectiveness, and cost-effectiveness of AI-supported lifestyle interventions, shaping future public health strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The MELIORA RCTs will employ a parallel-group, randomized controlled design with two groups: an intervention group and a control group. The study follows a superiority design, with individual-level randomization and a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| MELIORA Virtual Coach Intervention (VCI) Group | Experimental | Behavioral: MELIORA Virtual Coach InterventionThe intervention group will receive generic advice on a healthy lifestyle and breast cancer (BC) prevention plus access to the full MELIORA VCI app. |
| Control Group | Placebo comparator | Other: Control (generic advice)The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- MELIORA-HEALTHY study participants must meet all of the following criteria in order to be deemed eligible for study participation:
- Reside in Greece, Lithuania, or Spain.
- Be female and at least 18 years of age.
- Have access to and be able to use a smartphone (iOS or Android) compatible with the MELIORA app.
- Be willing and able to use the MELIORA app for the entire study duration.
Key exclusion criteria (19 listed)
- MELIORA-HEALTHY study participants will be excluded from study participation if they meet any of the following criteria:
- Inability to provide fully informed consent.
- Inability to understand or communicate in the local language i.e. Greek in Greece, Lithuanian in Lithuania, Spanish in Spain.
- Current or past diagnosis of cancer or other uncontrolled chronic diseases (e.g., cardiovascular disease, diabetes) that affect lifestyle, dietary habits, or communication skills.
- Mental illness or disorders that affect lifestyle, dietary habits, or communication skills.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MELIORA Virtual Coach InterventionBased on baseline assessments, the MELIORA VCI app will prompt intervention group participants to set weekly goals on lifestyle behaviours such as physical activity, diet, alcohol use, and sedentary time, and support daily self-monitoring and step count tracking. Goals will be dynamically adjusted by the virtual coach or the participant to remain realistic and achievable. Τhe app will also offer culturally adapted educational, motivational, and instructional support through mini-courses, tips, recommendations and an embedded library of relevant materials to ensure high adoption rates among women from diverse countries, socioeconomic backgrounds and minority groups. To boost motivation, it will include reminders, gamification features like badges and points, as well as personalized techniques such as action planning, problem solving, social reward, and positive self-talk. | Behavioural | MELIORA Virtual Coach Intervention (VCI) Group |
| Control (generic advice)The control group will receive the standard of care that is generic advice for a healthy lifestyle and BC prevention. A 'light' version of the MELIORA VCI app will be developed to host the control group materials, track participants' step counts, send reminders, and allow scheduling of follow-up visits. No other features will be available in this version of the app. | Other | Control Group |
Primary outcome
Physical activity levels - MVPA minutes
Time frame: From baseline (T0) until the end of the six-month intervention period (T1)
The primary outcome will be the mean change in physical activity levels as measured by MVPA minutes from baseline at the end of the six-month intervention period between the intervention and the control group.
Physical activity levels - Step count
Time frame: From baseline (T0) until the end of the six-month intervention period (T1)
The primary outcome will be the mean change in physical activity levels as measured by step count from baseline at the end of the six-month intervention period between the intervention and the control group.
30 secondary outcomes
Physical activity levels - MVPA minutes
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - MVPA minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - MVPA minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - Step count
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Physical activity levels - Step count
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Physical activity levels - Step count
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Aerobic exercise minutes
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Aerobic exercise minutes
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Aerobic exercise minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Aerobic exercise minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Muscle strengthening minutes
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Muscle strengthening minutes
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Muscle strengthening minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Muscle strengthening minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Sedentary minutes
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Sedentary minutes
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Sedentary minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Sedentary minutes
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Αlcohol consumption
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Αlcohol consumption
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Αlcohol consumption
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Αlcohol consumption
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Diet quality
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Diet quality
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Diet quality
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Diet quality
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Health-related quality of life
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Health-related quality of life
Time frame: From Baseline (T0) until the end of the six-month intervention period (T1)
Health-related quality of life
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Health-related quality of life
Time frame: From Baseline (T0) until the end of the 6-month follow-up period (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- MELIORA website linkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yannis Manios, Professor principal investigator
Department of Nutrition and Dietetics, School of Health Science & Education, Harokopio University, Athens, Greece
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MELIORA Virtual Coach Intervention in people with Breast Cancer Prevention, run by Harokopio University at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Lithuania, Spain, Sweden, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannis Manios, Professor (+30 2109549156, manios@hua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity levels - MVPA minutes (time frame: From baseline (T0) until the end of the six-month intervention period (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.