Status:
NOT_YET_RECRUITING
Better4All Personalized Intervention
Lead Sponsor:
Harokopio University
Collaborating Sponsors:
University of Navarra
CENTRO DE ESTUDOS E INVESTIGACAO EM DINAMICAS SOCIAIS E SAUDE ASSOCIACAO SEM FINS LUCRATIVOS
Conditions:
Obesity Prevention
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The BETTER4U (Preventing obesity through Biologically and bEhaviorally Tailored inTERventions for you) project, funded by the European Union, aims to address obesity through biologically and behaviour...
Detailed Description
Obesity is a major global public health issue with significant physical, psychosocial, and financial implications, especially in vulnerable populations. It results from complex interactions between ge...
Eligibility Criteria
Inclusion
- Age: Participant aged 18-65 years
- Body Mass Index (BMI): BMI ≥ 25 kg/m² (overweight or obesity)
- Willingness and ability to use wearable devices and an Android mobile application for the duration of the study
- Owning a smartphone device with Android operating system
- Eating utensil technique: dominant hand gestures that correspond to handling of food via a fork or a spoon
- Language proficiency: participant has the ability to read and understand the language in which the mobile app and study materials are provided
- Consent: participant is willing to provide informed consent to participate in the study
- Residency: participant is resident of the country
- Availability: participant is able to participate for the full three-week duration of the study and comply with the study protocol
Exclusion
- Pregnant or breastfeeding or intending to get pregnant in the short-term
- Comorbidities which might affect inflammation levels (i.e. type 1 diabetes, uncontrolled type 2 diabetes, unstable cardiovascular disease, eating disorders, gastrointestinal disorders)
- Mental illness affecting cognitive and communication skills, lifestyle and/or dietary habits
- History of cancer within 5 years prior to intervention onset
- Physical Limitations: any physical or mental condition that would prevent the participant from using the wearable device or mobile application as intended
- Any other criterion which would deem the participant unsuitable, according to the investigator's impression
- Technical Incompatibility: Individual does not own a compatible smartphone or are unable to use the provided wearable devices for technical reasons
- Documented and/or self-reported rapid changes in body weight in the six months preceding intervention onset, attributed to a diagnosed medical condition
- Interventional drug treatment in a clinical trial in the period within six months prior to intervention onset, which might affect intervention impact
- Inability to adhere to the proposed diet regimens, due to medical (i.e. gluten intolerance, allergies, swallowing problems) or religious reasons
- Medication promoting weight loss
- Bariatric surgery in the 12 months preceding intervention onset
- Use of supplements promoting weight loss or sleep quality, mood enhancing supplements, and/or consumption of probiotics and medications that influence the microbiome in the last three months preceding intervention onset Participation in a different clinical trial protocol or participation in different programs aiming at weight loss during the six months preceding intervention onset
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
1022 Patients enrolled
Trial Details
Trial ID
NCT06997510
Start Date
October 1 2025
End Date
April 1 2027
Last Update
May 30 2025
Active Locations (7)
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1
University of Cyprus (Ucy)
Nicosia, Cyprus, 2109
2
Universite Lyon 1 Claude Bernard (Ucbl)
Villeurbanne, France, 69622 CEDEX
3
Harokopio University
Athens, Aticca, Greece, 17676
4
Uniwersytet Swps (Swps)
Wroclaw, Poland, 53-238