Julie-Anne Nazare

Background: Obesity arises from complex interactions among genetic, biological, behavioral, and environmental factors. Traditional “one‐size‐fits‐all” interventions often yield modest, short‐term outcomes, failing to account inter‐individual variability. Advances in artificial intelligence (AI), polygenic risk scores (PRS), and digital health technologies now enable personalized and adaptive lifestyle interventions. Objective: This paper presents the design and evaluation framework of the BETTER4All personalized intervention, a multicentre randomized controlled trial within the EU‐funded BETTER4U project. The trial aims to integrate biological and behavioral data into tailored obesity prevention and management strategies. Methods: The BETTER4All trial will be conducted across seven European countries, targeting 1022 adults with body mass index (BMI) ≥ 25 kg/m ² . Participants will be randomized to an intervention group receiving AI and PRS‐based lifestyle recommendations via a smartphone application, wearable device, and structured counseling, or to a control group receiving standard hypocaloric diet and lifestyle advice. The primary outcome is change in BMI at 6 months. Secondary outcomes include weight‐loss maintenance at 1 year, metabolomic and gut microbiota biomarkers, lifestyle behaviors, and psychosocial parameters. Process evaluation incorporates measures of fidelity, acceptability, feasibility, and appropriateness, alongside adherence metrics from the digital tools. Conclusion: The BETTER4All trial will provide evidence on the effectiveness and scalability of AI‐driven, biologically informed personalization in obesity care, offering a methodological framework for integrating multimodal digital data, from omics and biomarkers to behavior and lifestyle, contributing to the advancement of precision public health strategies. Trial Registration: ClinicalTrials.gov identifier: NCT06997510

Understanding obesity involves evaluating numerous contributing factors. Collecting the necessary data for this can impose a significant burden on both research participants during clinical studies and real‐life deployments of digital tools aiding obesity management. The BETTER4U project (European Union's Horizon Europe, Grant Agreement ID 101080117) introduces 36 behavioral and 9 living environment indicators designed to unobtrusively and efficiently capture daily life through passive monitoring using market‐available smartphones and smartwatches while accounting for environmental confounders. This concise set, intended for dietitians, physical activity experts, and healthcare professionals as a standard for assessing obesity‐related behavior, summarizes the behavioral and environmental profile of a person with obesity/overweight. We present the selected indicators, their selection and implementation methodology and the high‐level plan for their verification, describing their conceptual foundations and technical realization. These indicators can be deployed in a modular framework: by transforming raw sensor data into structured, interpretable measures they provide a scalable foundation for long‐term monitoring of obesogenic behaviors, individual assessment, and evaluation of interventions targeting physical activity, diet, stress, and sleep. The indicators are intended for an expert‐facing dashboard within the BETTER4U Intervention Platform, a participant‐side interface within the BETTER4U application, and as input to the BETTER4U AI‐based causal model, supporting relationship modeling between behavior, environment, and obesity outcomes to inform personalized interventions. This work lays the basis for data‐driven validation of these indicators following the “BETTER4ALL Pilot Study” ( ClinicalTrials.gov ID: NCT07120802), ahead of their use in the BETTER4U RCT among individuals with obesity/overweight.

Objective : This scoping review aimed to explore the associations of mechanical and nervous gastric functions (i.e., gastric capacity and accommodation, gastric tone, gastric motility and postprandial electrical activity, gastric emptying, satiation), with food choices, food reward, gustation, olfaction, and eating behavior in people with obesity, with or without metabolic and bariatric surgery. Methods : Using PRISMA-ScR guidelines and an artificial-intelligence assistant tool (AS Review), we performed a scoping review for studies that concomitantly observed mechanical or nervous gastric outcomes and food choices, food reward, gustation, olfaction, or disordered eating. Results : Fifteen studies were selected from 8029 abstracts initially screened, with only one study in the metabolic and bariatric surgery population. In patients with obesity, greater gastric capacity and higher food consumption to achieve satiation were associated with higher consumption of carbohydrates and overeating behaviors (e.g., binge eating), while higher gastric emptying speed was associated with overeating behaviors. There were no studies concerning sensory functions. Interventions to increase gastric electrical activity seemed to reduce overeating behaviors. The effect of metabolic and bariatric surgery on these possible associations remains largely unknown. Conclusion : Potential associations of altered gastric functions with food choices and components of eating behaviors in the context of obesity should be further explored.

La réduction des excursions glycémiques postprandiales a été proposée comme un moyen pour limiter le risque de développement du diabète de type 2. L’intérêt s’est donc porté sur les outils nutritionnels susceptibles de moduler la biodisponibilité des glucides et ainsi leur impact sur la glycémie postprandiale. Les travaux réalisés au cours de cette thèse avaient pour but d’étudier les effets de différents ingrédients modifiant la biodisponibilité du glucose, non seulement sur la glycémie postprandiale à court terme (2 heures) mais aussi sur les cinétiques du débit d’apparition et de disparition de glucose (total, exogène et endogène - isotopes stables) et les autres paramètres métaboliques de la phase postprandiale au cours de la journée. Dans la première étude (β-glucanes), nous avons montré que l’addition de fibres β-glucanes à un repas glucidique chez des sujets sains en surpoids ralentit l’absorption du glucose dans le plasma. Ceci a prolongé la réponse insulinique et par conséquent l’inhibition de la lipolyse et de la production endogène de glucose. Dans la deuxième étude (Eurostarch), nous avons montré que la diminution de la biodisponibilité du glucose au petit-déjeuner (amidon lentement digestible, index glycémique bas) diminue l’apparition du glucose exogène dans le plasma et pourrait avoir un effet second-repas chez des sujets sains en surpoids. Mais nous n’avons pas mis en évidence d’amélioration de ces effets métaboliques à plus long terme (5 semaines). Dans la troisième étude présentée (Nutriose), nous avons montré que l’addition de dextrine résistante NUTRIOSE®10 (fermentescible) au petit-déjeuner chez des sujets sains, diminue les réponses glycémiques, insuliniques postprandiales et le profil de ghréline au cours de la journée (en comparaison à une maltodextrine). En parallèle, la prolongation observée de la fermentation et l’oxydation du NUTRIOSE®10 pourraient fournir de l’énergie en phase postprandiale tardive. En conclusion, l’analyse des paramètres métaboliques au-delà de 2 heures après le repas, a permis de mettre en évidence les effets métaboliques à plus long terme de la modulation de l’apparition du glucose dans le plasma (ralentissement, prolongation, réduction) sur les cinétiques du glucose, la réponse insulinique, la lipolyse et l’oxydation des substrats

[This corrects the article DOI: 10.2196/64894.].

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Background: Over the past 2 decades, the gut microbiota has emerged as a key player in human health, being involved in many different clinical contexts. Yet, many aspects of the relationship with its host are poorly documented. One obstacle is the substantial variability in wet-laboratory procedures and data processing implemented during gut microbiota studies, which poses a challenge of comparability and potential meta-analysis. Objective: The study protocol described here aimed to better understand the relationship between health, dietary habits, and the observed heterogeneity of gut microbiota composition in the general population. “Le French Gut – Le microbiote français” aimed to collect, sequence, and analyze 100,000 fecal samples from French residents using a high-quality shotgun metagenomic pipeline, complemented with comprehensive health, lifestyle, and dietary metadata. Methods: “Le French Gut – Le microbiote français” is a prospective, noninterventional French national study involving individuals, the creation of a biological collection (feces), and the exploitation of data from questionnaires and the National Health Data System (Système National des Données de Santé). This national study is open to all metropolitan French adult residents, excluding those who have undergone a colectomy or digestive stoma, or who have had a colonoscopy or taken antibiotics in the last 3 months. This is a home-based trial in which volunteers complete a questionnaire with insights about their health and habits, and in which stool samples are self-collected. Data analysis is structured into 6 work packages, each focusing on a specific aspect of the gut microbiome, including its composition and associations with lifestyle, quality of life, and health. Results: This paper outlines the study protocol, with recruitment having started in September 2022 and expected to continue until the end of December 2025. As of January 2025, a total of 20,000 participants have been enrolled. The first scientific publications based on the data analysis are expected by mid-2025. Conclusions: “Le French Gut” aims to provide a reference database and new ecosystem tools for understanding the relationship between the gut microbiota, its host, and diet. We expect to be able to find new signatures or targets and promote the design of innovative preventive strategies, personalized nutrition, and precision medicine. Trial Registration: ClinicalTrials.gov NCT05758961; https://clinicaltrials.gov/study/NCT05758961 International Registered Report Identifier (IRRID): DERR1-10.2196/64894

BACKGROUND Over the past 2 decades, the gut microbiota has emerged as a key player in human health, being involved in many different clinical contexts. Yet, many aspects of the relationship with its host are poorly documented. One obstacle is the substantial variability in wet-laboratory procedures and data processing implemented during gut microbiota studies, which poses a challenge of comparability and potential meta-analysis. OBJECTIVE The study protocol described here aimed to better understand the relationship between health, dietary habits, and the observed heterogeneity of gut microbiota composition in the general population. “Le French Gut – Le microbiote français” aimed to collect, sequence, and analyze 100,000 fecal samples from French residents using a high-quality shotgun metagenomic pipeline, complemented with comprehensive health, lifestyle, and dietary metadata. METHODS “Le French Gut – Le microbiote français” is a prospective, noninterventional French national study involving individuals, the creation of a biological collection (feces), and the exploitation of data from questionnaires and the National Health Data System (Système National des Données de Santé). This national study is open to all metropolitan French adult residents, excluding those who have undergone a colectomy or digestive stoma, or who have had a colonoscopy or taken antibiotics in the last 3 months. This is a home-based trial in which volunteers complete a questionnaire with insights about their health and habits, and in which stool samples are self-collected. Data analysis is structured into 6 work packages, each focusing on a specific aspect of the gut microbiome, including its composition and associations with lifestyle, quality of life, and health. RESULTS This paper outlines the study protocol, with recruitment having started in September 2022 and expected to continue until the end of December 2025. As of January 2025, a total of 20,000 participants have been enrolled. The first scientific publications based on the data analysis are expected by mid-2025. CONCLUSIONS “Le French Gut” aims to provide a reference database and new ecosystem tools for understanding the relationship between the gut microbiota, its host, and diet. We expect to be able to find new signatures or targets and promote the design of innovative preventive strategies, personalized nutrition, and precision medicine. CLINICALTRIAL ClinicalTrials.gov NCT05758961; https://clinicaltrials.gov/study/NCT05758961 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/64894