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Glossary

Glossary of Terms

  • Actionable genes

    Specific genes or genetic mutations associated with a particular disease or medical condition, which can be a target for interventions.
  • Body Mass Index (BMI)

    A numerical value calculated based on an individual's weight and height. It is used to evaluate whether their weight is healthy in relation to their height.
  • Biomarkers

    Measurable indicators or substances found in biological samples such as blood and urine. They provide information about a biological process, condition, or disease.
  • Epidemiology

    The study of how diseases and health conditions spread among populations and the factors that affect their distribution. This field is essential in public health as it helps us comprehend and regulate the spread of diseases and health conditions, identify risk factors, and develop health policies and interventions.
  • ELSI

    Ethical, Legal and Social Implications. They are integrated into research to ensure responsible progress and consider the wider implications for individuals and society.
  • Genetic aetiologies

    Genetic causes or factors contributing to developing a disease or medical condition.
  • Genetic predisposition

    The genetic makeup of an individual which influences their risk of developing a particular disease or medical condition.
  • Growth trajectories

    To track an individual's body measurements like height, weight, and BMI over time to monitor growth and development patterns.
  • Monogenic obesity

    A rare, early-onset, and severe form of obesity caused by mutations in a single gene.
  • Multi-omics

    Research involving the analysis of ‘omics’ data including genomics, transcriptomics, proteomics, metabolomics and epigenomics. This holistic approach enables researchers to discover complex relationships and mechanisms within biological systems.
  • Obesogenic environment

    A set of circumstances that increases the likelihood of an individual developing overweight or obesity.
  • Pathogenic pathways

    A sequence of biological events and interactions that lead to the development and progression of disease.
  • Precision medicine

    An approach to healthcare based on tailoring treatments to the specific characteristics of an individual including their genetic makeup, lifestyle, and environmental factors.
  • Primary prevention

    A strategy aimed at preventing a disease or medical condition in healthy individuals.
  • Polygenic

    A trait or characteristic influenced by multiple genes.
  • Secondary prevention

    A strategy to detect and intervene in individuals at risk of, or have, the early stages of a disease or medical condition. The aim is to manage the condition before it becomes more severe.
  • Transomic Analyses

    A complex technique used to understand more about how specific genes are turned on or off in response to biological, environmental and disease-related factors.
  • Whole exome sequencing

    A powerful and widely used genetic sequencing technique in genomics research and clinical genetics. It enables researchers to identify disease-causing mutations and understand more about the genetic basis of disease.

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Clinical Trials

Clinical Trials

The Obelisk project includes three clinical trials that aim to provide evidence for new models for selective prevention and therapeutic interventions for childhood obesity. All trials are consolidated within work package (WP) 5 - 4P Strategies for children with obesity (Prediction, Prevention, Precision, and Participation).
We will conduct the three trials in accordance with the Consolidated Standards of Reporting Trials (CONSORT). These trials will include per protocol and Intention to Treat (ITT) analyses to avoid bias caused by drop-out (selection bias), which is a common issue with interventions and outcomes. Our protocols will adhere to the principles of ethnicity, gender, feasibility, and generalisability provided by WP2 (Ethical, Legal and Social Implications (ELSI) & Policies). Additionally, we will pre-register all trials on clinicaltrials.gov and make their detailed protocols and ongoing results publicly available on the Obelisk website.

Trial 1

Targeted Prevention of Early Obesity - TAPE-Obesity Trial

This study is a randomised controlled trial that assesses the impact of a targeted programme for parents of newborns.

The intervention arm will receive comprehensive education and follow-up if their newborn scores in the top third (33%) of the Childhood Obesity Risk Score (COBRISC), a tool generated in WP3 (Transomic Analyses and Artificial Intelligence). Additionally, all parents of the intervention arm will have access to an interactive educational website, regardless of their newborn’s risk score.

In contrast, the control arm will not receive any intervention, regardless of their newborn's COBRISC category.

In phase 1 of TAPE-Obesity, the following endpoints will be evaluated:

Primary: The percentage of children on an obesity trajectory at three years of age (using the definition developed in WP1 - Cohorts and Trajectories) in the intervention arm compared to the comparator arm.

Secondary: To compare the percentage of children in the at-risk group who are on an obesity trajectory at three years of age between the intervention arm and the comparator arm. Additionally, physical activity and sedentary behaviour will be measured using the EY-PAQ questionnaire at 1.5 years of age. The Infant Feeding Styles Questionnaire (IFSQ) will be used to assess responsive feeding at 1.5 years of age, while dietary composition will be evaluated at three years of age using a dietary diary and food frequency questionnaire.

The study will continue beyond the Obelisk time frame, with further measurements conducted at six and ten years of age.

Partners involved:


Trial 2

Empowering Adolescents with Obesity to Unite for a Better Society - ADOBESIF Trial

This is a randomised controlled trial for adolescents aged between 12 to 15 years old with obesity from families with low incomes, conducted by two centres (the University of Verona and the University of Messina). The trial will evaluate two out-of-hospital interventions in addition to conventional treatment and follow-up. The trial has three arms:

Intervention Arm 1 will benefit from a nutritional follow-up at the tertiary centre (four visits) and a seven-month physical activity/self-esteem boosting programme (September-April) that includes remote group hip-hop sessions (dance), followed by two months (May-June) of in-person group hip-hop sessions. The intervention culminates in a final recital and the recording of an awareness-raising video against stigma/discrimination for large-scale dissemination.

Intervention Arm 2 will benefit from the nutritional follow-up and hip-hop package provided in arm 1, plus the weekly supply of a pack of healthy foods for the teenager’s family, with fast, healthy recipes tailored to the family’s preferences and habits.

The Control Arm will benefit from the nutritional follow-up only.

The parents from each family will answer questionnaires that will give us a detailed understanding of their socioeconomic status (such as their education level, occupation, and access to resources) and their attitudes (i.e. risk aversion, loss aversion and intertemporal preferences). Additionally, they will share their food shopping receipts from two months prior to recruitment and the last two months of the study period.

The following endpoints will be evaluated:

Primary: z-BMI score change after nine months of treatment; weight self-stigma (WSS-Questionnaire), perceived weight discrimination (PWD-questionnaire), quality of life (QoL-questionnaire), drop-out rate, treatment and food-related costs for families, for subsequent cost/effectiveness analysis.

Secondary: Nutritional patterns (FFQ), HbA1c and lipids (point of care measurements) and blood pressure.

Partners involved


Trial 3

Real-life Evaluation of Semaglutide Treatment in Adults with Monogenic Obesity – ObGeSema Trial

This trial is an observational study of the effects of Semaglutide (WEGOVY®) on weight change in adults with monogenic obesity, overseen by The Public Hospital of Paris (AP-HP). It will take place during the "early access programme" prior to the product's official marketing approval in France. The study will be conducted in a real-life setting, with patients receiving usual care. The AP-HP will work with the French Obesity Research Centre of Excellence (FORCE) to recruit patients, utilising their network of specialised obesity centres (Centres Spécialisés de l’ Obésité - CSO) to support the trial.

The aim is to evaluate the efficacy, tolerability, and safety of Semaglutide over a one-year period.

The primary objective is to verify that semaglutide is equally effective for this specific group of people and has the same tolerability and safety as it does for patients with common obesity. The primary endpoint measure will be assessing the change in weight and BMI from the beginning of the study to the end of the first year.

As a secondary objective, we will evaluate the efficacy, tolerability, and safety of the drug over a period of 2 to 3 years. Additionally, we will assess changes in eating behaviour, quality of life, and anxiety and depression scores. We will also examine how baseline factors such as socioeconomic status, physical activity level, age, baseline BMI, and type of genetic mutation may affect the drug's efficacy.

It is expected that adolescents may be granted early access to the treatment within the next two years. This will enable us to evaluate the effectiveness of the treatment earlier in the disease's natural progression.

Partners involved

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Work Packages

Work Packages

Obelisk has a five-year work plan comprising eight interconnected work packages (WPs).

WP1 Cohorts & Trajectories

Implementation of a harmonised and FAIR repertoire of longitudinal cohorts for trajectory analysis, multi-omics, and economics.

WP1 combines data management and longitudinal modelling to:

  • Guide and organise FAIR* data management from cohorts and other relevant clinical studies to support harmonisation and comparability for the study of childhood obesity trajectories.

  • Provide life course and micro-simulation models that inform the long-term health and economic consequences of childhood obesity trajectories. The epidemiological and economic forecasting will include counterfactual components to inform on the impact of childhood precision medicine throughout life.
*FAIR data meet the principles of Findability, Accessibility, Interoperability, and Reusability.

WP1 Objectives:

  • Manage Obelisk data and expand a European catalogue of longitudinal cohorts and clinical studies, focusing on childhood obesity and incorporating biological, social, economic, and health-related variables.
  • Harmonise methods of developing child growth trajectories by sex and ethnicity using repeated height, weight, and body composition measures from birth onwards.
  • Using the data collected from the first objective and the trajectories derived from the second objective, we will apply a life course approach that blends econometrics and epidemiological methods for causal modelling to identify the health and economic costs associated with childhood obesity at different stages of life, based on the polygenic and socioeconomic risk at birth.
  • Utilising data from the first objective and the trajectories derived from the second objective, use dynamic micro-simulation models to propose different preventive scenarios for public health and policy planning.

WP1 Lead:

Partners Involved:


WP2 Ethical, Legal and Social Implications (ELSI) & Policies

ELSI of predictive models for intervening on childhood obesity.

WP2 will support the ethical development and implementation of preventive interventions for childhood obesity.

WP2 Objectives:

  • Integrate the consideration of ethical issues throughout the duration of the project.
  • Undertake a literature and policy review to systematically identify ELSI regarding preventative measures for childhood obesity and policy-based options.
  • Explore critical stakeholders’ views and experiences regarding preventative measures for childhood obesity.
  • Develop ethical recommendations as an ELSI-specific policy brief.

WP2 Lead:

Partners Involved:


WP3 Transomic Analyses & AI

Pathogenic pathways and molecular/environmental interactions. Implementation of predictive models for obesity.

WP3 aims to:

  • Develop and use multi-omics analyses to provide novel insights into the complex pathogenic basis of childhood obesity, including sex/environmental interactions.

  • Deliver accurate and cost-efficient tools to predict childhood obesity at neonatal/infancy ages.

WP3 Objectives:

  • Produce and integrate multi-omics data in Obelisk cohorts.
  • Identify pathogenic pathways related to childhood obesity and characterise these clusters in humans.
  • Evaluate the causal impact of obesity risk factors.
  • Dissect the molecular mechanisms involved in these pathways using preclinical models.
  • Develop a tool (COBRISC: Childhood Obesity Risk Score) which can predict obesity development in children for use in clinical practice.

WP3 Lead:

Partners Involved:


WP4 New Genes

Exploration of genetic aetiologies of childhood obesity & the discovery of novel rare genetic forms of obesity.

WP4 aims to investigate the genetic aetiologies in individuals with obesity who are participating in the Obelisk interventions (WP5). Through this research, we can uncover new and uncommon genetic types of obesity, which could potentially reveal new targets for drug development.

WP4 Objectives:

  • Perform whole-exome sequencing data in all trial participants with obesity recruited in WP5.
  • Perform molecular diagnosis using the gold-standard guidelines.
  • Perform precision medicine in the carriers of pathogenic mutations in actionable genes.
  • Identify new genes involved in monogenic obesity and decipher their functional role.

WP4 Lead:

Partners Involved:


WP5 4P Strategies for Children with Obesity

(Prediction, Prevention, Precision, and Participation)

WP5 will demonstrate the safety and efficacy of novel approaches for preventing childhood obesity (primary prevention) or providing care to children and adolescents with obesity (secondary prevention). This will highlight novel approaches that can be implemented to achieve these objectives.

WP5 Objectives:

  • Demonstrate the safety and efficacy of a targeted prevention programme in decreasing the prevalence of obesity in preschool children and school-age children by providing comprehensive support and follow-up care from infancy to age 10. The focus will be on children who are at risk of developing obesity, as determined by the COBRISC score.
  • Demonstrate the safety, efficacy and cost-effectiveness of a programme designed to treat obesity, reduce perceived stigma related to obesity, and improve compliance with treatment follow-up among teenagers from low-income families. The programme involves remote hip-hop group sessions that culminate in the creation and sharing of music videos by the group. Alternatively, it may include a weekly supply of individually tailored healthy foods and recipes for the patient's family, along with the hip-hop element.
  • Demonstrate the safety, tolerability, and efficacy of treating patients with severe, early-onset monogenic obesity with the GLP-1 agonist semaglutide.

WP5 Lead:

Partners Involved:


WP6 Dissemination, Exploitation & Education

WP6 aims to maximise the impact of Obelisk by implementing an integrated communication strategy, disseminating results effectively, and translating research into key exploitable outcomes. This includes developing new evidence-based guidelines for policymakers to use.

WP6 Objectives:

  • Create and implement a plan for disseminating and exploiting the results of Obelisk.
  • Establish and execute the communication strategy of Obelisk, including creating key messages and tools.
  • Educate and share information to translate and apply the results.
  • Publish evidence-based policy guidelines.
  • Manage and implement the exploitation of Obelisk results.

WP6 Lead:

Partners Involved:


WP7 Management

The overall objective of WP7 is to provide efficient management and coordination of the project and the consortium and to ensure the progress of the project towards its planned objectives.

WP7 Objectives:

  • To provide efficient management and administration of the project, whilst fulfilling all legal requirements.
  • To act as the interface between Obelisk and the European Commission, and establish a functional management structure to ensure fruitful interaction among the partners, efficient communication, and smooth reporting.
  • To provide assistance and advice to the project partners regarding administration and reporting.
  • To develop and maintain the Data Management Plan.

WP7 Lead:

Partners Involved:


WP8 Ethics

The objective is to ensure compliance with the 'ethics requirements' set out in this work package.

WP8 Lead:

Partners Involved:

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Research

Research

Our Research Objectives

The Obelisk research teams aim to:
  • Explore the molecular mechanisms that cause or prevent the transition from normal weight to overweight or obesity during infancy, childhood, and adolescence, and investigate how causal or associated factors interact in this process.
  • Develop and exploit COBRISC (Childhood Obesity Risk Score), a tool that can predict the likelihood of early onset childhood obesity more accurately than previous tools developed by Obelisk partners. COBRISC will use various information from Obelisk research, including molecular, familial, clinical, social, and environmental factors, to create a comprehensive risk score. This new generation of predictive models will be essential in preventing and treating childhood obesity.
  • Identify and analyse at least three new genes related to childhood obesity, building on recent discoveries made by Obelisk partners. By doing this, we hope to find new targets for drugs that can complement ones previously discovered.
  • To prevent childhood obesity in high-risk infants, identified using COBRISC, we will use targeted interventions based on the ELSI (ethical, legal and social implications)-by-Design 4P approach, considering vulnerable groups, gender, and socio-economic status. Additionally, we will implement cost-effective management programmes to treat obesity, decrease early obesity trajectories by 25%, achieve a 25% "recovery" among treated adolescents, and reduce adolescent treatment dropouts by 50%. Our overall success will be measured by a 35% decrease in the number of children with obesity who become adults with obesity.
  • Advance non-surgical treatments for obesity by evaluating the effectiveness of an existing drug, an agonist for Glucagon Like Peptide 1 receptor [GLP1R], in reversing childhood-onset obesity. The target will be patients with pathogenic mutations in genes known to cause obesity.
  • Disseminate and exploit best practices and policy guidelines based on the Obelisk results to prevent and treat childhood obesity. This includes education programs for the European population, patients with obesity and their families, health professionals, and researchers. Evidence-based guidelines and proposals will be shared with policymakers to improve obesity care. Additionally, Obelisk partners will facilitate networking and knowledge sharing with other projects to optimise results and develop joint activities.

Work Packages

Obelisk research is defined by eight work packages (WP) to meet these objectives, bringing together expert teams from across Europe.

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Obelisk Results

Obelisk will produce several Key Exploitable Results, which are significant outputs from the research. These results will be disseminated to the scientific community, healthcare practitioners, European citizens, and policymakers, with varying distribution levels depending on their commercial sensitivity. They include:
  • Data catalogue and meta-review on the development of obesity, which includes social elements.
  • Well-defined childhood obesity trajectories.
  • Microsimulation models with health, social and economic outcomes.
  • ELSI-specific policy database and policy brief.
  • Novel prediction tool (Childhood Obesity Risk Score - COBRISC) and new biomarkers.
  • Novel genomic markers to diagnose and/or predict monogenic obesity in clinical practice.
  • New genes as targets for drug development.
  • Real-life evaluation of semaglutide treatment in patients with monogenic obesity.
  • Innovative and cost-effective intervention models that offer selective programmes to prevent or treat obesity. These programmes aim to decrease obesity-related perceived stigma and improve adherence for vulnerable groups, such as infants and children with high biological and/or socio-cultural risk of developing obesity, as well as adolescents with obesity from low-income families.
  • Educational tools for healthcare professionals and EU citizens.
  • Evidence-based policy guidelines for preventing and treating childhood obesity, including cost-benefit analysis.

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Partners

Obelisk Partners

The Obelisk project includes 15 partners from universities, research institutions and small and medium-sized enterprises from across nine European countries.

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