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.
Further information about the TAPE trial can be found on clinicaltrials.gov.
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
