About this trial
The investigators hypothesize that weight loss obtained with the French RNPC weight reduction program is beneficial for the general health of overweight/obese patients in the medium term.
The objective of this cohort study is to demonstrate the effectiveness of the RNPC program on the reduction of drug or instrumental treatments (for example, continuous positive pressure ventilation for the treatment of sleep apnea syndrome) and the improvement of overweight/obesity-associated comorbidities in the medium term.
This is a multicenter clinical study, as part of routine care, with standardized nutritional care (RNPC Program) in all RNPC centers in France. A cohort will be formed based on the clinical and biological data usually collected in the centers, enriched by data from additional clinical and biological examinations as well as by self-questionnaires completed by the participants. About 10,000 overweight or obese participants will be included for 2 years and followed 5 years.
The SCOOP-RNPC study will have benefits for individual participants, for the scientific community in terms of knowledge acquired and for society with a better definition of the impact of treatments.
Responding to the major public health issue represented by overweight, this prospective cohort of overweight or obese patients will make it possible to evaluate, in real-life conditions, the effects of weight loss obtained by the RNPC Program in the short, medium and long term on biological parameters predictive of cardiometabolic risk, drug consumption, quality of life, diet and eating behavior, sleep, physical activity, stress/anxiety, as well as depression.
This cohort will make it possible to identify clinical phenotypes and biomarkers to optimize the personalization of the management of overweight or obese patients, in particular those at risk of developing comorbidities associated with excess weight.
Eligibility criteria
Qualifiers
Body Mass Index (BMI) greater than or equal to 25 kg/m² and/or waist circumference greater than or equal to 80 cm in women and 94 cm in men;
Possessing a personal smartphone;
Subjects subject to the French health system;
Subjects able to sign the informed consent.
Disqualifiers
Persons refusing to sign the participation consent;
Pregnant, parturient and breastfeeding women;
Persons with missing limb(s);
People with an electrical medical device such as a pacemaker, battery, insulin pump or cochlear implant;
Trial design
Treatments tested in this trial
- Nutritional Psycho-Behavioral Reeducation Program
Treatment groups
Locations
Sponsors and collaborators
Groupe Éthique et Santé
Lead sponsor
University Grenoble Alps
Collaborator
Novo Nordisk A/S
Collaborator
Lyon Est University
Collaborator