NCT05857319Not yet recruiting
Study Consortium for Evaluation of RNPC Program in Obese and Overweight Patients (SCOOP-RNPC)
Assessment of the Impact of Short, Medium and Long-term Weight Loss, Obtained by a Standardized Nutritional and Psycho-Behavioral Rehabilitation Program (RNPC Program) and in Real Life Conditions, in Obese or Overweight Patients
Source: ClinicalTrials.gov · Last updated 12 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 29 Mar 2023
- Start date
- 15 Jul 2023
- Primary completion date
- 15 Jul 2030
- Lead sponsor
- Groupe Éthique et Santé
- NCT number
- NCT05857319
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 15 Jul 2023 to the primary completion date, 15 Jul 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- People with an electrical medical device such as a pacemaker, battery, insulin pump or cochlear implant;
Other illness
- People with an open wound or bleeding on the palms of the hands or soles of the feet (Neuropathy group only).
Other
- Persons refusing to sign the participation consent;
- Pregnant, parturient and breastfeeding women;
- Persons with missing limb(s);
- People carrying any metallic material present in the body, such as prostheses or screws;
- Persons under guardianship;
- Subject in period of exclusion from another study;
- Person deprived of liberty by judicial or administrative decision;
- Person subject to a legal protection measure, who cannot be included in clinical trials;
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.