Study Consortium for Evaluation of RNPC Program in Obese and Overweight Patients (SCOOP-RNPC)

Groupe Éthique et Santé

Status: Not yet enrolling

Conditions: NASH; Sleep Apnea, Obstructive; Overweight and Obesity; Cardiovascular Diseases; NAFLD; Metabolic Disease; Diabete Type 2

Treatments: Behavioral: Nutritional Psycho-Behavioral Reeducation Program

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05857319

2022-A01599-34

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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;
• People with an open wound or bleeding on the palms of the hands or soles of the feet (Neuropathy group only).

Trial design

10,000 participants in 4 patient groups

General Cohort

Description:

The General Cohort includes all participants of the study. These are enrolled in the RNPC Program and will provide clinical and biological data usually collected in the RNPC centers, enriched by data from additional clinical and biological examinations as well as by self-questionnaires completed by the participants.

Connected Objects Group

Description:

Depending on the RNPC center in which the participant is followed, he/she will be offered to be part of the Connected Objects subgroup, with specific additional examinations on inclusion as well as at certain key times of the intervention: * Measurement of anthropometric parameters and evaluation of arterial stiffness using the Body Cardio connected scale (Withings). * Sleep evaluation using the Sleep Analyzer (Withings); Measurements taken at the participant's home.

Treatment:

Behavioral: Nutritional Psycho-Behavioral Reeducation Program

Obstructive Sleep Apnea Syndrome (OSAS) Group

Description:

Depending on the RNPC center in which the participant is followed, he/she will be offered to be part of the OSAS subgroup, with specific additional examinations on inclusion as well as at certain key times of the intervention: * Sleep assessment and diagnosis of OSAS (if applicable) via the Sunrise device. Measurements taken at the participant's home.

Treatment:

Behavioral: Nutritional Psycho-Behavioral Reeducation Program

Neuropathies Group

Description:

Depending on the RNPC center in which the participant is followed, he/she will be offered to be part of the Neuropathies subgroup, with specific additional examinations at each visit: * Detection of diabetic neuropathies using SUDOSCAN/EZSCAN technology (Withings). Measurements taken at the center.

Treatment:

Behavioral: Nutritional Psycho-Behavioral Reeducation Program