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

Official title

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

Overview

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.

Interventions

• Behavioral Nutritional Psycho-Behavioral Reeducation Program
  The RNPC Program is based on a clinical protocol in three successive phases: 1. A weight loss phase during which food intake is restricted to 800-1000 kcal per day, with a nutrient distribution of 60% protein, 25% carbohydrates and 15% lipids. Patients eat two meals a day consisting of meat/fish/eggs/shellfish and vegetables, supplemented by products enriched in proteins, vitamins and minerals, and depleted in carbohydrates and lipids. 2. A stabilization phase specifically established for each

Primary outcome measures

• Effectiveness of the national RNPC weight reduction program on the change of treatments (drug or instrumental treatments) or in the comorbidities of overweight/obesity. [Time frame: Assessed at baseline, after the first phase of the intervention, after the second phase of the intervention, and every year after completion of the intervention for 5 years.]

Secondary outcome measures (12)

• Weight [Time frame: Data collected through study completion for 5 years.]
• Body mass index (BMI) [Time frame: Data collected through study completion for 5 years.]
• Waist circumference [Time frame: Data collected through study completion for 5 years.]
• Hip circumference [Time frame: Data collected through study completion for 5 years.]
• Waist-to-hip circumference ratio [Time frame: Data collected through study completion for 5 years.]
• Neck circumference [Time frame: Data collected through study completion for 5 years.]
• Muscle mass percentage [Time frame: Data collected through study completion for 5 years.]
• Fat mass percentage [Time frame: Data collected through study completion for 5 years.]
• Water mass percentage [Time frame: Data collected through study completion for 5 years.]
• Percentage of participants who changed BMI category at the end of each phase of the RNPC program. [Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.]
• Pain assessment [Time frame: Data collected through study completion for 5 years.]
• Fasting glycemia [Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Fabre O, Bailly S, Mithieux G, Legrand R, Costentin C, Astrup A, Pepin JL. Long-term trajectories of weight loss and health outcomes: protocol of the SCOOP-RNPC nationwide observational study. BMJ Open. 2024 Jul 11;14(7):e082575. doi: 10.1136/bmjopen-2023-082575. PMID 38991672

Identifiers

NCT: NCT05857319 · 2022-A01599-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗