NCT05857319: SCOOP-RNPC

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

Not yet recruiting Last updated 12 May 2023

What this trial tests

trial testing Nutritional Psycho-Behavioral Reeducation Program in Overweight and Obesity in 10,000 participants. Not yet recruiting.

Timeline

15 July 2023

Primary endpoint
15 July 2030

15 July 2030

Quick facts

Lead sponsor	Groupe Éthique et Santé
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	15 July 2023
Primary completion	15 July 2030
Estimated completion	15 July 2030

Drugs / interventions tested

• Nutritional Psycho-Behavioral Reeducation Program

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Metabolic Disease — all drugs for Metabolic Disease →
• Diabete Type 2 — all drugs for Diabete Type 2 →

Sponsor

Groupe Éthique et Santé

Who can join

Adults 18 to 85, any sex, with Overweight and Obesity or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Long-term trajectories of weight loss and health outcomes: protocol of the SCOOP-RNPC nationwide observational study.
   Fabre O, Bailly S, Mithieux G, Legrand R, et al · · 2024 · PMID 38991672 · DOI 10.1136/bmjopen-2023-082575