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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
Sponsor study identifier
observational
10,000
0 countries
N/A
Study Start
July 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 29, 2023
Actual (reported)May 12, 2023
Actual (reported)July 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Effectiveness of the national RNPC weight reduction program on the change of treatments (drug or instrumental treatments) or in the comorbidities of overweight/obesity.
The primary endpoint is defined as the number of participants who had at least one dose change of their initial drug and/or instrumental treatment(s) and/or disappearance of comorbidities of overweight/obesity (indicative list of comorbidities possibly concerned: arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, obstructive sleep apnea syndrome, depression, pain, etc.) at the end of the program (minimum duration of 6 months but not exceeding one year).
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.
Weight
Data collected through study completion for 5 years.
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.
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.
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.
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 patient according to their weight loss and their daily caloric needs, allowing them to gradually return to a balanced diet, with a nutrient distribution of 25% protein, 45% carbohydrates and 30% lipids. During this phase, the consumption of meal supplements gradually decreases. 3. A phase of return to dietary balance, unlimited in time, based on the precepts of the Mediterranean diet. Each patient is followed every 14 days by a dietitian during the entire program.
All new patients committing to follow the RNPC Program in the RNPC investigator centers are potentially eligible for the study and will be offered to participate.
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.
Jean-Louis Pépin, MD, PhD
Grenoble Alpes University, INSERM U1300
Arne Astrup, MD, PhD
Department of Obesity and Nutritional Sciences, Novo Nordisk Foundation
Gilles Mithieux, PhD
Lyon Est University, INSERM U1213
First Submitted
March 29, 2023
First Posted
May 12, 2023
Study Start
July 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 15, 2030
EstimatedBody mass index (BMI)
Data collected through study completion for 5 years.
Waist circumference
Data collected through study completion for 5 years.
Hip circumference
Data collected through study completion for 5 years.
Waist-to-hip circumference ratio
Data collected through study completion for 5 years.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 12, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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