Clinical trial NCT05857319: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Overweight and Obesity
Cardiovascular Diseases
Metabolic Disease
Diabete Type 2
Sleep Apnea, Obstructive
NAFLD
NASH
Keywords: Prospective Interventional Study
Real-Life Conditions
RNPC Program
Lead sponsor: Groupe Éthique et Santé
Sponsor class: INDUSTRY
Collaborators: name: University Grenoble Alps
name: Novo Nordisk A/S
name: Lyon Est University
First posted: 2023-05-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


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).

Primary outcomes:
measure: Effectiveness of the national RNPC weight reduction program on the change of treatments (drug or instrumental treatments) or in the comorbidities of overweight/obesity.
timeFrame: 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 outcomes:
measure: Weight
timeFrame: Data collected through study completion for 5 years.
measure: Body mass index (BMI)
timeFrame: Data collected through study completion for 5 years.
measure: Waist circumference
timeFrame: Data collected through study completion for 5 years.
measure: Hip circumference
timeFrame: Data collected through study completion for 5 years.
measure: Waist-to-hip circumference ratio
timeFrame: Data collected through study completion for 5 years.
measure: Neck circumference
timeFrame: Data collected through study completion for 5 years.
measure: Muscle mass percentage
timeFrame: Data collected through study completion for 5 years.
measure: Fat mass percentage
timeFrame: Data collected through study completion for 5 years.
measure: Water mass percentage
timeFrame: Data collected through study completion for 5 years.
measure: Percentage of participants who changed BMI category at the end of each phase of the RNPC program.
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Pain assessment
timeFrame: Data collected through study completion for 5 years.
measure: Fasting glycemia
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Fasting insulinemia
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: HbA1c percentage
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: HOMA-IR index
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: TyG index
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: QUICKI
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of total cholesterol
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of HDL-cholesterol
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of LDL-cholesterol
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of triglycerides
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: SCORE2/SCORE2-OP score
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Changes in the presence or not of a metabolic syndrome
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of ALAT
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of ASAT
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Ferritinemia
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: FibroMeter score
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of GGT
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Creatininemia
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Creatininuria
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Microalbuminuria
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: MDRD score
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Albumin-creatinine ratio
timeFrame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Levels of plasma amino acids (glutamine, glutamate and alanine)
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of lactate
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of pyruvate
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of glycerol
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Level of fatty acids
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Blood pressure
timeFrame: Data collected through study completion for 5 years.
measure: Score to the Epworth Sleepiness Scale (ESS) questionnaire
timeFrame: Questionnaire completed 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.
measure: Score to the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: Questionnaire completed 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.
measure: Score to the Insomnia Severity Index (ISI) questionnaire
timeFrame: Questionnaire completed 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.
measure: Score to the Chronotype questionnaire
timeFrame: Questionnaire completed at baseline.
measure: Evolution of Obstructive Sleep Apnea Syndrome (OSAS)
timeFrame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Score to the 5-level EQ-5D version (EQ-5D-5L) questionnaire
timeFrame: Questionnaire completed 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.
measure: Score to the EQVOD ('Échelle de Qualité de Vie, Obésité et Diététique') French questionnaire
timeFrame: Questionnaire completed 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.
measure: Score to the Food Frequency Questionnaire (FFQ)
timeFrame: Questionnaire completed at baseline.
measure: Score to the Three-Factor Eating Questionnaire (TFEQ)
timeFrame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Score to the Hospital Anxiety and Depression (HAD) scale
timeFrame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Score to the Perceived Stress Scale (PSS)
timeFrame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Responses to the general questionnaire
timeFrame: Questionnaire completed at baseline and every year after completion of the intervention for 5 years.
measure: Arterial stiffness
timeFrame: Data collected at baseline, after having lost 10% of initial body weight, after the first phase of the intervention and after the second phase of the intervention, at least.
measure: Prevalence of peripheral neuropathies at the start of the intervention
timeFrame: Data collected at baseline.
measure: Evolution of peripheral neuropathies
timeFrame: Data collected at baseline, after having lost 10% of initial body weight, after the first phase of the intervention and after the second phase of the intervention, at least.
measure: Score to the Baecke questionnaire
timeFrame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
measure: Distance traveled (by foot) per week
timeFrame: Data collected through study completion for 5 years.
measure: Number of steps per week
timeFrame: Data collected through study completion for 5 years.
measure: Dropout rate
timeFrame: Assessed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Grenoble Alpes University, INSERM U1300
name: Jean-Louis Pépin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obesity and Nutritional Sciences, Novo Nordisk Foundation
name: Arne Astrup, MD, PhD
role: STUDY_CHAIR
affiliation: Lyon Est University, INSERM U1213
name: Gilles Mithieux, PhD
role: STUDY_CHAIR
References: