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.
Study Type
OBSERVATIONAL
Enrollment
10,000
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.
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).
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.
Weight
Weight in kilograms (kg) of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Body mass index (BMI)
BMI, calculated according to the formula: \[weight (in kg) ÷ height x height (in meters)\], of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Waist circumference
Waist circumference (in centimeters) of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Hip circumference
Hip circumference (in centimeters) of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Waist-to-hip circumference ratio
Waist-to-hip circumference ratio of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Neck circumference
Neck circumference (in centimeters) of identified subgroups, defined according to the comorbidities initially present (i.e. before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Muscle mass percentage
Muscle mass percentage of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Fat mass percentage
Fat mass percentage of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
Time frame: Data collected through study completion for 5 years.
Water mass percentage
Water mass percentage of identified subgroups, defined according to the comorbidities initially present (i.e., before the start of the intervention; arterial hypertension, glucose intolerance, type 2 diabetes, dyslipidemia, OSAS) and the level of initial BMI.
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.
BMI category is determined at the initial visit, at the end of the weight loss phase and at the end of the stabilization phase. The following BMI categories will be considered: \< 25 kg/m², ≥ 25 and \< 30 kg/m², ≥ 30 and \< 35 kg/m², ≥ 35 and \< 40 kg/m², ≥ 40 kg/m².
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Pain assessment
Pain will be assessed by the dietitian using a visual analogue scale (VAS), with a score from 0 to 10.
Time frame: Data collected through study completion for 5 years.
Fasting glycemia
Fasting glycemia in g/L.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Fasting insulinemia
Fasting insulinemia in mUI/L.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
HbA1c percentage
Hemoglobin A1c (HbA1c; glycated hemoglobin), only in participants with type 2 diabetes.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
HOMA-IR index
HOMA-IR (homeostasis model assessment of insulin resistance) index is calculated according to the formula: \[fasting insulinemia (microU/L) x fasting glycemia (nmol/L) / 22.5\].
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
TyG index
TyG (triglyceride-glucose) index is calculated according to the formula: \[ln (triglyceridemia in g/L) x (fasting glycemia in g/L) / 2\].
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
QUICKI
QUICKI (quantitative insulin sensitivity check index) is calculated according to the formula: \[1 / (log fasting insulinemia in mIU/L) + (log fasting glycemia in g/L)\].
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of total cholesterol
Dosage of total cholesterol (in g/L) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of HDL-cholesterol
Dosage of HDL-cholesterol (in g/L) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of LDL-cholesterol
Dosage of LDL-cholesterol (in g/L) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of triglycerides
Dosage of triglycerides (in g/L) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
SCORE2/SCORE2-OP score
Calculation of SCORE2 (or SCORE2-OP for people aged ≥ 70 years) score, for evaluation of the overall cardiovascular risk score over 10 years, is based on the following biological parameters: * Age (year); * Systolic blood pressure (mm Hg); * Level of total cholesterol (g/L); * Level of HDL-cholesterol (g/L); * Blood pressure medication (yes or no); * Cigarette smoker (yes or no); * Diabetes present or not.
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Changes in the presence or not of a metabolic syndrome
Criteria for metabolic syndrome were determined by the International Diabetes Federation in 2005: Waist circumference ≥ 94 cm (men) and ≥ 80 cm (women), plus at least 2 of the following criteria: * Fasting glycemia ≥ 1 g/L and/or diagnosis of diabetes and/or treatment for diabetes; * Level of HDL cholesterol \< 0.4 g/L (men) and \< 0.5 g/L (women) or specific treatment for this lipid disorder; * Triglyceridemia ≥ 1.5 g/L or specific treatment for this lipid disorder; * Blood pressure ≥ 130/85 mm Hg (≥ 130/80 mm Hg if diabetes) and/or treatment for high blood pressure.
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of ALAT
Dosage of ALAT (alanine aminotransferase; in UI/L) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of ASAT
Dosage of ASAT (alanine aminotransferase) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Ferritinemia
Dosage of ferritin (in ng/mL) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
FibroMeter score
Calculation of FibroMeter score is based on the following biological parameters: * Platelet count (G/L); * ALAT (UI/L); * ASAT (UI/L); * Fasting glycemia (g/L); * Ferritinemia.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of GGT
Dosage of GGT (gamma-glutamyl transferase; in g/L) in blood samples.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Creatininemia
Creatininemia in mg/L.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Creatininuria
Creatininuria (in mg/L), dosed on a single sample of urine from the first urination in the morning.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Microalbuminuria
Microalbuminuria (in mg/L), dosed on a single sample of urine from the first urination in the morning.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
MDRD score
MDRD (modification of diet in renal disease) score is calculated according to the formula: \[186 x (creatininemia in mg/L/88.4) x (Age) x (0.742 if female) x (1.210 if black)\].
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Albumin-creatinine ratio
Urinary albumin-creatinine ratio.
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Levels of plasma amino acids (glutamine, glutamate and alanine)
Dosage of Plasma amino acids (glutamine, glutamate and alanine; in µmol/L). Intestinal and hepatic gluconeogenesis will be evaluated by quantitative determination of plasma amino acids (glutamine, glutamate and alanine), associated with the determination of lactate, pyruvate, glycerol and fatty acid levels.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of lactate
Dosage of lactate (in mg/L) in blood samples. Intestinal and hepatic gluconeogenesis will be evaluated by quantitative determination of plasma amino acids (glutamine, glutamate and alanine), associated with the determination of lactate, pyruvate, glycerol and fatty acid levels.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of pyruvate
Dosage of pyruvate (in mg/L) in blood samples. Intestinal and hepatic gluconeogenesis will be evaluated by quantitative determination of plasma amino acids (glutamine, glutamate and alanine), associated with the determination of lactate, pyruvate, glycerol and fatty acid levels.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of glycerol
Dosage of glycerol (in mg/L) in blood samples. Intestinal and hepatic gluconeogenesis will be evaluated by quantitative determination of plasma amino acids (glutamine, glutamate and alanine), associated with the determination of lactate, pyruvate, glycerol and fatty acid levels.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of fatty acids
Dosage of fatty acids in blood samples. Intestinal and hepatic gluconeogenesis will be evaluated by quantitative determination of plasma amino acids (glutamine, glutamate and alanine), associated with the determination of lactate, pyruvate, glycerol and fatty acid levels.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Blood pressure
Measurement of systolic and diastolic blood pressure (in mm Hg).
Time frame: Data collected through study completion for 5 years.
Score to the Epworth Sleepiness Scale (ESS) questionnaire
Score calculated from participants' responses to the sleep-related self-administered questionnaire Epworth Sleepiness Scale (ESS), completed online, between two visits to the RNPC center.
Time frame: 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.
Score to the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Score calculated from participants' responses to the sleep-related self-administered questionnaire Pittsburgh Sleep Quality Index (PSQI), completed online, between two visits to the RNPC center.
Time frame: 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.
Score to the Insomnia Severity Index (ISI) questionnaire
Score calculated from participants' responses to the sleep-related self-administered questionnaire Insomnia Severity Index (ISI), completed online, between two visits to the RNPC center.
Time frame: 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.
Score to the Chronotype questionnaire
Score calculated from participants' responses to the self-administered Chronotype questionnaire, completed online, between two visits to the RNPC center.
Time frame: Questionnaire completed at baseline.
Evolution of Obstructive Sleep Apnea Syndrome (OSAS)
OSAS is defined according to the apnea-hypopnea index (AHI), collected by connected devices (Sleep Analyzer and Sunrise). Only participants in the Connected Objects group and in the OSAS group will be concerned.
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Score to the 5-level EQ-5D version (EQ-5D-5L) questionnaire
Score calculated from participants' responses to the quality-of-life EQ-5D version (EQ-5D-5L) self-administered questionnaire, completed online, between two visits to the RNPC center.
Time frame: 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.
Score to the EQVOD ('Échelle de Qualité de Vie, Obésité et Diététique') French questionnaire
Score calculated from participants' responses to the quality-of-life EQVOD French self-administered questionnaire, completed online, between two visits to the RNPC center.
Time frame: 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.
Score to the Food Frequency Questionnaire (FFQ)
Score calculated from participants' responses to the eating habits-related Food Frequency Questionnaire (FFQ) self-administered questionnaire, completed online, between two visits to the RNPC center.
Time frame: Questionnaire completed at baseline.
Score to the Three-Factor Eating Questionnaire (TFEQ)
Score calculated from participants' responses to the eating behavior-related Three-Factor Eating Questionnaire (TFEQ) self-administered questionnaire, completed online, between two visits to the RNPC center.
Time frame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Score to the Hospital Anxiety and Depression (HAD) scale
Score calculated from participants' responses to the stress, anxiety and depression-related Hospital Anxiety and Depression (HAD) scale, self-administered and completed online, between two visits to the RNPC center.
Time frame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Score to the Perceived Stress Scale (PSS)
Score calculated from participants' responses to stress-related Perceived Stress Scale (PSS) self-administered questionnaire, completed online, between two visits to the RNPC center.
Time frame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Responses to the general questionnaire
Responses collected from a general questionnaire (information about socio-cultural level, life environment, family and social life, married life, etc.), completed online, between two visits to the RNPC center.
Time frame: Questionnaire completed at baseline and every year after completion of the intervention for 5 years.
Arterial stiffness
Arterial stiffness will be assessed by measuring pulse wave velocity (PWV), data collected regularly by the Body Cardio connected scale. Only participants in the Connected Objects group will be concerned.
Time frame: 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.
Prevalence of peripheral neuropathies at the start of the intervention
The SUDOSCAN device provides results as conductances of the feet and hands (in microsiemens; with the average of the left and right sides). High conductance levels are correlated with normal sweat function and healthy innervation (small C-fibers). Low conductances represent peripheral autonomic neuropathy. The EZSCAN risk score (classified in quadrants: at risk/moderate/no risk, with a color code) determined from these measures indicates the risk of developing diabetes. Only participants in the Neuropathies group will be concerned.
Time frame: Data collected at baseline.
Evolution of peripheral neuropathies
The SUDOSCAN device provides results as conductances of the feet and hands (in microsiemens; with the average of the left and right sides). High conductance levels are correlated with normal sweat function and healthy innervation (small C-fibers). Low conductances represent peripheral autonomic neuropathy. The EZSCAN risk score (classified in quadrants: at risk/moderate/no risk, with a color code) determined from these measures indicates the risk of developing diabetes. Only participants in the Neuropathies group will be concerned.
Time frame: 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.
Score to the Baecke questionnaire
Score calculated from participants' responses to the physical-activity-related Baecke self-administered questionnaire, completed online between two visits to the RNPC center.
Time frame: Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Distance traveled (by foot) per week
The dietician will collect, directly from the pedometer application of the participant's smartphone, the distance traveled by foot (in meters) of the past week.
Time frame: Data collected through study completion for 5 years.
Number of steps per week
The dietician will collect, directly from the pedometer application of the participant's smartphone, the number of steps of the past week.
Time frame: Data collected through study completion for 5 years.
Dropout rate
Drop-out of participants (who stopped the weight loss program before the end of the stabilization phase) during the intervention in all subgroups.
Time frame: Assessed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
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