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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Overweight and Obesity, Cardiovascular Diseases, Metabolic Disease, Diabete Type 2, Sleep Apnea, Obstructive, NAFLD, NASH

Intervention / Treatment
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* Behavioral: Nutritional Psycho-Behavioral Reeducation Program


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Cohort<br>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. | |
| Connected Objects Group<br>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. | Behavioral: Nutritional Psycho-Behavioral Reeducation Program<br>* The RNPC Program is based on a clinical protocol in three successive phases: 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. 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. 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.<br>* Other names: RNPC Program;|
| Obstructive Sleep Apnea Syndrome (OSAS) Group<br>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. | Behavioral: Nutritional Psycho-Behavioral Reeducation Program<br>* The RNPC Program is based on a clinical protocol in three successive phases: 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. 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. 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.<br>* Other names: RNPC Program;|
| Neuropathies Group<br>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. | Behavioral: Nutritional Psycho-Behavioral Reeducation Program<br>* The RNPC Program is based on a clinical protocol in three successive phases: 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. 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. 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.<br>* Other names: RNPC Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Data collected through study completion for 5 years. | 
| Fasting glycemia | Fasting glycemia in g/L. | 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. | 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. | 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]. | 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]. | 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)]. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention. | 
| Creatininemia | Creatininemia in mg/L. | 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. | 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. | 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)]. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Assessed collected at baseline, after the first phase of the intervention and after the second phase of the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective Interventional Study, Real-Life Conditions, RNPC Program