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

Cardiovascular Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05857319
• Other study ID #: 2022-A01599-34
• Status: Not yet recruiting
• Start date: July 15, 2023
• Est. completion date: July 15, 2030

Study information

• Verified date: May 2023
• Source: Groupe Éthique et Santé
• Contact: Odile Fabre, PharmD, PhD
• Phone: 0491434985
• Email: odile.fabre[@]ge-sante.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: July 15, 2030
• Est. primary completion date: July 15, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Nutritional Psycho-Behavioral Reeducation Program
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Groupe Éthique et Santé	Lyon Est University, Novo Nordisk A/S, University Grenoble Alps

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Creatininemia	Creatininemia in mg/L.	Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Blood pressure	Measurement of systolic and diastolic blood pressure (in mm Hg).	Data collected through study completion for 5 years.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.