Overweight and ObesitySCOOP-RNPCNCT05857319

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

An observational study of Overweight and Obesity and Cardiovascular Diseases, run by Groupe Éthique et Santé.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity, Cardiovascular Diseases, Metabolic Disease
What is being tested?: Nutritional Psycho-Behavioral Reeducation Program
Type of treatment: Lifestyle or therapy programme
How many people: 10,000 participants
Where: No sites listed yet
Study dates: 15 Jul 2023to 15 Jul 2030
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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;

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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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Odile Fabre, PharmD, PhD contact

0491434985 ext. 33

odile.fabre@ge-sante.fr

Sébastien Bailly, PharmD, PhD contact

0675759353 ext. 33

sbailly@chu-grenoble.fr

About this study

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

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.

Conditions: Overweight and Obesity, Cardiovascular Diseases, Metabolic Disease, Diabete Type 2, Sleep Apnea, Obstructive, NAFLD
Being tested: Nutritional Psycho-Behavioral Reeducation Program
Keywords: Prospective Interventional Study, Real-Life Conditions, RNPC Program
Medical subject headings: Overweight, Obesity, Cardiovascular Diseases, Metabolic Diseases, Diabetes Mellitus, Type 2, Sleep Apnea, Obstructive, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutritional Psycho-Behavioral Reeducation ProgramBehavioural
Also called RNPC Program
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.

Study groups in NCT05857319
Study group	Role	What they receive
General Cohort		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		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. Receives: Behavioral: Nutritional Psycho-Behavioral Reeducation Program
Obstructive Sleep Apnea Syndrome (OSAS) Group		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. Receives: Behavioral: Nutritional Psycho-Behavioral Reeducation Program
Neuropathies Group		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. Receives: Behavioral: Nutritional Psycho-Behavioral Reeducation Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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 (58)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Data collected through study completion for 5 years.
Fasting glycemia
Fasting glycemia in g/L.
Measured: 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.
Measured: 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.
Measured: 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].
Measured: 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].
Measured: 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)].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Creatininemia
Creatininemia in mg/L.
Measured: 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.
Measured: 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.
Measured: 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)].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202315 Jul 2030

First posted12 May 2023
Study start15 Jul 2023 (estimated)
Primary completion15 Jul 2030 (estimated)
Study completion15 Jul 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 10,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05857319
Sponsor's protocol ID: 2022-A01599-34
Acronym: SCOOP-RNPC
Status last verified: May 2023
First submitted: 29 Mar 2023
Last updated: 12 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Fabre O, Bailly S, Mithieux G, Legrand R, Costentin C, Astrup A, Pepin JL. Long-term trajectories of weight loss and health outcomes: protocol of the SCOOP-RNPC nationwide observational study. BMJ Open. 2024 Jul 11;14(7):e082575. doi: 10.1136/bmjopen-2023-082575.
PubMed 38991672

Interested in taking part?

Odile Fabre, PharmD, PhD

0491434985 ext. 33

odile.fabre@ge-sante.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05857319
Acronym / sponsor ID: SCOOP-RNPC / 2022-A01599-34
Conditions: Overweight and Obesity, Cardiovascular Diseases, Metabolic Disease, Diabete Type 2, Sleep Apnea, Obstructive, NAFLD
Keywords: Prospective Interventional Study, Real-Life Conditions, RNPC Program
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 10,000 participants (estimated)
Lead sponsor: Groupe Éthique et SantéIndustry (pharma, biotech, devices)
Collaborators: University Grenoble Alps, Novo Nordisk A/S, Lyon Est University
Study start: 15 Jul 2023 (estimated)
Primary completion: 15 Jul 2030 (estimated)
Study completion: 15 Jul 2030 (estimated)
First posted: 12 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
General Cohort	–	–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	–	Behavioral: Nutritional Psycho-Behavioral Reeducation ProgramDepending 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.
Obstructive Sleep Apnea Syndrome (OSAS) Group	–	Behavioral: Nutritional Psycho-Behavioral Reeducation ProgramDepending 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.
Neuropathies Group	–	Behavioral: Nutritional Psycho-Behavioral Reeducation ProgramDepending 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nutritional Psycho-Behavioral Reeducation ProgramAlso: RNPC ProgramThe 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.	Behavioural	Connected Objects Group, Neuropathies Group, Obstructive Sleep Apnea Syndrome (OSAS) Group

Primary outcome

Effectiveness of the national RNPC weight reduction program on the change of treatments (drug or instrumental treatments) or in the comorbidities of overweight/obesity.
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.
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).

58 secondary outcomes

Weight
Time frame: Data collected through study completion for 5 years.
Body mass index (BMI)
Time frame: Data collected through study completion for 5 years.
Waist circumference
Time frame: Data collected through study completion for 5 years.
Hip circumference
Time frame: Data collected through study completion for 5 years.
Waist-to-hip circumference ratio
Time frame: Data collected through study completion for 5 years.
Neck circumference
Time frame: Data collected through study completion for 5 years.
Muscle mass percentage
Time frame: Data collected through study completion for 5 years.
Fat mass percentage
Time frame: Data collected through study completion for 5 years.
Water mass percentage
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.
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Pain assessment
Time frame: Data collected through study completion for 5 years.
Fasting glycemia
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Fasting insulinemia
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
HbA1c percentage
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
HOMA-IR index
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
TyG index
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
QUICKI
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of total cholesterol
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
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
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of triglycerides
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
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
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of ALAT
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of ASAT
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Ferritinemia
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
FibroMeter score
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of GGT
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Creatininemia
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Creatininuria
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Microalbuminuria
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
MDRD score
Time frame: Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.
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)
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of lactate
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of pyruvate
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Level of glycerol
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
Time frame: Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.
Blood pressure
Time frame: Data collected through study completion for 5 years.
Score to the Epworth Sleepiness Scale (ESS) questionnaire
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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
Derived from this study: PubMed 38991672Fabre O, Bailly S, Mithieux G, Legrand R, Costentin C, Astrup A, Pepin JL. Long-term trajectories of weight loss and health outcomes: protocol of the SCOOP-RNPC nationwide observational study. BMJ Open. 2024 Jul 11;14(7):e082575. doi: 10.1136/bmjopen-2023-082575.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Odile Fabre, PharmD, PhD contact

0491434985 ext. 33

odile.fabre@ge-sante.fr

Sébastien Bailly, PharmD, PhD contact

0675759353 ext. 33

sbailly@chu-grenoble.fr

Jean-Louis Pépin, MD, PhD principal investigator

Grenoble Alpes University, INSERM U1300

Arne Astrup, MD, PhD study chair

Department of Obesity and Nutritional Sciences, Novo Nordisk Foundation

Gilles Mithieux, PhD study chair

Lyon Est University, INSERM U1213

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight and Obesity and Cardiovascular Diseases, run by Groupe Éthique et Santé.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Odile Fabre, PharmD, PhD (0491434985 ext. 33, odile.fabre@ge-sante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05857319, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.