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

NCT05857319 | Not Yet Recruiting

• 1 other identifier: 2022-A01599-34
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators hypothesize that weight loss obtained with the French RNPC weight reduction program is beneficial for the general health of overweight/obese patients in the medium term. The objective of this cohort study is to demonstrate the effectiveness of the RNPC program on the reduction of drug or instrumental treatments (for example, continuous positive pressure ventilation for the treatment of sleep apnea syndrome) and the improvement of overweight/obesity-associated comorbidities in the medium term. This is a multicenter clinical study, as part of routine care, with standardized nutritional care (RNPC Program) in all RNPC centers in France. A cohort will be formed based on the clinical and biological data usually collected in the centers, enriched by data from additional clinical and biological examinations as well as by self-questionnaires completed by the participants. About 10,000 overweight or obese participants will be included for 2 years and followed 5 years. The SCOOP-RNPC study will have benefits for individual participants, for the scientific community in terms of knowledge acquired and for society with a better definition of the impact of treatments. Responding to the major public health issue represented by overweight, this prospective cohort of overweight or obese patients will make it possible to evaluate, in real-life conditions, the effects of weight loss obtained by the RNPC Program in the short, medium and long term on biological parameters predictive of cardiometabolic risk, drug consumption, quality of life, diet and eating behavior, sleep, physical activity, stress/anxiety, as well as depression. This cohort will make it possible to identify clinical phenotypes and biomarkers to optimize the personalization of the management of overweight or obese patients, in particular those at risk of developing comorbidities associated with excess weight.

Conditions

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

Keywords

Prospective Interventional Study; Real-Life Conditions; RNPC Program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (58)

• Weight

  Data collected through study completion for 5 years.

• Body mass index (BMI)

  Data collected through study completion for 5 years.

• Waist circumference

  Data collected through study completion for 5 years.

• Hip circumference

  Data collected through study completion for 5 years.

• Waist-to-hip circumference ratio

  Data collected through study completion for 5 years.

Study Arms (4)

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.

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.

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.

Behavioral: Nutritional Psycho-Behavioral Reeducation Program

Interventions

Nutritional Psycho-Behavioral Reeducation Program BEHAVIORAL

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.

Also known as: RNPC Program

Connected Objects Group; Neuropathies Group; Obstructive Sleep Apnea Syndrome (OSAS) Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All new patients committing to follow the RNPC Program in the RNPC investigator centers are potentially eligible for the study and will be offered to participate.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Groupe Éthique et Santé: lead
• University Grenoble Alps: collaborator
• Novo Nordisk A/S: collaborator
• Lyon Est University: collaborator

Related Publications (1)

• 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.

  PMID: 38991672 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Cardiovascular Diseases; Metabolic Diseases; Diabetes Mellitus, Type 2; Sleep Apnea, Obstructive; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Jean-Louis Pépin, MD, PhD

  Grenoble Alpes University, INSERM U1300

  PRINCIPAL INVESTIGATOR

• Arne Astrup, MD, PhD

  Department of Obesity and Nutritional Sciences, Novo Nordisk Foundation

  STUDY CHAIR

• Gilles Mithieux, PhD

  Lyon Est University, INSERM U1213

  STUDY CHAIR

Central Study Contacts

Odile Fabre, PharmD, PhD

CONTACT

0491434985; odile.fabre@ge-sante.fr

Sébastien Bailly, PharmD, PhD

CONTACT

0675759353; sbailly@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 12, 2023
• Study Start: July 15, 2023
• Primary Completion (Estimated): July 15, 2030
• Study Completion (Estimated): July 15, 2030
• Last Updated: May 12, 2023

Record last verified: 2023-05