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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 主要终点
- Effectiveness of the national RNPC weight reduction program on the change of treatments (drug or instrumental treatments) or in the comorbidities of overweight/obesity.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Effectiveness of the national RNPC weight reduction program on the change of treatments (drug or instrumental treatments) or in the comorbidities of overweight/obesity.
时间窗: 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).
次要结局
- Neck circumference(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.)
- HbA1c percentage(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of triglycerides(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Weight(Data collected through study completion for 5 years.)
- Body mass index (BMI)(Data collected through study completion for 5 years.)
- Waist-to-hip circumference ratio(Data collected through study completion for 5 years.)
- Muscle mass percentage(Data collected through study completion for 5 years.)
- Fat mass percentage(Data collected through study completion for 5 years.)
- Water mass percentage(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.(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Fasting insulinemia(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- TyG index(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- QUICKI(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of ALAT(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Albumin-creatinine ratio(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Pain assessment(Data collected through study completion for 5 years.)
- Level of LDL-cholesterol(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- SCORE2/SCORE2-OP score(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of GGT(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Creatininuria(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Microalbuminuria(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- HOMA-IR index(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of total cholesterol(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of HDL-cholesterol(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of ASAT(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Ferritinemia(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of glycerol(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of fatty acids(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Score to the Insomnia Severity Index (ISI) questionnaire(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.)
- Distance traveled (by foot) per week(Data collected through study completion for 5 years.)
- Fasting glycemia(Data collected 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(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Evolution of Obstructive Sleep Apnea Syndrome (OSAS)(Data 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(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)(Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- MDRD score(Assessed at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Blood pressure(Data collected through study completion for 5 years.)
- Score to the 5-level EQ-5D version (EQ-5D-5L) questionnaire(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)(Questionnaire completed at baseline.)
- FibroMeter score(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Creatininemia(Data collected 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)(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Score to the Pittsburgh Sleep Quality Index (PSQI) questionnaire(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(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 Three-Factor Eating Questionnaire (TFEQ)(Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Arterial stiffness(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.)
- Level of lactate(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Level of pyruvate(Data collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Score to the Epworth Sleepiness Scale (ESS) questionnaire(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(Questionnaire completed at baseline.)
- Responses to the general questionnaire(Questionnaire completed at baseline and every year after completion of the intervention for 5 years.)
- Prevalence of peripheral neuropathies at the start of the intervention(Data collected at baseline.)
- Evolution of peripheral neuropathies(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(Questionnaire completed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Dropout rate(Assessed collected at baseline, after the first phase of the intervention and after the second phase of the intervention.)
- Number of steps per week(Data collected through study completion for 5 years.)