PDF(Pubmed)
Abstract：
BACKGROUND: Behavioural weight loss programmes are generally accepted as being beneficial in reducing cardiometabolic risk and improving patient-reported outcomes. However, prospective data from large real-world cohorts are scarce concerning the mid-term and long-term impact of such interventions. The objective of this large prospective cohort study (n>10 000 participants) is to demonstrate the effectiveness of the standardised Nutritional and Psycho-Behavioural Rehabilitation programme (RNPC Programme) in reducing the percentage of subjects requiring insulin and/or other diabetes drug therapy, antihypertensive drugs, lipid-lowering therapies and continuous positive airway pressure therapy for obstructive sleep apnoea after the end of the intervention. The rate of remission of hypertension, type 2 diabetes and sleep apnoea will also be prospectively assessed.
METHODS: This is a prospective multicentre observational study carried out in 92 RNPC centres in France. Participants will follow the standardised RNPC Programme. The prospective dataset will include clinical, anthropometric and biochemical data, comorbidities, medications, body composition, patient-reported outcome questionnaire responses, sleep study data with objective measurements of sleep apnoea severity and surrogate markers of cardiovascular risk (ie, blood pressure and arterial stiffness). About 10 000 overweight or obese participants will be included over 2 years with a follow-up duration of up to 5 years.
BACKGROUND: Ethical approval for this study has been granted by the Ethics Committee (Comité de protection des personnes Sud-Est I) of Saint-Etienne University Hospital, France (SI number: 23.00174.000237). Results will be submitted for publication in peer-review journals, presented at conferences and inform the design of a future randomised controlled trial in the specific population identified as good responders to the RNPC Programme.
BACKGROUND: NCT05857319.
METHODS: This is a prospective multicentre observational study carried out in 92 RNPC centres in France. Participants will follow the standardised RNPC Programme. The prospective dataset will include clinical, anthropometric and biochemical data, comorbidities, medications, body composition, patient-reported outcome questionnaire responses, sleep study data with objective measurements of sleep apnoea severity and surrogate markers of cardiovascular risk (ie, blood pressure and arterial stiffness). About 10 000 overweight or obese participants will be included over 2 years with a follow-up duration of up to 5 years.
BACKGROUND: Ethical approval for this study has been granted by the Ethics Committee (Comité de protection des personnes Sud-Est I) of Saint-Etienne University Hospital, France (SI number: 23.00174.000237). Results will be submitted for publication in peer-review journals, presented at conferences and inform the design of a future randomised controlled trial in the specific population identified as good responders to the RNPC Programme.
BACKGROUND: NCT05857319.
摘要：
背景：行为减肥计划通常被认为有利于降低心脏代谢风险和改善患者报告的结局。然而,关于此类干预措施的中期和长期影响,来自大型现实世界队列的前瞻性数据很少.这项大型前瞻性队列研究（n>10000名参与者）的目的是证明标准化营养和心理行为康复计划（RNPC计划）在减少需要胰岛素和/或其他糖尿病药物治疗的受试者百分比方面的有效性。抗高血压药物，干预结束后，阻塞性睡眠呼吸暂停的降脂治疗和持续气道正压通气治疗。高血压的缓解率，2型糖尿病和睡眠呼吸暂停也将进行前瞻性评估.
方法：这是一项在法国92个RNPC中心进行的前瞻性多中心观察性研究。参与者将遵循标准化的RNPC计划。前瞻性数据集将包括临床，人体测量和生化数据，合并症,药物,身体成分,患者报告的结果问卷回答，睡眠研究数据，客观测量睡眠呼吸暂停的严重程度和心血管风险的替代标志物(即，血压和动脉僵硬度)。大约10000名超重或肥胖的参与者将在2年内被纳入，随访时间长达5年。
背景：圣艾蒂安大学医院伦理委员会（Sud-EstI）已批准本研究的伦理批准，法国（SI编号：23.00174.000237）。结果将提交给同行评审期刊发表，在会议上提出，并告知在被确定为RNPC计划良好反应者的特定人群中设计未来的随机对照试验。
背景：NCT05857319。
方法：这是一项在法国92个RNPC中心进行的前瞻性多中心观察性研究。参与者将遵循标准化的RNPC计划。前瞻性数据集将包括临床，人体测量和生化数据，合并症,药物,身体成分,患者报告的结果问卷回答，睡眠研究数据，客观测量睡眠呼吸暂停的严重程度和心血管风险的替代标志物(即，血压和动脉僵硬度)。大约10000名超重或肥胖的参与者将在2年内被纳入，随访时间长达5年。
背景：圣艾蒂安大学医院伦理委员会（Sud-EstI）已批准本研究的伦理批准，法国（SI编号：23.00174.000237）。结果将提交给同行评审期刊发表，在会议上提出，并告知在被确定为RNPC计划良好反应者的特定人群中设计未来的随机对照试验。
背景：NCT05857319。
