Long-term trajectories of weight loss and health outcomes: protocol of the SCOOP-RNPC nationwide observational study

Abstract

Introduction: 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.

Ethics and dissemination: 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.

Trial registration number: NCT05857319.

Keywords: NUTRITION & DIETETICS; Obesity; Observational Study.

Figure 1. Overview of data collected. 1. Trajectories of overall state of heath (primary objective; in grey) 2. Trajectories of anthropometric and body composition parameters (in black) 3. Trajectories of biological parameters (in orange) 4. Trajectories of patient reported outcomes (in blue) 5. Trajectories of physical activity (in green) 6. Trajectories of sleep health (in purple) 7. Trajectories of surrogate markers of cardiometabolic risk (in red) 8. (Trajectories of subgroup with or without 10% reduction in initial weight). Data collected by two different means (sleep-related data and physical activity) are coloured in the two corresponding colours. ESS, Epworth Sleepiness Scale; FFQ, Food Frequency Questionnaire; HAD, Hospital Anxiety and Depression; ISI, Insomnia Severity Index; OSAS, obstructive sleep apnoea syndrome; PSQI, Pittsburgh Sleep Quality Index; PSS, Perceived Stress Scale; QOLOD, Quality Of Life, Obesity and Dietetics; TFEQ, Three-Factor Eating Questionnaire; VAS, Visual Analogue Scale.