ABSTRACT
OBJECTIVES: We tested the effects of a weight-loss intervention encouraging energy-reduced MedDiet and physical activity (PA) in comparison to ad libitum MedDiet on COVID-19 incidence in older adults. DESIGN: Secondary analysis of PREDIMED-Plus, a prospective, ongoing, multicentre randomized controlled trial. SETTING: Community-dwelling, free-living participants in PREDIMED-Plus trial. PARTICIPANTS: 6,874 Spanish older adults (55-75 years, 49% women) with overweight/obesity and metabolic syndrome. INTERVENTION: Participants were randomised to Intervention (IG) or Control (CG) Group. IG received intensive behavioural intervention for weight loss with an energy-reduced MedDiet intervention and PA promotion. CG was encouraged to consume ad libitum MedDiet without PA recommendations. MEASUREMENTS: COVID-19 was ascertained by an independent Event Committee until December 31, 2021. COX regression models compared the effect of PREDIMED-Plus interventions on COVID-19 risk. RESULTS: Overall, 653 COVID-19 incident cases were documented (IG:317; CG:336) over a median (IQR) follow-up of 5.8 (1.3) years (inclusive of 4.0 (1.2) years before community transmission of COVID-19) in both groups. A significantly lowered risk of COVID-19 incidence was not evident in IG, compared to CG (fully-adjusted HR (95% CI): 0.96 (0.81,1.12)). CONCLUSIONS: There was no evidence to show that an intensive weight-loss intervention encouraging energy-reduced MedDiet and PA significantly lowered COVID-19 risk in older adults with overweight/obesity and metabolic syndrome in comparison to ad libitum MedDiet. Recommendations to improve adherence to MedDiet provided with or without lifestyle modification suggestions for weight loss may have similar effects in protecting against COVID-19 risk in older adults with high cardiovascular risks.
Subject(s)
COVID-19 , Cardiovascular Diseases , Diet, Mediterranean , Metabolic Syndrome , Humans , Female , Aged , Male , Metabolic Syndrome/epidemiology , Metabolic Syndrome/prevention & control , Metabolic Syndrome/complications , Overweight/complications , Prospective Studies , Cardiovascular Diseases/etiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/complications , Obesity/complications , Obesity/epidemiology , Obesity/therapy , Life Style , Weight LossABSTRACT
OBJECTIVES: To evaluate the efficacy of a multi-disciplinary non-pharmacological intervention to reduce cardiovascular mortality and hospital re-admissions due to heart failure. DESIGN: Randomised, open, controlled, parallel, multi-centre prospective clinical trial. SETTING: Sardenya Primary Care Centre (PCC), les Corts PCC, "El Remei" PCC (Vic Sud), Vall d'Hebron Hospital, Hospital Clínic, Vic Hospital, Hospital Dos de Maig. PARTICIPANTS: 300 patients diagnosed with heart failure. INTERVENTION: Monthly home visits with intercalated phone calls from very well trained nursing staff to provide education on the illness and treatments, optimise therapy compliance, and inform on self-monitoring and management (especially early detection and treatment of decompensation). MAIN MEASUREMENTS: Combined variable of mortality for cardiovascular reasons and re-hospitalisation due to heart failure (via Casualty and/or Admissions) at 1 year. Health-related quality of life. DISCUSSION: Open study, as it is impossible to mask the intervention. The home intervention is not too complex and is easily performed by well-trained health professionals. Its use could be generalised, if a clinically relevant degree of efficacy was shown.
Subject(s)
Heart Failure/therapy , Home Care Services , Data Interpretation, Statistical , Follow-Up Studies , Heart Failure/mortality , Heart Failure/nursing , Hospitalization , Humans , Patient Compliance , Patient Education as Topic , Patient Selection , Prospective Studies , Quality of Life , Spain , Time FactorsABSTRACT
Objetivos. Evaluar la eficacia de una intervención multidisciplinaria no farmacológica para reducir la mortalidad cardiovascular y los reingresos hospitalarios por insuficiencia cardíaca. Diseño. Ensayo clínico prospectivo, aleatorizado, abierto, controlado, paralelo y multicéntrico. Emplazamiento. Centros de atención primaria Sardenya, Les Corts y Vic Sud «El Remei», y hospitales Vall d'Hebron, Clínic, Vic y Dos de Maig. Participantes. Participarán 300 pacientes con el diagnóstico de insuficiencia cardíaca. Intervención. Visitas domiciliarias mensuales con llamadas telefónicas intercaladas por personal de enfermería muy bien entrenado donde se proporcionará educación sobre la enfermedad y los tratamientos, optimización del cumplimiento terapéutico, educación sobre el autocontrol y el manejo (particularmente detección precoz y tratamiento de las descompensaciones). Mediciones principales. Variable combinada de mortalidad por causa cardiovascular y rehospitalizaciones por insuficiencia cardíaca (urgencias y/o ingresos) al cabo de 1 año. Calidad de vida relacionada con la salud. Discusión. Estudio de carácter abierto, ya que no es posible enmascarar la intervención. La intervención domiciliaria no es excesivamente compleja y puede ser realizada con facilidad por profesionales sanitarios bien entrenados; se podría generalizar su aplicación si se demostrara un grado de eficacia clínicamente relevante
Objectives. To evaluate the efficacy of a multi-disciplinary non-pharmacological intervention to reduce cardiovascular mortality and hospital re-admissions due to heart failure. ;;Design. Randomised, open, controlled, parallel, multi-centre prospective clinical trial. ;;Setting. Sardenya Primary Care Centre (PCC), les Corts PCC, "El Remei" PCC (Vic Sud), Vall d'Hebron Hospital, Hospital Clínic, Vic Hospital, Hospital Dos de Maig. ;;Participants. 300 patients diagnosed with heart failure. ;;Intervention. Monthly home visits with intercalated phone calls from very well trained nursing staff to provide education on the illness and treatments, optimise therapy compliance, and inform on self-monitoring and management (especially early detection and treatment of decompensation). ;;Main measurements. Combined variable of mortality for cardiovascular reasons and re-hospitalisation due to heart failure (via Casualty and/or Admissions) at 1 year. Health-related quality of life. ;;Discussion. Open study, as it is impossible to mask the intervention. The home intervention is not too complex and is easily performed by well-trained health
