At a glance
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Weight Loss in Elderly Patients With Atrial Fibrillation (LOSE-AF): A Randomised Controlled Trial
In Brief
A clinical study evaluating Meal Replacement Weight Loss Programme and Usual Care for Atrial Fibrillation and Overweight and Obesity. Completed, enrolled 119 participants across 1 site.
Detailed Summary
Background Atrial fibrillation (AF) affects over 1 million individuals in the UK and results in costs of over £450 million per year to the National Health Service (NHS). Current rhythm control strategies are limited by high recurrences of AF. New strategies tackling more upstream pathophysiological mechanisms are most needed. The incidence and prevalence of AF markedly increase with age, whilst obesity is the strongest modifiable risk factor for AF. Preliminary data in relatively young patients suggest that weight loss programmes may reduce AF burden and improve AF-related symptoms. Such programmes could be a widely-applicable and cost-effective option in AF management if they are also effective in elderly patients with AF, particularly if they also improve physical performance. Aim The aim of this study is to investigate whether, in older overweight/obese AF patients, referral to a dietary weight loss programme and behavioral support programme can reduce AF-related symptoms compared to usual care. Study design Parallel-group, open-label, multi-centre randomised controlled trial. Elderly individuals (60-85 years) with persistent AF and elevated body mass index (BMI; ≥ 27 kg/m2) will be recruited. Participants will be randomly allocated (1:1) to (a) referral to a dietary weight loss and behavioral support programme (intervention) or (b) usual care (control) for 32-to-36 weeks. The primary endpoint is AF-related symptoms determined using the AF Severity Scale (AFSS) Symptoms Severity score. Participants randomised to the study intervention will be referred to a commercial provider (CP) providing the intervention. The primary endpoint will be analysed irrespective of compliance during the scheduled treatment period following an intention-to-treat principle.
Study Details
Timeline
Interventions
The study intervention will be the referral to a commercial provider (CP) offering a Meal Replacement Programme. Briefly, participants will be referred to a nominated CP local counsellor who will set regular appointments during a period of 32-to-36 weeks to provide behavioural support, weight monitoring, and deliver formula meals. All counselors delivering the programme will receive, beyond their routine training and accreditation, specific information related to this study before being allocated patients.
Participants randomised to the control group will receive best usual care, consisting of a one-off face-to-face consultation on weight loss with a nurse at baseline (\~15 min), together with supporting written information.