Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: A randomised controlled trial in the UK (NULevel Trial).

Falko F Sniehotta ,Alison Steel ,Alan M Batterham ,Ashley J Adamson ,Heather Brown ,Stephan U Dombrowski ,Frauke Becker ,Luke Vale ,Rute Vieira ,Denise Howel ,Elaine Mccoll ,Martin White ,Patrick Olivier ,E Hywel Evans ,Dan Jackson ,Peter J Wright ,Kirby Sainsbury ,Karim Ladha ,Alexander J Rothman ,Vera Araújo‐Soares

doi:10.1371/journal.pmed.1002793

Abstract

BackgroundScalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice.Methods and findingsThe NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5–3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6–3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: −0.07 [95% CI 1.7 to −1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed.ConclusionsThere was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial.Trial registrationThis trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

Highlights

Helping people with obesity to avoid weight regain after clinically significant weight loss ( 5%) [1] is vital for tackling the increasing global burden of obesity-linked preventable morbidity and mortality [2]
There was no difference in the weight loss maintenance (WLM) of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter
Our aim was to determine whether a lower-intensity, mobile internet technology-assisted behavioural intervention could reduce weight regain among adults with obesity with clinically significant weight loss achieved outside of a research context and whether such an intervention is cost-effective, compared to standard lifestyle advice

Summary

Introduction

Helping people with obesity to avoid weight regain after clinically significant weight loss ( 5%) [1] is vital for tackling the increasing global burden of obesity-linked preventable morbidity and mortality [2]. Maintenance interventions are needed because obesity is a chronic, relapsing condition in which a third of weight loss is typically regained in a year and the rest within 3 to 5 years [5,6] This rate of recidivism greatly attenuates the health and economic benefits of weight loss [7] and has been branded the most substantial current problem in obesity management [8]. Few previous studies have recruited participants who undertook initial weight loss independently of the maintenance intervention programme [11,12,13] Effective, these interventions involved multiple one-to-one or groupbased participant contacts over prolonged periods, which may reduce their cost-effectiveness and limits their scalability. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss ( 5%) compared to standard lifestyle advice

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