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

Falko Sniehotta, Elizabeth Evans, Kirby Sainsbury, Ashley J. Adamson, Alan M Batterham, Frauke Becker, Heather Brown, Stephan Dombrowski, Daniel Jackson, Denise Howell, Karim Ladha, Elaine McColl, Patrick Olivier, Alexander Rothman, Alison Steel, Luke Vale, Rute Viera, Martin White, Peter Wright, Vera Araújo-Soares

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Abstract

Background
Scalable weight loss maintenance 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 weight loss maintenance in adults with
obesity after clinically-significant weight loss (≥5%), compared to standard lifestyle
advice.
Methods and Findings
The 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 ≥30kg/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 weight loss maintenance
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 that they would receive
feedback on their weight. After 12 months we measured the primary outcome, weight
(kg) and also 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 ±2.5kg at follow up. Overall, 264 participants (92%)
completed the trial. Mean weight gain from baseline to 12 months was 1.8kg (95% CI
0.5 to 3.1) in the intervention group (n=131) and 1.8kg (95% CI 0.6 to 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, greater confidence for healthy eating, weight loss and weight
loss maintenance.
Conclusions
There was no difference in the weight loss maintenance 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
Original languageEnglish
Number of pages36
JournalPLoS Medicine
Publication statusAccepted/In press - 28 Mar 2019

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