The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: Study protocol for a randomised controlled trial

Elizabeth Evans, Vera Araújo-Soares, Ashley Adamson, Alan M. Batterham, Heather Brown, Miglena Campbell, Stephan U. Dombrowski, Alison Guest, Daniel Jackson, Dominika Kwasnicka, Karim Ladha, Elaine McColl, Patrick Olivier, Alexander J. Rothman, Kirby Sainsbury, Alison Steel, Ian Nicholas Steen, Luke Vale, Martin White, Peter WrightFalko F. Sniehotta

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Abstract

BACKGROUND: Effective weight loss interventions are widely available but, after weight loss, most individuals regain weight. This article describes the protocol for the NULevel trial evaluating the effectiveness and cost-effectiveness of a systematically developed, inexpensive, scalable, technology-assisted, behavioural intervention for weight loss maintenance (WLM) in obese adults after initial weight loss.\n\nMETHODS/DESIGN: A 12-month single-centre, two-armed parallel group, participant randomised controlled superiority trial is underway, recruiting a total of 288 previously obese adults after weight loss of ≥5 % within the previous 12 months. Participants are randomly assigned to intervention or control arms, with a 1:1 allocation, stratified by sex and percentage of body weight lost (
Original languageEnglish
Number of pages17
JournalTrials
Volume16
DOIs
Publication statusPublished - 22 Sep 2015

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    Evans, E., Araújo-Soares, V., Adamson, A., Batterham, A. M., Brown, H., Campbell, M., Dombrowski, S. U., Guest, A., Jackson, D., Kwasnicka, D., Ladha, K., McColl, E., Olivier, P., Rothman, A. J., Sainsbury, K., Steel, A., Steen, I. N., Vale, L., White, M., ... Sniehotta, F. F. (2015). The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: Study protocol for a randomised controlled trial. Trials, 16. https://doi.org/10.1186/s13063-015-0931-7