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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Elizabeth H. 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 J. Steel, Ian Nicholas Steen, Luke Vale, Martin White, Peter Wright, Falko F. Sniehotta

Published in: Trials | Issue 1/2015

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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.

Methods/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 (<10 % vs ≥10 %). Change in weight (kg) from baseline to 12 months is the primary outcome. Weight, other anthropometric variables and 7-day physical activity (assessed via accelerometer) measures are taken at 0 and 12 months. Questionnaires at 0, 6 and 12 months assess psychological process variables, health service use and participant costs. Participants in the intervention arm initially attend an individual face-to-face WLM consultation with an intervention facilitator and then use a mobile internet platform to self-monitor and report their diet, daily activity (via pedometer) and weight through daily weighing on wirelessly connected scales. Automated feedback via mobile phone, tailored to participants’ weight regain and goal progress is provided. Participants in the control arm receive quarterly newsletters (via links embedded in text messages) and wirelessly connected scales. Qualitative process evaluation interviews are conducted with a subsample of up to 40 randomly chosen participants. Acceptability and feasibility of procedures, cost-effectiveness, and relationships among socioeconomic variables and WLM will also be assessed.

Discussion

It is hypothesised that participants allocated to the intervention arm will show significantly lower levels of weight regain from baseline than those in the control arm. To date, this is the first WLM trial using remote real-time weight monitoring and mobile internet platforms to deliver a flexible, efficient and scalable intervention, tailored to the individual. This trial addresses a key research need and has the potential to make a vital contribution to the evidence base to inform future WLM policy and provision.

Trial registration

http://​www.​isrctn.​com/​ISRCTN14657176 (registration date 20 March 2014).
Footnotes
1
The technology for the scales has been released as WeighAX, part of the Open Movement open-source project (http://​openmovement.​co.​uk).
 
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Metadata
Title
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
Authors
Elizabeth H. 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 J. Steel
Ian Nicholas Steen
Luke Vale
Martin White
Peter Wright
Falko F. Sniehotta
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0931-7

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