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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  http://www.isrctn.com/ISRCTN14657176 (registration date 20 March 2014).
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. elizabeth.evans@ncl.ac.uk.
authors.forename: Elizabeth H
authors.initials: EH
authors.lastname: Evans
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. vera.araujo-soares@ncl.ac.uk.
authors.forename: Vera
authors.initials: V
authors.lastname: Araújo-Soares
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. ashley.adamson@ncl.ac.uk.|Fuse, the UK CRC Centre for Translational Research in Public Health, Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. ashley.adamson@ncl.ac.uk.|Human Nutrition Research Centre, Institute of Health & Society, University of Newcastle, William Leech Building, Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK. ashley.adamson@ncl.ac.uk.
authors.forename: Ashley
authors.initials: A
authors.lastname: Adamson
authors.affiliation: Health and Social Care Institute, Teesside University, Parkside West, Middlesbrough, Tees Valley, TS1 3BA, UK. a.batterham@tees.ac.uk.
authors.forename: Alan M
authors.initials: AM
authors.lastname: Batterham
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. heather.brown@ncl.ac.uk.
authors.forename: Heather
authors.initials: H
authors.lastname: Brown
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. mia.campbell@northumbria.ac.uk.
authors.forename: Miglena
authors.initials: M
authors.lastname: Campbell
authors.affiliation: School of Natural Sciences, Division of Psychology, University of Stirling, Stirling, FK9 4LA, UK. s.u.dombrowski@stir.ac.uk.
authors.forename: Stephan U
authors.initials: SU
authors.lastname: Dombrowski
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. alison.guest@newcastle.ac.uk.
authors.forename: Alison
authors.initials: A
authors.lastname: Guest
authors.affiliation: Open Lab, School of Computing Science, Newcastle University, 89 Sandyford Road, Newcastle upon Tyne, NE1 8HW, UK. dan.jackson@ncl.ac.uk.
authors.forename: Daniel
authors.initials: D
authors.lastname: Jackson
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. dominika.kwasnicka@ncl.ac.uk.|Fuse, the UK CRC Centre for Translational Research in Public Health, Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. dominika.kwasnicka@ncl.ac.uk.
authors.forename: Dominika
authors.initials: D
authors.lastname: Kwasnicka
authors.affiliation: Open Lab, School of Computing Science, Newcastle University, 89 Sandyford Road, Newcastle upon Tyne, NE1 8HW, UK. karim.ladha@ncl.ac.uk.
authors.forename: Karim
authors.initials: K
authors.lastname: Ladha
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. elaine.mccoll@ncl.ac.uk.|Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK. elaine.mccoll@ncl.ac.uk.
authors.forename: Elaine
authors.initials: E
authors.lastname: McColl
authors.affiliation: Open Lab, School of Computing Science, Newcastle University, 89 Sandyford Road, Newcastle upon Tyne, NE1 8HW, UK. patrick.olivier@ncl.ac.uk.
authors.forename: Patrick
authors.initials: P
authors.lastname: Olivier
authors.affiliation: Department of Psychology, University of Minnesota, 75 East River Road, Minneapolis, MN, 55455, USA. rothm001@umn.edu.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Rothman
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. kirby.sainsbury@ncl.ac.uk.
authors.forename: Kirby
authors.initials: K
authors.lastname: Sainsbury
authors.affiliation: Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK. alison.steel@ncl.ac.uk.
authors.forename: Alison J
authors.initials: AJ
authors.lastname: Steel
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. nick.steen@ncl.ac.uk.
authors.forename: Ian Nicholas
authors.initials: IN
authors.lastname: Steen
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. luke.vale@ncl.ac.uk.
authors.forename: Luke
authors.initials: L
authors.lastname: Vale
authors.affiliation: Centre for Diet and Activity Research (CEDAR), MRC Epidemiology Unit, School of Clinical Medicine, University of Cambridge, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. Martin.White@mrc-epid.cam.ac.uk.
authors.forename: Martin
authors.initials: M
authors.lastname: White
authors.affiliation: Open Lab, School of Computing Science, Newcastle University, 89 Sandyford Road, Newcastle upon Tyne, NE1 8HW, UK. p.c.wright@ncl.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Wright
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. falko.sniehotta@ncl.ac.uk.|Fuse, the UK CRC Centre for Translational Research in Public Health, Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. falko.sniehotta@ncl.ac.uk.
authors.forename: Falko F
authors.initials: FF
authors.lastname: Sniehotta
mesh_terms: D056044:Actigraphy / Q000295:instrumentation; D000886:Anthropometry; D001521:Behavior Therapy / Q000191:economics / Q000295:instrumentation* / Q000379:methods; D040421:Cell Phone; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004032:Diet; D004739:England; D005240:Feasibility Studies; D030141:Feedback, Psychological; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D063731:Mobile Applications; D009043:Motor Activity; D009765:Obesity / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D015430:Weight Gain; D015431:Weight Loss