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 trialReportar como inadecuado




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Trials

, 16:421

First Online: 22 September 2015Received: 02 June 2015Accepted: 27 August 2015DOI: 10.1186-s13063-015-0931-7

Cite this article as: Evans, E.H., Araújo-Soares, V., Adamson, A. et al. Trials 2015 16: 421. doi:10.1186-s13063-015-0931-7

Abstract

BackgroundEffective 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-DesignA 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.

DiscussionIt 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 registrationhttp:-www.isrctn.com-ISRCTN14657176 registration date 20 March 2014.

KeywordsBehaviour Randomised controlled trial Clinical protocol Obesity Overweight Weight loss Weight loss maintenance AbbreviationsBMIbody mass index

IMDIndex of Multiple Deprivation

NHSNational Health Service

QALYquality-adjusted life year

RCTrandomised controlled trial

SMSshort message service

UKUnited Kingdom

USUnited States

WLMweight loss maintenance

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Autor: Elizabeth H. Evans - Vera Araújo-Soares - Ashley Adamson - Alan M. Batterham - Heather Brown - Miglena Campbell - Stephan

Fuente: https://link.springer.com/







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