Dataset Information

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

ABSTRACT:

Background

Scalable weight loss maintenance (WLM) 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 WLM 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 ?30 kg/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 WLM 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 told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as 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 ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) 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, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed.

Conclusions

There was no difference in the WLM 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.

Trial registration

This trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

SUBMITTER: Sniehotta FF

PROVIDER: S-EPMC6504043 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Sniehotta Falko F FF Evans Elizabeth H EH Sainsbury Kirby K Adamson Ashley A Batterham Alan A Becker Frauke F Brown Heather H Dombrowski Stephan U SU Jackson Dan D Howell Denise D Ladha Karim K McColl Elaine E Olivier Patrick P Rothman Alexander J AJ Steel Alison A Vale Luke L Vieira Rute R White Martin M Wright Peter P Araújo-Soares Vera V

PLoS medicine 20190507 5

<h4>Background</h4>Scalable weight loss maintenance (WLM) 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 WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice.<h4>Methods and findings</h4>The NULevel trial was an open-label ran ...[more]

PMID: 31063507

Similar Datasets

Project description:ObjectiveTo test the effectiveness of a brief behavioural intervention to prevent weight gain over the Christmas holiday period.DesignTwo group, double blinded randomised controlled trial.SettingRecruitment from workplaces, social media platforms, and schools pre-Christmas 2016 and 2017 in Birmingham, UK.Participants272 adults aged 18 years or more with a body mass index of 20 or more: 136 were randomised to a brief behavioural intervention and 136 to a leaflet on healthy living (comparator). Baseline assessments were conducted in November and December with follow-up assessments in January and February (4-8 weeks after baseline).InterventionsThe intervention aimed to increase restraint of eating and drinking through regular self weighing and recording of weight and reflection on weight trajectory; providing information on good weight management strategies over the Christmas period; and pictorial information on the physical activity calorie equivalent (PACE) of regularly consumed festive foods and drinks. The goal was to gain no more than 0.5 kg of baseline weight. The comparator group received a leaflet on healthy living.Main outcome measuresThe primary outcome was weight at follow-up. The primary analysis compared weight at follow-up between the intervention and comparator arms, adjusting for baseline weight and the stratification variable of attendance at a commercial weight loss programme. Secondary outcomes (recorded at follow-up) were: weight gain of 0.5 kg or less, self reported frequency of self weighing (at least twice weekly versus less than twice weekly), percentage body fat, and cognitive restraint of eating, emotional eating, and uncontrolled eating.ResultsMean weight change was -0.13 kg (95% confidence interval -0.4 to 0.15) in the intervention group and 0.37 kg (0.12 to 0.62) in the comparator group. The adjusted mean difference in weight (intervention-comparator) was -0.49 kg (95% confidence interval -0.85 to -0.13, P=0.008). The odds ratio for gaining no more than 0.5 kg was non-significant (1.22, 95% confidence interval 0.74 to 2.00, P=0.44).ConclusionA brief behavioural intervention involving regular self weighing, weight management advice, and information about the amount of physical activity required to expend the calories in festive foods and drinks prevented weight gain over the Christmas holiday period.Trial registrationISRCTN Registry ISRCTN15071781.

Project description:IntroductionBehavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2 or ≥35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients' use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients' weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being.Methods and analysisIn the pilot phase, the app will be adapted, piloted and optimised for BWL treatment following a participatory patient-oriented approach. In the subsequent single-centre, assessor-blind, exploratory randomised controlled trial, 90 adults with SO will be randomised to BWL treatment over 6 months with versus without adjunctive app. Primary outcome is the amount of weight loss (kg) at post-treatment (6 months), compared with pretreatment, derived from measured body weight. Secondary outcomes encompass feasibility, acceptance, weight management skills use, well-being and anthropometrics assessed at pretreatment, midtreatment (3 months), post-treatment (6 months) and 6-month follow-up (12 months). An intent-to-treat linear model with randomisation arm, pretreatment weight and stratification variables as covariates will serve to compare arms regarding weight at post-treatment. Secondary analyses will include linear mixed models, generalised linear models and regression and mediation analyses. For safety analysis (serious) adverse events will be analysed descriptively.Ethics and disseminationThe study was approved by the Ethics Committee of the University of Leipzig (DE-21-00013674) and notified to the Federal Institute for Drugs and Medical Devices. Study results will be disseminated through peer-reviewed publications.RegistrationThis study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de.Trial registration numberDRKS00026018.

Project description:BackgroundMany young people report they want to stop smoking and have tried to do so, but most of their quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates. However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit.FindingsA cluster randomised trial for young people trying to stop smoking to compare the efficacy of a school-based 9 week intensive group behavioural support course versus a school-based 7 week brief advice only course. Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT) was used if it was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred participants from approximately ten schools.The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard. Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit attempts and 1) psychological assessments of dependence prior to quitting 2) salivary cotinine concentration prior to quitting and 3) sociodemographic characteristics would also have been assessed. The proportion of participants who stopped smoking in each arm of the trial were compared using Chi square tests.The trial was stopped shortly after it had started because funding to support the therapists running the stop smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed (two group support courses and one brief advice pharmacotherapy course). Seventeen participants in total entered the trial. At the end of the courses, one participant (10%) attending the group support programme had stopped smoking and no participant attending the brief advice programme had stopped smoking.DiscussionThe trial was stopped so we were unable to determine whether group support helped more young people to stop smoking than brief advice. Engagement and recruitment of participants proved much more difficult than had been anticipated. Fifteen of the seventeen participants reported that quitting smoking was either pretty important or very important to them. Thus, the stop smoking success rate could, nevertheless, be considered disappointing.Trial registrationCurrent Controlled Trials ISRCTN25181936.

Dataset Information

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

Background

Methods and findings

Conclusions

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets