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).
Bibliographical noteFunding Information:
The study is funded by the UK National Prevention Research Initiative (NPRI) Phase 4 (grant MR/J000477/1). The NPRI includes the following Funding Partners (in alphabetical order): Alzheimer’s Research Trust, Alzheimer’s Society, Biotechnology and Biological Sciences Research Council, British Heart Foundation, Cancer Research UK, Chief Scientist Office, Scottish Government Health Directorate, Department of Health, Diabetes UK, Economic and Social Research Council, Health and Social Care Research and Development Division of the Public Health Agency (HSC & R&D Division), Medical Research Council, The Stroke Association, Wellcome Trust, Welsh Assembly Government, and World Cancer Research Fund. FFS is funded by Fuse, the Centre for Translational Research in Public Health, a UKCRC Public Health Research Centre of Excellence based on funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, and the National Institute for Health Research, under the auspices of the UK Clinical Research Collaboration. AA is funded by the National Institute of Health Research as an NIHR Research Professor. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
© 2019 Sniehotta et al.