A Digital Toolkit for Weight Loss Maintenance in European Adults (NoHoW): 2×2 Factorial Randomized Controlled Trial.

Abstract

Digital approaches to weight management have the potential to produce cost-effective and scalable weight management solutions. Effective behavior change interventions typically promote self-regulation of energy balance behaviors, which may be enhanced by incorporating emotion regulation strategies. This study aimed to evaluate the effectiveness of a digital behavior change toolkit for weight loss maintenance in European adults who had achieved ≥5% weight loss in the previous 12 months. We hypothesized that a combined intervention targeting self-regulation or motivation and emotion regulation would be more effective than either component alone, and that each would outperform an active control. The Navigating to a Healthier Weight (NoHoW) trial was a 2×2 factorial randomized, single-blind, controlled trial involving 1627 adults who had achieved ≥5% weight loss in the previous 12 months (initial BMI ≥25 kg/m2) across 3 European centers (the United Kingdom, Denmark, and Portugal). The trial evaluated a digital toolkit for weight management subsequent to an initial ≥5% weight loss in the prior 12 months. Participants were assigned using adaptive stratified sampling to one of four groups: (1) self-regulation or motivation (n=403), (2) emotion regulation (n=416), (3) combined motivation and emotion (n=408), or (4) active control (generic content, regular self-weighing, and Fitbit use, n=400). The primary outcome was weight change from baseline to 12 months. Prespecified secondary outcomes included cardiometabolic markers. Linear models adjusted for recruitment center, sex, age group, BMI group, and pretrial weight loss. Subgroup analyses were conducted by sex. At 12 months, 76% (364/1627) of participants remained in the study. In the primary ITT analysis in all participants, none of the intervention arms (motivation, emotion, or combined) differed significantly from the active control for weight change at 12 months. Completer and per-protocol analyses produced similar patterns and did not change the overall interpretation. In the per-protocol sample, men regained 0.14 kg, and women regained 0.54 kg of their pretrial weight loss. Subgroup analyses indicated a small effect of the motivation intervention in men, but this was not clinically meaningful and did not alter the primary null findings. Nearly half of ITT participants regained weight, and no significant intervention effects were observed for cardiometabolic secondary outcomes. The NoHoW trial was the first large-scale, multicountry 2×2 factorial randomized controlled trial to evaluate a digital-only toolkit based on self-regulation or motivation and emotion regulation techniques for weight loss maintenance. NoHoW found no evidence in the primary ITT analysis that digital interventions targeting self-regulation or emotion regulation improved weight loss maintenance compared with the active control. A small subgroup effect in men should be interpreted cautiously and does not change this conclusion. The trial provides evidence on both the limitations and potential of digital behavior change interventions for long-term weight outcomes. Future digital interventions may benefit from enhanced engagement and tailored content to improve long-term weight outcomes.