Gamification and neurotraining to engage men in behavioral weight loss : Protocol for a factorial randomized controlled trial

Over 70% of men are overweight, and most desire weight loss; however, men are profoundly underrepresented in weight loss programs. Gamification represents a novel approach to engaging men and may enhance efficacy through two means: (1) game-based elements (e.g., streaks, badges, team-based competition) to motivate weight control behaviors and (2) arcade-style “neurotraining” to enhance neurocognitive capacities to resist the temptation of unhealthy foods and more automatically select healthy foods. This study will use a 2 × 2 factorial design to examine the independent and combinatory efficacy of gamification and inhibitory control training (ICT). Men with overweight/obesity (N = 228) will receive a 12-month mobile weight loss program that incorporates behavioral weight loss strategies (e.g., self-monitoring, goal setting, stimulus control). Men will be randomly assigned to a non-gamified or gamified version, and an active or sham ICT. A game design company will create the program, with input from a male advisory panel. Aims of the project are to test whether a gamified (versus non-gamified) weight loss program and/or ICT (versus sham) promotes greater improvements in weight, diet, and physical activity; whether these treatment factors have combinatory or synergistic effects; to test whether postulated mechanisms of action (increased engagement, for gamification, and inhibitory control, for ICT) mediate treatment effects; and whether baseline gameplay frequency and implicit preferences for ICT-targeted foods moderate effects. It is hoped this study will contribute to improved mHealth programs for men and enhance our understanding of the impact of gamified elements and neurocognitive training on weight control

Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy

International audienceBACKGROUND Nusinersen is an antisense oligonucleotide drug that modulates pre-messenger RNA splicing of the survival motor neuron 2 (SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). METHODS We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2: 1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274. The primary end point was the least-squares mean change from baseline in the Hammersmith Functional Motor Scale-Expanded (HFMSE) score at 15 months of treatment; HFMSE scores range from 0 to 66, with higher scores indicating better motor function. Secondary end points included the percentage of children with a clinically meaningful increase from baseline in the HFMSE score (>= 3 points), an outcome that indicates improvement in at least two motor skills. RESULTS In the prespecified interim analysis, there was a least-squares mean increase from baseline to month 15 in the HFMSE score in the nusinersen group (by 4.0 points) and a least-squares mean decrease in the control group (by -1.9 points), with a significant between-group difference favoring nusinersen (least-squares mean difference in change, 5.9 points; 95% confidence interval, 3.7 to 8.1; P< 0.001). This result prompted early termination of the trial. Results of the final analysis were consistent with results of the interim analysis. In the final analysis, 57% of the children in the nusinersen group as compared with 26% in the control group had an increase from baseline to month 15 in the HFMSE score of at least 3 points (P< 0.001), and the overall incidence of adverse events was similar in the nusinersen group and the control group (93% and 100%, respectively). CONCLUSIONS Among children with later-onset SMA, those who received nusinersen had significant and clinically meaningful improvement in motor function as compared with those in the control group. (Funded by Biogen and Ionis Pharmaceuticals; CHERISH ClinicalTrials. gov number, NCT02292537.