Browsing by Subject "Proof of Concept Study"
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Item Open Access Development and Preliminary Feasibility of iByte4Health: A Mobile Health (mHealth) Pediatric Obesity Prevention Intervention to Engage Parents with Low-Income of Children 2-9 Years.(Nutrients, 2021-11-25) Tripicchio, Gina L; Kay, Melissa; Herring, Sharon; Cos, Travis; Bresnahan, Carolyn; Gartner, Danielle; Sosinsky, Laura Stout; Bass, Sarah BThis research describes the development and preliminary feasibility of iByte4Health, a mobile health (mHealth) obesity prevention intervention designed for parents with a low-income of children 2-9 years of age. Study 1 (n = 36) presents findings from formative work used to develop the program. Study 2 (n = 23) presents a 2-week proof-of-concept feasibility testing of iByte4Health, including participant acceptability, utilization, and engagement. Based on Study 1, iByte4Health was designed as a text-messaging program, targeting barriers and challenges identified by parents of young children for six key obesity prevention behaviors: (1) snacking; (2) physical activity; (3) sleep; (4) sugary drinks; (5) fruit and vegetable intake; and (6) healthy cooking at home. In Study 2, participants demonstrated high program retention (95.7% at follow-up) and acceptability (90.9% reported liking or loving the program). Users were engaged with the program; 87.0% responded to at least one self-monitoring text message; 90.9% found the videos and linked content to be helpful or extremely helpful; 86.4% found text messages helpful or extremely helpful. iByte4Health is a community-informed, evidenced-based program that holds promise for obesity prevention efforts, especially for those families at the increased risk of obesity and related disparities. Future work is warranted to test the efficacy of the program.Item Open Access Effect of the S-nitrosoglutathione reductase inhibitor N6022 on bronchial hyperreactivity in asthma.(Immunity, inflammation and disease, 2018-06) Que, Loretta G; Yang, Zhonghui; Lugogo, Njira L; Katial, Rohit K; Shoemaker, Steven A; Troha, Janice M; Rodman, David M; Tighe, Robert M; Kraft, MonicaRationale
Patients with asthma demonstrate depletion of the endogenous bronchodilator GSNO and upregulation of GSNOR.Objectives
An exploratory proof of concept clinical study of N6022 in mild asthma to determine the potential bronchoprotective effects of GSNOR inhibition. Mechanistic studies aimed to provide translational evidence of effect.Methods
Fourteen mild asthma patients were treated with intravenous N6022 (5 mg) or placebo and observed for 7 days, with repeated assessments of the provocative dose of methacholine causing a 20% fall in FEV1 (methacholine PC20 FEV1), followed by a washout period and crossover treatment and observation. In vitro studies in isolated eosinophils investigated the effect of GSNO and N6022 on apoptosis.Measurements and main results
This was a negative trial as it failed to reach its primary endpoint, which was change from baseline in methacholine PC20 FEV1 at 24 h. However, our exploratory analysis demonstrated significantly more two dose-doubling increases in PC20 FEV1 for N6022 compared with placebo (21% vs 6%, P < 0.05) over the 7-day observation period. Furthermore, a significant treatment effect was observed in the change in PC20 FEV1 from baseline averaged over the 7-day observation period (mean change: +0.82 mg/ml [N6022] from 1.34 mg/ml [baseline] vs -0.18 mg/ml [placebo] from 1.16 mg/ml [baseline], P = 0.023). N6022 was well tolerated in mild asthmatics. In vitro studies demonstrated enhanced eosinophilic apoptosis with N6022.Conclusions
In this early phase exploratory proof of concept trial in asthma, N6022 did not significantly alter methacholine PC20 FEV1 at 24 h, but did have a treatment effect at 7 days compared to baseline. Further investigation of the efficacy of S-nitrosoglutathione reductase inhibition in a patient population with eosinophilic asthma is warranted.