Obesity and overweight is a global health crisis and novel methods of treatment are needed to address it. Low-level laser therapy (LLLT) is a currently available non-invasive procedure for lysing excess fat, but there is a lack of consensus exists on LLLT frequency and limited research from studies of LLLT. The purpose of this pilot study is to compare the effect of three of the most common LLLT frequencies on weight, waist circumference, body fat percentage, and quality of life. Sixty overweight (body mass index (BMI) 25-29.9 kg/m 2 ) adult participants were randomized to 12 LLLT treatments: (1) three times weekly for 4 weeks, (2) twice weekly for 6 weeks, or (3) once weekly for 12 weeks. All participants attended an in-person visit at baseline and at weeks 4, 6, 12, and 26. Participants were recruited September 30, 2016 through to August 27, 2017. The majority of the 60 participants were female (90%) with an average age of 43.7 years (± 9.2 years). Most participants (98%) completed 10 or more of the 12 LLLT treatments. When comparing across treatment groups, the greatest reductions from baseline were observed in those assigned to twice weekly for 6 weeks in weight (1 ± 1.7 (±SD) kg by week 6), waist circumference (− 2.0 ± 3.2 in. by week 6 and − 1.5 ± 3.2 in. by week 26), body mass index (− 0.4 ± 0.6 kg/m 2 ), and body fat mass (− 1.1 ± 1.6 kg). This group also had the most significant improvement from baseline in quality of life (+ 0.5 ± 0.8 by week 6), body satisfaction (+ 0.2 ± 0.4 by week 6 and week 26), and body appreciation (+ 0.2 ± 0.3 by week 6 and + 0.3 ± 0.3 by week 26). LLLT twice weekly for 6 weeks could be proposed as the optimal frequency and duration for the management of body weight. Trial registration: https://clinicaltrials.gov/ ct2/show/NCT02877004. Registered August 24, 2016.
study concept and design, analysis and interpretation of data, drafting and revising the paper, and have seen and approved the final version of the manuscript. EK-Dr. Kapoor was the co-principal investigator on the study. She contributed to development of the study protocol, recruitment of participants, and their follow-up in the study. She is the primary author of the manuscript._SSF -Dr. Faubion was a co-principal investigator for the study. She and Dr. Croghan collaborated in obtaining funding for the study concept and with Drs. Croghan and Kapoor participated in the study design. She and Drs. Kapoor and Hurt were responsible for safety screening for study entry and the safety oversight of the study participants while on study. She also participated in the review and interpretation of study results, and critical revision of the manuscript for important intellectual content. RTH -participated in the study design and was responsible for safety screening for study entry and the safety oversight of the study participants while on study. He also participated in the review and interpretation of study results, and critical revision of the manuscript for important intellectual content. KF and DRS participated in the study design and were responsible for data quality checks and data analysis; they also had full access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis as well as participating in the manuscript reviews and edits. SCF-reviewed the study flow, screened the study participants, oversaw all the study visits and lorcaserin treatments, as well as worked with the study clinicians and PI to address patient safety issues and with the PI and statistician to clean out the electronic data as well as provide reviews and edits to the manuscript. ITC -Dr. Croghan was a co-principal investigator on the study. She conceived the study concept and design; collaborated with Drs. Faubion and Kapoor in refining the working study design; and collaborated with Dr. Faubion in obtained study funding. She provided administrative, technical, and material support; she, along with Drs. Faubion and Kapoor, had full oversight of the study conduct during data collection; had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis; and participated in critical revision of the manuscript for important intellectual content.
Objective: The purpose of this pilot study was to evaluate the safety and use of a nature-based virtual reality (VR) experience among health care providers (HCP) during a pandemic. Methods: Twenty-four frontline HCP participated in this crossover pilot where the viewing order of the experiences were randomized. All participants attended in-person consent, baseline, and end-of-study visits. The intervention consisted of viewing 2 nature-based scenes (“walk in the woods” and “forest of focus”) through 3-D VR and with computer 4K graphic imagery. Randomization took place with regards to the viewing order (VR vs 4K computer video, scene 1 and 2). Outcomes measured were safety, acceptability and changes in intensity of anxiety feelings, resilience, emotional distress, cognitive function, and self-efficacy. Results: Among the 26 HCP expressing interest in the study, 24 enrolled in this study. The majority were male (58.3%), white (66.7%) and of an average age of 46.3 ± 10.5 years (standard deviation (SD)). End of the study survey showed that almost all participants (96%) would participate in the study again and recommend it to others. Twenty-three of the 24 participants also felt relaxed after seeing the imagery. With respect to anxiety (as measured by the STAI Y1), the VR “walk in the woods” had the greatest reduction from pre to post (6.4 points, SD = 5.98) followed by VR “forest of focus” (5.8 points, SD = 9.29), computer screen “forest of focus” (5.0 points, SD = 8.89), and computer screen “walk in the woods” (4.1 points, SD = 6.22). All 4 sessions had a significant decrease in score from pre to post (P-values ≤.005), but there was no significant difference in the change from pre- to post-session between the 4 groups (P-value = .5835). Conclusion: The use of the VR among HCP has promise for reducing stress among health care providers during a high stress period, such as a pandemic but much larger studies are needed.
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