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.
Objective: The purpose of this feasibility pilot study was to evaluate safety and adherence of a wearable brain sensing wellness device designed to reduce stress among healthcare professionals (HCP). Methods: A total of 40 HCP were invited to participate in an open-label pilot study. Participants were asked to use a brain sensing wearable device (MUSE-S™) on a daily basis to reduce their stress, for a total of 90 days. Total study participation duration was 180 days. Study enrollment began in August 2021 and ended December 2021. The exploratory outcomes included stress, depression, sleep, burn-out, resilience, quality of life, and cognition. Results: Among the 40 HCP in study, the majority were female (85%), white (87.5%) and with an average age of 41.3 ± 11.0 years (SD). Participants used the wearable device an average of 23.8 times over a 30-day period with a mean duration of 5.8 min with each use. Study results demonstrate the positive impact of guided mindfulness using the wearable device MUSE-S™ and its accompanying application (APP). A statistically significant improvement was found for a reduction in stress ( P < .001) and improvement in resilience ( P = .02), quality of life ( P = .003), and cognition ( P < .001). The majority (91.9%) of the participants indicated they felt more relaxed after using the device, and 73% indicated they would continue to use this device at end-of-study. No adverse effects were reported. Conclusion: Study results show that 3 to 10 min of guided meditation during work hours through the use of a brain sensing wearable device is safe and acceptable, with associated health benefits for HCP.
Introduction: Mindfulness is a promising intervention for female sexual dysfunction (FSD); however, of the mindfulness interventions studied, few treat the woman and her partner. Aim: We developed a brief online mindfulness, resilience, and psychoeducation intervention, Stress Management and Resiliency Training for Sexuality (Sex SMART), for women with sexual health concerns and their partners. Methods: Women with female sexual interest/arousal disorder and their partners were recruited between February 24, 2015, and October 6, 2016, and randomized to treatment or control groups (received educational pamphlets). The treatment intervention comprised of an online SMART and sexual health psychoeducation module. Main Outcome Measures: The Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), Sexual Desire Inventory-2 (SDI-2), Revised Dyadic Adjustment Scale (RDAS), International Index of Erectile Function (IIEF), and other subjective measures were used to assess sexual function and sexual distress at baseline and 12 weeks. Results: The study included 60 women and their partners (30 couples in each group). In both groups, sexual function by total FSFI scores and sexual distress scores significantly improved at 12 weeks compared with baseline, with no significant between-group differences (FSFI effect estimate for Sex SMART vs control = +1.4 (90% CI [−0.6 to +3.4]; P=.13). Both participants and partners randomized to the intervention reported significantly improved attitude and feelings, comfort as a sexual person, and subjective sexual functioning at 12 weeks. The findings provide preliminary evidence for efficacy of an online intervention for couples with sexual health problems. Conclusions: A brief online mindfulness, resilience, and psychoeducation−based intervention showed no significant improvement in many outcomes (FSFI, FSDS-R, SDI-2, RDAS) of sexual health versus controls. Although this is the first online randomized controlled trial to evaluate a mindfulness-based therapy intervention, it was limited by its lack of population diversity and high attrition rate. Significant improvements in subjective sexual health and partner sexual function by the International Index of Erectile Function were reported only in the intervention group. Rullo JE, Sood R, Fokken SC, et al. Couples' Use of Online Stress Management and Resiliency Training for Sexual Health Concerns: A Randomized Controlled Trial. Sex Med 2021;XX:XX −XXX.
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