IMPORTANCE Effective strategies for preventing type 2 diabetes are needed. Many people turn to complementary medicines, but there is little well-conducted scientific evidence to support their use. OBJECTIVETo assess the efficacy of α-cyclodextrin for cholesterol control and that of hydrolyzed ginseng for glycemic control in people with prediabetes and overweight or obesity. DESIGN, SETTING, AND PARTICIPANTSThis 6-month double-blind, placebo-controlled, randomized clinical trial, with a 2 × 2 factorial design, was conducted between July 2015 and October 2018 at 2 locations in Sydney, Australia. Eligible participants were aged 18 years or older, had a body mass index (weight in kilograms divided by height in meters squared) of 25 or higher, and had prediabetes within 6 months of study entry according to the American Diabetes Association guidelines. Data analysis was performed from May to August 2019. INTERVENTIONSParticipants were randomized to 1 of 4 groups to take active or placebo versions of each supplement (α-cyclodextrin plus hydrolyzed ginseng, α-cyclodextrin plus placebo, placebo plus hydrolyzed ginseng, or placebo plus placebo) for 6 months. All participants received dietetic advice for weight loss. MAIN OUTCOMES AND MEASURESThe primary outcomes were the differences in total cholesterol and fasting plasma glucose between groups after 6 months. The primary analysis used the intention-to-treat principle. Multiple predetermined subsample analyses were conducted. RESULTSA total of 401 participants were eligible for the study (248 women [62%]; mean [SD] age, 53.5 [10.2] years; mean [SD] body mass index, 34.6 [6.2]). One hundred one patients were randomized to receive α-cyclodextrin plus hydrolyzed ginseng, 99 were randomized to receive α-cyclodextrin plus placebo, 101 were randomized to receive placebo plus hydrolyzed ginseng, and 100 were randomized to receive placebo plus placebo. For 200 participants taking α-cyclodextrin compared with 201 participants taking placebo, there was no difference in total cholesterol after 6 months (−1.5 mg/dL; 95% CI, −6.6 to 3.5 mg/dL; P = .51). For 202 participants taking hydrolyzed ginseng compared with 199 participants taking placebo, there was no difference in fasting plasma glucose after 6 months (0.0 mg/dL; 95% CI, −1.6 to 1.8 mg/dL; P = .95). Use of α-cyclodextrin was associated with constipation (16 participants vs 4 participants; P = .006) and cough (8 participants vs 1 participant; P = .02). Use of hydrolyzed ginseng was associated with rash and pruritus (13 participants vs 2 participants; P = .006). Only 37 of 401 participants (9.2%) experienced these adverse events. (continued) Key Points Question Can α-cyclodextrin and hydrolyzed ginseng aid in cholesterol and glycemic control, respectively, in people with prediabetes and overweight or obesity? Findings In this double-blind, placebocontrolled, randomized clinical trial of 401 participants, there was no significant difference in total cholesterol in those taking α-cyclodextrin or in fasting plasma glucose in those t...
Background Early detection and treatment are essential to ensuring the best possible health outcomes for people with eating disorders (EDs). However, low diagnostic accuracy and a lack of specific ED training are common workforce challenges in Australia and internationally. Online learning provides a potential solution in facilitating the access to evidence-based training programs. The InsideOut Institute has developed the first online clinical training program in EDs to assist with educating health professionals in the identification, assessment, and management of EDs. The aim of the study is to evaluate the effectiveness of the online training program, The Essentials , in mitigating barriers to health professionals treating patients with EDs. Methods Pre and post training questionnaires assessed participants’ attitudes, knowledge, and skills in relation to treating people with EDs. Demographic and work-related information (gender, discipline, work setting, practice length and remoteness) and participants’ ratings of the online learning experience and satisfaction on completion were collected. The Wilcoxon signed rank test was applied to test for changes in learning outcomes before and after completion of the program. A multivariate linear regression model was estimated for each of the learning outcomes with personal and work-related characteristics as covariates. Results Among 1813 health professionals who registered for The Essentials program between 1 October 2013 and 31 July 2018, 1160 completed at least 80% of the five learning modules. There were significant improvements in confidence, knowledge, skills to treat EDs and a reduction in stigmatised beliefs among the 480 participants who completed both pre and post assessments. Results from the regression models suggest that psychologists, dieticians, and those working in rural areas were more willing to treat EDs after completing the program. Additionally, those working in hospitals and regional or rural areas experienced the largest improvement in confidence for treating patients with EDs. Conclusions The Essentials program represents a new and effective way of meeting the educational needs of partaking health professionals working with ED patients. Greater investment in the development and testing of evidence-based online training programs for EDs may help to address some of the considerable workforce development challenges in EDs. Electronic supplementary material The online version of this article (10.1186/s40337-019-0243-5) contains supplementary material, which is available to authorized users.
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