Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial.
Importance: Pediatric guidelines for the management of nonalcoholic fatty liver disease (NAFLD) recommend a healthy diet as treatment. Reduction of sugary foods and beverages is a plausible but unproven treatment. Objective: To determine the effects of a diet low in free sugars (those sugars added to foods and beverages and occurring naturally in fruit juices) in adolescent boys with NAFLD. Design, Setting, and Participants: An open-label, 8-week randomized clinical trial of adolescent boys aged 11 to 16 years with histologically diagnosed NAFLD and evidence of active disease (hepatic steatosis >10% and alanine aminotransferase level ≥45 U/L) randomized 1:1 to an intervention diet group or usual diet group at 2 US academic clinical research centers from August 2015 to July 2017; final date of follow-up was September 2017. Interventions: The intervention diet consisted of individualized menu planning and provision of study meals for the entire household to restrict free sugar intake to less than 3% of daily calories for 8 weeks. Twice-weekly telephone calls assessed diet adherence. Usual diet participants consumed their regular diet. Main Outcomes and Measures: The primary outcome was change in hepatic steatosis estimated by magnetic resonance imaging proton density fat fraction measurement between baseline and 8 weeks. The minimal clinically important difference was assumed to be 4%. There were 12 secondary outcomes, including change in alanine aminotransferase level and diet adherence. Results: Forty adolescent boys were randomly assigned to either the intervention diet group or the usual diet group (20 per group; mean [SD] age, 13.0 [1.9] years; most were Hispanic [95%]) and all completed the trial. The mean decrease in hepatic steatosis from baseline to week 8 was significantly greater for the intervention diet group (25% to 17%) vs the usual diet group (21% to 20%) and the adjusted week 8 mean difference was -6.23% (95% CI, -9.45% to -3.02%; P < .001). Of the 12 prespecified secondary outcomes, 7 were null and 5 were statistically significant including alanine aminotransferase level and diet adherence. The geometric mean decrease in alanine aminotransferase level from baseline to 8 weeks was significantly greater for the intervention diet group (103 U/L to 61 U/L) vs the usual diet group (82 U/L to 75 U/L) and the adjusted ratio of the geometric means at week 8 was 0.65 U/L (95% CI, 0.53 to 0.81 U/L; P < .001). Adherence to the diet was high in the intervention diet group (18 of 20 reported intake of <3% of calories from free sugar during the intervention). There were no adverse events related to participation in the study. Conclusions and Relevance: In this study of adolescent boys with NAFLD, 8 weeks of provision of a diet low in free sugar content compared with usual diet resulted in significant improvement in hepatic steatosis. However, these findings should be considered preliminary and further research is required to assess long-term and clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02513121.
The impact of an exercise program on quality of life in older breast cancer survivors undergoing aromatase inhibitor therapy: a randomized controlled trial.
Health and quality of life outcomes. 2019;(1):17
BACKGROUND This study evaluated the impact of an exercise program on quality of life in older breast cancer survivors undergoing aromatase inhibitor therapy. METHODS Older breast cancer survivors were randomized into two groups: combined training: resistance + aerobic exercise program for nine months (n = 18) or control group (n = 18). Quality of life was assessed by the questionnaires SF36, EORTC QLQ-C30, and EORTC QLQ-BR23 at baseline, and at three, six, and nine months. The exercise group performed 40 min of resistance exercises on machines followed by 30 min of aerobic training on a treadmill 3x/wk. Repeated measures ANOVA was used to compare the groups over time. RESULTS Significant time x group interactions and moderate to high effect sizes were found for physical functioning, physical health, bodily pain, general health perception, vitality, social functioning, fatigue, sleep disturbance, body image, and upset by hair loss, favoring the exercise group. CONCLUSION This study demonstrated the potential benefits and high clinical relevance of exercise programs to improve quality of life in older breast cancer survivors undergoing aromatase inhibitor therapy.
The FLEX study school-based physical activity programs - measurement and evaluation of implementation.
BMC public health. 2019;(1):73
BACKGROUND Increasing children's physical activity (PA) at school is critical to obesity prevention and health promotion. Implementing novel, low-cost PA programs offers potential to contribute to children's in-school PA, particularly in resource-constrained schools. This evaluation describes implementation fidelity, reach, and dose of two PA programs in the Fueling Learning through Exercise (FLEX) Study. METHODS Thirteen diverse, low-income Massachusetts elementary schools were recruited and randomized to the 100 Mile Club walking/running program (n = 7) or CHALK/Just Move classroom activity break PA program (n = 6). Intervention programs were delivered across two school years. Surveys with program champions/teachers and children, in-session measurement of children's PA by accelerometry (Actigraph GT3X) in a subset of schools, and key informant interviews were used to collect information on implementation, including fidelity, dose, reach, and sustainability, and to calculate an implementation score. RESULTS Six CHALK/Just Move schools implemented the program in both years. Two schools randomized to 100 Mile Club did not implement at all, and only three schools implemented both years. Implementing schools had similar implementation scores (range = 0-3; 100 Mile Club = 2.0 vs. CHALK/Just Move = 1.9) but fidelity to core and enhanced elements differed between programs. In 100 Mile Club schools, dose of program delivered was greater than in CHALK/Just Move schools (34.9 vs. 19.7 min per week). Dose of PA received per session was also greater in 100 Mile Club schools (n = 55, 2 schools) compared with CHALK/Just Move schools (n = 160, 2 schools) (13.6 min vs. 2.7 min per session). A slightly higher proportion of eligible children participated in CHALK/Just Move compared to 100 Mile Club (54.0% vs. 31.2%). Both programs were well received by champions/teachers and students. CONCLUSIONS Program implementation varied across programs and schools, and erosion in delivery was seen over the two years. However, among implementing schools, additional PA was delivered and received, and the programs were generally well-received. Although school resource issues remain barriers to implemention, this evaluation demonstrates that low-cost programs may enhance PA opportunities. Future research should evaluate how multiple programs can be implemented to increase children's PA at school. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02810834 . Registered May 11, 2015.
Mindfulness mechanisms and psychological effects for aMCI patients: A comparison with psychoeducation.
Complementary therapies in clinical practice. 2019;:93-104
Amnestic mild cognitive impairment (aMCI), an Alzheimer's disease prodrome, is characterized by cognitive and psychological symptoms, the latter aggravating prognosis. A mindfulness-based intervention (MBI) represents a promising non-pharmacological framework for Alzheimer's disease prevention. The Monitoring + Acceptance Theory (MAT) postulates that MBI improves cognition through monitoring, and psychological well-being, through acceptance. This single-blind preliminary randomized-controlled study investigated the effects of a MBI on anxio-depressive symptoms, quality of life, and memory, compared to a psychoeducation-based intervention in older adults with aMCI. The contribution of MAT components and of ruminations' reduction to intervention efficacy were examined. Participants assigned to both conditions experienced similar benefits regarding anxio-depressive symptoms and aging-related quality of life. General quality of life and memory remained unchanged. A partial support of the MAT and of ruminations reduction to the MBI's efficacy was found. The findings provide new insights on the effects and mechanisms of a MBI on aMCI symptoms.
Cost-effectiveness and quality of life of a diet intervention postpartum: 2-year results from a randomized controlled trial.
BMC public health. 2019;(1):38
BACKGROUND Pregnancy has been identified as a contributor to obesity. We have shown that a diet intervention postpartum produced a 2-y weight loss of 8%. Here, we present the impact of the diet intervention on cost-effectiveness and explore changes in quality of life (QOL). METHODS A total of 110 postpartum women with overweight/obesity were randomly assigned to diet (D-group) or control (C-group). D-group received a 12-wk diet intervention within primary health care followed by monthly emails up to the 1-y follow-up. C-group received a brochure. Changes in QOL were measured using the 36-item Short Form Health Survey and EQ-5D. The analysis of cost-effectiveness was a cost-utility analysis with a health care perspective and included costs of intervention for stakeholder, quality-adjusted life-years (QALYs) gained and savings in health care. The likelihood of cost-effectiveness was examined using the net monetary benefit method. RESULTS The D-group increased their QOL more than the C-group at 12 wk. and 1 y, with pronounced differences for the dimensions general health and mental health, and the mental component summary score (all p < 0.05). Cost per gained QALY was 1704-7889 USD. The likelihood for cost-effectiveness, based on a willingness to pay 50,000 USD per QALY, was 0.77-1.00. CONCLUSIONS A diet intervention that produced clinically relevant postpartum weight loss also resulted in increased QOL and was cost-effective. TRIAL REGISTRATION Clinical trials, NCT01949558 , 2013-09-24.
Exercise training as an adjunctive therapy to montelukast in children with mild asthma: A randomized controlled trial.
BACKGROUND This study investigated the effectiveness and safety of exercise training (ET) as an adjunctive therapy to montelukast for children with mild asthma (MA). METHODS A total of 72 children, ages 4 to 12 years with MA were randomly assigned to a treatment group or a control group at a ratio of 1:1. The subjects in the treatment group received ET plus montelukast, while the participants in the control group received montelukast alone. The primary endpoint was lung function, as measured by forced expiratory volume in 1 second (FEV1) and ratio between FEV1 and forced vital capacity (FEV1/FVC). The secondary endpoints included the symptom improvements, as measured by clinical assessment score, and quality of life (QoL), as assessed with Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) scores. In addition, adverse events were also assessed during the period of this study. All outcomes were measured at baseline, at the end of 6-week treatment and 2-week follow-up after the treatment. RESULTS After 6-week treatment and 2-week follow-up, although ET plus montelukast did not show better effectiveness in improving lung function, as evaluated by the FEV1 (P > .05) and FEV1/FVC (P > .05) than montelukast alone, significant relief in clinical symptoms (P < .01), and improvement in QoL (P < .01) have achieved. Additionally, both groups had similar safety profile. CONCLUSION The results of this study showed that ET as an adjunctive therapy to montelukast may benefit for children with MA. Further studies are still needed to warrant the results of this study.
Water protection in patients with tympanostomy tubes in tympanic membrane: a randomized clinical trial.
Einstein (Sao Paulo, Brazil). 2019;(2):eAO4423
OBJECTIVE To analyze the incidence of otorrhea in the postoperative period of patients submitted to tympanotomy to place ventilation tube, and who did not protect the ear when exposed to water. METHODS Open, randomized-controlled trial. Eighty patients submitted to unilateral or bilateral ear grommet tympanostomy were included and divided into two groups: Auricular Protection and Non-Protection to water during bathing and activities in water. RESULTS In the first postoperative month, the Non-Protection Group presented a significant increase in the number of patients with otorrhea and in the incidence. Four patients of the Protection Group (11%) presented at least one episode of otorrhea in this period, representing an incidence of 0.11 (standard deviation ±0.32) episode/month, whereas in the Non-Protection Group there were 12 episodes (33%; p=0.045) and incidence of 0.33 (±0.48; p=0.02). Between the 2nd and the 13th postoperative months, there was no difference between groups. Seven patients in the Protection Group (20%) had at least one episode of otorrhea, representing an incidence of 0.04 (±0.09) episodes/month, while in the Non-Protection Group there were seven episodes (22%; p=0.8) and incidence of 0.05 (±0.1; p=0.8). CONCLUSION Patients who underwent ear protection when exposed to water had a lower incidence of otorrhea in the first postoperative month than those who did not undergo protection. From the second month, there was no difference between groups.
Fusing character strengths and mindfulness interventions: Benefits for job satisfaction and performance.
Journal of occupational health psychology. 2019;(1):150-162
In recent years, both mindfulness and character strengths have started to garner interest in industrial and organizational psychology. The growing research interest in their effects on employee well-being and performance, individually, has strong practical implications for organizations. Given the interconnection of mindfulness and character strengths, the present study examined the effectiveness of training that combined the two practices regarding well-being and work-related outcomes, and it tested the potential mediators of the effects at work. A total of 63 participants from various job branches were randomly assigned to three conditions: (a) mindfulness-based strengths practice (MBSP), (b) mindfulness-based stress reduction (MBSR), and (c) wait-list control. Participants' applicability of character strengths at work, well-being, perceived stress, job satisfaction, and task performance (supervisor rating) were assessed before and after the intervention, and 1, 3, and 6 months afterward. A set of linear mixed-effects models was applied, modeling changes in participants' outcome variables over time. Potential mediators for the intervention effect of MBSP at work were tested using four criteria adapted from a previous study. Results showed the MBSR was effective for increasing well-being, reducing perceived stress, and increasing job satisfaction, whereas the MBSP was effective for increasing well-being, job satisfaction, and task performance. These findings suggest that mindfulness alone seems to function better when regarding well-being at work, while fusing character strengths on top of it seems to influence the participants, on a motivational level, and thus bolsters task performance. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
Psychometric properties of the Patient Assessment of Chronic Illness Care measure (PACIC-5A) among patients with obesity.
BMC health services research. 2019;(1):61
BACKGROUND The Patient Assessment of Chronic Illness Care (PACIC-5A) was developed to assess the satisfaction with patient-provider interaction based on the Chronic Care Model. The additional 5A approach (assess, advise, agree, assist, arrange) allows to score behavioral counseling. The aim of the study was to assess the psychometric properties of the German adaptation of the PACIC-5A questionnaire in a sample of general practitioners (GP) patients with obesity. METHODS Analyses were based on data from the study "Five A's counseling in weight management of obese patients in primary care: a cluster randomized controlled trial (INTERACT)". Data were collected via standardized questionnaires containing the 26-item version of the PACIC-5A questionnaire. A total of 117 patients with obesity were included in the analyses. Statistical procedures comprised descriptive analyses, the calculation of Cronbach's alpha, test-retest analyses and factor analyses in order to assess the psychometric properties including reliability and validity of the PACIC-5A. RESULTS The patient's mean age was 43.4 years and the sample was mostly female (59%). Middle educational level was found for the majority (78%) and the mean Body Mass Index was 38.9 kg/m2. Descriptive analyses revealed a mean PACIC score of 2.33 and 5A sum score of 2.29. Notable floor effects were found. PACIC-5A showed high level of internal consistency (Cronbach's alphas > 0.9) and exploratory factor analyses resulted in a unidimensional structure. CONCLUSION The results of this study provide evidence regarding the psychometric properties of the German version of the PACIC-5A used in a sample of GP patients with obesity and make an important contribution to the reliable and valid assessment of the patient-GP interaction with regard to obesity counseling in primary care.
Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa.
BMC infectious diseases. 2019;(1):110
BACKGROUND Community-based GeneXpert MTB/RIF testing may increase detection of prevalent TB in the community and improve rates of TB treatment completion. METHODS We conducted a pilot randomized trial to evaluate the impact of GeneXpert screening on a mobile HIV testing unit. Adults (≥18y) underwent rapid HIV testing and TB symptom screening and were randomized to usual mobile unit care (providing sputum on the mobile unit sent out for GeneXpert testing) or the "Test & Treat TB" intervention with immediate GeneXpert testing. Symptomatic participants in usual care produced sputum that was sent for hospital-based GeneXpert testing; participants were contacted ~ 7 days later with results. In the "Test & Treat TB" intervention, HIV-infected or HIV-uninfected/TB symptomatic participants underwent GeneXpert testing on the mobile unit. GeneXpert+ participants received expedited TB treatment initiation, monthly SMS reminders and non-cash incentives. We assessed 6-month TB treatment outcomes. RESULTS 4815 were eligible and enrolled; median age was 27 years (IQR 22 to 35). TB symptoms included cough (5%), weight loss (4%), night sweats (4%), and fever (3%). 42% of eligible participants produced sputum (intervention: 56%; usual care: 26%). Seven participants tested GeneXpert+, six in the intervention (3%, 95% CI 1%, 5%) and one in usual care (1%, 95% CI 0%, 6%). 5 of 6 intervention participants completed TB treatment; the GeneXpert+ participant in usual care did not. CONCLUSION GeneXpert MTB/RIF screening on a mobile HIV testing unit is feasible. Yield for GeneXpert+ TB was low, however, the "Test & Treat TB" strategy led to high rates of TB treatment completion. TRIAL REGISTRATION This study was registered on November 21, 2014 at ClinicalTrials.gov ( NCT02298309 ).