Between-group Difference In Change Research Articles

Electrically assisted cycling for individuals with type 2 diabetes mellitus: a pilot randomized controlled trial

BackgroundType 2 diabetes mellitus (T2DM) and its associated complications puts considerable strain on healthcare systems. With the global incidence of T2DM increasing, effective disease management is essential. Physical activity (PA) is a key component of T2DM management; however, rates of PA engagement are low in this population. Developing effective and sustainable interventions that encourage PA is a high priority. Electrically assisted bicycles are becoming increasingly popular and may increase PA in healthy adults. This study aimed to provide evidence of the feasibility of conducting a randomized controlled trial to evaluate the efficacy of an e-cycling intervention to increase PA and improve health in individuals with T2DM.MethodsA parallel-group two-arm randomized, waitlist-controlled pilot study was conducted. Individuals were randomized to either an e-bike intervention or standard care. The intervention incorporated two one-to-one e-bike skills training and behavioural counselling sessions delivered by a community-based cycling charity, followed by a 12-week e-bike loan with two further sessions with the instructors. Feasibility was assessed via measures related to recruitment, retention and intervention implementation. Post-intervention interviews with instructors and participants explored the acceptability of the study procedures and intervention. Clinical, physiological and behavioural outcomes were collected at baseline and post-intervention to evaluate the intervention’s potential.ResultsForty participants (Mage = 57) were randomized, of which 34 were recruited from primary care practices. Thirty-five participants were retained in the trial. The intervention was conducted with high fidelity (> 80% content delivered). E-bike training provided participants with the skills, knowledge and confidence needed to e-bike independently. Instructors reported being more confident delivering the skills training than behavioural counselling, despite acknowledging its importance. The study procedures were found to be acceptable to participants. Between-group differences in change during the intervention were indicative of the interventions potential for improving glucose control, health-related quality of life and cardiorespiratory fitness. Increases in overall device measured moderate-to-vigorous PA behaviour following the intervention were found, and there was evidence that this population self-selected to e-cycle at a moderate intensity.ConclusionsThe study’s recruitment, retention, acceptability and potential efficacy support the development of a definitive trial subject to identified refinements.Trial registrationISRCTN, ISRCTN67421464. Registered 17/12/2018.

Effects of Controlled Supramaximal High-Intensity Interval Training on Cardiorespiratory Fitness and Global Cognitive Function in Older Adults: The Umeå HIT Study-A Randomized Controlled Trial.

This study examined the effects of regulated and controlled supramaximal high-intensity interval training (HIT) adapted for older adults, compared to moderate-intensity training (MIT), on cardiorespiratory fitness; cognitive, cardiovascular, and muscular function; and quality of life. Sixty-eight nonexercising older adults (66-79 years, 44% males) were randomized to 3 months of twice-weekly HIT (20-minute session including 10 × 6-second intervals) or MIT (40-minute session including 3 × 8-minute intervals) on stationary bicycles in an ordinary gym setting. Individualized target intensity was watt controlled with a standardized pedaling cadence and individual adjustment of the resistance load. Primary outcomes were cardiorespiratory fitness (V̇o2peak) and global cognitive function (unit-weighted composite). V̇o2peak increased significantly (mean 1.38 mL/kg/min, 95% CI [0.77, 1.98]), with no between-group difference (mean difference 0.05 [-1.17, 1.25]). Global cognition did not improve (0.02 [-0.05, 0.09]), nor differed between groups (0.11 [-0.03, 0.24]). Significant between-group differences in change were observed for working memory (0.32 [0.01, 0.64]), and maximal isometric knee extensor muscle strength (0.07 N·m/kg [0.003, 0.137]), both in favor of HIT. Irrespective of the group, there was a negative change in episodic memory (-0.15 [-0.28, -0.02]), a positive change in visuospatial ability (0.26 [0.08, 0.44]), and a decrease in systolic (-2.09 mmHg [-3.54, -0.64]) and diastolic (-1.27 mmHg [-2.31, -0.25]) blood pressure. In nonexercising older adults, 3 months of watt-controlled supramaximal HIT improved cardiorespiratory fitness and cardiovascular function to a similar extent as MIT, despite half the training time. In favor of HIT, there was an improvement in muscular function and a potential domain-specific effect on working memory. NCT03765385.

Improving the mental health and well-being of healthcare providers using the transcendental meditation technique during the COVID-19 pandemic: A parallel population study.

Frontline Healthcare provider (HCP) burnout has dramatically increased due to the COVID 19 pandemic. Hospitals are supporting wellness programs and techniques to reduce burnout including the Transcendental Meditation (TM) technique. This study evaluated the use of TM on HCP symptoms of stress, burnout and wellness. A total of 65 HCPs at three South Florida hospitals were recruited and instructed in the TM technique which they practiced at home for 20 minutes twice a day. A parallel lifestyle as usual control group was enrolled. Validated measurement scales (Brief Symptom Inventory 18 (BSI-18), Insomnia Severity Index (ISI), Maslach Burnout Inventory-Human Services Survey [MBI-HSS (MP)] and the Warwick Edinburgh Mental Well Being Scale (WEMWBS) were administered at baseline, 2 weeks, one and three months. No significant demographic differences were seen between the 2 groups; however, some baseline scales were higher in the TM group. TM average weekly session completion rate was very high at 83%. After 2-weeks, symptoms of somatization, depression, and anxiety in the TM group had all shown near 45% reductions, while insomnia, emotional exhaustion, and well-being had improved by 33%, 16%, and 11% respectively (P = 0.02 for somatization and < .001 for all others); no significant change was noted in the LAU group. At 3-months, in the TM group, the improvement in symptoms showed a mean reduction of in anxiety, 62%, somatization, 58%, depression, 50%, insomnia, 44%, emotional exhaustion 40%, depersonalization, 42%, and improvement of well-being 18% (for all p<0.004). P-values for between-group differences in change from baseline, based upon repeated measures ANCOVA covarying for baseline measurements, showed significance for all scales at 3-months. The study confirmed the reported significant and rapid benefits of the practice of TM and demonstrated its positive psychological impact on healthcare workers in a high stress setting.

Study protocol for a multicenter randomized controlled trial of personalized exercise therapy and self-management support for people with multimorbidity: The MOBILIZE study.

Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it. The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity. This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience. Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.

Effect of Curcuma longa extract on serum inflammatory markers and MRI-based synovitis in knee osteoarthritis: secondary analyses from the CurKOA randomised trial

BackgroundCurcuma longa (CL) extract is modestly effective for relieving knee symptoms in knee osteoarthritis (OA) patients; however, its mechanism of action is unclear. PurposeWe aimed to determine the effects of CL treatment on serum inflammatory markers over 12 weeks and to explore its potential effects on synovitis assessed by contrast-enhanced magnetic resonance imaging (CE-MRI) of the knee. MethodsSecondary analyses were conducted on the CL for knee OA (CurKOA) trial, which compared CL (n = 36) and placebo (n = 34) over 12 weeks for the treatment of knee OA. Systemic inflammatory markers (TNFα, IL6, and hsCRP) and a cartilage extracellular matrix degradative enzyme (MMP-3) were measured. A subgroup of participants (CL, n = 7; placebo, n = 5) underwent CE-MRI at baseline and a 12-week follow-up. ResultsOver 12 weeks, there were no between-group differences in change in hsCRP, IL-6, and TNFα levels. MMP-3 levels decreased in both CL (-1.31 ng/ml [95%CI: -1.89 to -0.73]) and placebo (-2.34 ng/ml [95%CI: -2.95 to -1.73]) groups, with the placebo group having a slightly greater decrease (1.03 ng/ml [95%CI: 0.19 to 1.88]). Most (10 of 12) sub-study participants had normal synovial thickness scores at baseline. One participant had mild synovitis in each of the placebo and CL groups. Synovitis status was stable for all except two participants, one each in the CL and placebo group, whose synovitis score increased. ConclusionThis is the first study that explored the effect of CL treatment on local and systemic inflammation using biochemical markers and CE-MRI outcomes on knee OA patients. Secondary analyses from this pilot study suggest that CL is unlikely to have clinically significant effects on systemic (inflammatory and cartilage) or local synovitis (CE-MRI) biomarkers compared to placebo. The mechanism of action for CL effect on pain remains unclear.

P01.06.B Interim results from CAR-Study B: An ongoing randomized trial on the effect of SRS or WBRT on cognitive performance in patients with 11-20 brain metastases

Abstract Background Both stereotactic radiosurgery (SRS) and whole brain radiation therapy (WBRT) have proven to be effective treatments for multiple brain metastases (BM) with similar overall survival. Cognition and Radiation (CAR) Study B is a randomized trial on the effect of Gamma Knife radiosurgery (GKRS) or WBRT on cognitive performance in patients with 11-20 BM. The primary and secondary aim of this interim analysis were to check whether Bayesian stopping rules for cognitive failure were met, and to compare cognitive changes after treatment respectively, for the first 45 patients enrolled. Material and Methods Patients with 11-20 newly diagnosed BM on a triple-dose contrast-enhanced MRI-scan, expected survival &amp;gt;3 months and Karnofsky Performance Status (KPS) ≥70, were stratified by age, histology, total BM volume, systemic treatment, KPS, and baseline Hopkins Verbal Learning total recall (HVLT-R TR) score, and randomized 1:1 (minimization) to GKRS or WBRT. Neuropsychological tests were administered before (T0) treatment (n=21 vs n=20), and at 3 (T3; n=16 vs n=14) and 6 (T6; n=9 vs n=9) months thereafter. A decline of ≥5 points in HVLT-R TR score was considered a cognitive failure. The trial would be halted if the posterior probability for a higher cognitive failure rate in one group versus the other was &amp;gt;0·975 at T3 or T6 according to the employed beta (2.09,2.91) prior (prior mean of 42%), based on the average failure rates at 4 months reported by Chang et al. (2009). Between-group differences in changes of test performances over 6 months were analyzed using mixed ANOVAs. Proportions of cognitive changes (T0-T6) at the individual level based on reliable change indices correcting for practice effects, were determined. Results HVLT-R TR failure rates in the GKRS versus WBRT group were 31% versus 29% at T3, and 0% versus 33% at T6. The observed failure rates after WBRT at T3 and T6 were lower than the average failure rates of Chang et al. (2009). Posterior probabilities were 0·451 at T3 and 0·918 at T6. Over 6 months, changes in performance on tests of immediate (p=·003) and delayed recall (p=·024), and information processing speed (p=·003) were significantly different between groups (large effect sizes), with significant declines after WBRT, but not after GKRS. Over 6 months, at the individual patient level, there were no declines in performances across all tests in the GKRS group (n=8) while performances declined in 4 out of 8 patients in the WBRT group. Conclusion The stopping rules were not met since the posterior probabilities did not cross the threshold. Other preliminary findings in this small sample suggest that cognitive decline, both at group and individual level, is more pronounced after WBRT compared to GKRS. Accrual is continued (NCT02953717; ZonMw 842003006).

A Comparison Of Protein And Carbohydrate-fed Sprint Interval Training On Skeletal Muscle And Performance Adaptations

Sprint interval training (SIT) has emerged as a potent metabolic stimulus inducing beneficial musculoskeletal adaptations. However, nutritional support to optimise the adaptive response to SIT remains poorly characterised. Carbohydrate (CHO) has previously been shown to blunt metabolic adaptations to training while there is increased interest in the role of protein in regulating training adaptations. PURPOSE: The aim of this study was to determine the effects of whey protein concentrate (WPC) compared with CHO feeding on the acute regulation of skeletal muscle mitochondrial gene expression, enzyme activity and performance following a 3 week SIT intervention. METHODS: This study was ethically approved and conducted in line with the Declaration of Helsinki. Healthy, recreationally active (VO2 max <50 ml.kg-1.min-1) males (n = 17) were randomised to complete SIT under CHO or WPC conditions. Participants attended the lab after an overnight fast (≥10 h) and ingested 0.33 g.kg-1 body mass (BM) of WPC, or 0.91 g.kg-1 BM maltodextrin (CHO) 45 min prior to SIT consisting of four 30 s sprints at a resistance of 7.5 % BM, interspersed with 4 min recovery. Muscle biopsies were obtained under local anaesthetic from m. vastus lateralis at rest and 3 h post-exercise. RNA extracted from skeletal muscle underwent multiplex PCR to determine mRNA expression relative to reference gene UBE2D2. Independent t-tests determined between-group differences in changes from baseline. RESULTS: Acute changes in PGC-1α, NMRK2, NNMNAT1/3 were not differentially regulated by condition (p > 0.05). Fold-change in PDK4, SIRT4, NAMPT and NNMT were differentially regulated by nutrient condition following an acute bout of SIT (WPC vs CHO: 6.6. vs 2.6; 0.62 vs 0.86; 1.73 vs 1.14; 6.0 vs 2.8, respectively, p < 0.05). Citrate synthase and β-3-Hydroxyacyl-CoA dehydrogenase (HAD) enzyme activity increased to a greater extent in response to SIT with WPC (Fold change WPC vs CHO: 1.3 vs 1.1; 1.23 vs 1.02, respectively, p < 0.05). Post-SIT Wingate performance changes were not different between conditions (% change WPC vs CHO: 6.3 vs 4.1%, p > 0.05). CONCLUSION: Pre-exercise nutrients result in divergent regulation of mitochondrial enzyme activity and some genes in response to SIT, however this is not associated with differential performance adaptations.

Effects of computerized cognitive training on cognitive function, activity, and participation in individuals with stroke: A randomized controlled trial.

Computerized cognitive training (CCT) is an emerging alternative intervention for stroke survivors. This study investigated the effects of CCT on the cognition, activity, and participation of stroke survivors and compared the findings with those of match-dosed conventional cognitive training. This randomized controlled trial included 39 patients with stroke who were divided into the intervention group (n = 19; receiving CCT with Lumosity software) and the control group (n = 20; receiving conventional cognitive training). Both the groups were trained for 20 min, twice a week, for 12 weeks. Participants were evaluated at pretest, posttest, and 4-week follow-up. Outcome measures included various cognitive function tests and the Stroke Impact Scale scores. The CCT group exhibited significant improvement in global cognitive function (evaluated using the Mini-Mental State Examination and Montreal Cognitive Assessment) and specific cognitive domains: verbal working memory (backward digit span test), processing speed (Symbol Digit Modalities Test), and three MoCA subtests (attention, naming, and delayed recall). CCT exerted no significant effect on activities and participation. No significant between-group differences in changes in cognitive function were noted. However, CCT significantly improved cognitive function domains immediately after training, and these effects were sustained at the 4-week follow-up. Cognitive function of individuals with chronic stroke could improve after administration of CCT. However, future studies with a more rigorous design and higher training dose are warranted to validate our findings.

REGN1908/1909 prevented cat allergen–induced early asthmatic responses in an environmental exposure unit

The dominant allergen in cat dander, Felis domesticus allergen 1 (Fel d 1), is a persistent trigger for allergic rhinitis and asthma symptoms. We evaluated the efficacy of Fel d 1 monoclonal antibodies (REGN1908/1909) in preventing cat allergen-induced early asthmatic responses (EARs) in cat-allergic patients with mild asthma. Patients were randomized to single-dose REGN1908/1909 600 mg (n= 29) or placebo (n= 27). The FEV1 was measured for up to 4 hours in a cat allergen environmental exposure unit up to 85 days after dosing. Assessments included between-group differences in change from baseline in FEV1 area under the curve (AUC; 0-2 hours) and incidence of EAR (FEV1 reduction ≥20%). NCT03838731. Single-dose REGN1908/1909 significantly prevented reductions in FEV1 on days 8, 29, 57, and 85. Most REGN1908/1909 patients did not have an EAR by 4 hours (the last time point tested). In contrast, placebo-treated patients experienced a ≥20% mean FEV1 reduction on days 8, 29, 57, and 85 after dosing, with most experiencing an EAR within 1 hour. REGN1908/1909-treated patients tolerated 3-fold higher allergen quantities (P< .05 at all time points) versus placebo. REGN1908/1909 substantially reduced skin test reactivity to cat allergen versus placebo at all time points tested (nominal P< .001). REGN1908/1909 was generally well tolerated; no serious adverse events or deaths were reported. Single-dose REGN1908/1909 significantly prevented reductions in FEV1 in cat-allergic patients with mild asthma on cat allergen environmental exposure unit exposure at 8 days and up to 85 days after dose.

Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study

Objective The Pediatric Adverse Event Rating Scale (PAERS) measured adverse events of children aged 6–12 years with ADHD and emotional dysregulation in the Micronutrients for ADHD in Youth (MADDY) study, an eight week multi-site randomized clinical trial of a broad-spectrum multinutrient treatment. Treatment sensitivity of the PAERS was assessed by calculating the treatment difference in change of the item scores from baseline to end of the RCT. Methods Principal component analysis retained 14 “adverse events” (out of 43 in the PAERS) that reflected ADHD symptoms and emotional dysregulation and was used to group the variables of interest. A combined score ranging from 0 to 5 was created based on symptom presence, functional impairment, and severity. Mean score change was calculated from baseline to week 8 by treatment (multinutrient vs placebo) with intention-to-treat and per-protocol samples. The study has been registered on clinicaltrials.gov as Micronutrients for ADHD in Youth (MADDY) Study, trial registration # NCT03252522 (https://clinicaltrials.gov/ct2/show/NCT03252522 ). Results The 126 children in the ITT sample had a mean age of 9.8 (SD = 1.7), with majority (73%) male, and 72% diagnosed with ADHD prior to the study screening. Baseline presence of PAERS symptoms was similar between treatment groups: the highest proportion was ADHD symptoms, followed by Irritable symptoms. The micronutrient group showed a greater decrease (improvement) in the mean anxiety combined score than the placebo group with a between-group difference in change of −0.36 (95% CI: −0.67, −0.04; p = .03) with ITT data and −0.48 (95% CI: −0.81, −0.15; p = .005) with per-protocol (n = 93) data. Conclusion The multinutrient supplement did not result in more adverse events than placebo, suggesting it is a safe intervention. In addition to assessing actual adverse events, the PAERS may be a useful adjunct outcome measure for ADHD behaviors.

Guided Self-Help for Pediatric Obesity in Primary Care: A Randomized Clinical Trial.

Our aim was to compare the effect of 2 treatment models on attendance and child weight status: a less intense guided self-help (GSH) program delivered in the primary care setting versus traditional family-based behavioral treatment (FBT) delivered in an academic center. We conducted a randomized clinical trial among 164 children between 5 and 13 years old with a BMI ≥85th percentile and their parents. The intervention group (GSH) received 14 individual sessions over 6 months, with 5.3 hours of treatment. The control group (FBT) received 20 group-based sessions over 6 months, with 20 hours of treatment. Main outcomes included proportion of sessions families attended and change in child BMI z-score (BMIz), percentage from the 95th BMI percentile, difference from the 95th BMI percentile at the end of treatment, and 6-month follow-up. Mean age of children was 9.6 years, BMI z-score 2.1, 49% female, and >90% Latino. The odds of attending GSH compared to FBT was 2.2 (P < 0.01). Those assigned to GSH had a 67% reduced risk of attrition (hazard ratio = 0.33, 95% confidence interval 0.22-0.50, P < .001). Intent-to-treat analysis showed no between-group differences in change in BMIz and percentage from the 95th BMI percentile over time. Combined, there was a significant reduction in BMIz from baseline to posttreatment (β = -0.07 (0.01), P < .01, d: 0.60) and a slight increase from posttreatment to follow-up (β = 0.007 (0.13), P = .56). This study provides support for a novel, less intense GSH model of obesity treatment, which can be implemented in the primary care setting. Future studies should examine effective approaches to dissemination and implementation of GSH in different settings to increase access to treatment.

An examination into the mental and physical effects of a saffron extract (affron®) in recreationally-active adults: A randomized, double-blind, placebo-controlled study.

ABSTRACTBackgroundSaffron, derived from the stigmas of the Crocus Sativus flower, has been shown in several studies to improve mood and wellbeing in adults experiencing low mood and anxiety. The goals of this study were to examine its mental and physical effects in healthy, recreationally active adults.MethodsIn this 6-week, randomized, double-blind, placebo-controlled study, 62 adults engaging in regular exercise were recruited and randomized to receive a placebo or 28 mg daily of a standardized saffron extract (affron®). Self-report outcome measures include the Physical Activity Enjoyment Scale, Profile of Mood States, and Patient-Reported Outcomes Measurement Information System-29. Participants also wore a wrist-worn heart rate, activity, and sleep monitoring device (WHOOP) to measure changes in sleep quality, resting heart rate, and heart rate variability. To help identify mechanisms of action associated with saffron intake, changes in plasma concentrations of brain-derived neurotrophic factor, oxytocin, and neuropeptide Y were also measured.ResultsBased on data collected from all participants, there were no statistically significant between-group differences in changes in any of the outcome measures. However, when changes were analyzed by sex, there were statistically significant greater increases in enjoyment associated with exercise (p =.009) and heart rate variability (p =.001) in male participants taking saffron compared to the placebo. No statistically significant between-group differences were identified in females.ConclusionsThe results of this trial suggest saffron may have beneficial effects in recreationally active males, as evidenced by increased exercise enjoyment and heart rate variability. However, no such benefits were identified in females. Future research using larger sample sizes, varying treatment periods, and additional outcome measures will be required to validate the results from this study and help clarify the mechanisms of action associated with saffron intake.This study was prospectively registered on 30 October 2020 with the Australian and New Zealand Clinical Trials Registry (Trial ID. ACTRN12621000501842).

Effect of Daily Avocado Intake for Six Months on Flow-Mediated Dilation: A Sub-Study of the Habitual Diet and Avocado Trial, a Randomized Controlled Study

ObjectivesThe Habitual diet and Avocado Trial (HAT), a multicenter parallel randomized controlled trial, was designed to examine the health effects of consuming 1 avocado per day for 6-months compared to a habitual diet limited in avocados in individuals with abdominal obesity. We assessed the effects of the intervention on endothelial function using flow-mediated dilation (FMD) of the brachial artery. MethodsAll participants were ≥25 years of age with an elevated waist circumference (≥88 cm women; ≥102 cm men). Participants were randomized into either a control group (HD: consumed <2 avocados/month for 6 months) or an experimental group (AVO: consumed 1 avocado/day for 6 months). At the Pennsylvania State University, University Park site (n = 134), FMD was measured at baseline and end of the study. Within-person change scores were calculated by subtracting FMD at baseline from FMD at the end of the study. Linear regression was used to examine between-group differences in change across 6 months. ResultsThe sample was 78% female (BMI 33 ± 5 kg/m2). At baseline, FMD was 7.73 ± 3.37% in the AVO group, and 6.85 ± 2.67% in the HD group. FMD decreased by –0.10 ± 2.94% in the AVO group and increased by 0.52 ± 3.17% in the HD group. There were no significant between-group differences in 6-month change in FMD (0.62%, 95%CI = –0.46–1.70, p = 0.26). The results remained unchanged after adjustment for sex, BMI, and baseline FMD (0.15%, 95%CI = –0.77–1.06, p = 0.75). ConclusionsResults suggest that consumption of 1 avocado per day for 6 months in adults with abdominal obesity is not associated with a significant improvement in endothelial function, compared to adults following their habitual diet. Participants in this study had relatively high FMD at baseline, which may have reduced our ability to observe improvements in endothelial function. Funding SourcesAvocado Nutrition Center and the National Center for Advancing Translational Sciences, National Institutes of Health (1UL1TR002014-01)

Can personality feedback improve the process of self-management in cancer? Results from a randomized controlled trial.

12130 Background: Although personality characteristics predict emotional and physical quality of life in cancer, personality assessments are rarely used to inform care. This study examined whether a personality feedback intervention improved three patient-reported outcomes underlying the process of cancer self-management: 1) self-awareness, 2) self-efficacy for managing symptoms, treatment/medication, and emotions, and 3) positive affect. Methods: A sample of 372 adults with a history of cancer participated in a single-session, pre-post randomized controlled trial via Qualtrics (Control n= 188, Intervention n= 184). The sample was recruited online through ResearchMatch.org and cancer social media sites. Participants completed a baseline survey of demographics, Big Five personality traits, and study outcomes using validated measures. Next, they were immediately randomized to receive either intervention or control materials, followed by a post-test of study outcomes. Intervention participants received a feedback report of their personality results and tailored self-management tips, while control participants received only a general description of the Big Five personality traits. Three general linear models tested between-group differences in changes from baseline to post-test on each outcome, while controlling for baseline scores and demographic and health characteristics. Significance thresholds for all coefficients across all three models were simultaneously adjusted for a false discovery rate of 15%. Intervention participants also responded to a 5-item acceptability scale. Results: Participants were mostly non-Latino/a White (91%), middle-to-older aged ( M= 58.40, SD= 13.56), women (72%), and diagnosed with cancer an average of 6.06 years prior ( SD= 3.91). Compared to controls, intervention participants experienced a greater increase on a composite measure of self-efficacy for illness self-management ( d= 0.32, p=.002), as well as on the individual domain of self-efficacy for managing symptoms ( d= 0.36, p&lt;.001). Contrary to hypotheses, the intervention did not improve self-awareness or positive affect ( ps ≥.132). Intervention participants rated the activity’s acceptability a mean of 3.97 ( SD= 0.68) on a scale from 1 to 5. Conclusions: This was the first study to demonstrate that a personality feedback intervention can improve self-efficacy in the context of managing a chronic illness. Findings call for follow-up studies to test whether these results translate into improved self-management behaviors and quality of life among individuals living with cancer. Clinical trial information: NCT04625439.

Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality.

Women with low household income and from racial/ethnic minority groups are at elevated risk of food insecurity. Food insecurity during pregnancy is associated with overall less healthy diets, lower intake of the pregnancy-supportive nutrients iron and folate, and significant variations in diet across the course of a month. The goal of this study was to explore the impact of an ongoing $40/month supplement for fruits and vegetables (F&Vs) provided to pregnant people enrolled in the Special Supplemental Nutrition Program for Women and Children (WIC). Our primary outcome was food insecurity using the USDA 6-item survey, and our secondary outcome was dietary intake of F&Vs based on the 10-item Dietary Screener Questionnaire. Participants in intervention and comparison counties completed surveys at enrollment and approximately three months later (n = 609). Mean ± SD food insecurity at baseline was 3.67 ± 2.79 and 3.47 ± 2.73 in the intervention and comparison groups, respectively, and the adjusted between-group change from baseline to follow-up in food insecurity was 0.05 [95% CI: −0.35, 0.44] (p > 0.05). F&V intake (in cup equivalents) was 2.56 ± 0.95 and 2.51 ± 0.89 at baseline in the two groups, and the adjusted mean between-group difference in changes from baseline was −0.06 [−0.23, 0.11] (p > 0.05). Recruitment and data collection for this study coincided with the most intensive of America’s COVID relief efforts. Our results may indicate that small increases in highly targeted food resources make less of a difference in the context of larger, more general resources being provided to individuals and households in need.

Effects of a 12-month home-based exercise program on functioning after hip fracture - Secondary analyses of an RCT.

Long-term functional limitations are common after hip fractures. Exercise may alleviate these negative consequences but there is no consensus on an optimal training program. The objective was to study the effects of a 12-month home-based supervised, progressive exercise program on functioning, physical performance, and physical activity. Secondary analysis of a randomized controlled trial targeting patients with surgical repair of a hip fracture, aged ≥60 years, Mini-Mental State Examination (MMSE) score of ≥12. The participants were randomized into Exercise (n= 61) or Usual care (n= 60). Assessments at baseline, 3, 6, and 12 months included Lawton's Instrumental Activities of Daily Living (IADL), Short Physical Performance Battery (SPPB), handgrip strength, and self-reported frequency of sessions of leisure-time physical activity. Analyzed using mixed-effects models. Participants' (n=121) mean age was 81 years (SD 7), and 75% were women. The mean IADL score at baseline was 17.1 (SD 4.5) in the exercise group, and 17.4 (5.1) in the usual care group. The mean SPPB scores were 3.9 (1.6) and 4.2 (1.8), and handgrip strength was 17.7 (8.9) kg and 20.8 (8.0) kg, respectively. The age- and sex-adjusted mean changes in IADL over 12 months were 3.7 (95% CI 2.8-4.7) in the exercise and 2.0 (1.0-3.0) in the usual care group (between-group difference, p=0.016); changes in SPPB 4.3 (3.6-4.9) and 2.1 (1.5-2.7) (p < 0.001); and changes in handgrip strength 1.2 kg (0.3-2.0) and 1.0 kg (-1.9 to -0.2) (p < 0.001), respectively. We found no between-group differences in changes in the frequency of leisure-time activity sessions. A 12-month home-based supervised, progressive exercise program improved functioning and physical performance more than usual care among patients with hip fractures. However, the training did not increase leisure-time physical activity.

Early time-restricted eating compared with daily caloric restriction: A randomized trial in adults with obesity.

This trial aimed to evaluate the acceptability and efficacy of early time-restricted eating plus daily caloric restriction (E-TRE+DCR) compared with DCR alone within a behavioral weight-loss intervention. Participants (n = 81, 69 women, mean [SD] age: 38.0 [7.8] years, BMI: 34.1 [5.7] kg/m2 ) were randomized to E-TRE (10-hour eating window starting within 3 hours of waking) plus DCR or DCR alone (~35% DCR) for 39 weeks. The primary outcome was body weight (measured with digital scale) at week 12. Secondary outcomes measured at week 12 included hemoglobin A1c, lipids, energy intake (photographic food records), physical activity (accelerometry), dietary adherence (questionnaires), and body composition (dual-energy x-ray absorptiometry). Weight and body composition were also assessed at week 39. Mean [SD] weight loss was not different between groups at week 12 (E-TRE+DCR: -6.2 [4.1] kg vs. DCR: -5.1 [3.2] kg) or at week 39 (E-TRE: -4.9 [5.3] kg vs. DCR: -4.3 [5.3] kg). There were no between-group differences in changes in body composition, dietary adherence, energy intake, physical activity, hemoglobin A1c, or lipids at week 12. E-TRE+DCR was found to be an acceptable dietary strategy, resulting in similar levels of adherence and weight loss compared with DCR alone.

Cognitive behavioral therapy versus general health education for family caregivers of individuals with heart failure: a pilot randomized controlled trial

BackgroundWhile support from family caregivers is essential in the care of patients with heart failure (HF), caregiving places a considerable burden on family caregivers. We examined the preliminary effects of cognitive behavioral therapy (CBT) for caregivers of individuals with HF.MethodsIn this pilot randomized controlled trial, patients with HF and their primary family caregivers (30 dyads) were randomized into CBT (n = 15) or general health education (GHE, n = 15) groups. Caregivers received 8 weekly individual sessions of either CBT (intervention) or GHE (attention control condition). Caregivers completed questionnaires at baseline, post-intervention, and 6 months. Saliva samples collected from caregivers at baseline and post-intervention were analyzed for salivary cortisol. The cortisol awakening response (CAR) and area under the curve (AUC) were calculated using log-transformed cortisol values. We analyzed data from 26 (14 receiving CBT and 12 receiving GHE) caregivers who received at least one session of CBT or GHE (modified intention-to treat) using linear mixed models. Each model included time, study group, and time-by-study group interaction as fixed effects.ResultsPatients were older (66.94 ± 14.01 years) than caregivers (55.09 ± 15.24 years), and 54% of patients and 54% of caregivers were female. Most caregivers (58%) were spouses. A total of 14 (93%) CBT and 12 (80%) GHE participants received at least 1 session (p = .60), and 11 (73%) CBT and 11 (73%) GHE participants completed all 8 sessions (p = 1.00). There were no significant between-group differences in change for salivary cortisol or psychological outcomes. However, the CBT group had significant within-group improvements in perceived stress (p = .011), stress symptoms (p = .017), depression (p = .002), and anxiety (p = .006) from baseline to post-intervention, while the control group had no significant within-group change in the outcomes except for anxiety (p = .03). The significant improvements observed in the CBT group lasted for 6 months. No adverse effects were observed.ConclusionsIn this pilot trial, although between-group differences in change were not significant, CBT resulted in significant improvements in some psychological outcomes with no improvement in the control group. Our findings suggest the potential of the intervention to alleviate psychological distress in HF caregivers. Further examination in larger randomized trials is warranted.Trial registrationClinicalTrials.gov Identifier: NCT01937936 (Registered on 10/09/2013).

Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study

Since there are few treatment options for young people with type 2 diabetes, we aimed to assess the efficacy and safety of dapagliflozin as add-on therapy in children, adolescents, and young adults with type 2 diabetes receiving metformin, insulin, or both. This multicentre, placebo-controlled, double-blind, randomised phase 3 study was undertaken at 30 centres in five countries (Hungary, Israel, Mexico, Russia, and the USA). Participants aged 10-24 years with type 2 diabetes and HbA1c concentration of 6·5-11% (48-97 mmol/mol) were randomly assigned 1:1 to oral dapagliflozin 10 mg or placebo during a 24 week double-blind period, which was then followed by a 28 week open-label safety extension in which all participants received dapagliflozin. Participants and study personnel were masked and participants were randomly assigned treatment (placebo or study drug) using an interactive web and voice response system. The primary outcome was between-group differences in change in HbA1c concentration from baseline to 24 weeks (intention-to-treat analysis). A prespecified sensitivity analysis of the primary outcome was also assessed in the per-protocol population, which included only protocol-compliant participants. This trial is registered with ClinicalTrials.gov, NCT02725593. Between June 22, 2016, and March 15, 2019, 72 participants (19 [26%] of whom were aged 18-24 years) were randomly assigned (39 to dapagliflozin and 33 to placebo). Mean age was 16·1 (SD 3·3) years. In the intention-to-treat analysis, after 24 weeks, mean change in HbA1c concentration was -0·25% (95% CI -0·85 to 0·34; -2·7 [-9·3 to 3·7] mmol/mol) for dapagliflozin and 0·50% (-0·18 to 1·17; 5·5 [-2·0 to 12·8] mmol/mol) for placebo. The between-group difference was -0·75% (95% CI -1·65 to 0·15; -8·2 [-18·0 to 1·6] mmol/mol; p=0·10). In a sensitivity analysis in the per-protocol population (34 in the dapagliflozin group and 26 in the placebo group) after 24 weeks, mean change was -0·51% (-1·07 to 0·05; -5·6 [-11·7 to 0·5] mmol/mol) for dapagliflozin and 0·62% (-0·04 to 1·27; 6·8 [-0·4 to 13·9] mmol/mol) for placebo. The between-group difference was -1·13% (-1·99 to -0·26; -12·4 [-21·8 to -2·8] mmol/mol; p=0·012). Adverse events occurred in 27 (69%) dapagliflozin-assigned participants and 19 (58%) placebo-assigned participants over 24 weeks, and in 29 (74%) participants who received dapagliflozin over 52 weeks. Hypoglycaemia occurred in 11 (28%) dapagliflozin-assigned and six (18%) placebo-assigned participants who received dapagliflozin over 24 weeks and in 13 participants (33%) who received dapagliflozin over 52 weeks; none were considered as serious adverse events. No adverse events of diabetic ketoacidosis occurred. The primary outcome of change in HbA1c concentration was not significant in the intention-to-treat analysis of children, adolescents, and young adults with type 2 diabetes receiving dapagliflozin in addition to standard-of-care treatment. A prespecified sensitivity analysis of protocol-compliant participants showed a significant difference in HbA1c concentration between groups. No new safety signals were identified and there was a low risk of severe hypoglycaemia. AstraZeneca.

Minimally important differences of EORTC QLQ-C30 scales in patients with lung cancer or malignant pleural mesothelioma – Interpretation guidance derived from two randomized EORTC trials

ObjectivesA minimally important difference (MID) is the smallest difference in quality of life (QoL) perceived as relevant by patients or clinicians. MIDs aid interpretation of QOL data in research and clinical practice. We aimed to determine MIDs for the EORTC QLQ-C30 for patients with lung cancer or malignant pleural mesothelioma. Materials and MethodsData were drawn from two EORTC-sponsored randomized clinical trials (RCTs): a three-arm RCT of two cisplatin-based treatments and paclitaxel plus gemcitabine in advanced non–small-cell lung cancer, and an RCT comparing cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. MIDs for interpreting within-group change and between-group differences in change over time were computed using anchor-based approaches, for improvements and deteriorations separately. Distribution-based approaches provided corroborative evidence. ResultsThe combined data from the trials comprised 730 patients. Available data allowed us to determine 8/14 anchor-based MIDs for EORTC scales for improvements, and 9/14 MIDs for deterioration. Furthermore, we provided distribution-based estimates for all 14 QLQ-C30 scales. Most MIDs for improvements ranged between 5 and 10, for both within-group and between-group differences. Outliers were appetite loss and constipation, with MIDs up to 15 score points. MIDs were slightly larger for within-group deterioration, ranging from –5 to − 15, with the largest for Nausea/vomiting (−1 to 4) and Appetite loss (−1 to 5). MIDs for between-group differences in deterioration ranged from − 4 (Physical, Role, and Social functioning, and Global quality of life) to −9 (Nausea/vomiting, Appetite loss and Constipation). ConclusionsMIDs vary over scales and for between- versus within-group comparisons; this must be taken into account when interpreting changes. Nevertheless, the majority of MIDs range between 5 and 10 score points, in line with previously used thresholds for QLQ-C30. These findings and those from other tumor-specific MID analyses will inform a planned consensus process identifying commonalities and differences across tumor sites.