UC Participants Research Articles

A randomized controlled study of auricular point acupressure to manage chemotherapy-induced neuropathy: Study protocol.

Chemotherapy-induced neuropathy (CIN) significantly impacts cancer patients, leading to functional disability, diminished quality of life, and increased healthcare costs amid the ongoing opioid crisis. Auricular point acupressure (APA), a non-invasive and non-pharmacological alternative, has shown potential for alleviating the pain, numbness, and tingling associated with CIN. This study aims to assess the efficacy of APA for CIN symptoms and physical function and to examine the mechanisms underlying APA's effects on CIN. This is a three-arm randomized controlled clinical trial protocol. Patients aged 18 and older who are experiencing CIN are randomly assigned to one of the three groups: an APA group (in-person APA; mAPA), a sham control group (virtual APA; vAPA), and a wait-list usual care control group (UC). During the four-week program, participants in the mAPA receive an in-person APA treatment and training; the sham control participants (vAPA) receive a self-guided smartphone APA application with APA demonstration videos; and the UC participants will continue with the usual care and be re-randomized into one of the APA groups. The primary outcomes are changes in CIN symptoms and physical function. Secondary outcomes include evaluating pain sensory thresholds, motor and cognitive functioning, inflammatory signaling, brain connectivity, opioid use, and quality of life. The outcomes are measured at baseline, program completion (4 weeks), and at monthly follow-up for 3 months post-intervention. This study will provide evidence supporting the potential viability of APA as an intervention for CIN. ClinicalTrials.gov, ID NCT04920097 registered on 3 June 2021.

EFFECT OF A HOME-BASED EXERCISE PROGRAM ON SUBSEQUENT FALLS IN OLDER ADULTS WITH COGNITIVE FRAILTY

Abstract Cognitive frailty is characterized by concurrent physical frailty and mild cognitive impairment. and increases the risk for falls. Whether exercise can reduce falls in older adults with cognitive frailty is unknown. We examined the effects of a home-based exercise intervention on subsequent falls among community-dwelling older adults with cognitive frailty and a history of falls. A secondary of a 12-month randomized controlled trial among older adults aged ≥70 years with a fall in the last 12 months. Participants were randomized to either 12 months of home-based exercise (EX; n=172) or usual care (UC; n=172). For this analysis, we only included participants who were classified as cognitively frail based on a Short Physical Performance Battery (SPPB) score ≤ 9/12 and a Montreal Cognitive Assessment score < 26/30. Our primary analysis examined the effect of EX on self-reported falls over 12 months. The secondary analysis examined whether higher exercise adherence, or dose, benefits physical frailty among the EX participants. At baseline, 192 participants were classified as cognitively frail (EX=93; UC=99). Falls rates were lower in EX participants vs. UC participants (IRR=0.65; p=0.042). At 12 months, in the EX group, SPPB score was significantly higher among participants with high adherence vs. those with low adherence (estimated mean difference: 1.22; p=0.004). Exercise is a promising strategy for reducing subsequent falls in older adults with cognitive frailty and a history of falls. Greater exercise adherence, or dose, may reduce physical frailty in this population at high risk for disability.

Assessment of myelin in Alzheimer’s by a R1 and the relationship to amyloid burden

AbstractBackgroundAlzheimer’s disease (AD) is well known as a grey matter disorder, characterized by substantial and progressive neurodegeneration. However, less is known about myelin loss in AD, particularly as the disease progresses in severity. To gain a better insight on the role of myelin over the clinical and biologic progression of AD, we tested for differences in quantitative relaxometry R1, a metric sensitive to brain myelin, among individuals who were cognitively unimpaired (CU), diagnosed with mild cognitive impairment (MCI), and diagnosed with AD, in addition to testing for associations between R1 and amyloid PET. Understanding the course of myelin injury in disease progression is expected to address the gap in knowledge about the trajectory of myelin alterations in AD.MethodsParticipants from the Alzheimer’s Disease Connectome Project underwent T1‐weighted (T1w) MPnRAGE with motion‐correction and amyloid imaging with [11C]PiB PET. Composite T1w images and R1 maps were reconstructed at 1mm isotropic resolution. T1w scans were bias‐field corrected and denoised before undergoing tissue segmentation. R1 was sampled and bilaterally averaged across cortical‐adjacent white matter (WM). An average WM‐R1 was generated for each participant by calculating the mean of cortical regions R1. MANOVA and regression analyses were used to analyze the difference and relationship between each group’s WM‐R1 and PiB‐Index.ResultThe three groups showed an association with PiB‐Index and WM‐R1, Pillai’s Trace = 0.28, F(4, 110) = 4.56, p<0.01. Participants with AD showed higher amyloid and lower WM‐R1. In contrast, UC and MCI participants showed lower amyloid and WM‐R1. A significant correlation was found in individuals with AD wherein amyloid burden was positively correlated with WM‐R1 across the whole brain, R2 = 0.64, F(1, 6) = 10.99, p = 0.016.ConclusionOur findings indicate myelin differences by clinical status, in addition to relationships between amyloid and R1 indices of myelin. While AD was associated with lower myelin as indexed by R1, we unexpectedly found that higher cortical amyloid in AD was associated with higher myelin indexed by R1, suggesting an increase in myelination as AD progresses. Overall, lower myelin in clinical AD, accompanied by the higher myelin with greater amyloid burden suggests possible reparative mechanisms in response to neurodegeneration in AD.

Combined Histological and Endoscopic Endpoints at Post-induction Lack Additional Prognostic Value Compared with Endoscopic Improvement Alone in Ulcerative Colitis: A Post hoc Analysis of the VARSITY study.

Evaluating histological outcomes in ulcerative colitis [UC] has become common in recent clinical trials. In this study, we explored the additional value of the combined endpoint of histo-endoscopic mucosal improvement [HEMI] compared with endoscopic improvement [EI] at post-induction [Week 14] and post-maintenance [1 year]. This post hoc analysis included 620 UC participants with available data from the VARSITY trial. Participants achieving post-induction and post-maintenance HEMI [Mayo endoscopic subscore ≤1 and Geboes score <3.2] were compared across clinical outcomes, patient-reported outcomes [PROs], and inflammatory markers. Univariate analyses were performed to identify variables associated with the outcome of interest. Multivariate analyses included covariates with a p <0.05 on univariate analyses. Among the 468 patients with 1-year data available, a total of 166 [35.5%] attained HEMI and 209 [44.7%] attained EI at post-induction. No difference in achievement of clinical remission [CR] at 1 year was observed among those who attained post-induction HEMI vs EI (121/166 [72.9%] vs 147/209 [70.3%], p = 0.903). Similar findings were observed for the outcome of 1-year treatment failure (45/166 [27.1%] vs 55/209 [26.3%], p = 0.781). Patients who achieved HEMI at post-induction had lower total and partial Mayo scores and had the largest improvement from baseline. Faecal calprotectin and C-reactive protein [CRP] were also significantly lower among HEMI achievers at post-induction [p <0.001]. Similar findings were observed at post-maintenance. In this post hoc analysis, at post-induction, HEMI did not demonstrate additional prognostic value in predicting 1-year outcomes over EI. However, HEMI was associated with lower clinical disease activity at post-induction and at 1 year compared with endoscopic or histological outcomes in isolation.

Randomized trial of diet and exercise on chemotherapy completion in women with breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis (LEANer) study.

12007 Background: In observational studies, 25%-55% of women with breast cancer (BC) do not complete chemotherapy as initially prescribed, primarily due to toxicity. Relative dose intensity (RDI) is an integrated measure of chemotherapy dose delays and reductions and is associated with cancer mortality. Physical activity (PA) and diet may reduce treatment toxicity, but less is known about their effect on RDI. We conducted a randomized trial of a diet and PA intervention on RDI (primary endpoint) in women with newly diagnosed BC initiating chemotherapy. Methods: 173 women with Stage I-III BC were randomized to usual care (UC, n = 86) or a yearlong, 16-session, in-person or telephone-administered diet and PA intervention (n = 87) delivered by registered dietitians. Dates, doses and reason for dose-adjustments/delays of chemotherapy were abstracted from electronic medical records or obtained from treating oncologists. T-tests and Chi-square tests were used to examine the effect of the intervention vs. UC on RDI. Results: Participants were 53±11 years old, had a body mass index of 29.7+6.8 kg/m2, 51% had stage I BC and 22% were under-represented minorities. 27 different chemotherapy regimens were prescribed. Participants randomized to intervention completed 94% of counseling sessions during chemotherapy and had statistically significant improvements in PA and diet compared to UC. Average continuous RDI was unexpectedly high in both groups, with 93%+14% of prescribed chemotherapy completed (p = 0.92). However, 17% and 15% of intervention and UC participants, respectively, had &lt; 85% RDI (p = 0.70) and more than one-third had at least one toxicity-associated dose reduction and/or delay (&gt; 7 days) for at least one chemotherapy drug (39% intervention and 37% UC, p = 0.80). In posthoc analyses, there was a benefit of the intervention on chemotherapy completion compared to UC in the 74 women receiving neoadjuvant chemotherapy (RDI: 95% intervention vs. 90% UC, p = 0.05). Among intervention women, a dose-response effect was seen with participants who achieved more PA and better diet quality via the Healthy Eating Index (above median) experiencing higher RDI vs participants who were below the median for PA and/or diet quality (97% vs 90% RDI, p = 0.05). Conclusions: A primarily telephone-based diet and PA intervention led to improved diet and PA, but did not improve RDI compared to UC. However, a dose-response effect of the intervention was observed with higher PA and diet associated with higher RDI. Future analyses will examine intervention effects on secondary endpoints of endocrine therapy adherence and patient-reported outcomes when all women reach the 1-year timepoint (end of intervention). Further study of diet and PA interventions in patients receiving neoadjuvant chemotherapy are necessary. Clinical trial information: NCT03314688.

987-P: Cost-Effectiveness of a Diabetes Prevention Program among Latino Youth with Prediabetes

Introduction: Lifestyle intervention is a cost-effective approach for preventing type 2 diabetes among adults with prediabetes. Little is known about the cost effectiveness of lifestyle programs for children with prediabetes. The purpose of this study was to examine the cost and incremental cost effectiveness of an adapted diabetes prevention intervention compared to usual care among Latino youth with prediabetes. Methods: Latino youth (age 13.5±1.4 years, mean±SD) with obesity and prediabetes were randomized to a community-based lifestyle intervention (INT, N=79) or usual care (UC, N=38) . The 6-month INT was delivered at a YMCA and included 1 d/wk of lifestyle education for families and 3 d/wk of physical activity. UC included 2 visits with a pediatric endocrinologist and registered dietician to discuss diabetes risks and healthy lifestyle changes. Data on health care costs and resource utilization were collected prospectively. Efficacy was examined as changes in 2-hr glucose concentrations during an OGTT. Cost analyses were performed from health care sector and societal perspectives. Results: The INT led to decreases in 2-hr glucose (144.5±3.4 to 132.2±3.4 mg/dL, p=0.002) but these changes were not significantly different from changes in 2-hr glucose observed in UC participants (144.1±4.6 to 139.0±4.6; interaction p=0.260) . The average health care costs per participant were $1,032 for the INT and $1,251 for the UC. Total societal costs (health care plus patient and family opportunity costs) per participant were $3,641 for the INT and $1,331 for the UC. For health care costs alone, the incremental cost-effectiveness ratio (ICER) for 2-hr glucose was -$30.3 per mg/dL. When taking total costs into account, the ICER for 2-hr glucose was $320.8 per mg/dL. Conclusion: From a health care sector perspective, INT led to greater reductions in 2-hr glucose at a lower cost compared to UC among Latino youth with prediabetes. The cost-effectiveness of INT decreases when total societal costs are included. Disclosure M.Olson: None. A.Pena: None. M.E.Putz: None. S.Ayers: None. W.C.Knowler: None. M.Mccullough: None. G.Q.Shaibi: None. Funding National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Disease (R01DK10757901)

MO589: Exertion2 Trial: THE Weight Gain Prevention in Renal Transplant Online Study—a Randomized Controlled Feasibility Trial

BACKGROUND AND AIMSAdverse weight gain within the first year of receiving a kidney transplant is associated with adverse health outcomes. Kidney transplant recipients (KTRs) have asked for support with physical activity and following healthy lifestyles. There is no recognised intervention to address weight gain prevention for new KTRs. Usability of an online intervention to prevent weight gain in new KTRs has recently been reported. The aim of this study was to examine the feasibility of undertaking a randomised controlled trial of an online intervention group (IG) compared with usual care UC) to address weight gain prevention in new KTRs.METHODParticipants were recruited from two south-London transplant sites, had a kidney transplant within 3 months, and had access to an internet compatible device. Exclusion criteria included history of an unstable medical condition, non-English speaking or <18 years. At baseline assessment participants were randomized to either UC or IG. The UC group received standard dietary and physical activity education. The IG received access to a 12-week password-protected website, weekly email reminders, and could contact the research physiotherapist via a secure message function.Primary feasibility outcomes included screening rates, consent rates, adherence to study visits, acceptability of outcomes, engagement with the intervention, retention, willingness to be randomized, adverse events, hospitalizations, experience using the online intervention and experience taking part in the trial. Secondary outcomes were recorded at baseline, 3- and 12-months. These included body weight, body mass index (BMI), bioimpedance (BIA), pulse wave velocity (PWV), augmentation index (AI) and six-minute walk distance (6MWD).RESULTSSeventeen new KTRs (median age 49 years, 10 males, median 62 days post-transplant) were randomized to the IG (n = 9) or UC (n = 8). Screening rate was 84.2% (95% CI: 68.8–94.0), recruitment 62.5% (95% CI: 43.7–79.0) and intervention adherence at 12 months was 76.4% (95% CI: 50.0–93.2). All pre-set progression criteria for feasibility were achieved. There were no associated adverse events. Qualitative analysis revealed four themes; optimizing participation and recruitment, impact of Coronavirus disease 2019 (COVID-19), engagement is a choice (technical and personal factors) and mechanisms of action (assessment and intervention factors). The IG appeared to stabilize median body weight across the study; 94.5 kg, (IQR: 63.0, 102.0), 95.0 kg, (IQR: 66.7, 105.3) and 94.7 kg (IQR: 77.2, 117.3). Whereas UC participants increased [81.3 kg, (IQR: 73.6,94.6), 86.2 kg (75.4, 96.5) and 93.3 kg (70.3, 101.9)]. IG increased 6MWD [450 m, (IQR: 450, 540), 525 m (IQR: 472.5, 615) and 495 m (IQR: 465, 615)] and UC decreased 6MWD [517.5 m (IQR: 436, 570), 507.5 m (IQR: 442.5, 605) and 435 m (IQR 435, 555)]. All other outcomes were comparable across the sample.CONCLUSIONLimitations include inadequate power and small sample size, and it was a single-centre study. Integrated mixed methods analysis demonstrate congruency of both qualitative and quantitative data. Participant attitudes, experiences and engagement with the study and intervention provide insight for future trial design. A future definitive trial is warranted and welcomed by KTRs.

Psychosocial impact of proactive rapid genetic counseling following breast cancer diagnosis.

As germline genetic referral becomes increasingly routine as part of the care of newly diagnosed breast cancer patients, it is important to understand the psychosocial impact of genetic counseling at the time of diagnosis. We examined the psychosocial and quality of life (QOL) impact of providing proactive rapid genetic counseling and testing (RGCT) in the immediate aftermath of a breast cancer diagnosis. We randomized 330 patients in a 2:1 ratio to proactive rapid genetic counseling (RGCT; N=222) versus usual care (UC; N=108). Participants completed a baseline telephone survey before randomization and definitive surgery and a follow-up survey at 1-month post-randomization. We evaluated the impact of RGCT versus UC on breast cancer genetic knowledge, distress, QOL, and decisional conflict. Given that 43% of UC participants and 86% of RGCT participants completed genetic counseling prior to the 1-month assessment, we also evaluated the impact of genetic counseling participation over and above group assignment. The RGCT intervention led to increased breast cancer genetic knowledge relative to UC but did not differentially impact other study outcomes. Across groups patients who participated in genetic counseling had significantly increased knowledge and improved QOL compared to those who did not participate in genetic counseling. While prior research has documented the impact of genetic counseling and testing on surgical decisions, these results confirm that participation in genetic counseling at the time of diagnosis can yield improvements in knowledge and QOL in the short-term.

Evaluating educational interventions to increase breast density awareness among Latinas: A randomized trial in a Federally Qualified Health Center.

The objective of this randomized trial was to evaluate the short-term effect of bilingual written and interpersonal education regarding mammographic breast density (MBD). Latinas aged 40 to 74 years who were presenting for screening mammography were recruited and randomized 1:1:1 to receive a letter with their mammogram and MBD results (usual care [UC]), a letter plus a brochure (enhanced care [ENH]), or a letter plus a brochure and telephonic promotora education (interpersonal care [INT]). Surveys were administered at enrollment (T0 ) and 2 weeks to 6 months after intervention delivery (T1 ). Differences were assessed with χ2 , Kruskal-Wallis, and McNemar tests and pairwise comparisons as appropriate. INT metrics and audio recordings were analyzed with descriptive statistics and qualitative content analysis. Between October 2016 and October 2019, 943 of 1108 Latina participants (85%) completed both surveys. At T1 , INT participants were more likely (P < .001) to report seeing their MBD results in the letter (70.2%) than UC (53.1%) or ENH participants (55.1%). The percentage of INT women who reported speaking with a provider about MBD (29.0%) was significantly greater (P < .001) than the percentage of UC (14.7%) or ENH participants (15.6%). All groups saw significant (P < .001) but nondifferential improvements in their knowledge of MBD as a masking and risk factor. In the INT group, the promotora delivered education to 77.1% of the 446 participants randomized to INT and answered questions at 28.3% of the encounters for an average of $4.70 per participant. Among Latinas in a low-resource setting, MBD knowledge may increase with written or interpersonal education, but with modest investment, interpersonal education may better improve MBD awareness and prompt patient-provider discussions.

P479 Biological therapies and bio-microbial dynamics in inflammatory bowel diseases

Abstract Background Therapeutic aims in IBDs are to induce remission through rapidly effective treatment. Conventional therapeutic methods including immunosuppression have been available for more than half a century with biological therapies the treatment of choice in patients who fail immunosuppressive drugs. There has been little attempt to longitudinally examine the differences in biopsychological factors and their associations with treatment modalities in IBD patients. Methods 50 IBD participants (24 UC, 26 CD) in clinical remission were followed for 12 months. Complete longitudinal datasets and monthly stool and blood samples for inflammatory biomarkers were collected for analysis of association. Microbiome analysis was performed using V4 16SrRNA for identification of microbial phylogenetic relationships. Patients were grouped on whether or not they were in remission and on biological agents. Results At the baseline there were similar ecological indices between the two treatment options in both disease classes; (Shannon, p = 0.380; Pielou’s, p = 0.246; Chao1, p = 0.934). At family level, the CD group showed significant differences (Wilcoxon, p ≤ 0.05) between the treatment received (biologics vs non-biologic) in the abundance of Barnesiellaceae, Bifidobacteriaceae, unclassified Clostridia, and Clostridiaceae (Figure 1A). Results showed similar ecological index values in samples from the two treatment options. Samples in UC groups on biological and non-biologic treatment modes were found to have significantly different microbial communities based on Bray-Curtis dissimilarity (PERMANOVA, p = 0.0031). Microbial family composition in UC group and on two treatment modalities showed a total of 12 families that were significantly different (Wilcoxon, p ≤ 0.05): Acidaminococcaceae, unclassified Bacteroidales, Barnesiellaceae, Christensenellaceae, Clostridiales vadinBB60 group, Coriobacteriaceae, Defluvitaleaceae, Eggerthelaceaem Fusobacteriaceae, Muribaculaceae, Prevotellaceae, and Streptococcaceae (Figure1B). Results identified significant differences in microbial diversity (Shannon index, p = 0.041), and evenness (Pielou’s evenness, p = 0.045) between the two treatment modes. No differences were identified in richness (Chao1) in UC participants. Conclusion Conclusion: Baseline biological indices were mostly similarly distributed between the two treatment options in remissive IBD patients, however biological therapy significantly influenced longitudinal trends of some microbiome dynamics, especially in UC. This suggests an underlying interrelationship between mode of treatment and biopsychological trajectories which might overshadow response to the treatment, requiring further assessment.

The impact of primary care behavioral health services on patient behaviors: A randomized controlled trial.

Greater understanding of the impact of low intensity psychosocial interventions delivered by behavioral health clinicians (BHCs) working in an integrated care program (ICP) may promote better depression care. In a randomized controlled trial, 153 participants identified as depressed by their primary care provider (PCP) were assigned to ICP or usual care (UC, management by PCP, including specialty referral). In the ICP condition, BHCs worked collaboratively with PCPs and liaison psychiatrists. ICP participants with lower and higher severity symptoms reported significantly greater use of coping strategies than UC participants at the 1-month follow up (lower: p = .002; higher: p = .016). ICP participants with lower severity continued to report significantly greater use of coping strategies than UC participants at the 4-month (p = .024), and 7-month (p = .012) follow ups. ICP participants were more likely to be following relapse preventions plans at the 4-month follow up (lower: 89.5% vs. 50%, p = .0.000; higher 74.1% vs. 33%, p = .0001). ICP participants also reported use of antidepressant medications on more days than UC participants at the 4-month follow up (lower: 21.27 vs. 14.49 days, p = .049; higher: 24.61 vs. 17.08 days, p = .035). Patient retention in the ICP was high, and ICP participants were significantly more satisfied with depression care than UC participants at follow-up assessments. Delivery of low intensity psychosocial interventions by BHCs was associated with improvements to behavior charge targets. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Young Adult Males' Perspectives of Male Hormonal Contraception [9S

INTRODUCTION: There is an interest and willingness among men in the United States to use Male Hormonal Contraception (MHC), however, data is limited among younger men (18 to 35 years old). Our objective is to evaluate the willingness of young males to use MHC and to determine which method (pill, injection, or transdermal gel) is most desirable. METHODS: An IRB-approved survey measuring willingness to use MHC was dispersed to two distinct populations: University of Cincinnati post-graduate programs (UC) and Cincinnati Health Department (CHD) clinics. Results were reported as frequencies in each population and chi-square analyses were performed to compare groups. P-values <.05 were considered significant. RESULTS: Of 162 total survey participants, 45% would use MHC while 30.9% were unsure and 23.5% would not use MHC. Overall, the UC survey population was more likely to be interested in using MHC than the CHD population (P<.05). The majority of both populations were most interested in using the injection form. Cited concerns deterring participants from using MHC were different between these two populations, with UC participants having concern about possible failure of contraceptive method, while CHD participants had concern about potential side effects (P<.001). CONCLUSION: This study suggests that there is a significant interest among young adult males to use various forms of MHC, especially in injection or pill form. Interest in MHC is more common among individuals with an advanced educational background, employed, or in a relationship. With further research and funding, MHC may serve as a significant way to decrease unintended pregnancies in the future.

Quality of life, binge eating and sexual function in participants treated for obesity with sustained release naltrexone/bupropion.

SummaryObjectiveThis multicenter, randomized, controlled, open‐label trial examined weight‐related quality of life, control over eating behaviour and sexual function after 26 weeks of treatment with either 32 mg naltrexone sustained release (SR)/360 mg bupropion SR plus a comprehensive lifestyle intervention program (NB + CLI, N = 153) or usual care (UC, N = 89), which included minimal lifestyle intervention.MethodsImpact of Weight on Quality of Life‐Lite, Binge Eating Scale and Arizona Sexual Experiences Scale were assessed at baseline (BL) and weeks 16 and 26.ResultsNB + CLI and UC participants lost 9.46 and 0.94% respectively of initial body weight at week 26 (P < 0.0001). NB + CLI participants had greater improvements in Impact of Weight on Quality of Life‐Lite total score than UC participants (P < 0.0001). In participants with moderate/severe Binge Eating Scale scores at BL, 91% of NB + CLI and 18% of UC participants experienced categorical improvements. In participants with Arizona Sexual Experiences Scale‐defined sexual dysfunction at BL, 58% of NB + CLI and 19% of UC participants no longer met dysfunction criteria at week 26. The most frequent adverse events leading to discontinuation before week 26 in NB + CLI included nausea (10.5%); anxiety (3.3%); and headache, hypertension, insomnia and palpitations (1.3% each).ConclusionCompared with UC, participants treated with NB + CLI experienced greater improvements in weight‐related quality of life, control over eating behaviour, and sexual function.

The More Vivid the Imagination the Better: The Role of the Vividness of Imagination in Vasoconstriction Training and Vasodilatation Training

Blood volume pulse biofeedback represents an effective non-pharmacological treatment for migraine. However, the underlying mechanisms of blood volume pulse biofeedback are still unclear. This study investigated the influence of vividness of imagination, private body consciousness, perfectionism, and general self-efficacy on physiological (blood volume pulse amplitude) and psychological (session performance rated by participants and by trainers) success. Changes in skin conductance and skin temperature indicating habituation to training context were examined. Forty-five healthy male participants were randomized to four sessions of vasoconstriction training or vasodilatation training. Hierarchical linear models were estimated. Results showed significant changes of session performance rated by participants (UC = 0.62, p < .05), by trainers (UC = 0.52, p < .001), and skin temperature (UC = 0.01, p < .001) over time. A change of blood volume pulse amplitude could not be observed (UC = -0.01, p = .65). Vividness of imagination was highly important for both psychological achievement ratings (UC participants = 1.3, p < .001; UC trainers = 0.29, p < .01). Relations between skin temperature and general self-efficacy or personal standards were small (UC self-efficacy = 0.002, p < .10; UC personal standards = 0.002, p < .05). A time × group interaction regarding trainers' achievement ratings indicated a specific judgement effect. In conclusion, biofeedback trainers should pay attention to their beliefs and participants' vividness of imagination.

Conservation agriculture: Systems thinking for sustainable farming

Outlook Conservation agriculture: Systems thinking for sustainable farming by Jeffrey Mitchell, Ron Harben, Garrison Sposito, Anil Shrestha, Daniel Munk, Gene Miyao, Randy Southard, Howard Ferris, William R. Horwath, Eric Kueneman, Judee Fisher, Monte Bottens, Phil Hogan, Robert Roy, Jim Komar, Dwayne Beck, Don Reicosky, Michelle Leinfelder-Miles, Brenna Aegerter, Johan Six, Tom Barcellos, Dino Giacomazzi, Alan Sano, Jesse Sanchez, Mike Crowell, John Diener, Darrell Cordova, Trevor Cordova and Jerry Rossiter C alifornia is an unquestioned global leader in the productivity of its farms and the diversity and quality of its crops. However, there are significant threats to the sustainability of the state’s agricultural systems. The scarcity of water has received great attention in recent years, but that is just one of many concerns. Fossil fuel use, carbon emissions, nitrate pollution of groundwater, labor cost and availability, air pollution and loss of soil fertility all present challenges to the long-term viability of farming in California. Conservation agriculture can help to address all of these issues. Fundamentally, conservation agriculture is about “kindly use” of the land, to quote farmer-essayist Wendell Berry. It is based on three principles: reducing soil disturbance (tilling less, or not at all), retaining crop residues on the soil surface year-round and fostering crop and soil biodiversity. By designing farming systems around these principles, our work has shown that farmers can save water, store more carbon in the soil, burn less fossil fuel, cut labor costs, lower dust emissions and increase profits. Despite conservation agriculture’s promise, how- ever, its adoption has been slow in California. In the Midwest and Great Plains regions, conservation ag- riculture is practiced on more than 30% of cropland, • Water: No-till, surface mulching practices and in- creases in soil organic matter can reduce soil wa- ter evaporation by 4 to 5 inches annually (Klocke et al. 2009; Mitchell, Singh et al. 2012; van Donk et al. 2010) and increase soil water storage ca- pacity by the equivalent of roughly 2 inches (Franzluebbers 2010; Hudson 1994). If applied on a significant amount of California’s roughly 8.5 million acres of irrigated lands, these measures could reduce statewide irrigation demand by millions of acre-feet. • Cost: By limiting tractor passes and other opera- tions, reduced-tillage practices cut production costs by $100 to $150 per acre across a range of crops grown in California (Mitchell, Carter et al. 2012; Mitchell, Klonsky et al. 2012). http://californiaagriculture.ucanr.edu • APRIL–JUNE 2016 53 Ron Harben In 2010, CASI held a public education event on cover crops for farmers and private sector, UC and NRCS participants at the UC ANR West Side Research and Extension Center in Five Points. compared with less than 5% of annual cropland in California. As founders and members of the Conservation Agriculture Sustainability Innovation center (CASI), we are partnering with California farmers and equipment makers to develop conser- vation agriculture practices and technologies that are effective and appropriate for the state’s produc- tion systems, and to build networks to help their adoption. The magnitude of the benefits possible with con- servation agriculture is striking. A few examples:

Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling.

Telephone genetic counseling (TC) for hereditary breast/ovarian cancer risk has been associated with positive outcomes in high risk women. However, little is known about how patients perceive TC. As part of a randomized trial of TC versus usual care (UC; in-person genetic counseling), we compared high risk women's perceptions of: (1) overall satisfaction with genetic counseling; (2) convenience; (3) attentiveness during the session; (4) counselor effectiveness in providing support; and (5) counselor ability to recognize emotional responses during the session. Among the 554 participants (TC, N = 272; UC, N = 282), delivery mode was not associated with self-reported satisfaction. However, TC participants found counseling significantly more convenient than UC participants (OR = 4.78, 95% CI = 3.32, 6.89) while also perceiving lower levels of support (OR = 0.56, 95% CI = 0.40-0.80) and emotional recognition (OR = 0.53, 95% CI = 0.37-0.76). In exploratory analyses, we found that non-Hispanic white participants reported higher counselor support in UC than in TC (69.4% vs. 52.8%; OR = 3.06, 95% CI = 1.39-6.74), while minority women perceived less support in UC vs. TC (58.3% vs. 38.7%; OR = 0.80, 95% CI = 0.39-1.65). We discuss potential research and practice implications of these findings which may further improve the effectiveness and utilization of TC.

Motivational interviewing to improve diabetes outcomes in African Americans adults with diabetes.

The purpose of this study was to determine the effect of a motivational interviewing intervention (MII) on regimen adherence and diabetes markers among African Americans with diabetes. Sixty-two participants were assigned to the usual care (UC; n = 36) or MII (n = 26) groups. UC participants received the usual clinic care. MII participants received a maximum of six motivational interviewing (MI) sessions over 3 months. Outcome variables were obtained at baseline and 3-month follow-up. Data were obtained using medical records, self-reports, and glucose monitor and accelerometer print-outs. MII significantly increased the odds of participants adhering to recommended physical activity level (66.7% vs. 38.8%, odds ratio = 2.92, 95% confidence interval = [1.6, 14.3], p = .018) and significantly decreased glucose levels (p = .043) and body mass index (p = .046) over time when compared with UC. Findings support using MI as an intervention for improving health outcomes and regimen adherence rates among the study population.

Randomized Noninferiority Trial of Telephone Versus In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer

Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery. Participants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n = 334) or telephone counseling (TC; n = 335). UC participants received in-person pre- and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC. TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0.03; lower bound of 97.5% CI, -0.61), perceived stress (d = -0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d = -0.16; lower bound of 97.5% CI, -0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d = -1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of $114 per patient. Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.

Examining the Effect of a Patient Navigation Intervention on Outpatient Cardiac Rehabilitation Awareness and Enrollment

Awareness of and enrollment in outpatient cardiac rehabilitation (OCR) following a cardiac event or procedure remain suboptimal. Thus, it is important to identify new approaches to improve these outcomes. The objectives of this study were to identify (1) the contributions of a patient navigation (PN) intervention and other patient characteristics on OCR awareness; and (2) the contributions of OCR awareness and other patient characteristics on OCR enrollment among eligible cardiac patients up to 12 weeks posthospitalization. In this randomized controlled study, 181 eligible and consenting patients were assigned to either PN (n = 90) or usual care (UC; n = 91) prior to hospital discharge. Awareness of OCR was assessed by telephone interview at 12 weeks posthospitalization, and OCR enrollment was confirmed by staff at collaborating OCR programs. Of the 181 study participants, 3 died within 1 month of hospital discharge and 147 completed the 12-week telephone interview. Participants in the PN intervention arm were nearly 6 times more likely to have at least some awareness of OCR than UC participants (OR = 5.99; P = .001). Moreover, participants who reported at least some OCR awareness were more than 9 times more likely to enroll in OCR (OR = 9.27, P = .034) and participants who were married were less likely to enroll (P = .031). Lay health advisors have potential to improve awareness of outpatient rehabilitation services among cardiac patients, which, in turn, can yield greater enrollment rates in a program.

Patient satisfaction with participation in a randomized exercise trial: Effects of randomization and a usual care posttrial exercise program

Participation in an exercise trial is a major commitment for cancer survivors, but few exercise trials have evaluated patient satisfaction with trial participation. To examine patient satisfaction with participation in the Healthy Exercise for Lymphoma Patients (HELP) Trial and to explore possible determinants. The HELP Trial randomized 122 lymphoma patients to 12 weeks of supervised aerobic exercise training (AET; n = 60) or to usual care (UC; n = 62), with the option of participating in a 4-week posttrial exercise program. At the 6-month follow-up assessment, participants evaluated their overall trial satisfaction. Personal satisfaction with trial participation was strongly influenced by group assignment with participants randomized to AET reporting participation to be more rewarding (p < 0.001) and personally useful (p < 0.001) than participants randomized to UC. UC participants who completed the optional 4-week posttrial exercise program reported participation to be more rewarding (p = 0.008) and personally useful (p < 0.001) than UC participants who declined the program. The study is limited by the lack of a validated measure of participant satisfaction, and the fact that the offer of participation in the posttrial exercise program to the UC group was not randomized. Lymphoma patients randomized to UC viewed it as less rewarding and personally useful despite being offered a 4-week posttrial exercise program. UC participants who completed the 4-week program reported personal satisfaction levels similar to the AET group; however, the causal direction of this association is unknown. Researchers should continue to evaluate participant satisfaction in exercise trials.