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Social isolation and loneliness have both been associated with psychological health and cognitive decline in older adults. This study investigated the impact of social interaction through remote communication technologies during the COVID-19 pandemic on the cognitive and psychological status of older adults with and without cognitive impairment. Participants were recruited from Boston (USA) and Chieti (Italy). The study used a randomized single-blinded controlled crossover design with an intervention (remote social conversations with research staff over 20-minute video or telephone calls three times per week) and a passive control condition, each one of 4-weeks duration. The primary outcome was a composite cognitive score change from baseline to week 4. Secondary outcomes included scales for mood, anxiety, and loneliness. Out of 196 participants recruited from April 2020 to April 2021, 17% dropped out. Based on the blind MoCA, 52% had cognitive impairment, and 25% were at risk of social isolation according to the Lubben social network scale. We observed that larger social networks were linked to better cognitive status and lower depression and anxiety levels, while loneliness was directly associated to depression severity. Older adults with cognitive impairment exhibited higher levels of depression and anxiety and were at greater risk for social isolation. In terms of the intervention, 91% preferred telephone over video calls. The intervention did not lead to improvements in cognitive or psychological scores. More work is needed to assess the utility of this intervention for the support of a heterogenous cross-cultural sample of older adults at-risk for social isolation, including individuals with cognitive impairment. Future research should explore longer intervention periods, categorize participants by call type, and target those meeting social isolation criteria. ClinicalTrials.gov NCT04480112.

This clinical trial examined the individual and combined effects of three different approaches to reducing alcohol misuse among a sample of sexual minority men (SMM) with HIV. Specifically, we used a 2 × 2 × 2 randomized factorial design to compare: (a) behavioral intervention based in motivational interviewing (MI) vs. brief intervention (BI), (b) interactive text messaging (ITM) for alcohol use vs. no ITM, and (c) extended intervention (EI) length of nine months vs. a one-month intervention duration. Participants (N = 188) were SMM with HIV and alcohol misuse recruited in Miami, FL, and Boston, MA. Participants were randomized to one of eight intervention combinations and assessed at 6- and 12-month follow-ups. Large reductions of over 50% in drinks per week and heavy drinking days were observed in all conditions at follow-up. Those who received ITM, compared to those who did not, reported significantly lower drinks consumed per week at 6 and 12 months (incidence rate ratios = 0.73 [95% CI = 0.57, 0.90] and 0.72 [95% CI = 0.56, 0.87], respectively), and increased odds of cessation of alcohol misuse at 12 months, odds ratio = 1.46, 95% CI = 1.03, 2.08. Results provided no evidence of better alcohol use outcomes for either MI or EI relative to their comparison conditions, and no specific combination of intervention components demonstrated a notable benefit. This study suggests a two-session BI can effectuate substantial reductions in alcohol use in SMM with HIV and that adding one month of ITM can yield further improvements.Clinical Trials Number: NCT02709759

Evidence from observational and intervention studies has shown a high intake of tree nuts is associated with a reduced risk of cardiovascular disease (CVD), mortality from type 2 diabetes (T2DM), and all-cause mortality. However, there is limited data regarding their effects on indicators of cardiometabolic risk other than hypercholesterolemia, and little is known about the demonstrable health benefits of pecans (Carya illinoensis (Wangenh.) K.Koch). We conducted a randomized, controlled feeding trial to compare the effects of a pecan-rich diet with an isocaloric control diet similar in total fat and fiber content, but absent nuts, on biomarkers related to CVD and T2DM risk in healthy middle-aged and older adults who are overweight or obese with central adiposity. After 4 weeks on a pecan-rich diet, changes in serum insulin, insulin resistance (HOMA-IR) and beta cell function (HOMA-β) were significantly greater than after the control diet (p < 0.05). Pecan consumption also lowered the risk of cardiometabolic disease as indicated by a composite score reflecting changes in clinically relevant markers. Thus, compared to the control diet, the pecan intervention had a concurrent and clinically significant effect on several relevant markers of cardiometabolic risk.

Background Tobacco smoking remains the leading preventable cause of death in the US. A hospital admission provides smokers with a unique opportunity to stop smoking because it requires temporary tobacco abstinence while illness may enhance motivation to quit. Hospital interventions must continue post-discharge to increase tobacco abstinence long-term, but how best to accomplish this remains unclear. Building on two previous randomized controlled trials, each of which tested smoking cessation interventions that began in hospital and continued after discharge, this trial compares two interventions that provide sustained smoking cessation treatment after hospital discharge with the goal of improving long-term smoking cessation rates among hospitalized smokers. Methods/design Helping HAND 4 is a three-site randomized controlled trial that compares the effectiveness of two active interventions for producing validated past 7-day tobacco abstinence 6 months after hospital discharge. Smokers who are admitted to three hospitals receive a standard in-hospital smoking intervention, and those who plan to quit smoking after discharge are recruited and randomly assigned to two interventions that begin at discharge, Personalized Tobacco Care Management (PTCM) or Quitline eReferral. Each lasts 3 months. At discharge, PTCM provides 8 weeks of free nicotine replacement (NRT; a participant’s choice of patch, gum, lozenge, or a combination) and then proactive smoking cessation support using an automated communication platform and live contact with a tobacco treatment specialist who is based in the health care system. In the eReferral condition, a direct referral is made from the hospital electronic health record to a community-based resource, the state’s telephone quitline. The quitline provides up to 8 weeks of free NRT and offers behavioral support via a series of phone calls from a trained coach. Outcomes are assessed at 1, 3, and 6 months after discharge. The study hypothesis is that PTCM will produce higher quit rates than eReferral. Discussion Helping HAND 4 is a pragmatic trial that aims to evaluate interventions in real-world conditions. This project will give hospital systems critical evidence-based tools for meeting National Hospital Quality Measures for tobacco treatment and maximizing their ability to improve cessation rates and overall health for the millions of smokers hospitalized annually in the US. Trial registration Prospectively registered prior to start of enrollment at Clinicaltrials.gov, NCT03603496 (July 27, 2018). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00084MJ&selectaction=Edit&uid=U00002G7&ts=2&cx=ff0oxn

Background The Dietary Approaches to Stop Hypertension (DASH) Eating Plan is proven to lower blood pressure; however, the original DASH diet involved a set menu of meals prepared in a metabolic kitchen. There is little evidence mapping this dietary pattern to real-world groceries, tailored to a range of personal preferences and dietary practices. Methods The GoFresh Trials, two parallel-arm randomized, controlled trials, are studying the impact of DASH-patterned, home-delivered groceries on the blood pressure of Black adults living in communities with reduced access to grocery stores. Participants were able to choose the groceries according to their preferences for themselves and up to five family members from local supermarkets. A dietitian assisted participants with selection to ensure that groceries followed a DASH pattern and met a potassium/sodium ratio of > 2.0 with kilocalories from saturated fat ≤ 7%. Dietitians also provided weekly educational modules on sustainably adopting DASH. To support meal preparation, a recipe book and 24 demonstration videos were created in collaboration with Boston Chefs. A community advisory board participated in the conception of intervention materials to ensure the program was feasible and grounded in community priorities. Results Compliance assessments include 24-h urine paired with 24-h nutrition recalls, seated blood pressure, and surveys on food preparation and shopping habits. A knowledge assessment and palatability form were used to assess changes in DASH knowledge and acceptability before and after the intervention. Conclusion By describing the unique features and development process of GoFresh, this paper offers practical guidance for adapting and scaling similar nutrition interventions in other communities. Trial registration ClinicalTrials.gov NCT05121337. Registered on November 16, 2021. https://clinicaltrials.gov/ct2/show/NCT05121337 .

Lower rates of smoking cessation are a major reason for the higher prevalence of smoking among socioeconomically disadvantaged adults. Because barriers to quitting are both more numerous and severe, socioeconomically disadvantaged smokers may benefit from more intensive intervention. We sought to determine whether a smoking cessation intervention delivered by public housing residents trained as Tobacco Treatment Advocates (TTAs) could increase utilization of cessation resources and increase abstinence. We conducted a group-randomized trial among Boston public housing residents who were interested in quitting smoking. Participants at control sites received standard cessation materials and a one-time visit from a TTA who provided basic counseling and information about cessation resources. Participants at intervention sites were eligible for multiple visits by a TTA who employed motivational interviewing, cessation counseling, and navigation to encourage smokers to utilize cessation treatment (Smokers' Quitline and clinic-based programs). Utilization and 7-day and 30-day point prevalence abstinence were assessed at 12 months. Self-reported abstinence was biochemically verified. Intervention participants (n = 121) were more likely than control participants (n = 129) to both utilize treatment programs (adjusted odds ratio [aOR]: 2.15; 95% confidence interval [CI]: 0.93-4.91) and 7-day and 30-day point prevalence abstinence (aOR: 2.60 (1.72-3.94); 2.98 (1.56-5.68), respectively). Mediation analysis indicated that the higher level of utilization did not explain the intervention effect. An intervention delivered by peer health advocates was able to increase utilization of treatment programs and smoking abstinence among public housing residents. Future studies of similar types of interventions should identify the key mechanisms responsible for success. In order to narrow the large and growing socioeconomic disparity in smoking rates, more effective cessation interventions are needed for low-income smokers. Individual culturally-relevant coaching provided in smokers' residences may help overcome the heightened barriers to cessation experienced by this group of smokers. In this study among smokers residing in public housing, an intervention delivered by peer health advocates trained in motivational interviewing, basic smoking cessation skills, and client navigation significantly increased abstinence at 12 months. Future research should address whether these findings are replicable in other settings both within and outside of public housing.

Background Black adults are underrepresented in cardiovascular disease clinical trials. Individual and social circumstances may limit when they are available to complete trial prescreening requirements. Characterizing preferences related to callback times and the impact of calling during preferred times could inform strategies to improve the recruitment of Black adults into clinical research. Our objectives were to characterize prescreening call preferences and successfully reaching a potential participant among adults inquiring about participation in two trials for Black residents of Boston. Methods The GoFreshRx and GoFresh trials examine the effect of a home-delivered Dietary Approaches to Stop Hypertension (DASH)-patterned grocery intervention on blood pressure among Black adults with or without hypertension treatment in Boston. With the exception of the study population, both trials were identical and used the same recruitment apparatus for outreach. Interested persons completed a common online form for both trials and indicated their preferred callback time. Staff call attempts and participant screening status were logged prospectively. Gender was estimated based on first name, using a published algorithm. Odds ratios (OR) were determined via logistic regression models with adjustment for estimated gender, recruitment source, method of inquiry, and first call during preferred callback time. Results Of 2870 inquiries (September 2022–July 2023), 1740 participants were called and 1286 were reached. Out of the 1740 participants, 25% preferred to be called before noon and 22% after 4 pm, yet only 10% of the latter were called after 4 pm. Calling during preferred times significantly increased the odds of reaching participants (OR: 1.44; 95% CI: 1.12, 1.85) and completing a prescreening interview (OR: 1.39; 95% CI: 1.14, 1.71). Staff outreach 8–12 weeks (vs 0–4 weeks) after inquiry submission was significantly associated with lower odds of completing a prescreening interview (OR: 0.41; 95% CI: 0.23, 0.73). Participants who made inquiries via return mail were significantly less likely to be reached outside work hours (OR: 0.49; 95% CI: 0.27, 0.90) and in the afternoon (OR: 0.51; 95% CI: 0.30, 0.88). Participants recruited through community events were more likely to be reached in the afternoon (OR: 2.71; 95% CI: 1.06, 6.97). Conclusion Contacting participants during their preferred callback time was associated with reaching them and completing a prescreening interview. These data highlight the importance of study teams’ flexibility in outreach time to enhance the recruitment of Black adults into cardiovascular clinical trials.

Background With improvements in in vitro culture techniques there has been a steady shift in practice to transfer embryos at the blastocyst stage (post fertilization day (p.f.d.) 5–7), when embryos reach the endometrial cavity during natural conception. For patients with > 5 zygotes on day 1 of embryo development, fresh blastocyst embryo transfer (ET) increases live birth rates when compared to cleavage stage (p.f.d. 3) transfer. In poorer prognosis patients (≤ 5 zygotes) cleavage stage ET is commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst stage. However, there is a dearth of randomized controlled trial (RCT) data demonstrating improved live birth rates per cycle for cleavage vs blastocyst stage ET in this subgroup of patients. The hypothesis of the PRECiSE (PooR Embryo Yield Cleavage Stage Versus blaStocyst Embryo Transfer) trial is that blastocyst ET is not inferior to cleavage stage ET with regard to live birth rates per retrieval in poorer prognosis patients. The adoption of routine blastocyst culture for all patients would result in higher rates of single embryo transfers (SET), reduced incidence of multiple pregnancies and simplified laboratory protocols, thereby reducing costs. Methods/design Multicenter, non-inferiority randomized controlled trial (RCT) comparing blastocyst to cleavage stage embryo transfer in poorer prognosis patients with ≤5 zygotes on day 1 after fertilization. The primary outcome is live birth per retrieval. Secondary outcomes include: time to pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage and multiple pregnancy rate (per retrieval). This trial will enroll 658 women with ≤5 zygotes on day 1 at 6 IVF centers over the course of 22 months. Discussion If the hypothesis is proven true, the data from this trial may facilitate the adoption of uniform blastocyst culture in all IVF patients. Trial registration ClinicalTrials.gov Identifier: NCT03764865 . Registered 5 December 2019, Protocol issue date: 4 December 2018, Original.

Background Health-related quality of life (HRQoL) and absence of depressive symptoms are of great importance for older people, which may be achieved through lifestyle interventions, e.g., exercise and nutrition interventions. The aim of this investigation was to analyze the effects of a physical activity program in combination with protein supplementation on HRQoL and depressive symptoms in community-dwelling, mobility-limited older adults. Methods In the Vitality, Independence, and Vigor 2 Study (VIVE2), community-dwelling men and women with an average age of 77.5 ± 5.4 years, some mobility limitations and low serum vitamin D levels (25(OH)Vit D 22.5–60 nmol/l) from two study sites (Stockholm, Sweden and Boston, USA) were randomized to receive a nutritional supplement or a placebo for 6 months. All took part in a physical activity program 2–3 times/ week. The primary outcome examined in VIVE2 was 400 M walk capacity. HRQoL was measured using the Medical Outcomes Study 36-item Short Form Health Survey (SF36), consisting of the Physical Component Summary (PCS) and Mental Component Summary (MCS), and depressive symptoms were measured using The Centre for Epidemiologic Studies Depression Scale (CES-D). In the sensitivity analyses, the sample was divided into sub-groups based on body measures and function (body mass index (BMI), appendicular lean mass index (ALMI), handgrip strength and gait speed). Results For the whole sample, there was a significant improvement in both MCS, mean (95% CI) 2.68 (0.5, 4.9) (p 0.02), and CES-D -2.7 (− 4.5, − 0.9) (p 0.003) during the intervention, but no difference was detected between those who received the nutritional supplement and those who received the placebo. The results revealed no significant change in PCS or variation in effects across the sub-categories. Conclusions This study demonstrates that a six-month intervention using a physical activity program had positive effects on mental status. No additional effects from nutritional supplementation were detected. Trial registration Registered at ClinicalTrials.gov, March 2 2012, NCT01542892 .

Uncertainty exists regarding the degree to which infants with congenitally malformed hearts are at risk of behavioural disorders in childhood. Data was collected as part of a randomized clinical trial involving 155 children with surgically corrected transposition (concordant atrioventricular and ventriculo-arterial connections or alignments). As infants, they underwent the arterial switch operation, involving deep hypothermia with predominantly total circulatory arrest or predominantly low-flow continuous cardiopulmonary bypass as the method of providing support to the vital organs. Parents completed the Child Behavior Checklist when the patients were aged 4 and 8 years, and the Connors’ Parent Rating Scale at the age of 8 years. When the children were aged 8, teachers completed the Teacher’s Report Form and the Connors’ Teacher Rating Scale. In the cohort as a whole, the frequencies of behavioural problems identified by both parents and teachers were elevated, particularly on the scales for competence of the Child Behavior Checklist, and the Adaptive scales of the Teacher’s Report Form. Approximately 1 in 5 patients had scores for Total Problem Behavior in the range of clinical concern on both the Child Behavior Checklist and the Teacher’s Report Form. Few differences were found, however, according to the method of operative treatment. Postoperative seizures were associated with social and attention problems. Children experiencing academic problems at the age of 8 showed a larger increase in behavioural problems between the ages of 4 and 8 than did children making adequate academic progress. Children with congenitally malformed hearts who underwent reparative surgery in infancy using a strategy of severe haemodilution and alpha stat are at increased risk of behavioural problems in middle childhood.