Effect of Intermittent vs. Continuous Energy Restriction on Visceral Fat: Protocol for The Healthy Diet and Lifestyle Study 2 (HDLS2).

Obesity in the United States and Western countries represents a major health challenge associated with an increased risk of metabolic diseases, including cardiovascular disease, hypertension, diabetes, and certain cancers. Our past work revealed a more pronounced obesity-cancer link in certain ethnic groups, motivating us to develop a tailored dietary intervention called the Healthy Diet and Lifestyle 2 (HDLS2). The study protocol is described herein for this randomized six-month trial examining the effects of intermittent energy restriction (5:2 Diet) plus the Mediterranean dietary pattern (IER + MED) on visceral adipose tissue (VAT), liver fat, and metabolic biomarkers, compared to a standard MED with daily energy restriction (DER + MED), in a diverse participant group. Using MRI and DXA scans for body composition analysis, as well as metabolic profiling, this research aims to contribute to nutritional guidelines and strategies for visceral obesity reduction. The potential benefits of IER + MED, particularly regarding VAT reduction and metabolic health improvement, could be pivotal in mitigating the obesity epidemic and its metabolic sequelae. The ongoing study will provide essential insights into the efficacy of these energy restriction approaches across varied racial/ethnic backgrounds, addressing an urgent need in nutrition and metabolic health research. Registered Trial, National Institutes of Health, ClinicalTrials.gov (NCT05132686).

Effects of a Novel Applet-Based Personalized Dietary Intervention on Dietary Intakes: A Randomized Controlled Trial in a Real-World Scenario.

The objective of this study was to assess the feasibility and effectiveness of a novel WeChat applet-based personalized dietary intervention aimed at promoting healthier dietary intakes. A two-arm parallel, randomized, controlled trial was conducted in a real-world scenario and involved a total of 153 participants (the intervention group, n = 76; the control group, n = 77), lasting for 4 months in Shanghai, China. The intervention group had access to visualized nutrition evaluations through the applet during workday lunch time, while the control group received no interventions. A total of 3413 lunch dietary intake records were captured through the applet. Linear mixed models were utilized to assess the intervention effects over time. At baseline, the participants' lunchtime dietary intakes were characterized by insufficient consumption of plant foods (86.9% of the participants) and excessive intake of animal foods (79.7% of the participants). Following the commencement of the intervention, the intervention group showed a significant decrease in the animal/plant food ratio (ß = -0.03/week, p = 0.024) and the consumption of livestock and poultry meat (ß = -1.80 g/week, p = 0.035), as well as a borderline significant increase in the consumption of vegetables and fruits (ß = 3.22 g/week, p = 0.055) and plant foods (ß = 3.26 g/week, p = 0.057) over time at lunch compared to the control group. The applet-based personalized dietary intervention was feasible and effective in improving dietary intakes and, consequently, possibly may manage body weight issues in real-world scenarios.

Is it feasible and ethical to randomize patients between surgery and non-surgical treatments for gastrointestinal cancers?

Background: In several settings in the treatment of gastrointestinal cancers, it is unclear if the addition of surgery to a multimodal treatment strategy, or in some circumstances its omission, lead to a better outcome for patients. In such situations of clinical equipoise, high-quality evidence from randomised-controlled trials is needed to decide which treatment approach is preferable. Objective: In this article, we outline the importance of randomised trials comparing surgery with non-surgical therapies for specific scenarios in the treatment of gastrointestinal cancers. We explain the difficulties and solutions of designing these trials and recruiting patients in this context. Methods: We performed a selective review based on a not systematic literature search in core databases, supplemented by browsing health information journals and citation searching. Only articles in English were selected. Based on this search, we discuss the results and methodological characteristics of several trials which randomised patients with gastrointestinal cancers between surgery and non-surgical treatments, highlighting their differences, advantages, and limitations. Results and conclusions: Innovative and effective cancer treatment requires randomised trials, also comparing surgery and non-surgical treatments for defined scenarios in the treatment of gastrointestinal malignancies. Nevertheless, potential obstacles to designing and carrying out these trials must be recognised ahead of time to avoid problems before or during the trial.

Macroeconomic expectations and consumer sentiment during the COVID-19 pandemic: The role of others' beliefs.

This paper investigates the effect of information about cross-country ratings of the government's and the public's reaction to the COVID-19 pandemic on consumers' macroeconomic expectations and sentiment. We conduct consumer surveys with randomized control trials (RCTs) in two waves in Thailand and Vietnam. The information treatments have the strongest effect when the information shown contradicts consumers' prior beliefs. In the first survey, conducted when the first lockdown was eased, treatment effects are stronger in Vietnam, causing more optimistic expectations and sentiment. In the second survey, conducted at the start of the second wave of infections, treatment effects are stronger in Thailand, causing a more pessimistic outlook.

Study protocol of a double-blind randomized control trial of transcranial direct current stimulation in post-stroke fatigue.

Rationale: Post-stroke fatigue (PSF) is a frequent problem in stroke survivors and often hinders their rehabilitation. PSF is difficult to treat, and pharmacological therapy is often ineffective. Transcranial direct current stimulation (tDCS) can modulate motor, sensory, cognitive and behavioral responses, as it alters neuronal activity by delivering a small amount of current via the scalp to the cortex, resulting in prolonged alterations to brain function. tDCS has been studied for the treatment of fatigue associated with other neurological diseases, namely, multiple sclerosis, Parkinson's disease and post-polio syndrome. Aims: This proposed project will examine the effect of tDCS on PSF. Sample size estimates: We will recruit 156 participants aged 18 to 80 with chronic stroke and allocate them equally to two groups (i.e., n = 78 per group). Methods and design: This proposed project will be a double-blind randomized control trial. The participants will be randomly divided into two groups. The control group will receive sham tDCS, and the treatment group will receive active tDCS. The latter treatment will involve application of a constant 2-mA current via one 5 × 5-cm anodal electrode positioned on the scalp over the C3 or C4 positions (motor cortex) of the lesioned hemisphere and one cathodal electrode positioned at the ipsilateral shoulder in two 20-min sessions per day for 5 days. The period of follow-up will be 4 weeks. Study outcomes: The primary outcome measure will be a change in fatigue severity, as measured using the modified fatigue impact scale (MFIS). The participants' scores on the MFIS (total score and physical, cognitive and psychosocial subscores) will be collected before treatment (T0), after 10 treatment sessions, i.e., 1 day after the fifth treatment day (T1), and 1 week (T2), 2 weeks (T3) and 4 weeks (T4) thereafter. Both per-protocol analysis and intention-to-treat analysis will be performed. Discussion: This proposed project will provide proof-of-concept, i.e., demonstrate the benefits of tDCS for the treatment of PSF. The beneficiaries are the subjects participated in the study. This will stimulate further research to optimize tDCS parameters for the treatment of PSF. Clinical trial registration: www.Chictr.org.cn, identifier: ChiCTR2100052515.

Primary and secondary cardiovascular disease prevention interventions targeting lifestyle risk factors in women: A systematic review and meta-analysis.

Background and aims: Over seven million women die from cardiovascular disease (CVD) annually. While lifestyle modification is recommended for CVD prevention, there are no systematic reviews evaluating the effectiveness of interventions targeted to women. The primary aim of this systematic review is to determine the efficacy of primary and secondary CVD prevention interventions targeting lifestyle risk factors in women. Methods: Six electronic databases were searched up to January 2022. Eligible studies included randomized controlled trials of primary or secondary CVD prevention interventions targeting CVD lifestyle risk factors (diet, physical activity, sedentary behavior, smoking, alcohol, sleep, and weight management) in women (≥18 years) that reported CVD risk markers or lifestyle risk factors. Meta-analyses were conducted on CVD risk markers and body mass index (BMI), and the level of evidence was applied to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria and reported. Results: Thirty-five RCTs were included (24 primary and 11 secondary prevention). Meta-analyses demonstrated that lifestyle CVD prevention interventions achieved statistically significant reductions in BMI at ≤ 6 months (0.95 kg/m2, 95% CI = 0.54 to 1.35, p < 0.0001), 12 months (0.61 kg/m2, 95% CI = 0.07 to 1.16, p = 0.03) and >12 months (0.58 kg/m2, 95% CI = 0.01 to 1.16, p = 0.05), and systolic blood pressure (mmHg) at ≤ 6 months (3.51, p < 0.001). Conclusions: Lifestyle interventions are important for the prevention of CVD in women, specifically to reduce systolic blood pressure in the short term (≤ 6 months) and BMI long term (>12 months). Systematic review registration: https://osf.io/bkwqm, identifier: osf-registrations-bkwqm-v1.

Titanium versus polyetheretherketone versus structural allograft in anterior cervical discectomy and fusion: A systematic review.

Introduction: Anterior cervical discectomy and fusion (ACDF) is a common procedure to address cervical spine pathology. The most common grafts used are titanium, polyetheretherketone (PEEK), or structural allograft. Comparison of fusion rate is difficult due to non-standardized methods of assessment. We stratified studies by method of fusion assessment and performed a systematic review of fusion rates for titanium, PEEK, and allograft. Research question: Which of the common implants used in ACDF has the highest reported rate of fusion? Materials and methods: An experienced librarian performed a five-database systematic search for published articles between 01/01/1990 and 08/07/2021. Studies performed in adults with at least 1 year of radiographic follow up were included. The primary outcome was the rate of fusion. Fusion criteria were stratified into 6 classes based upon best practices. Results: 34 studies met inclusion criteria. 10 studies involving 924 patients with 1094 cervical levels, used tier 1 fusion criteria and 6 studies (309 patients and 367 levels) used tier 2 fusion criteria. Forty seven percent of the studies used class 3-6 fusion criteria and were not included in the analysis. Fusion rates did differ between titanium (avg. 87.3%, range 84%-100%), PEEK (avg. 92.8%, range 62%-100%), and structural allograft (avg. 94.67%, range 82%-100%). Discussion and conclusion: After stratifying studies by fusion criteria, significant heterogeneity in study design and fusion assessment prohibited the performance of a meta-analysis. Fusion rate did not differ by graft type. Important surgical goals aside from fusion rate, such as degree of deformity correction, could not be assessed. Future studies with standardized high-quality methods of assessing fusion, are required.

Combining mussel with fucoidan as a supplement for joint pain and prediabetes: Study protocol for a randomized, double-blinded, placebo-controlled trial.

Introduction: Pharmaceutical drugs are beneficial to inflammatory conditions but with side effects, which led to the search for alternative therapies. Perna canaliculus, the New Zealand green-lipped mussel, have shown promise in placebo-controlled trials for inflammatory conditions. Fucoidan, an extract from seaweed Undaria pinnatifida, has been found to have beneficial effects on joint pain and insulin resistance. However, green-lipped mussel and fucoidan have never been combined. Methods and analysis: A parallel, two-arm, double-blind, randomized, placebo-controlled trial will be conducted in New Zealand to determine whether a food product supplemented with green-lipped mussel and fucoidan improves joint pain and/or insulin resistance. Those who are ethnically Chinese, are aged over 30 years, have prediabetes and hip or knee joint pain will be eligible to participate. They will be randomized at 1:1 ratio to consume either dark chocolate supplemented with 1000 mg mussel powder and 1000 mg fucoidan or dark chocolate with no active substances daily for 100 days. The primary endpoints are change in insulin resistance and patient-reported joint pain. Secondary endpoints include anthropometry, fasting glucose and insulin, HbA1c, inflammatory markers, satiety, quality of life, physical function, pain intensity, and analgesic medication use. A sample size of 150 (75 per arm) will provide 90% power at an overall significance level of 5% (two-sided) to detect a standardized effect size of 0.625 on either of the two co-primary outcomes allowing for 10% loss. Ethics and dissemination: The study was approved by the Health and Disability Ethics Committee (number: 20/STH/153). Results will be made available to participants, funders, and other researchers. Discussion: This trial will provide data on the potential utility of a mussel-fucoidan supplement in reducing joint pain and/or insulin resistance, to inform the development of a supplemented food product suitable for the Chinese market. Clinical trial registration: https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621000413820, ANZCTR Registration: ACTRN12621000413820, on 15 April 2021.

The effect of a short, animated story-based video on COVID-19 vaccine hesitancy: A study protocol for an online randomized controlled trial.

Introduction: Exposure to a high volume of vaccine misinformation on social media can have a negative effect on vaccine confidence and rates. To counteract misinformation, we designed a collage of three short, animated story-based (SAS) videos to convey scientifically informed and accessible information about COVID-19 vaccine applicable to a social media context. Methods and analysis: We will conduct an online randomized controlled trial primarily to: (1) determine the effectiveness of SAS videos in improving COVID-19 vaccine knowledge; (2) evaluate the effectiveness of SAS videos in increasing behavioral intent for COVID-19 vaccination; and (3) quantify people's interest in watching SAS videos about the COVID-19 vaccine. We also aim to identify barriers and facilitators to COIVD-19 vaccinations that have been shown to minimize vaccine hesitancy between vaccinated and unvaccinated populations. Using a web-based recruitment platform, a total of 10,000 adults from the United States will be recruited and randomly assigned to (1) a SAS video collage arm, (2) an attention placebo control video arm, or (3) no intervention arm (1:1:1). Furthermore, we will measure behavioral intent to obtain information on vaccination regarding COVID-19. At the end of the trial, participants randomized to arm 2 and arm 3 will be given the option of watching one of the intervention videos voluntarily to assess participant engagement with SAS videos. Finally, we will assess individual factors associated with vaccine hesitancy - hope, optimism, COVID-19 perceived risks and benefits, self-efficacy, perceived social norms, and trust - and compare vaccinated and unvaccinated participants across the three arms. Discussions: Evidence-based information from official channels can be complex and inaccessible to the general public, whereas false information on social media is frequently shared in brief postings, images, or videos that can easily reach the general public, thereby rapidly disseminating (mis-)information. To avoid the spread of misinformation, social media may be used to deliver evidence-based and emotionally compelling information in a readily accessible format in order to pre-empt misinformation. Our findings may help inform future SAS efforts addressing COVID-19 and other important public health challenges. Ethics and dissemination: The study was approved by the Heidelberg University Hospital's Ethics Committee (S-163/2022). The trial was registered with German Clinical Trials Register (www.drks.de) on 5 January 2022: number DRKS00027938. Findings of the study will be published in peer-reviewed scientific publications and possibly presented at scientific conferences.

Dexmedetomidine to reduce vasopressor resistance in refractory septic shock: Protocol for a double-blind randomized controlled pilot trial (ADRESS Pilot study).

Introduction: Refractory septic shock (RSS) is characterized by high vasopressor requirements, as a consequence of vasopressor resistance, which may be caused or enhanced by sympathetic hyperactivation. Experimental models and clinical trials show a reduction in vasopressor requirements and improved microcirculation compared to conventional sedation. Dexmedetomidine did not reduce mortality in clinical trials, but few septic shock patients were enrolled. This pilot trial aims to evaluate vasopressor re-sensitization with dexmedetomidine and assess the effect size, in order to design a larger trial. Methods: This is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial, comparing dexmedetomidine versus placebo in RSS patients with norepinephrine dose ≥0.5µg/kg/min. The primary outcome is blood pressure response to phenylephrine challenge, 6 hours after completion of a first challenge, after study treatment initiation. Secondary outcomes include feasibility and safety outcomes (bradycardia), mortality, vasopressor requirements, heart rate variability, plasma and urine catecholamines levels. The sample size is estimated at 32 patients to show a 20% improvement in blood pressure response to phenylephrine. Randomization (1:1) will be stratified by center, sedation type and presence of liver cirrhosis. Blood pressure and ECG will be continuously recorded for the first 24 h, enabling high-quality data collection for the primary and secondary endpoints. The study was approved by the ethics committee "Sud-Est VI" (2019-000726-22) and patients will be included after informed consent. Discussion: The present study will be the first randomized trial to specifically address the hemodynamic effects of dexmedetomidine in patients with septic shock. We implement a high-quality process for data acquisition and recording in the first 24 h, ensuring maximal quality for the evaluation of both efficacy and safety outcomes, as well as transparency of results. The results of the study will be used to elaborate a full-scale randomized controlled trial with mortality as primary outcome in RSS patients. Trial registration: Registered with ClinicalTrials.gov (NCT03953677). Registered 16 May 2019, https://clinicaltrials.gov/ct2/show/NCT03953677.

Effects of Dental Implants and Nutrition on Elderly Edentulous Subjects: Protocol for a Factorial Randomized Clinical Trial.

Background: Loss of masticatory function consequent to tooth loss has been associated with changes in food choices and insufficient nutritional intake. To date, interventions based on dental prostheses alone did not significantly improve nutrient intake. Pilot studies have shown positive impacts of interventions combining implant-supported fixed dental prosthesis with brief dietary advice. The relative contribution and the potential synergy of the components of such interventions need to be determined as it has major public health implications for the community-dwelling aging population that continues to disproportionately suffer from tooth loss and its consequences. Objective: To assess the effect of rehabilitation of masticatory function with fixed implant supported dentures and nutrition education in older subjects with terminal dentition (stage IV periodontitis) or full edentulism. Methods: A 2 × 2 factorial randomized controlled trial with 16-month follow-up of eligible adults (≥60 years) with loss of masticatory function consequent to full arch edentulism or terminal dentition (n = 120) will be conducted to test whether the rehabilitation of masticatory function with fixed implant supported dentures, nutrition education and/or their combination improves intake of fresh fruits and vegetables for aging subjects. The study has been designed to detect changes in fresh fruits and fresh vegetables intake at 4 months using the 24-h dietary recall method. Changes in protein as percentage of total energy, nutritional biomarkers, plasma metabolomics, oral and gut microbiome, quality of life and masticatory function will also be assessed. Discussion: We hypothesize that receiving rehabilitation of masticatory function with fixed implant dentures together with nutrition education is the most effective intervention for improving nutrient intake in aging community-dwelling subjects with extensive tooth loss. The results of this study will assist in designing better treatment regimens, guide medical care for individual subjects, and inform public health and policy. Clinical Trials Registration: NCT05334407.

Efficacy of myo-inositol in improving pregnancy rate and regulation of menstrual cycle for patients with polycystic ovarian syndrome: A systematic review and meta-analysis

Background@#Polycystic ovarian syndrome (PCOS) is a common, reproductive endocrinopathy associated with ovarian dysfunction, cardiovascular disorders, obesity, and infertility. Myo-inositol is a novel treatment for women with PCOS that claimed to have improved fertility rate in this population. This systematic review and meta-analysis examined the effect of myo-inositol on pregnancy rate, menstrual cycle, and adverse effects from randomized controlled trials (RCTs). @*Methods@#RCTs that evaluated the efficacy of myo-inositol in improving pregnancy rate and regulation of menstrual cycle in women with PCOS. Electronic databases were searched and studies published up to October 24, 2021 were included in the systematic review and meta-analysis. Study selection and assessment of quality were conducted independently by two review authors. @*Results@#Seven studies with 729 patients treated with myo-inositol and 677 patients treated with placebo and/or metformin were included in the analysis. The research groups did not diverge significantly in terms of basic characteristics, such as age, adnexal or uterine pathology, body mass index, and duration of infertility. In the myo-inositol group, regulation of the normal menstrual cycle is at 20%, significantly higher than the metformin group at 12%, (p<0.001). However, there is no significant difference in the pregnancy rate between myoinositol and placebo (p=0.42) and/or metformin (p=0.17). @*Conclusion@#This systematic review and meta-analysis showed that myo-inositol can be an alternative treatment for PCOS in terms of regulation of menses and may improve the success of spontaneous pregnancies. However, additional randomized, double-blind controlled trials with larger sample sizes, low heterogeneity, and uniform inclusion criteria are recommended to establish the effects of myo-inositol on PCOS treatment and pregnancy rate.

Direct observation in a large-scale randomized trial of parent training in children with autism spectrum disorder and disruptive behavior.

A direct observation strategy (Standardized Observation Analogue Procedure, SOAP) was used in a large-scale randomized trial of parent training versus parent education in young children with autism spectrum disorder (ASD) and disruptive behavior. The 16-minute SOAP, modified from an earlier version of this same measure, included parentchild interaction to assess child behavior in a clinical laboratory setting. Despite study entry criteria for all child participants requiring moderate levels of disruptive behavior in this project, 126 of 168 children with complete SOAP data at baseline showed no disruptive behavior on this measure. Although the primary purpose of the study was to determine whether the SOAP could detect differences between the two conditions (i.e.,parent training (PT) and parent education (PE)), baseline observation data was not consistent with parent ratings at baseline or subsequent follow up visits, leaving little room to demonstrate improvement with this observation measure. This and the challenging, time-consuming and resource intensive effort involved in using such a measure in a large randomized scale trial, raises fundamental questions about the validity of the SOAP as an outcome measure in such a study. Further consideration related to the feasibility and practicality of using direct observation as a primary measure in larger scale efforts overall are also discussed.

Occupational Performance Coaching With Parents to Promote Community Participation of Young Children With Developmental Disabilities: Protocol for a Feasibility and Pilot Randomized Control Trial.

Background: High rates of restricted community participation have been reported in young children with developmental disabilities. Occupational performance coaching (OPC), grounded in self-determination theory, aims to facilitate children's participation in life situations through coaching parents. However, there have been limited randomized controlled trials demonstrating the efficacy of OPC, especially with a specific focus on children's community participation. The proposed study is the first step in evaluating the feasibility and acceptability of conducting a pilot randomized controlled trial of OPC in Hong Kong and testing its initial efficacy (in comparison to parent consultation) in promoting children's community participation. Method/Design: A feasibility and pilot double-blind randomized controlled trial will be undertaken. Fifty children aged 6 years or below with developmental disabilities and their parents will be recruited from early intervention centers and/or through social media in Hong Kong. Parents will be randomly assigned to receive OPC or consultation, and will be blinded to group allocation. Outcomes will be assessed by blinded assessors at baseline, pre-intervention, post-intervention, and follow-up. Predetermined success criteria will be used to assess the feasibility of the trial. Qualitative interviews will be conducted with parents to explore the acceptability and perceived impact of OPC. Discussion: This trial will test whether the study protocol and OPC are feasible and acceptable, as well as assess the initial efficacy of OPC to obtain effect size estimates. The results of the trial will inform future preparations for conducting a full-scale efficacy trial of OPC. Trial Registration: ClinicalTrials.gov, U.S. National Library of Medicine, National Institutes of Health (#NCT04796909), Registered on 15th March 2021.

The Effect of Risk Communication on Public Behavior to Non-Conventional Terrorism-Randomized Control Trial.

Non-conventional terrorism (NCT) incorporates an extended dimension of uncertainty that can lead to fear among the public. Health officials have an unsubstantiated assumption that thousands will seek treatment in hospitals following NCT. This study aims to examine public behavioral intentions in the case of NCT and the effect of risk communication on intents. An online randomized controlled trial was conducted among 1802 adult participants in Israel. Threat perception and behavioral intent before and after exposure to hypothetical NCT scenarios were assessed stratified to the type of media, exposure to rumors, and risk communication. The majority (~64%) of participants are aware of the NCT threat. Almost half (45%) of participants indicated a "high" or "very high" chance of seeking medical attention following an NCT incident. Regression analysis suggests that the odds of participants exposed to risk communication to report an elevated intent of seeking medical attention were 0.470 (95% CI: 0.359, 0.615) times that of participants not exposed to risk communication, χ2 = 30.366, p < 0.001. The findings demonstrate the importance of effective risk communication in reducing undesired public behavior during NCT crises. Efforts must be invested to create a robust risk communication infrastructure to allow the proper management of possible NCT incidents.

The Effectiveness of Behavior Change Techniques Underpinning Psychological Interventions to Improve Glycemic Levels for Adults With Type 2 Diabetes: A Meta-Analysis.

An existing systematic review and meta-analysis found a significant reduction in glycemic levels for adults with type 2 diabetes who received a psychological intervention over control conditions. To help develop effective interventions in the future, there is a need to understand the active ingredients which underpin these psychological interventions. We conducted a secondary meta-analysis including 67 randomized controlled trials (RCTs) reported in English. We reviewed the psychological intervention descriptions of the included studies of the existing review and extracted the behavior change techniques (BCTs) according to the BCT taxonomy (BCTTv1). We also extracted information on primary behavioral target versus primary outcome, and presence of fidelity assessment. The most frequent BCTs across RCTs were 'social support (unspecified)' (n=50), 'problem solving' (n=38) and 'goal setting (behavior') (n=30). These BCTs were independently associated with a significant reduction in glycemic levels (HbA1c) compared to control conditions, but not significantly different from studies that did not include these BCTs. Meta-regressions revealed no significant associations between HbA1c, and psychological intervention category (counselling versus cognitive behavioral therapy interventions) (p=0.84), frequency of BCTs per psychological intervention (p=0.29), primary behavioral target versus primary outcome (p=0.48), or presence of fidelity assessment (p=0.15). Social support (unspecified), problem solving, and goal setting (behavior) could be useful BCTs to develop psychological interventions for people with type 2 diabetes to improve glycemic levels. However, more research is required to understand which combination of individual BCTs are most effective for this population. Systematic Review Registration: Registered with the international prospective register of systematic reviews registration (PROSPERO) CRD42016033619.

Clinical Benefits From Administering Probiotics to Mechanical Ventilated Patients in Intensive Care Unit: A PRISMA-Guided Meta-Analysis.

BACKGROUND: The use of probiotics has been considered as a new intervention for ventilator-associated pneumonia (VAP) prevention in the intensive care unit (ICU). The aim of this meta-analysis was to evaluate the effect of probiotics on mechanical-ventilated patients in ICU. METHODS: PubMed, Embase, Scopus, and the Cochrane Library were searched for relevant randomized controlled trials (RCTs) from their respective inception through October 10, 2021. All studies meeting the inclusion criteria were selected to evaluate the effect of probiotics on patients receiving mechanical ventilation in ICU. RESULTS: A total of 15 studies involving 4,693 participants met our inclusion criterion and were included in this meta-analysis. The incidence of VAP in the probiotic group was significantly lower (odds ratio [OR] 0.58, 95% CI 0.41 to 0.81; p = 0.002; I 2 = 71%). However, a publication bias may be present as the test of asymmetry was significant (p = 0.007). The probiotic administration was associated with a significant reduction in the duration of mechanical ventilation (mean difference [MD] -1.57, 95% CI -3.12 to -0.03; p = 0.05; inconsistency [I]2 = 80%), length of ICU stay (MD -1.87, 95% CI -3.45 to -0.28; p = 0.02; I 2 = 76%), and incidence of bacterial colonization (OR 0.59, 95% CI 0.45 to 0.78; p = 0.0001; I 2 = 34%). Moreover, no statistically significant differences were observed regarding the incidence of diarrhea (OR 0.90, 95% CI 0.65 to 1.25; p = 0.54; I 2 = 12%) and mortality (OR 0.91, 95% CI 0.80 to 1.05; p = 0.19; I 2 = 0%) between probiotics group and control group. CONCLUSION: Our meta-analysis shows that probiotics are associated with a reduction in VAP, as well as the duration of mechanical ventilation, ICU length of stay, and bacterial colonization, but no significant effects on ICU mortality and occurrence of diarrhea. However, in consideration of the significant heterogeneity and publication bias, our findings need to be further validated. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier: CRD42020150770.

Genomic Effects Associated With Response to Placebo Treatment in a Randomized Trial of Irritable Bowel Syndrome.

Background and Aims: Irritable bowel syndrome (IBS), a functional pain disorder of gut-brain interactions, is characterized by a high placebo response in randomized clinical trials (RCTs). Catechol-O-methyltransferase (COMT) rs4680, which encodes high-activity (val) or low-activity (met) enzyme variants, was previously associated with placebo response to sham-acupuncture in an IBS RCT. Examining COMT effects and identifying novel genomic factors that influence response to placebo pills is critical to identifying underlying mechanisms and predicting and managing placebos in RCTs. Methods: Participants with IBS (N = 188) were randomized to three placebo-related interventions, namely, double-blind placebo (DBP), open-label placebo (OLP), or simply trial enrollment without placebo treatment [no placebo (i.e., no pill) treatment control (NPC)], for 6 weeks. COMT rs4680, gene-set, and genome-wide suggestive (p < 10-5) loci effects on irritable bowel symptom severity score (IBS-SSS) across all participants were examined. Results: Participants with IBS homozygous for rs4680 met (met/met) had the greatest improvement across all arms, with significantly greater improvement compared to val/val in DBP (beta (SE), -89.4 (42.3); p = 0.04). Twelve genome-wide suggestive loci formed a gene regulatory network highly connected to EGR1, a transcription factor involved in placebo-related processes of learning, memory, and response to stress and reward. EGR1 gene expression in peripheral blood mononuclear cells (PBMC) was significantly reduced at the endpoint across all treatment arms (log fold-change, -0.15; p = 0.02). Gene-set enrichment analysis returned three genome-wide significant ontology terms (GO:0032968, GO:0070934, and GO:0070937) linked to transcription regulation and GO:0003918 associated with DNA topoisomerase regulation. Conclusion: These results suggest common molecular mechanisms in response to varying forms of placebo that may inform personalized IBS treatment and placebo response prediction. Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT0280224.

Effects of a Home Visiting Program on Parenting: Mediating Role of Intimate Partner Violence.

Young women aged 18 to 24 years are in the highest risk group for intimate partner violence (IPV), and adolescent mothers are at particularly high risk for IPV and for risky health behaviors. Exposure to IPV may contribute to parenting stress and risky behaviors, and may compromise parenting behavior and healthy child development. The present study examined whether program effects of a statewide home visiting program for adolescent parents on young mothers' parenting stress and risky behaviors measured 2 years post program enrollment were mediated by program effects on their exposure to IPV measured 1 year post enrollment. Using longitudinal data from a subsample of young mothers (n = 448; 58% program, 42% control) who participated in a randomized controlled trial evaluation of a statewide home visiting program, Healthy Families Massachusetts (HFM), we estimated path analyses to examine whether home visiting program effects observed on IPV mediated home visiting program effects on subsequent assessments of parenting distress and mothers' risky behaviors. Findings indicated that IPV mediated associations between home visiting program effects on mothers' parenting distress and risky behavior. Although most newborn home visiting programs do not have an explicitly stated goal of reducing IPV, helping mothers and their partners to reduce violent behavior can have further-reaching impacts on other key goals of home visiting programs, such as parenting stress and risky behaviors.