A randomized controlled trial to evaluate and assess the effect of comprehensive pre-end stage kidney disease education on home dialysis use in veterans, rationale and design.

BACKGROUND: Informed dialysis selection and greater home dialysis use are the two long-desired, underachieved targets of advanced chronic kidney disease (CKD) care in the US healthcare system. Observational institutional studies have shown that comprehensive pre-kidney failure, conventionally referred to as end stage kidney disease education (CPE) can improve both these outcomes. However, lack of validated protocols, well-controlled studies, and systemic models have limited wide-spread adoption of CPE in the US. We hypothesized that a universal CPE and patient-centered initiation of kidney replacement therapy can improve multiple clinical, patient-centered and health service outcomes in advanced CKD and kidney failure requiring dialysis therapy. METHODS: Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans (TEACH-VET) is a multi-method randomized controlled trial aimed to evaluate the effects of a system-based approach for providing CPE to all Veterans with advanced CKD across a regional healthcare System. The study will randomize 544 Veterans with non-dialysis stage 4 and 5 CKD in a 1:1 allocation stratified by their annual family income and the stage of CKD to an intervention (CPE) arm or control arm. Intervention arm will receive a two-phase CPE in an intent-to-teach manner. Control arm will receive usual clinical care supplemented by resources for the freely-available kidney disease information. Participants will be followed after intervention/control for the duration of the study or until 90-days post-kidney failure, whichever occurs earlier. RESULTS: The primary outcome will assess the proportion of Veterans using home dialysis at 90-days post-kidney failure, and secondary outcomes will include post-intervention/control CKD knowledge, confidence in dialysis decision and home dialysis selection. Qualitative arm of the study will use semi-structured interviews to in-depth assess Veterans' satisfaction with the intervention, preference for delivery, and barriers and facilitators to home dialysis selection and use. Several post-kidney failure clinical, patient-centered and health services outcomes will be assessed 90-days post-kidney failure as additional secondary outcomes. CONCLUSION: The results will provide evidence regarding the need and efficacy of a system-based, patient-centered approach towards universal CPE for all patients with advanced CKD. If successful, this may provide a blueprint for developing such programs across the similar healthcare infrastructures throughout the country. TRIAL REGISTRATION: NCT04064086 .

Serving Rural Veterans with Disabilities: A National Survey of Centers for Independent Living.

This study comprises a systematic national examination of how Centers for Independent Living can and do support Veteran consumers, especially those living in rural communities. This research provides contextualized understanding of rural Veteran needs for community-based services and resources available through Centers for Independent Living. A survey was administered to the leadership of 383 Centers for Independent Living throughout the United States, the majority of which have rural catchment areas and serve rural Veterans through both main and satellite offices. Descriptive univariate analysis was used to describe responses. Study respondents represented a total of 39 states, with 20% of respondents reporting that their consumers were 100% rural and only 3% entirely urban. Services and supports from Centers for Independent Living provided to rural Veterans most frequently included housing, transportation, and peer support. Approximately half of all Centers for Independent Living reported tracking the status of their Veteran consumers.

Las Bolitas Syndrome in Penaeus vannamei Hatcheries in Latin America.

In September 2023, several hatcheries in Latin America experienced significant mortality rates, up to 90%, in zoea stage 2 of Penaeus vannamei. Observations of fresh mounts revealed structures resembling lipid droplets, similar to those seen in a condition known as "las bolitas syndrome". Routine histopathological examinations identified detached cells and tissues in the digestive tracts of affected zoea, contrasting with the typical algal cell contents seen in healthy zoea. Polymerase chain reaction (PCR) testing for over 20 known shrimp pathogens indicated minimal differences between diseased and healthy batches. Both groups tested negative for acute hepatopancreatic necrosis disease (AHPND) but positive for Vibrio species and Rickettsia-like bacteria in the diseased samples. Histological analyses of the affected zoea revealed characteristic tissue degeneration in the hepatopancreas, forming spheres that eventually migrated into the upper gut, midgut, and midgut caeca, a pathology identified as bolitas syndrome (BS). Microbiological assessments revealed Vibrio species at concentrations of 106 CFU zoea/g in affected zoea, approximately two orders of magnitude higher than in healthy zoea. Bacterial isolation from both healthy and BS-affected zoea on thiosulphate-citrate-bile salts-sucrose (TCBS) agar and CHROMagar™ (Paris, France), followed by identification using API 20E, identified six strains of Vibrio alginolyticus. Despite similarities to "las bolitas syndrome" in fresh mounts, distinct histopathological differences were noted, particularly the presence of sloughed cells in the intestines and variations in hepatopancreatic lobes. This study highlights the critical need for further research to fully understand the etiology and pathology of bolitas syndrome in zoea stage 2 of P. vannamei to develop effective mitigation strategies for hatchery operations.

Informed Dialysis Modality Selection Among Veterans With Advanced CKD: A Community-Level Needs Assessment.

Rationale & Objective: The Advancing Americans Kidney Health Executive order has directed substantial increases in home dialysis use for incident kidney replacement therapy (KRT). Clinical guidelines recommend patients' self-selection of KRT modality through a shared decision-making process, which, at the minimum, requires predialysis nephrology care and KRT-directed comprehensive prekidney failure patient education (CoPE). The current state of these essential services among Americans with advanced (stages 4 and 5) chronic kidney disease (CKD) and their informed preferences for home dialysis are unknown. Study Design: We conducted a community-based, cross-sectional, observational cohort study across a large regional Veteran Healthcare System from October 1, 2020, to September 30, 2021. Setting & Participants: Of the 928 Veterans with advanced CKD, 287 (30.9%) were invited for needs assessment evaluations. Of the 218 (76% of invited cohort) responding, 178 (81.6%) were receiving nephrology care, with approximately half of those (43.6%) receiving such care from non-Veterans Affairs providers. Outcomes: The study was targeted to assess the prevalent state of ongoing nephrology care and KRT-directed pre-kidney failure education among Veterans with advanced CKD. The secondary outcome included evaluation of dialysis decision-making state among Veterans with advanced CKD. Analytical Approach: Veterans with advanced CKD with 2 sustained estimated glomerular filtration rates <30 mL/min/1.73 m2 were identified through an electronic database query, and a randomly selected cohort was invited for their current state of and outstanding needs for predialysis nephrology care and CoPE, essential for informed KRT selection. Results: Basic awareness of kidney disease was high (92.2%) among Veterans with advanced CKD, although only 38.5% were aware of the severity of their CKD. KRT-directed education during clinical care was reported by 46.8% of Veterans, of which 21.1% reported having received targeted CoPE classes. Three-quarters (74.3%) of Veterans expressed interest in receiving CoPE services. Overall, awareness of CKD and its severity and receipt of KRT-directed education were significantly higher among Veterans with nephrology care than among those without. Of the 61 Veterans providing their KRT preferences, overall decision making was poor, with three-quarters (73.8%) of the cohort unable to choose any KRT modality, irrespective of ongoing nephrology care. Only 8 (13%) felt confident choosing home KRT modalities. Limitations: The study results are primarily applicable to the Veterans with advanced CKD. Furthermore, a limited numbers of respondents provided data on their KRT decision-making state, prohibiting broad generalizations. Conclusions: In a first-of-its-kind community-based needs assessment evaluation among Veterans with advanced CKD, we found that awareness of kidney disease is positively associated with nephrology care; however, the informed KRT selection capabilities are universally poor, irrespective of nephrology care. Our results demonstrate a critical gap between the recommended and prevalent nephrology practices such as KRT-directed education and targeted CoPE classes required for informed patient-centered home dialysis selection in advanced CKD.

The Advancing American Kidney Health Executive Order recommended substantial, potentially unrealistic increases in societal home dialysis use. Unfortunately, we have not examined patient preferences for these targets to guide health care policies. Conducting a community-level needs assessment study among Veterans with advanced kidney disease, we found significant deficits in basic clinical care, namely the specialty nephrology care and dialysis-directed patient education services essential for informed patient-centered dialysis selection. This was expectedly associated with a suboptimal state of dialysis decision making, with about three-quarters of those surveyed being unable to select any dialysis modality. Our results show a critical need for provider and system-level efforts to ensure universal availability of specialty kidney care and targeted education for all patients with advanced chronic kidney disease.

Electronic Phenotype for Advanced Chronic Kidney Disease in a Veteran Health Care System Clinical Database: Systems-Based Strategy for Model Development and Evaluation.

BACKGROUND: Identifying advanced (stages 4 and 5) chronic kidney disease (CKD) cohorts in clinical databases is complicated and often unreliable. Accurately identifying these patients can allow targeting this population for their specialized clinical and research needs. OBJECTIVE: This study was conducted as a system-based strategy to identify all prevalent Veterans with advanced CKD for subsequent enrollment in a clinical trial. We aimed to examine the prevalence and accuracy of conventionally used diagnosis codes and estimated glomerular filtration rate (eGFR)-based phenotypes for advanced CKD in an electronic health record (EHR) database. We sought to develop a pragmatic EHR phenotype capable of improving the real-time identification of advanced CKD cohorts in a regional Veterans health care system. METHODS: Using the Veterans Affairs Informatics and Computing Infrastructure services, we extracted the source cohort of Veterans with advanced CKD based on a combination of the latest eGFR value ≤30 ml·min-1·1.73 m-2 or existing International Classification of Diseases (ICD)-10 diagnosis codes for advanced CKD (N18.4 and N18.5) in the last 12 months. We estimated the prevalence of advanced CKD using various prior published EHR phenotypes (ie, advanced CKD diagnosis codes, using the latest single eGFR <30 ml·min-1·1.73 m-2, utilizing two eGFR values) and our operational EHR phenotypes of a high-, intermediate-, and low-risk advanced CKD cohort. We evaluated the accuracy of these phenotypes by examining the likelihood of a sustained reduction of eGFR <30 ml·min-1·1.73 m-2 over a 6-month follow-up period. RESULTS: Of the 133,756 active Veteran enrollees at North Florida/South Georgia Veterans Health System (NF/SG VHS), we identified a source cohort of 1759 Veterans with advanced nondialysis CKD. Among these, 1102 (62.9%) Veterans had diagnosis codes for advanced CKD; 1391(79.1%) had the index eGFR <30 ml·min-1·1.73 m-2; and 928 (52.7%), 480 (27.2%), and 315 (17.9%) Veterans had high-, intermediate-, and low-risk advanced CKD, respectively. The prevalence of advanced CKD among Veterans at NF/SG VHS varied between 1% and 1.5% depending on the EHR phenotype. At the 6-month follow-up, the probability of Veterans remaining in the advanced CKD stage was 65.3% in the group defined by the ICD-10 codes and 90% in the groups defined by eGFR values. Based on our phenotype, 94.2% of high-risk, 71% of intermediate-risk, and 16.1% of low-risk groups remained in the advanced CKD category. CONCLUSIONS: While the prevalence of advanced CKD has limited variation between different EHR phenotypes, the accuracy can be improved by utilizing two eGFR values in a stratified manner. We report the development of a pragmatic EHR-based model to identify advanced CKD within a regional Veterans health care system in real time with a tiered approach that allows targeting the needs of the groups at risk of progression to end-stage kidney disease.

Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD.

Kidney health advocacy organizations and leaders in the nephrology community have repeatedly emphasized the need to increase home dialysis utilization in the United States. Limited awareness and understanding of options for the management of kidney failure among patients living with advanced CKD is a significant barrier to increasing the selection and use of home dialysis. Studies have shown that providing targeted comprehensive patient education before the onset of kidney failure can improve patients' awareness of kidney disease and substantially increase the informed utilization of home dialysis. Unfortunately, in the absence of validated evidence-based education protocols, outcomes associated with home dialysis use vary widely among published studies, potentially affecting the routine implementation and reporting of these services among patients with advanced CKD. This review provides pragmatic guidance on establishing effective patient-centered education programs to empower patients to make informed decisions about their KRT and, in turn, increase home dialysis use.

Study protocol of a telephone problem-solving intervention for Spanish-speaking caregivers of veterans post-stroke: an 8-session investigator-blinded, two-arm parallel (intervention vs usual care), randomized clinical trial.

BACKGROUND: Stroke is one of the leading causes of death and the main cause of long-term disability in the United States. The significant risk factors of stroke among Hispanics are well-documented. The majority of stroke survivors return home following a stroke and are cared for by family caregivers. Due to the abrupt nature of strokes, caregivers experience unexpected changes and demands that oftentimes lead to caregiver burden and depression. Given the significant risk factors for stroke in Hispanics and the influence of culture in family norms and family management, we developed a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers. This study tests the impact of a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers on caregiver outcomes. METHODS: The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 290 caregivers from 3 Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a problem-solving intervention that uses telephone and online education and care management tools on the previously developed and nationally available RESCUE en Español Caregiver website. In the usual care group, participants receive the information and/or support caregivers of veterans with stroke normally receive through existing VA resources (e.g., stroke-related information and support). The primary outcome is change in caregiver's depressive symptoms at 1- and 12-weeks post-intervention. Secondary outcomes include changes in stroke caregivers' burden, self-efficacy, problem-solving, and health-related quality of life (HRQOL) and veterans' functional abilities. We will also determine the budgetary impact, the acceptability of the intervention and participation barriers and facilitators for Spanish-speaking stroke caregivers. DISCUSSION: This is an ongoing study. It is the first known randomized controlled trial testing the effect of a telephone and online problem-solving intervention in Spanish for caregivers of veterans post-stroke. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post-stroke. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03142841- Spanish Intervention for Caregivers of Veterans with Stroke (RESCUE Español). Registered on February 23, 2018. Protocol version 8. 08.11.2022.

Providers' Shift to Telerehabilitation at the U.S. Veterans Health Administration During COVID-19: Practical Applications.

Telerehabilitation provides Veteran patients with necessary rehabilitation treatment. It enhances care continuity and reduces travel time for Veterans who face long distances to receive care at a Veterans Health Administration (VHA) medical facility. The onset of the COVID-19 pandemic necessitated a sudden shift to telehealth-including telerehabilitation, where a paucity of data-driven guidelines exist that are specific to the practicalities entailed in telerehabilitation implementation. This paper explicates gains in practical knowledge for implementing telerehabilitation that were accelerated during the rapid shift of VHA healthcare from out-patient rehabilitation services to telerehabilitation during the COVID-19 pandemic. Group and individual interviews with 12 VHA rehabilitation providers were conducted to examine, in-depth, the providers' implementation of telerehabilitation. Thematic analysis yielded nine themes: (i) Willingness to Give Telerehabilitation a Chance: A Key Ingredient; (ii) Creativity and Adaptability: Critical Attributes for Telerehabilitation Providers; (iii) Adapting Assessments; (iv) Adapting Interventions; (v) Role and Workflow Adaptations; (vi) Appraising for Self the Feasibility of the Telerehabilitation Modality; (vii) Availability of Informal, In-Person Support Improves Feasibility of Telerehabilitation; (viii) Shifts in the Expectations by the Patients and by the Provider; and (ix) Benefit and Anticipated Future of Telerehabilitation. This paper contributes an in-depth understanding of clinical reasoning considerations, supportive strategies, and practical approaches for engaging Veterans in telerehabilitation.

Utilization of CMS pre-ESRD Kidney Disease Education services and its associations with the home dialysis therapies.

BACKGROUND: Kidney Disease Education (KDE) has been shown to improve informed dialysis selection and home dialysis use, two long-held but underachieved goals of US nephrology community. In 2010, the Center for Medicare and Medicaid Services launched a policy of KDE reimbursements for all Medicare beneficiaries with advanced chronic kidney disease. However, the incorporation of KDE service in real-world practice and its association with the home dialysis utilization has not been examined. METHODS: Using the 2016 US Renal Data System linked to end-stage renal disease (ESRD) and pre-ESRD Medicare claim data, we identified all adult incident ESRD patients with active Medicare benefits at their first-ever dialysis during the study period (1 January 2010 to 31 December 2014). From these, we identified those who had at least one KDE service code before their dialysis initiation (KDE cohort) and compared them to a parsimoniously matched non-KDE control cohort in 1:4 proportions for age, gender, ESRD network, and the year of dialysis initiation. The primary outcome was home dialysis use at dialysis initiation, and secondary outcomes were home dialysis use at day 90 and anytime through the course of ESRD. RESULTS: Of the 369,968 qualifying incident ESRD Medicare beneficiaries with their first-ever dialysis during the study period, 3469 (0.9%) received KDE services before dialysis initiation. African American race, Hispanic ethnicity, and the presence of congestive heart failure and hypoalbuminemia were associated with significantly lower odds of receiving KDE services. Multivariate analyses showed that KDE recipients had twice the odds of initiating dialysis with home modalities (15.0% vs. 6.9%; adjusted odds ratio (aOR):95% confidence interval (CI) 2.0:1.7-2.4) and had significantly higher odds using home dialysis throughout the course of ESRD (home dialysis use at day 90 (17.6% vs. 9.9%, aOR:CI 1.7:1.4-1.9) and cumulatively (24.7% vs. 15.1%, aOR:CI 1.7:1.5-1.9)). CONCLUSIONS: Utilization of pre-ESRD KDE services is associated with significantly greater home dialysis utilization in the incident ESRD Medicare beneficiaries. The very low rates of utilization of these services suggest the need for focused systemic evaluations to identify and address the barriers and facilitators of this important patient-centered endeavor.

Telerehabilitation for Rural Veterans: A Qualitative Assessment of Barriers and Facilitators to Implementation.

PURPOSE: Telerehabilitation (TR) is increasingly being used to meet the rehabilitation needs of individuals living in rural areas. Nevertheless, reports on TR implementation for rural patients remain limited. As part of a broader evaluation, this study investigated barriers and facilitators to the implementation of a national TR program to meet the needs of rural Veterans Health Administration (VHA) patients. METHODS: This study applied a qualitative approach to the RE-AIM framework to investigate barriers and facilitators impacting TR implementation. We conducted in-depth, semi-structured interviews with ten program managers and medical directors within the VHA at three time points during the first 18 months of implementation. Interviews were analyzed using thematic analysis. RESULTS: Three themes were identified describing key cultural, infrastructural and logistical, and environmental barriers impacting the reach, adoption, and implementation of TR. Within the themes, facilitators for TR were also identified to include, allowing providers flexibility in implementing TR, mentorship and development of creative approaches to TR training, overcoming infrastructural and logistical TR barriers through championing, and continuous sharing of lessons learned in a community of practice. DISCUSSION: This study explicates salient barriers and facilitators encountered during the first 18 months of implementation of a TR program within a national healthcare system in the United States. Implementing TR to meet the rehabilitation needs of Veterans in resource-limited rural environments requires creative approaches and flexibility, as well as perseverance and consistent championing in order to overcome cultural challenges. This, in combination with infrastructural challenges, such as lack of broadband, adds greater complexity to meeting the needs of rural patients. This study provides new and in-depth understanding of the processes by which TR is implemented in a large healthcare system and points to practical real-world lessons in implementing TR for rural patients.

Trends in VA Telerehabilitation Patients and Encounters Over Time and by Rurality.

Telerehabilitation fills a need and helps ensure treatment adherence for rural and other veterans who find it difficult to access health care.

Enhancing health and independent living for veterans with disabilities by leveraging community-based resources.

The number of US veterans with disabilities has increased in recent years as service members have returned home with extensive injuries and veterans from previous wars acquire functional limitations as a consequence of aging with chronic diseases. Veterans with severe disabilities need assistance and support to maintain independence at home and to avoid institutionalization. The US Department of Veterans Affairs (VA) strives to network with community organizations to achieve the best possible outcomes for veterans. Key community resources in the US for individuals with disabilities are Centers for Independent Living (CILs) that provide a wide range of services, promoting independent living and well-being for people across disabilities. The widespread availability and services of CILs nationwide suggest their potential as a community-based resource for veterans, particularly for those with limited access to VA care. In this article, we discuss long-term needs of veterans with disabilities, efforts to address veterans' rehabilitation needs at the VA and opportunities for leveraging the strengths of community-based organizations for veterans. More research is warranted to investigate CIL services and potential for CIL-VA partnerships.

Regional variation in post-stroke multidisciplinary rehabilitation care among veteran residents in community nursing homes.

INTRODUCTION: Effective post-acute multidisciplinary rehabilitation therapy improves stroke survivors' functional recovery and daily living activities. The US Department of Veterans Affairs (VA) places veterans needing post-acute institutional care in private community nursing homes (CNHs). These placements are made under the same rules and regulations across the VA health care system and through individual per diem contracts between local VA facilities and CNHs. However, there is limited information about utilization of these veterans' health services as well as the geographic variation of the service utilization. AIM: The aims of this study were to determine rehabilitation therapy and restorative nursing care utilization by veterans with stroke in VA-contracted CNHs and to assess risk-adjusted regional variations in the utilization of rehabilitation therapy and restorative nursing care. METHODS: This retrospective study included all veterans diagnosed with stroke residing in VA-contracted CNHs between 2006 and 2009. Minimum Dataset (a health status assessment tool for CNH residents) for the study CNHs was linked with veterans' inpatient and outpatient data within the VA health care system. CNHs were grouped into five VA-defined geographic regions: the North Atlantic, Southeast, Midwest, Continental, and Pacific regions. A two-part model was applied estimating risk-adjusted utilization probability and average weekly utilization days. Two dependent variables were rehabilitation therapy and restorative nursing care utilization by veterans during their CNH stays. RESULTS: The study comprised 6,206 veterans at 2,511 CNHs. Rates for utilization of rehabilitation therapy and restorative nursing care were 75.7% and 30.1%, respectively. Veterans in North Atlantic and Southeast CNHs were significantly (p<0.001) more likely to receive rehabilitation therapies than veterans from other regions. However, veterans in Southeast CNHs were significantly (p<0.001) less likely to receive restorative nursing care compared with veterans in all other regions, before and after risk adjustment. CONCLUSION: The majority of veterans with stroke received rehabilitation therapy, and about one-third had restorative nursing care during their stay at VA-contracted CNHs. Significant regional variations in weekly days for rehabilitation therapy and restorative nursing care utilization were observed even after adjusting for potential risk factors.

La auriculopuntura disminuye los niveles de ansiedad en adultos chilenos con malnutrición por exceso / Auriculopuncture decreases anxiety levels in Chilean adults with malnutrition by excess

Resumen Introducción: A pesar del incremento en el uso de la medicina tradicional china para el tratamiento de la obesidad son pocos los estudios que evalúan su efecto. Objetivo: Determinar el efecto de la auriculopuntura sobre la ansiedad, ingesta nutricional y medidas antropométricas en chilenos con malnutrición por exceso. Materiales y métodos: estudio cuasi-experimental, con muestra probabilística conformada por 21 sujetos, divididos en dos grupos, intervenido GI (n=11) y control GC (n=10). La intervención consistió en realizar auriculopuntura durante siete semanas al GI y administrar un placebo al GC. En ambos grupos se determinó antropometría, ingesta nutricional y niveles de ansiedad. Todos los participantes firmaron consentimiento informado. Para comparar medias entre grupos e intra grupos, se utilizó la prueba t-Student para muestras pareadas. La significancia estadística se estableció a un (α<0,05). Resultados: Se encontró en el GI una disminución de la ansiedad (p=0,036) y de la ingesta de sodio (p=0,035). No se encontraron diferencias estadísticamente significativas en las variables de ingesta calórica-nutricional y antropométrica en ningún grupo. Conclusiones: Es necesario incrementar el tiempo de intervención para evaluar el efecto en el largo plazo y de esta forma, establecer asociaciones causales.

Abstract Introduction: Despite the increase in the use of traditional Chinese medicine for the treatment of obesity, there are few studies which evaluate its effect. Objective: To determine the effect of auriculopuncture on anxiety, nutritional intake and anthropometric measures in Chilean adults with malnutrition by excess. Materials and methods: A quasi-experimental study was conducted with a probabilistic sample conformed by 21 subjects, divided into two groups: intervened GI (n=11) and control GC (n=10). The intervention consisted in performing auriculopuncture for seven weeks to GI and administering a placebo to GC. In both groups anthropometry, nutritional intake and anxiety levels were determined. All participants signed informed consent. To compare averages between groups and intra groups, the T-student test was used for paired samples. Statistical significance was set to one (α < 0.05). Results: A decrease in anxiety (p=0.036) and sodium intake (p=0.035) was found in the GI. No statistically significant differences were found in the variables of caloric-nutritional and anthropometric intake in any group. Conclusions: It is necessary to increase the intervention time to evaluate the long-term effect and thus establish causal associations.