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DATA AVAILABILITY | The source data (containing the subjects personal information) that support the findings of this study are available from Jiangsu Hansoh Pharmaceutical Group Co., Ltd. Restrictions apply to the availability of these data, which were used under license for this study. Data are available from Shuwen Yu with the permission of Jiangsu Hansoh Pharmaceutical Group Co., Ltd. | PMC10720486 |
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SUPPLEMENTAL MATERIAL | The following material is available online at | PMC10720486 |
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aac.01075-23-s0001.docx | Criteria for inclusion and exclusion and Tables S1 and S2.Click here for additional data file.ASM does not own the copyrights to Supplemental Material that may be linked to, or accessed through, an article. The authors have granted ASM a non-exclusive, world-wide license to publish the Supplemental Material files. Please contact the corresponding author directly for reuse. | PMC10720486 |
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REFERENCES | PMC10720486 |
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Background | skin cancer | DISEASE, SKIN CANCER, OF SKIN CANCER | Incidence of skin cancer has been increasing among U.S. Hispanics, who often are diagnosed with larger lesions and at later stage disease. Behaviors to decrease exposure to ultraviolet radiation can reduce risk of skin cancer. We describe skin cancer prevention behaviors and psychosocial variables among Hispanic participants recruited into a skin cancer prevention trial. | PMC10644628 |
Methods | REGRESSION | Self-reported Hispanic participants from eight primary care clinics in Tampa, Florida and Ponce, Puerto Rico were recruited into a randomized controlled prevention trial. Information on demographics, sun-related behaviors, and psychosocial variables were collected before intervention materials were provided. Multivariable regression models were used to compare baseline sun-related behaviors and psychosocial variables across groups defined by geographic location and language preference. | PMC10644628 |
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Results | sunburned, skin cancer, sunburn | SKIN CANCER | Participants reported low levels of intentional outdoor tanning, weekday and weekend sun exposure, and very low levels of indoor tanning. However, only a minority of participants practiced sun-protective behaviors often or always, and about 30% experienced a sunburn in the past year. Participants had low levels of recent worry and concern about skin cancer, modest levels of perceived risk and severity, and high levels of response efficacy and self-efficacy. When comparing across groups defined by geographic location and language preference, English-preferring Tampa residents (hereafter referred to as Tampeños) had the highest proportion who were sunburned (35.9%) and tended toward more risky behavior but also had higher protective behavior than did Spanish-preferring Tampeños or Puerto Ricans. Spanish-preferring Puerto Ricans had higher recent concern about skin cancer, comparative chance of getting skin cancer, and response efficacy compared to either English- or Spanish-preferring Tampeños. Spanish-preferring Tampeños had the highest levels of familism and recent distress about skin cancer. | PMC10644628 |
Conclusions | skin cancer | SKIN CANCER | Our results mirror previous observations of low levels of sun-protective behavior among U.S. Hispanics compelling the need for culturally appropriate and translated awareness campaigns targeted to this population. Because Hispanics in Tampa and Puerto Rico reported modest levels of perceived risk and severity, and high levels of response efficacy and self-efficacy, interventions aiming to improve skin cancer prevention activities that are anchored in Protection Motivation Theory may be particularly effective in this population subgroup. | PMC10644628 |
Keywords | PMC10644628 |
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Background | melanoma, SCC, basal cell carcinoma, skin cancer, skin cancer-related psychosocial variables | MELANOMA, BCC, SKIN CANCER, OF SKIN CANCER, SQUAMOUS CELL CARCINOMA, BASAL CELL CARCINOMAS | Incidence rates of skin cancer, including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma, have risen among U.S. Hispanics over the past several decades [The major environmental risk factor common to melanoma, SCC, and BCC is exposure to ultraviolet radiation [One of the strongest predictors of acculturation among US Hispanics is language preference [We conducted a prevention intervention trial among Hispanics from Tampa, Florida and Ponce, Puerto Rico to determine whether receipt of skin cancer prevention information anchored in In this report, we present baseline measures of sun-related primary prevention behaviors and skin cancer-related psychosocial variables, including those measuring Protection Motivation Theory constructs. We sought to characterize the pre-intervention levels of primary prevention behavior to better understand the potential of the population to adopt preventive behaviors recommended by the intervention. Because acculturation is associated with skin cancer knowledge, beliefs, behaviors, distress, and worry, we also assessed differences in sun-related behavior and psychosocial variables across groups defined by language preference and geographic location. | PMC10644628 |
Methods | PMC10644628 |
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Participants | HD, Damas, melanoma | BCC, MELANOMA | Full details and efficacy results of the intervention trial have been published (Lacson et al., 2022). Briefly, we recruited participants from eight primary care clinics in Tampa, FL (hereafter referred to as Tampeños), and Ponce, Juana Díaz, and Salinas, PR (Puerto Ricans) between September 2018 and January 2020. Participants were self-identified Hispanics at least 18 years old in Tampa and at least 21 years old in Puerto Rico, which are the respective ages of majority. We excluded individuals who had a skin examination within the past year, a previous diagnosis of melanoma, and more than one previous diagnosis of BCC and/or SCC.All participants gave written informed consent. The study was conducted based on the Declaration of Helsinki and was approved by the Institutional Review Boards of the University of South Florida (Tampa, FL; Pro00020044, approved August 30, 2018), Ponce Health Sciences University (Ponce, PR; 170,807-BS, approved December 6, 2017) and the Comité de Seguimiento de la Investigación Clínica at Hospital Damas (HD 19 − 17, approved December 18, 2017). | PMC10644628 |
Study questionnaires | cancers, ’s cancer worry, melanoma, cancer, skin cancer | CANCER, CANCERS, SKIN CANCER, MELANOMA | The baseline questionnaire (A) was completed using tablet computers while participants were in clinic, or a paper copy and prepaid envelope were given to participants who preferred to complete it at home. Baseline questionnaire A solicited information on age, sex, marital status, educational level, family history of melanoma, skin cancer, and other cancers, paid/unpaid work outdoors, health literacy [Baseline questionnaire A also assessed several psychosocial variables, using questions adapted from Hay & colleagues [Other psychosocial variables included a 3-item skin cancer adaptation of Lerman’s cancer worry scale (range 1–5) [A supplemental baseline questionnaire (B) was provided for participants to complete in the clinic, at home, or online. Participants were provided with a postage prepaid return envelope. Baseline questionnaire B included questions on phenotypic traits including hair color, eye color, freckling, burnability after acute sun exposure, and ability to tan after chronic sun exposure. It also collected information on cancer fatalism, measured using the 15-item Powe Fatalism Inventory (range 0–14) [Participants had two weeks to return both baseline questionnaires A & B. If either questionnaire was not received within one week, participants were sent an email reminder. After two weeks, a second reminder and an additional copy of the unreturned questionnaire (A and/or B) were mailed to the participant. The third and last reminder was by phone or email. | PMC10644628 |
Statistical analyses | sunburned, ’s cancer worry, melanoma, sunburn, sunburns, skin cancer | REGRESSION, SKIN CANCER, MELANOMA | All participants who completed baseline questionnaire were included in these analyses, regardless of whether they contributed further to the intervention study. Differences in baseline participant characteristics across groups defined by geography and language (English-preferring Tampeños, Spanish-preferring Tampeños, and Spanish-preferring Puerto Ricans) were tested using Kruskal-Wallis, ANOVA, or chi-squared tests. Participant characteristics with a statistically significant global difference (For sun-related behaviors and psychosocial variables, univariate differences across the three groups were also tested using Kruskal-Wallis, ANOVA, or chi-square tests. We examined differences in weekday and weekend sun exposure, frequency of outdoor intentional tanning, Lerman’s cancer worry scale, recent worry about skin cancer, recent concern about skin cancer, perceived risk of getting skin cancer, recent distress about skin cancer, response efficacy, self-efficacy, perceived severity, fatalism and familism. The frequencies of sun protection behaviors were examined individually as binary dependent variables (often or always vs. sometimes, rarely, or never), while absolute chance of getting skin cancer was treated as a nominal multinomial variable. Ever having a sunburn was examined as a binary dependent variable, and we assessed number of sunburns among those ever sunburned as a continuous dependent variable. We also tested the difference in the total number of sun protection behaviors practiced often or always in the past year (range 0–5).To estimate the multivariable-adjusted population predicted marginal mean or proportion for dependent variables, and for multivariable modeling of differences across the three groups, we used linear regression for ordinal variables (weekday and weekend sun exposure, number of sunburns, frequency of outdoor intentional tanning, total number of sun protection behaviors, Lerman’s cancer worry scale, recent worry about skin cancer, recent concern about skin cancer, comparative chance of getting skin cancer, recent distress about skin cancer, response efficacy, self-efficacy, perceived severity, fatalism, familism, and sun protection behaviors; all of which were assumed to have a normal distribution), logistic regression for binary variables (frequencies of the five sun protection behaviors), and multinomial logistic regression for multinomial variables (absolute chance of getting melanoma). Pairwise comparisons were adjusted for multiple hypotheses testing using Tukey’s studentized range method. Due to the inclusion of baseline questionnaire B variables in the model, these analyses were limited to participants who answered both baseline questionnaires.All analyses were conducted using R software (ver 4.1.0, R Foundation for Statistical Computing, Vienna, Austria, RRID:SCR_001905), RStudio (ver 1.4.1717, RStudio Team, Boston, MA, RRID:SCR_000432), and SAS (ver. 9.4., Statistical Analysis System, RRID:SCR_008567). | PMC10644628 |
Results | SD | Of 974 participants who consented to the study, 944 (96.9%) completed baseline questionnaire A, including 497 Tampeños (121 Spanish-preferring and 376 English-preferring) and 447 Puerto Ricans (440 Spanish-preferring and 7 English-preferring). Of these, 795 (84.2%) completed supplemental questionnaire B. Overall, the mean age of participants was 45.7 years (SD = 15.7), and a majority (70.4%) were female (Table Participant characteristics by location and language preference
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Behaviors, beliefs, distress, and worry in the overall study population | intentional tanning, sunburned, sunburn, sunburns, SD, skin cancer worry, skin cancer | SKIN CANCER, OF SKIN CANCER | Participants reported an average of 1.70 h/day (SD = 1.62) of weekday sun exposure, 2.02 h/day (SD = 1.62) of weekend sun exposure, and rare outdoor intentional tanning (M = 1.65, SD = 0.87) over the past year. Nearly a third of participants (29.7%) reported ever having a sunburn in the past 12 months, with an average of 1.71 sunburns (SD = 1.01) among those ever sunburned. Only 2.3% of participants reported indoor tanning in the past year. Wearing of sleeved shirts was practiced often or always by a majority (61.2%) of participants, nearly half (47.9%) wore sunglasses, and 40.8% sought shade or used an umbrella; less than a quarter of participants wore a hat (17.4%) or used sunscreen (22.6%) often or always. The average total number of the five sun protection behaviors practiced often or always over the past year was 1.91 (SD = 1.27).Participants had a low average skin cancer worry (M = 1.99, SD = 0.83, Table 1). One-fifth (20.8%) of participants reported recently worrying about skin cancer sometimes to all the time, while a quarter (26.8%) reported recently being a bit to very concerned. About a third (31.8%) of participants reported being likely to get skin cancer, and 11.2% believed their chances of getting skin cancer to be above or well above the average. There was a modest level of perceived severity (M = 2.48, SD = 0.40) of skin cancer, and high levels of response efficacy (M = 3.32, SD = 0.71) and self-efficacy (M = 3.40, SD = 0.59). Participants had low mean levels of recent distress about skin cancer (M = 7.50, SD = 12.0). | PMC10644628 |
Comparison of behaviors, beliefs, distress, and worry across groups defined by geographic location and language preference | cancers, skin cancer | CANCERS, SKIN CANCER | Crude differences in behaviors, beliefs, distress, and worry across Spanish-preferring Tampeños, English-preferring Tampeños, Spanish-preferring Puerto Ricans, and English-preferring Puerto Ricans are presented in Table After adjustment for age, sex, marital status, education, race, ethnic identity, family history of other cancers, health literacy, health numeracy, hair color, freckling, and burnability after sun exposure, there was a statistically significant global difference across the three groups for weekday sun exposure (
Box plots, stratified by language preference and geographic location, show the raw distribution of weekday (For psychosocial measures and after adjustment, there were statistically significant global differences across the three groups for recent worry about skin cancer (
Box plots, stratified by language preference and geographic location, show the raw distribution of recent worry about skin cancer (There also was a statistically significant global difference in absolute chance of getting skin cancer across the three groups ( | PMC10644628 |
Discussion | sunburned, sunburn, sunburns, indoor intentional tanning, skin cancer, low skin cancer worry | STRUCK, SKIN CANCER | We found low to modest baseline levels of weekday and weekend sun exposure and outdoor and indoor intentional tanning among our Hispanic participants. However, about 30% of our participants reported having a sunburn in the past 12 months, with an average of almost two sunburns among those ever sunburned; and most participants in our study did not practice sun protection behaviors often or always, with an average of only two out of five sun protection behaviors being practiced often or always.Overall, our results reflect previous literature demonstrating high rates of experiencing sunburns among Hispanics, and low prevalence of routine sun protection behaviors. Compared to a report on sunburns among Hispanics who completed the 2015 National Health Interview Survey, our study population had a similar proportion of individuals who had a sunburn in the past year [English-preferring Tampeños had the lowest weekday sun exposure, and the highest frequencies of wearing sunglasses, sunscreen, and sleeved shirts. However, they also had the highest weekend sun exposure, highest frequency of outdoor intentional tanning, and the highest proportion who were ever sunburned in the past year. It is unlikely that daytime outdoor work accounts for the observed difference in lower weekday sun exposure since similar proportions of English-preferring Tampeños (35.1%), Spanish-preferring Tampeños (38%), and Puerto Ricans (38%) reported such work. These percentages are similar to the percentage of the US Hispanic workforce (35.0%) that are employed in building and grounds cleaning and maintenance, farming, construction, installation, and maintenance occupations [Hispanic participants in our study reported low skin cancer worry, recent worry, recent concern, and recent distress about skin cancer, high levels of response efficacy and self-efficacy, and a plurality reported being unlikely to get skin cancer or having below or well below average comparative risk. Yet, participants also reported modest levels of perceived severity. Two previous studies examined these psychosocial variables among U.S. Hispanics [Compared to both English- and Spanish-preferring Tampeños, Spanish-preferring Puerto Ricans had the highest recent concern about skin cancer, comparative chance of getting skin cancer, and response efficacy, and, non-significantly, the highest recent worry about skin cancer. These results are similar to previous study among U.S. Hispanics, comprised of mostly Mexicans from California and Texas, that found Spanish-acculturated Hispanics had higher perceived risk and worry compared to English-acculturated Hispanics [Because Hispanic men and individuals with low education, health literacy and health numeracy were underrepresented in our study, our findings may have limited generalizability to these groups. Similarly, our findings are likely to be most relevant to Hispanics reporting a Puerto Rican identity. It also is important to appreciate temporal trends that may have influenced reported measures obtained from participants living in Ponce, Juana Díaz, and Salinas, where Hurricane Irma and Maria struck in September 2017, which likely affected typical sun-related activities and prevention behaviors reported over the 1-year ‘think back’ timeframe anchoring our baseline questions. | PMC10644628 |
Conclusions | skin cancer, sunburn | SKIN CANCER | Although Hispanics in Florida and Puerto Rico have low levels of risky sun-related behavior, they also have suboptimal levels of sun-protective behavior and had a high occurrence of sunburn in the past year. Thus, we recommend culturally appropriate Spanish-language awareness campaigns about skin cancer risk targeted at this population. Because sun-protective behaviors were particularly low among English-preferring Tampeños, educational materials in both Spanish language and English language may optimize uptake of prevention messages. Hispanics in Florida and Puerto Rico also reported modest levels of perceived risk and severity, and high levels of response efficacy and self-efficacy, making them an ideal target for an intervention anchored in Protection Motivation Theory. We also found other differences in sun-related behavior and psychosocial variables by location and language preference that may inform future interventions and prevention initiatives. | PMC10644628 |
Acknowledgements | We thank the patients at the USF Morsani Family Medicine and General Internal Medicine Clinics, the Suncoast Community Health Centers of Brandon and Palm River, Hospital Damas, Ponce Health Sciences University Wellness Center, Juana Díaz Wellness Center, and Centro Médico Salinas for their interest in our study, and the physicians and clinical staff of these clinics for their support of our research efforts. | PMC10644628 |
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Authors' contributions | Conceptualization, P.A.K.; data curation, J.C.A.L., S.H.D.; formal analysis, J.C.A.L., S.H.D., P.A.K.; funding acquisition, B.S.T., P.A.K.; investigation, S.T.V.; methodology, J.C.A.L., Y.K., S.K.S., P.A.K.; supervision, R.R., S.T.V., B.S.T., P.A.K.; validation, J.C.A.L.; visualization, J.C.A.L.; writing—original draft preparation, J.C.A.L., B.S.T., P.A.K.; writing—review and editing, all authors. All authors have read and agreed to the published version of the manuscript. | PMC10644628 |
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Funding | Cancer | CANCER | This work was supported by the National Cancer Institute Ponce Health Sciences University-Moffitt Cancer Center Partnership (U54 CA163071 and U54 CA163068). This work also was supported, in part, by the Tissue, Molecular Genomics, and Biostatistics and Bioinformatics Shared Resources at the H. Lee Moffitt Cancer Center & Research Institute, a National Cancer Institute-designated Comprehensive Cancer Center (P30 CA076292).The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. | PMC10644628 |
Availability of data and materials | Data used in this manuscript can be obtained upon request from the corresponding author. | PMC10644628 |
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Declarations | PMC10644628 |
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Ethics approval and consent to participate | Damas | All participants gave written informed consent. The study was conducted based on the Declaration of Helsinki and was approved by the Institutional Review Boards of the University of South Florida (Tampa, FL; Pro00020044, approved August 30, 2018), Ponce Health Sciences University (Ponce, PR; 170807-BS, approved December 6, 2017) and the Comité de Seguimiento de la Investigación Clínica at Hospital Damas (HD 19-17, approved December 18, 2017). | PMC10644628 |
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Consent for publication | Not applicable. | PMC10644628 |
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Competing interests | The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. | PMC10644628 |
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References | PMC10644628 |
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Subject terms | Sjogren’s Syndrome, pSS | The purpose of this trial was to clinically assess the effect and safety of Adipose Tissue-derived Stem Cells (ADSCs) treatment on primary Sjogren’s Syndrome (pSS). In this 6-month randomized, triple-blind, placebo-controlled clinical trial, pSS patients were randomly assigned to two groups. After demographic characteristics and clinical examination were achieved, local injection of ADSCs into bilateral glands was performed with patients in ADSCs group (n = 35) and placebo solution was used for another group (n = 39) at three time points. Patients were followed up at 1-, 3- and 6-month. At each visit, studies of clinical and laboratory outcomes, as well as subjective symptoms, were conducted. A total of 74 subjects who met the including criteria were allocated in two groups and eventually 64 subjects (86.5%) completed the treatments and the follow-up assessments. Secretion of salivary and lachrymal glands were significantly improved in 3-month ( | PMC10439962 |
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Introduction | SS, pSS, autoimmune chronic disease, Sjogren’s syndrome, dryness of mouth, exocrine glandular dysfunction | INFILTRATION, AUTOIMMUNE DISEASE | Sjogren’s syndrome (SS) is a systemic autoimmune chronic disease characterized by marked exocrine glandular dysfunction such as salivary and lachrymal glands, presenting a persistent dryness of mouth and eyespSS has a very heterogeneous clinical presentations and the etiology has not been fully elucidated. Infiltration of a large number of lymphocytes and expression of various cytokines in the exocrine glands were detected in animal modelsIn recent decades, a wide range of animal and clinic-based methods have emerged as novel therapeutic methods, with evidence showing that the transplantation of ADSCs may benefit in treating autoimmune diseaseAccording to our literature research, although many in vitro and in vivo studies have investigated the effects of ADSCs on exocrine gland function and autoimmune disease, to date, the effectiveness of ADSCs for patients with pSS in a clinical setting remains inadequate and inconclusive. With this background, the main objective of this trial is to evaluate the safety and potential efficacy of ADSCs on pSS patients, by assessing subjective symptoms, clinical and laboratory outcomes. | PMC10439962 |
Methods | PMC10439962 |
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Ethical statement | This trial was conducted in full accordance with the 2010 CONSORT guidelines of the World Medical Association Declaration of Helsinki. The study protocol was approved by the Ethic Committee of the the Affiliated Huai'an Hospital of Xuzhou Medical University (institutional approval number: HEYLL2020325). It was registered at Chinese Clinical Trial Registry (Registration umber: ChiCTR2000033420, | PMC10439962 |
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Participants | sarcoidosis, pSS, ’s Syndrome, amyloidosis, glaucoma, head and neck radiation, Systemic lupus erythematosus | SARCOIDOSIS, POSITIVE, ACQUIRED IMMUNODEFICIENCY SYNDROME, GRAFT VERSUS HOST DISEASE, DISEASE, LYMPHOCYTIC INFILTRATION, HEPATITIS C INFECTION, SYNDROMES, AMYLOIDOSIS, GLAUCOMA, IGG4-RELATED DISEASE, RHEUMATOID ARTHRITIS, SYSTEMIC LUPUS ERYTHEMATOSUS | Patients were consecutively recruited referred to Department of Rheumatology, Stomatology and Ophthalmology, Affiliated Huai'an Hospital of Xuzhou Medical University. Eligible patients were diagnosed as having pSS according to the American College of Rheumatology (ACR) Diagnostic Criteria for Sjögren’s Syndrome. At least two syndromes with following three objective features will meet the criteria: (1)patients are newly diagnosed with pSS and have not received previous treatments; (2) Positive serum anti-SSA (Ro) and/or anti-SSB (La); (3) Labial salivary gland biopsy exhibiting focal lymphocytic infiltration with a focus score ≥ 1 focus/4 mmThe exclusion criteria for all patients were: (1) not currently using daily eye drops for glaucoma, and has not had corneal surgery or cosmetic eyelid surgery in the last 5 years; (2) any of the following conditions: history of head and neck radiation treatment, hepatitis C infection, acquired immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4-related disease; (3) other systemic conditions that could affect the progression of pSS, such as Systemic lupus erythematosus and Rheumatoid arthritis; (4) a history disease of chronic obstructive sialadenitis disease; (5) status of pregnancy or lactation.Patients were interviewed to provide of informations including their socio-demographic characteristics, life-style factors, compliance to drugs and self-care knowledge at study entry. Clinical assessments of disease activity were also performed at the first screening. | PMC10439962 |
Randomization and masking | Patients were assigned to two groups via a computer-generated randomization schedule. The ADSCs Group was injected with ADSCs while Placebo Group was received 0.9% saline solution administration. Concealed allocated codes were kept in signed and sealed envelopes. An external investigator performed the randomization. Investigators, patients and investigators were masked to group assignment. Blinding was revealed after the treatments were performed and the data were analysed. | PMC10439962 |
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Sample size analysis | Sample size analysis using G Power version3.1.9.2 was determined with Walters’s method by considering two groups of subjects, an effect size of 0.30 and a standard deviation of 1.7 by a previous randomized controlled clinical study. With an assumption of normal sample distribution, we set power of 0.8 and an error of | PMC10439962 |
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The preparation of ADSCs | The drug in this trial was a solution of ADSCs. Adipose tissues were harvested with liposuction of abdomen from a healthy donor. They are washed in phosphate-buffered saline (PBS) and digested of fat aspirates with 0.075% collagenase. These stem cells were then packed in dimethyl sulfoxide and human platelet lysate and 1% antibiotics at a culture condition of 37 °C and 5% CO | PMC10439962 |
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Procedures | STERILE | The final therapeutic drug solution was composed of 5 million cells per milliliter of solution. After disinfecting the surface projection of bilateral parotid glands with Iodophor and draping in a sterile fashion, the injection site was anesthetized with 1% lidocaine. A dose of 1 ml ADSCs solution was diluted in 5 ml 0.9% saline solution. The final stem cell solution was injected into bilateral glands with 0.05 ml ADSCs and saline mixed-solution (5 × 10 | PMC10439962 |
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Outcome measures | PMC10439962 |
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Sialometry | STERILE | Patients were asked to attend at 8:00–10:00 am in the same room with constant temperature and humidity to minimize diurnal variation. Eating/chewing, drinking and brushing teeth were refrained 90 min prior to each appointment. After resting for 10 min, unstimulated whole saliva (UWS) was collected by a sterile and pre-weighed plastic container every 30 s for a 5 min period. Stimulated whole saliva (SWS) was collected by asking patients to chew a piece of sterilized silicone rubber tubing (4*8 mm) and to spit all the saliva into another container as the same frequency and period of UWS. UWS and SWS were determined by the result of reweighting each container after collection subtracting the weight of empty container | PMC10439962 |
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Schirmer I test | We introduced the Schirmer I test to measure lacrimal flow (LF) without previous topical anesthetic to measure the tear secretion. A Whatman special filter paper strip of 20 mm*5 mm (Cytiva®, Shanghai, China) were placed in the lateral 1/3 of the lower bilateral eyelid. The length of the moistened portion of the strip was measured at the fifth minute | PMC10439962 |
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ESSDAI and ESSPRI | ’s Syndrome Disease Activity, dryness, fatigue, pain | DISEASE, DISEASE, RHEUMATISM | Disease activity was assessed using and European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ESSDAI). These questionnaires were filled out by the patients at baseline and the follow-ups. The ESSDAI includes 12 domains, including cutaneous, respiratory, kidney, articular, muscular, peripheral nervous system, central nervous system, hematological, glandular, constitutional, lymphadenopathic, and immunological, with a total score ranging from 0–3 points.European Alliance of Associations for Rheumatology SS Patient Reported Index (ESSPRI) is a patient-administered questionnaire to assess disease symptoms on a 10-point scale for pain, fatigue and dryness. The patients were required to show the maximal scale they had experienced during the last 3 days on the VAS ruler. The scores on the ruler were at least 10 cm with 10 visual analogue scales, indicating dryness, pain, and fatigue. | PMC10439962 |
Immunological indexes | ’ venous blood samples | Patients’ venous blood samples were drawn at 6:00–8:00 am prior to administration of ADSCs injection and at each follow-up. Serum samples were transported at − 20 °C and kept at − 80 °C in a freezer until analysis. Immunological indexes, including IgA, IgG, IgM, complement 3 (C3), complement 4 (C4) and erythrocyte sedimentation rate (ESR), were analyzed using a flow cytometer (Beckman Coulter®, Fullerton, CA). | PMC10439962 |
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Safety assessments | ADVERSE EVENTS | To evaluate safety and toxic effects, clinical laboratory values, vital sign, physical examination and 12-lead electrocardiography were recorded at baseline and follow-ups. A treatment-emergent adverse events (AE) was defined as any untoward symptom, occurred from the first dose of medication until the end of the study. Those were possibly, probably or definitely related to the study medication in the judgment of the investigator. | PMC10439962 |
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Statistical analysis | In this study, data were statistically analyzed using SPSS v20.0 software (IBM Corp, Armonk, NY, USA) and visualized using GraphPad Prism 7 (GraphPad Software Inc., La Jolla, CA, USA). The demographic and health status information at baseline was summarized using Means (Standard Deviation, SD) for continuous variables and Frequencies (Percentages) for categorical variables. Data were first examined for normality by the Kolmogorov–Smirnov test and, the data that achieved normality were analyzed using parametric methods while the others used non-parametric methods. Differences in continuous variables between groups were tested by t-test or MannWhitney U test, while differences in categorical variables were tested by Chi-squared tests or Fisher’s exact tests. In our trial, Unpaired t-test was applied to test UWS, SWS, LF, ESSDAI and ESSPRI, immunological indexes to determine significant difference between baseline and follow-up. Paired t-test was used to analyze significant differences of intergroup at each data point. All reported p-values were from two-side tests and compared with a significance level of 0.05 ( | PMC10439962 |
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Discussion | pSS, itching sensation | ADVERSE EVENTS, PATHOGENESIS, SYSTEMIC LUPUS ERYTHEMATOSUS, OTHER AUTOIMMUNE DISEASE | This is a triple-blinded clinical trial aiming at the effect of ADSCs treatment on pSS patients. In general, the results of our study indicate that ADSCs improved the symptoms in to a certain extend objectively and subjectively. The dysfunction of salivary and lachrymal glands was significantly improved in a short period. The level of immunological and inflammatory indexes was reduced after ADSCs treatment. Previous studies found that transplantation of ADSCs could significantly inhibit autoimmune progression in MRL/lpr mice by injecting with ADSCs via the tail veinAlthough the past few years have led to much greater knowledge of the features of patients with pSS, in contrast with other autoimmune diseases such as systemic lupus erythematosus, there is little diagnostic information on clinical pSSBecause the pathogenesis of pSS is not fully elucidated and has a very heterogeneous course, which made the treatments challenging in the pastRecently, the positive effect of ADSCs therapy has been suggested in autonomous immunity diseasesNotably, the origin of ADSCs contributes to the properties of it, such as downstream application. Thus, a standardized protocol for clinical utility will be helpful. A controlled trial by Vangsness et al. introduced a dose of 3 million cells for an individual for an injection to the knee following partial medial meniscectomy and showed an improvement of recoveryAnother finding from our trial is that there were no other adverse events except for two patients with itching sensation in the skin lasting no more than 2 h. A possible reason may be the method used for ADSCs expansion and culture in our study. Unlike in other studies, we used human platelet lysate as the culture media that may have the advantage of diminishing the immune reaction of animal-derived factors. Until recently, fetal bovine serum (FBS) was the supplement of choice for growing MSCs. However, there were some concerns that an immune response could be triggered in the host for FBS as being xenogeneic. Abundant growth factors and cytokines in platelets are vital for the growth of any animal cell including stem cells. Additionally, ADSCs are found in numerous human tissues, which could be accessed and obtained easily on the superficial layers of the skin. These make the ADSCs therapy is a promising method in pSS.Many studies have been conducted to explore the unclear pathogenesis of pSS. Various cells and cytokines such as B cells and T cells are involved in pSSIn order to evaluate the efficacy more comprehensively, we chose both ESSDAI and ESSDAI as the index of subjective symptoms and systemic characteristics that showing to be valid and sensitive measuresA strength of this trial is the use of very strict inclusion criteria and defining activity levels that are crucial for clinical trial design in pSS. The availability of repeated clinical and laboratory assessment over a long follow-up period made it possible to detect the changes of the treatment outcome.However, there are some limitations to the present trial that need to be addressed. The sample size limited the precision of detection some potential significant differences that we hypothesized to detect prior to the trial. Moreover, further analysis of the ADSCs could be conducted such as assessing the immunomodulatory properties, examining whether cells are present at the injection site and monitoring changes in growth factors or cytokines secreted by MSCs. Further limitation is that the dosage and interval of ADSCs administration have not been thoroughly compared. | PMC10439962 |
Author contributions | F.L. designed the trial, analyzed the clinical data and wrote the manuscript as first author. J.L., X.S., D.L., T.Z. contributed to clinical therapy and follow-up evaluation. T.J. analyzed the clinical data, S.W. analyzed the clinical data, edited and reviewed the manuscript. | PMC10439962 |
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Competing interests | The authors declare no competing interests. | PMC10439962 |
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References | PMC10439962 |
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Materials and methods | MAY | We conducted a cluster randomized controlled trial in 45 administrative Locations (clusters) in Nyanza Region between May 2014 and June 2016 among uncircumcised men aged 25–34 years. In arm one, an IPC toolkit was used to address barriers to VMMC. In the second arm, men were referred to DSO that were modified to address their preferences. Arm three combined the IPC and DSO arms, and arm four was standard of care (SOC). Randomization was done at Location level (11–12 per arm). The primary outcome was the proportion of enrolled men who received VMMC within three months. Generalized estimating equations were used to evaluate the effect of interventions on the outcome. | PMC9897540 |
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Results | At baseline, 9,238 households with men aged 25–39 years were enumerated, 9,679 men were assessed, and 2,792 (28.8%) were eligible. For enrollment, 577 enrolled in the IPC arm, 825 in DSO, 723 in combined IPC + DSO, and 667 in SOC. VMMC uptake among men in the SOC arm was 3.2%. In IPC, DSO, and combined IPC + DSO arms, uptake was 3.3%, 4.5%, and 4.4%, respectively. The adjusted odds ratio (aOR) of VMMC uptake in the study arms compared to SOC were IPC aOR = 1.03; 95% CI: 0.50–2.13, DSO aOR = 1.31; 95% CI: 0.67–2.57, and IPC + DSO combined aOR = 1.31, 95% CI: 0.65–2.67. | PMC9897540 |
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Discussion | Using these interventions among men aged 25–39 years did not significantly impact VMMC uptake. These findings suggest that alternative demand creation strategies for VMMC services are needed to reach men aged 25–39 years. | PMC9897540 |
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Trial registration | clinicaltrials.gov identifier: | PMC9897540 |
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Data Availability | All relevant data are within the paper and its | PMC9897540 |
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Introduction | infections | INFECTIONS | Male circumcision (MC) has been demonstrated to reduce female-to-male transmission of HIV by approximately 60% in randomized controlled trials [Kenya’s Ministry of Health began implementing voluntary medical male circumcision (VMMC) for HIV prevention services in 2008, with a four-year goal of increasing the proportion of circumcised men aged 15–49 years to 94%, which was estimated to be 860,000 males nationwide, and the goal for Nyanza Province was to increase circumcision coverage from 46.4% to 80% [Studies have demonstrated that to maximize the immediacy of VMMC’s impact on HIV incidence, VMMC must be provided to HIV-negative males in the age groups where most new infections are likely to occur [In response to barriers of VMMC uptake identified by older men, we designed a cluster randomized trial to determine the effect of two interventions aimed at increasing VMMC uptake among men aged 25–39 years ( | PMC9897540 |
Intervention groups | pain | COMPLICATIONS | Those residing in the intervention clusters (IPC, DSO, and combined IPC + DSO) were reached with the respective intervention within two weeks of study enrollment. For the IPC arm, we developed a toolkit consisting of common barriers and facilitators related to VMMC based on a literature review and from TASCO’s formative data on VMMC uptake in Nyanza Region. The toolkit was used to facilitate one-on-one discussions between RAs and uncircumcised men, which permitted the RAs to respond to and address personal concerns about circumcision communicated by uncircumcised men. The topics covered in the IPC toolkit included accurate information about pain during and after VMMC surgery, likelihood of complications, dealing with recommended sexual abstinence post-surgery, etc. In the DSO arm, the physical layout of included VMMC sites was modified to accommodate older men’s preferences. The DSO arm was based on literature from sub-Saharan African countries implementing VMMC that suggested that older men seeking VMMC services preferred separate waiting areas at clinics, male-only service providers, shorter waiting times, and flexible service delivery hours. Thus, the study services provided in DSO locations included male-only providers, separate waiting areas, private access to the theater in some facilities, and flexible hours for selected facilities, (e.g., two weekends a month or two evenings a week to serve only men ≥ 25 years of age). RAs went to the homes of eligible men in the Locations randomized to the DSO arm and referred them to these DSO sites. In the combined IPC + DSO arm, we used the toolkit to address men’s reasons for not going for circumcision and referred them to DSO sites. In the routine standard of care arm, routine demand creation activities under the VMMC program continued [ | PMC9897540 |
Statistical methods | PMC9897540 |
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Sample size calculation | A previous demand creation and HIV community-based study found that circumcision prevalence among men aged 25–49 years in sub-Locations included in our study area was 35.6% [ | PMC9897540 |
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Statistical analyses | We summarized baseline characteristics at individual level stratified by study arm. Categorical variables were summarized using counts and proportions with Rao-Scott Chi-square [ | PMC9897540 |
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Results | MAY | Between May 2014 and June 2016, 9,238 households with men aged 25–39 years were enumerated, from which 9,679 men were screened and 2,792 (28.8%) enrolled in the study. The main reasons for men not enrolling included already being circumcised (41.3%), planning to move away from the study area (18.4%), ineligibility due to age (9.3%), not found after four household visits (9.2%), and ineligibility due to residence (4.1%). In addition, 764 participants (11.1%) were eligible but refused to participate. Among the 2,792 uncircumcised men who were eligible and enrolled, 577 were in the IPC arm, 825 in DSO arm, and 723 in the combined IPC + DSO arm and 667 in the standard of care Locations ( | PMC9897540 |
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Participant screening, enrollment, and follow-up. | *Clinicaltrials.gov incorrectly lists the number of participants “actually enrolled” as 2,785, which is incorrect, as 2,792 participants were enrolled into the study.In all arms at baseline, most uncircumcised men were married, Christian, had completed up to primary level education, and employed. Baseline socio-demographic characteristics of uncircumcised men are presented by study arm in | PMC9897540 |
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Baseline socio-demographic characteristics of uncircumcised men by study arm. | The proportion of VMMC uptake documented at the service delivery sites or via home visits among enrolled men aged 25–39 years within 3 months of enrollment in the standard of care arm was 3.2%. In the IPC, DSO, and the combined IPC + DSO arms, VMMC uptake was 3.3%, 4.5%, and 4.4%, respectively. There were no significant differences in odds of VMMC uptake across the intervention arms when compared to the standard of care arm. The adjusted odds ratio (aOR) and their corresponding 95% confidence intervals (95% CI) were: IPC aOR = 1.03, 95% CI: 0.50–2.13); DSO aOR = 1.31, 95% CI: 0.67–2.57; and IPC + DSO combined aOR = 1.31, 95% CI: 0.65–2.67 ( | PMC9897540 |
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Analysis of the effects of the interventions on uptake of VMMC three months after enrollment. | *Adjusted for baseline factors: age, marital status, religion, education and employment.** Men who underwent VMMC who were verified to have enrolled in the study via referral coupon, names, national identification, and/or phone number | PMC9897540 |
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Discussion | This cluster randomized trial did not provide sufficient evidence that targeted demand creation strategies for men aged 25–39 years were effective at significantly increasing the odds of VMMC uptake among men aged 25–39 years in the Nyanza Region of western Kenya. Overall VMMC uptake across each of the four study arms ranged from 3.2%– 4.5%. It is likely that the DSO and IPC + DSO arms had some effect, but the smaller than expected sample size prevented the detection of these effects. Based on the original sample size calculations, we estimated that 1,480 men in intervention arms and 370 in the standard of care arm would be needed to provide 80% power to detect any intervention effect. Only 109 men of the expected 1,850 men underwent VMMC. Due to higher VMMC prevalence than anticipated in study Locations, only 2,792 participants were enrolled for the study, as many men were circumcised and therefore ineligible (n = 2,847). Logistical challenges and funding limitations prevented the study team from expanding the study scope to increase the number of enrolled participants and study power.While mathematical modeling has suggested that circumcising men aged 20–34 years in several VMMC priority countries in sub-Saharan Africa would result in a more immediate reduction in HIV incidence [VMMC has been successful in Kenya in the non-traditionally circumcising communities in the former Nyanza Province with over 1.1 million males circumcised by 2016, which represents 132% of the initial target set in 2011 [Kenya is also a leader in the scale-up of VMMC for HIV prevention, as Kenya’s Ministry of Health first launched VMMC services in 2008 following development of the National Guidance on Male Circumcision and Kenya National Strategy for Voluntary Medical Male Circumcision [The low uptake of VMMC across all study arms suggests that men aged 25–39 years were likely not adequately encouraged to pursue VMMC. One recent study about post-operative follow-up in former Nyanza Province found that 98.8% of VMMC clients who returned for post-operative follow-up lived within 5km of a VMMC site, and men living farther than 5km were significantly less likely to attend VMMC post-operative follow-up visits [Another VMMC demand creation trial took place in Nyanza Region for uncircumcised men aged 25–49 years offered food vouchers of varying amounts conditional on getting circumcised [Our trial had several limitations. Firstly, two of the intervention arms showed some increased VMMC uptake, but the low sample size did not allow us to detect these effects, thus potentially large effects cannot be ruled out. Secondly, the short time of the observation (three months) may have limited the period for men, the majority of whom were employed hence needed permission to be away, to become circumcised in each of the study arms. Thirdly, some men who received circumcision may have been in the study, but RAs were unable to verify their enrollment or to find them at home to document circumcision status. And finally, participants in all four study arms received a text message reminder about VMMC, so the differential impact of this component is unknown.In conclusion, our study showed that due to low service uptake across all study arms, enhanced interpersonal communication and modified facilities did not significantly increase VMMC uptake among men aged 25–39 years in Nyanza Region, Kenya. Additional demand creation strategies need to be designed and evaluated to determine how best to encourage older men to seek VMMC for HIV prevention, especially in settings with mature VMMC programs. HIV prevention programs should explore whether men aged 20–39 years in Nyanza Region are not interested in VMMC regardless of the intervention types, and if males aged 10–19 years should be the focus of the limited HIV prevention resources. | PMC9897540 |
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Supporting information | PMC9897540 |
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CONSORT 2010 checklist of information to include when reporting a cluster randomised trial. | (DOCX)Click here for additional data file. | PMC9897540 |
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TASCO locations by randomization into the 4 study arms. | This map was generated by the implementing partner, IRDO, and was previously published in another manuscript related to this study: (DOC)Click here for additional data file.(DOCX)Click here for additional data file.The authors wish to thank the study participants for giving their time to take part in this study. And we would like to thank the staff at IRDO for ensuring successful implementation of this study. | PMC9897540 |
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References | PMC9897540 |
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Background | non-alcoholic | The use of alcohol-flavored beverages not containing alcohol (hereinafter referred to as non-alcoholic beverages) is recommended to reduce alcohol consumption. However, it is unclear if this reduces excessive drinking. | PMC10544561 |
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Objective | non-alcoholic beverages | To verify whether non-alcoholic beverages impact the alcohol consumption of excessive drinkers. | PMC10544561 |
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Study design | Single-center, open-label, randomized, parallel-group study. | PMC10544561 |
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Methods | non-alcoholic, alcoholism | Participants aged 20 years or older who were not diagnosed with alcoholism, who drank at least four times a week, and whose alcohol consumption on those days was at least 40 g in males and 20 g in females, were recruited. Participants were randomized into the intervention or control group by simple randomization using a random number table. In the intervention group, free non-alcoholic beverages were provided once every 4 weeks for 12 weeks (three times in total), and thereafter, the number of alcoholic and non-alcoholic beverages consumed were recorded for up to 20 weeks. The consumption of alcoholic and non-alcoholic beverages was calculated based on a drinking diary submitted with the previous 4 weeks of data. The primary endpoint was the change from baseline in total alcohol consumption during past 4 weeks at week 12. The participants were not blinded to group allocations. | PMC10544561 |
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Results | Fifty-four participants (43.9%) were allocated to the intervention group and 69 (56.1%) to the control group. None of the participants in the intervention group dropped out, compared to two (1.6%) in the control group. The change in alcohol consumption was − 320.8 g (standard deviation [SD], 283.6) in the intervention group and − 76.9 g (SD, 272.6) in the control group at Week 12, indicating a significant difference ( | PMC10544561 |
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Conclusions | non-alcoholic beverages | Providing non-alcoholic beverages significantly reduced alcohol consumption, an effect that persisted for 8 weeks after the intervention. | PMC10544561 |
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Trial registration | UMIN UMIN000047949. Registered 4 June 2022. | PMC10544561 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12916-023-03085-1. | PMC10544561 |
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Keywords | PMC10544561 |
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Background | non-alcoholic beverages | Excessive alcohol consumption is a global public health issue. In 2020, an estimated 1.34 billion people (1.03 billion males and 310 million females) consumed a harmful amount of alcohol [In Japan, efforts to reduce excessive drinking have been made through Health Japan 21, a program that constitutes Japan’s primary prevention strategy, and the enforcement of the Basic Law on Measures to Prevent Damage to Health Due to Alcohol, but their effects have been insufficient [One strategy that has been discussed is the use of low-alcohol or non-alcoholic beverages [There is currently limited evidence on the effect of non-alcoholic beverages [ | PMC10544561 |
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Methods | PMC10544561 |
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Study design | This was a single-center, open-label, randomized, parallel group study. | PMC10544561 |
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Participants | With reference to preceding studies [ | PMC10544561 |
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Setting | non-alcoholic beverages, alcoholism | MAY | The survey was conducted from May 2022 to January 2023. Participants were recruited from May 30 to July 15, 2022, through the employee website of the University of Tsukuba, by putting up flyers inside and outside the University of Tsukuba campus, and by snowball sampling by the study personnel. The participants were randomly allocated to either the intervention or control group. People who wished to participate in the study were asked to answer an online questionnaire in advance to confirm eligibility and exclusion criteria, as well as to participate in an in-person 2-h briefing held on the University of Tsukuba campus and to provide written consent to participate. Nine briefings were held, and the number of attendees at each meeting was restricted to 15 as a COVID-19 prevention measure. In addition to interviews for alcoholism with physicians, measurement of height and weight and collection of saliva samples, this 2-h face-to-face orientation session prior to randomization included careful explanation about this study. We explained the effect of providing non-alcoholic beverages on alcohol consumption was unknown. We also asked participants in both groups to go about their daily lives as usual, with the exception of keeping a drinking diary. | PMC10544561 |
Intervention | non-alcoholic | During the 12-week intervention period, free non-alcoholic beverages were provided once every 4 weeks (three times in total). Each case included 24 350-mL bottles. Up to three cases were provided at a time, with the exact number depending on each participant’s preference. Participants selected beverages from among 22 products from four manufacturers, specifically the six top-ranked beer-flavored products and the 16 top-ranked cocktail-flavored products according to the sales ranking in the Japanese market in 2021. The selected non-alcoholic beverages were shipped to participants’ homes by a package delivery company. | PMC10544561 |
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Measurement | HED, non-alcoholic, ® | The self-administered questionnaire used in the briefing included questions regarding basic attributes such as age, sex, race, marital status, the highest level of education, employment status, household income, smoking history, and subjective view of health [As genetic information related to alcohol metabolism, the gene activities of alcohol dehydrogenase 1B (The drinking diary was designed in a calendar format, in which the amount of alcoholic and non-alcoholic beverages consumed were to be entered under each date. The drinking diary was provided to the study participants in printed form or in a Microsoft® Excel® file according to their choice, and they were asked to submit it to the study secretariat once every 4 weeks, either in an e-mail attachment or by LINE® (whereby photos of the filled-out diary were attached). For alcoholic beverages, participants were asked to specify the type, alcohol content, and the amount of consumption in order to calculate alcohol consumption, and the number of episodes of heavy episodic drinking (HED) was also counted. HED was defined as the consumption of at least 60 g of pure alcohol on at least one occasion in the past 30 days [ | PMC10544561 |
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Outcome | The primary endpoint was the change in total alcohol consumption from baseline during the past 4 weeks at Week 12 [ | PMC10544561 |
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Sample size | The necessary sample size was calculated based on the effect size of the change in alcohol consumption (Cohen’s | PMC10544561 |
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Randomization and blinding | non-alcoholic, non-alcoholic beverages | A random number table was used to perform simple randomization and to select the number of participants in the intervention group. After the eligibility and exclusion criteria were confirmed and consent was obtained, participants were allocated into either the intervention or control group and notified of the randomization results via e-mail within 2 weeks after the briefing. Allocation was performed by Investigator K, without disclosing the allocation or its order to the other investigators. Because people can choose their preferred non-alcoholic beverages in their everyday lives, and since the dropout rate might be increased if participants were provided with beverages that they did not like, those in the intervention group were not blinded so that they could choose their non-alcoholic beverages. For this reason, no items to facilitate blinding were provided to the control group participants during the study, but instead non-alcoholic beverages were provided after the study period had ended. The drinking diary data were evaluated by Investigators K, S, and O, who were blinded to the allocations of participants in both groups. Investigator D was not involved in briefings, randomization, questionnaire development, or the evaluation of drinking diary data, and therefore was able to perform data analysis in a blinded manner. | PMC10544561 |
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Statistical methods | The available data of all participants were included according to the original allocation in an intention-to-treat analysis. The unsubmitted data of the participants who dropped out were treated as missing data. The normality of the data was evaluated by the Kolmogorov–Smirnov test. Intergroup comparisons of baseline data were performed by As post hoc tests, Dunnett’s test was performed to compare temporal sequences within the same group with reference to Week 4, and Bonferroni’s test was performed to analyze intergroup differences at individual time points. Correlations were evaluated based on Spearman’s rank correlation coefficients. The significance level was 5%. Stata 17.0 for Windows (Stata Corp., College Station, TX, USA) and GraphPad Prism v. 9.0 (GraphPad Inc., La Jolla, CA, USA) were used for all analyses. | PMC10544561 |
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Discussion | non-alcoholic, alcoholism, non-alcoholic beverages consumed, non-alcoholic beverage, alcohol-related problems, non-alcoholic beverages | DISORDER | In this study, the provision of free non-alcoholic beverages for 12 weeks significantly reduced alcohol consumption. In the intervention group, this effect persisted not only during the intervention period but also up to 8 weeks following completion of the 12-week intervention. Our study is the first to suggest that providing non-alcoholic beverages reduces alcohol consumption.At Week 12, alcohol consumption was reduced by an average of 11.5 g per day. On the other hand, the average volume of non-alcoholic beverages consumed per day was 314.3 mL. Correlation analysis showed a significant and moderate negative correlation between changes from baseline in alcohol consumption and non-alcoholic beverage consumption, but only in the intervention group. This suggests that the reduced alcohol consumption in the intervention group may have been caused by the replacement of alcoholic beverages with the provided non-alcoholic beverages. A previous study demonstrated that greater availability of non-alcoholic beverages increased the odds of selecting non-alcoholic beverages rather than alcoholic beverages [However, the correlation between the changes in alcohol consumption and non-alcoholic beverage consumption in the intervention group gradually weakened after Week 8, and the significant correlation between them disappeared at Week 20. Although the reason remains unclear, it is possible that some of the non-alcoholic beverages provided at Weeks 0, 4, and 8 were consumed by the participants in the intervention group even after Week 12. Thus, although the effect of replacing alcoholic beverages lasted for a certain period, it was weakened when all the available non-alcoholic beverages were consumed. While the participants were not restricted from purchasing either alcoholic or non-alcoholic beverages throughout the study period, we could not distinguish whether the consumed non-alcoholic beverages were provided or voluntarily purchased because our information from the participants pertained only to the consumption amount. Thus, further studies are warranted to clarify this hypothesis. Nevertheless, the reduction of alcohol consumption in the intervention group was not affected by time and was still observed at Week 20 (8 weeks after completion of the intervention). This suggests that a certain degree of behavioral modification may have occurred, in addition to the effect of replacing alcoholic with non-alcoholic beverages, and this may have contributed to the persistent reduction in alcohol consumption in the intervention group after the intervention was complete. As this study was not conducted in a blinded manner, the Hawthorne effect, which refers to behavioral changes driven by attention or expectation from others, including investigators, may have affected the results [Although there was no significant difference in the intervention group between alcohol consumption at Week 12 and that at Week 20, the mean value did increase slightly, suggesting that the alcohol consumption-reducing effect of providing non-alcoholic beverages did not persist long term after the intervention was complete. However, the reduction of alcohol consumption over at least 20 weeks is considered beneficial in terms of public health.The control group in this study also exhibited reduced alcohol consumption at Week 12, on average 2.7 g/day. This change may have been caused by the requirement to keep a drinking diary. According to a systematic review, self-monitoring of substance use disorder was effective in 29% of the analyzed studies, ineffective in 63%, and harmful in 8% [Since the purpose of this study was to investigate whether increased availability of non-alcoholic beverages would change the amount of alcohol consumption, we first examined the effect of providing non-alcoholic beverages purchased by the research group. The fact that alcohol consumption decreased when these non-alcoholic beverages were provided to the participants indicates that this strategy may be useful as a public health policy (e.g., providing price incentives for non-alcoholic beverages) in the real world [From a clinical point of view, it will be beneficial to examine whether alcohol use changes if individuals purchase non-alcoholic beverages themselves. However, as the non-alcoholic beverages delivered to the intervention group were selected from a list specified by the participants based on their own preferences, we believe that this study serves as a valuable foundation for future studies.In this study, the number of participants differed between the two groups because of simple randomization, but there was no significant bias in basic attributes or baseline data, and the low percentage of dropouts (1.6%) contributed to the validity of the study. However, there are roughly five major limitations to this study. The first is that almost all participants were Japanese, and therefore, caution should be exercised when generalizing the results across different races. Information was collected on alcohol metabolism-related genes as well as on body size (height and body weight), and these data are considered to be helpful for interpreting the results of this study. The second limitation is the narrowly defined target population in this study. Since none of the participants had a history of alcoholism, it remains unknown whether the results of this study can be applied to individuals with alcoholism or those at high risk of other alcohol-related problems [ | PMC10544561 |
Conclusions | non-alcoholic beverages | Our results suggested that providing free non-alcoholic beverages was associated with significantly reduced alcohol consumption. This effect persisted for 8 weeks after the completion of the intervention. Providing non-alcoholic beverages may be a strategic option for reducing alcohol consumption among people with excessive drinking. | PMC10544561 |
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Acknowledgements | The authors thank all participants in this study. | PMC10544561 |
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Authors’ contributions | H.Y. conceived and designed the study. H.Y., K.K., G.S., and Y.O. performed the intervention and data collection. S.D. analyzed the data. All authors interpreted the data. H.Y. and S.D. drafted the manuscript. S.D. prepared the table and figures. K.K., G.S., and Y.O. revised it critically for important intellectual content. All authors mentioned above made substantial contributions to the content of the paper. All authors read and approved the final manuscript. | PMC10544561 |
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Funding | This study was conducted jointly with Asahi Breweries, Ltd., which provided funding. | PMC10544561 |
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Availability of data and materials | Not applicable. | PMC10544561 |
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Declarations | PMC10544561 |
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Ethics approval and consent to participate | This study was conducted after approval by the ethics committee of the University of Tsukuba (Notification Number G299) and written informed consent was provided prior to participation. | PMC10544561 |
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Consent for publication | Not applicable. | PMC10544561 |
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Competing interests | H.Y. received research funding from Asahi Breweries. H.Y. also received them from Sanwa Shurui, which is not related to the conduct of our study. Study planning and conduct, data analysis, and writing of the manuscript were performed only by the investigators, independently from the company, under the supervision and instruction of the University of Tsukuba. Transparency and neutrality were strictly maintained during the conduct of the study. K.K., S.D., G.S., and Y.O. declare that they have no competing interests. | PMC10544561 |
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References | PMC10544561 |
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1. Introduction | obesity, health-risk behaviors, adiposity, overweight or obesity, sedentary behaviors | OBESITY, CHILDHOOD OBESITY, ADIPOSITY | Some studies have found associations between the peer network and childhood obesity. The present study aimed to analyze the association of the peer network with obesity-related cognition, behaviors and adiposity indicators, and explore whether peer network influences the effect of a childhood-obesity intervention. Based on DECIDE-Children, 1392 children’s friendship nominations within the class were collected and peer network indicators including the network size, network density, and in- and out-degree centrality were calculated. The linear mixed model was used to analyze the association between peer network indicators and children’s cognition, behaviors and adiposity indicators (body mass index (BMI), BMI z score, the prevalence of overweight and obesity). Children with a higher in-degree centrality had 34.4% (95%CI: 17.4% to 48.1%) lower risk of overweight or obesity. The baseline degree centrality was inversely associated with the BMI and BMI z score at the end of the trial. For each unit increase in in-degree centrality at baseline, the BMI at the end of the trial decreased by 0.047 (95%CI: 0.015 to 0.080), and the BMI z score decreased by 0.015 (95%CI: 0.003 to 0.028). Children’s popularity reflected by centrality in their peer network was associated with cognition, behaviors, and adiposity indicators. Future childhood-obesity intervention research could pay more attention to socially inactive children.Individuals are embedded in thick networks of social relationships and interactions. Social networks represent relatively stable systems composed of relationships among individuals (e.g., friendship), and reflect an individual’s social environment [Traditional epidemiological research has mainly focused on health-risk behaviors of individuals in a group, while the network theory suggests that individuals’ health and health-related behaviors are affected by the embedded social network [To date, some observational evidence has supported the idea that the social environment is one of major determinants of health and health-related behaviors, and highlighted the role of the peer network in the children’s health. Children’s activeness or popularity in a peer network might affect their health-related behaviors, such as sleep, physical activity and sedentary behaviors [Based on a multifaceted intervention program for preventing obesity in primary school children in China, the present study aimed to analyze the association of the peer network with obesity-related cognition, behaviors and adiposity indicators, and explore whether centrality in a peer network influences the effect of a childhood-obesity intervention (i.e., adiposity indicators at the end of the trial), in order to provide scientific evidence for the future childhood-obesity intervention strategies. | PMC10574409 |
2. Methods | PMC10574409 |
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