Single-arm Interventional Study Research Articles

B-063 Changes in nonalcoholic fatty liver disease and M2BPGi due to lifestyle intervention in primary healthcare

Abstract Background A healthy lifestyle is the most important method for managing nonalcoholic fatty liver disease (NAFLD). Mac-2-binding protein glycosylated isomer (M2BPGi) has been suggested as a biomarker for NAFLD. This study aimed to determine the efficacy of personalized lifestyle interventions on NAFLD remission. Methods This single-arm intervention study recruited participants with NAFLD who underwent health checkups at seven health-promotion centers in five South Korean cities. Fatty liver diagnosis was based on ultrasonography (US). The 109 individuals were recruited for personalized lifestyle interventions of hypocaloric diets and exercise. The participants attended the lifestyle intervention programs once per month for the first 3 months, and once every 3 months for the subsequent 6 months. And phone-based self-monitoring were also provided monthly during the 3-month follow-up period. The primary outcome was NAFLD remission at month 12 as measured on US and magnetic resonance elastography. The secondary outcomes were the changes in metabolic factors and M2BPGi. Results The 108 individuals (62 males and 46 females; age 51.1±12.4 years, mean±standard deviation) were finally analyzed after the 12month intervention. Body mass index, waist circumference (WC), blood pressure, blood lipids (total cholesterol, triglycerides, and HDL-C), and fasting blood sugar levels were improved relative to baseline (all P<0.05). Fatty liver at or above the moderate grade according to US was decreased at month 12 relative to baseline (67.6% vs 50.9%) (P=0.002). M2BPGi levels decreased during the 12-month study period (P<0.001). M2BPGi levels were moderately correlated with hepatic fat fraction by magnetic resonance imaging (r=0.33, P=0.05). WC (OR=0.82, 95% CI=0.67-1.00, P=0.05) and HDL-C (OR=1.17, 95% CI=1.03-1.32, P=0.014) were associated with remission of fatty liver in the multivariate analysis. Conclusions The personalized lifestyle intervention was effective in improving fatty liver and metabolic factors, but not hepatic stiffness, in NAFLD.

Implementing a genetic testing station in a safety net setting for equitable genetic testing and counseling.

167 Background: Genetic testing (GT) in patients with hereditary cancers has significant implications for treatment options and risk reduction among family members. Recent GT guidelines have expanded the eligibility criteria with limited genetic counseling staff. Patients who are from marginalized groups, are under or uninsured, or have limited English proficiency continue to experience disparities in GT, underscoring the need for innovations in care delivery. Methods: From March 2021 to June 2023, we conducted a single-arm intervention study of a point-of-care genetic testing station (GTS) in a safety net hospital. Patients who met NCCN criteria for GT were eligible. We compared this group to a historical cohort who received GT either in person or via telehealth in the preceding two years and non- GTS cohort. The GTS intervention consisted of (1) screening of clinic schedules for eligible patients, (2) GT video-based education in English, Spanish, and Cantonese, (3) consent and collection of blood or saliva samples by a genetic counseling assistant, and (4) telehealth-based post-test counseling with a genetic counselor (GC). The historical cohort underwent GT in a traditional model: (1) oncologist-initiated electronic referral, (2) pretest counseling with a GC, (3) GT if appropriate, and (4) post-test counseling to review and discuss results. Our primary outcomes were completion of GT and time to result delivery. We evaluated all associations with the Chi-square test for categorical variables. Results: We enrolled a total of 256 participants, 26% were Asian, 18% were Black, 30% were Hispanic/Latinx, 13% were Non-Hispanic White, and 2% were Native Hawaiian/Pacific Islander. The most common languages were English 48%, Spanish 28%, Cantonese 20%, and Other 4%. 251 (98%) of GTS participants completed GT, and 241 (95%) completed the post-test GC visit, compared to the Non-GTS cohort (79%, p<0.001), pre-GTS cohort (85%, p<0.001) with traditional GT model with in-person at 122 (95%) and telehealth (72%). The median time to result delivery was 35 days (IQR 27 - 52) for the GTS cohort, 56 days for non-GTS cohort, 97 days for pre-GTS telehealth (IQR 24.7 - 111), and 21 days ( IQR 14-31) days for in-person. Conclusions: GTS resulted in more patients completing GT and promptly receiving their results with telehealth genetic counseling. As GT eligibility criteria broaden, innovative interventions, workflows, and tailored educational resources for diverse populations are needed to ensure equitable access to GT.

Rationale and Design of the Study to Investigate the Metabolic Action of Imeglimin on Patients with Type2 Diabetes Mellitus (SISIMAI).

Imeglimin is a first-in-class, novel, oral glucose-lowering agent for the treatment of type2 diabetes mellitus. The efficacy and safety of imeglimin as an antidiabetic agent have been investigated in clinical trials. However, its metabolic effects in humans have not yet been fully elucidated. The Study to InveStIgate the Metabolic Action of Imeglimin on patients with type2 diabetes mellitus (SISIMAI) is a single-arm intervention study. In this study, we have recruited 25 patients with type2 diabetes to receive 2000mg/day imeglimin for 20weeks. We perform a 75-g oral glucose tolerance test (OGTT) with double-glucose tracers, a two-step hyperinsulinemic-euglycemic clamp with glucose tracer, ectopic fat measurement by proton magnetic resonance spectroscopy, visceral/subcutaneous fat area measurement by magnetic resonance imaging, muscle biopsy, and evaluation of fitness level by cycle ergometer before and after imeglimin administration. The primary outcome is the change in area under the curve of glucose levels during the OGTT after 20weeks of imeglimin treatment. We also calculate the endogenous glucose production, rate of oral glucose appearance, and rate of glucose disappearance from the data during the 75-g OGTT and compare them between pre- and post-treatment. Additionally, we will compare other parameters, such as the changes in tissue-specific insulin sensitivity, ectopic fat accumulation, visceral/subcutaneous fat area accumulation, and fitness level between each point. This is the first study to investigate the organ-specific metabolic action of imeglimin in patients with type2 diabetes mellitus using the 75-g OGTT with the double tracer method. The results of this study are expected to provide useful information for drug selection based on the pathophysiology of individual patients with type2 diabetes mellitus. jRCTs031210600.

Effect of Flaxseed on Pain Relief and Quality of Life in Patients With Mastalgia: A Single Arm Interventional Study.

Mastalgia, a common complaint among women, denotes breast discomfort that can manifest as cyclical or non-cyclical. Reassurance, mechanical support and various non-pharmacological treatments, like flaxseeds, have been seen to have a good effect in treating mastalgia. Thus, the aim of this study was to investigates the efficacy of flaxseed in alleviating pain associated with mastalgia and its impact on the overall health-related quality of life among female patients. Conducted at a tertiary care center in Northern India over 18 months, it employed a single-arm interventional design. The participants included females aged 18 years and older presenting with breast pain at the Department of General Surgery. The intervention involved daily consumption of 30 g of milled flaxseed for each participant, administered over a period of six months. Pain severity was assessed using the visual analogue scale (VAS) before supplementation and at follow-up intervals up to six months. Concurrently, the Short Form-12 (SF-12) items Health Survey measured health-related quality of life, encompassing both physical and mental health domains. Statistical analysis employed parametric (paired t-test) and non-parametric tests (chi-square, McNemar) where appropriate, with statistical significance set at p<0.05. Two hundred women with mastalgia were included with a significant reduction in mean VAS scores from 6.03±0.83 at baseline to 2.19±0.66 at six months post-intervention (p = 0.0001). This reduction in pain intensity demonstrated a positive correlation with duration of flaxseed supplementation, notably declining after the initial three months. The mean difference in physical and mental SF-12 score at first visit and at 6 months after intervention was significant (p = 0.0001). This study underscores the potential of flaxseed as a therapeutic option for managing mastalgia and enhancing health-related quality of life among affected individuals.

Use of a decision support tool and quick start onboarding tool in individuals with type 1 diabetes using advanced automated insulin delivery: a single-arm multi-phase intervention study

BackgroundMultiple clinician adjustable parameters impact upon glycemia in people with type 1 diabetes (T1D) using Medtronic Mini Med 780G (MM780G) AHCL. These include glucose targets, carbohydrate ratios (CR), and active insulin time (AIT). Algorithm-based decision support advising upon potential settings adjustments may enhance clinical decision-making.MethodsSingle-arm, two-phase exploratory study developing decision support to commence and sustain AHCL. Participants commenced investigational MM780G, then 8 weeks Phase 1-initial optimization tool evaluation, involving algorithm-based decision support with weekly AIT and CR recommendations. Clinicians approved or rejected CR and AIT recommendations based on perceived safety per protocol. Co-design resulted in a refined algorithm evaluated in a further identically configured Phase 2. Phase 2 participants also transitioned to commercial MM780G following “Quick Start” (algorithm-derived tool determining initial AHCL settings using daily insulin dose and weight). We assessed efficacy, safety, and acceptability of decision support using glycemic metrics, and the proportion of accepted CR and AIT settings per phase.ResultsFifty three participants commenced Phase 1 (mean age 24.4; Hba1c 61.5mmol/7.7%). The proportion of CR and AIT accepted by clinicians increased between Phases 1 and 2 respectively: CR 89.2% vs. 98.6%, p < 0.01; AIT 95.2% vs. 99.3%, p < 0.01. Between Phases, mean glucose percentage time < 3.9mmol (< 70mg/dl) reduced (2.1% vs. 1.4%, p = 0.04); change in mean TIR 3.9-10mmol/L (70-180mg/dl) was not statistically significant: 72.9% ± 7.8 and 73.5% ± 8.6. Quick start resulted in stable TIR, and glycemic metrics compared to international guidelines.ConclusionThe co-designed decision support tools were able to deliver safe and effective therapy. They can potentially reduce the burden of diabetes management related decision making for both health care practitioners and patients.Trial registrationProspectively registered with Australia/New Zealand Clinical Trials Registry(ANZCTR) on 30th March 2021 as study ACTRN12621000360819.

To study the efficacy of autologous non-cultured nontrypsinized epidermal cell grafting (Jodhpur technique) by using of suction blister membrane in stable vitiligo

Objectives: This study aimed to evaluate the efficacy of autologous non-cultured non-trypsinized melanocytekeratinocyte grafting (JT) with suction blister membrane as biological dressing in stable vitiligo patches. Material and Methods: The study was conducted at Mathura Das Mathur Hospital (MDM), Jodhpur, on 43 patches of Stable vitiligo. It was a prospective single-arm interventional study. All patients were examined clinically and history and informed consent were taken before starting the procedure. Results: About 95% of patches showed &gt;50% repigmentation with 83.72% having good to excellent repigmentation. About 88% of patches showed good color matches with an excellent decline in Dermatology Life Quality Index (DLQI). No serious complication was observed in the present study. The most common complication observed both in the donor and recipient area was pain. Conclusion: Our study indicates that combining JT with suction blister epidermal grafting is a comparatively effective technique in terms of good repigmentation (≥75% extent of repigmentation), color match, fewer side effects, good patient satisfaction, and DLQI reduction.

Radiofrequency as a method of localizing impalpable breast lesions

BackgroundThe incidence of early stage breast cancer has risen as a result of increased detection of non-palpable tumors through the implementation of screening programs and greater public awareness. Performing breast-conserving surgery can be challenging due to the need for accurate localization of non-palpable breast lesions, particularly given the logistical difficulties associated with wire localization. After implementing a new technique for localizing non-palpable breast lesions (LOCalizerTM Radiofrequency identification TAG-Hologic®), a radiofrequency identification tag localization device manufactured by Hologic, Inc. in Marlborough, MA, was launched in 2017, our objective was to investigate its impact on surgical outcomes, whether there was an increase in re-excision rates for positive margins and whether the attainment of clear margins was dependent on the exact positioning of the RFID device. MethodA single-center single-arm interventional study, data were gathered both in a forward-looking manner for 1 year (prospectively) and by looking back at past records for 1 year (retrospectively) for a total period of two years. Individuals who were diagnosed with non-palpable breast lesions, as confirmed by histological analysis, or invasive breast cancer and who were scheduled to undergo breast-conserving surgery were eligible for inclusion in the study. The RFID (Radiofrequency Identification) method was used to localize the lesions prior to surgery. Either with a mammogram or ultrasound scan position of the Tag was recorded, including the distance of the lesion from the center of the lesion and the lesion depth from the skin in millimeters. The rate of re-excision was documented and examined in relation to the parameters mentioned above. ResultsTwo hundred and twenty RFID Tags were inserted in two hundred and seventeen (three patient had bilateral tags insertion), patients aged between 30 and 85 had a localizer Tag inserted between Oct 2020 and Oct 2022. Three patients had non-palpable breast lesions in both breasts. Fourteen were inserted under stereotactic guidance and two hundred and six under ultrasound guidance. Ten patients subsequently had wire insertion also due to Tag position. Of 210 procedures, RFIF Tags within the lesion was seen in hundred and sixty patients (76.19 %). An additional 50 procedures were performed using the RFID Tag system, which were not directly related to the lesion but were deemed appropriate to proceed with.Out of a total of 220 procedures, positive margins were observed in 38 cases (17.27 %). Among these cases, eleven (28.94 %) involved the use of the RFID Tag system, not within the lesion but adjacent to it (within 15 mm surrounding the lesion). ConclusionRFID is a good alternative to wire localization of non-palpable breast lesions. Re-excision rates are higher in patients with Tag outside the lesion compared to those with Tag within the lesion.

Feasibility of individualized home exercise programs for patients with head and neck cancer-study protocol and first results of a multicentre single-arm intervention trial (OSHO #94).

Patients with head and neck cancer (PwHNC) benefit from targeted exercise interventions: symptom relief, compensation for dysfunction, improvement in quality of life (QoL). Data on acceptance physical interventions in PwHNC are rare. The 'OSHO #94' trial investigates the short- and medium-term effects of individualized home exercise in PwHNC on QoL, physical activity and functionality. The study includes a feasibility phase (proof of concept) in order to evaluate the acceptance. Here we present the study protocol as well as the feasibility results. This prospective, multicentre, single-arm intervention study includes PwHNC ≥18 years of age in aftercare or palliative care with stable remission under immunotherapy. The study opened in January 01, 2021, with estimated completion by December 31, 2024. The PwHNC receive an individualized home exercise program consisting of mobilization, coordination, strengthening and stretching exercises. This should be carried out at least three times a week over 12 weeks for 15 to 30 minutes, supplemented by aerobic training two to three times a week for 30 minutes (intervention). Once weekly telephone calls with a physiotherapist are performed. Subsequently, there is a 12-week follow-up (FU) without exercise specifications/contact. Outcomes are measured before and after the intervention and following the FU. Primary outcome of the feasibility phase (n = 25) was the determination of the dropout rate during the intervention with a termination cut off if more than 30% PwHNC withdrew premature. The primary outcome of the OSHO #94' trial (N = 53) is the change in global QoL score from pre- to post-intervention (EORTC QLQ-C30). Secondary outcomes include clinical and patient-reported measures, training details as well as functional diagnostic data (e.g. level of physical activity, training frequency, flexibility, fall risk and aerobic performance). 25 PwHNC were enrolled onto the feasibility cohort. Only16% (4/25 patients) did not complete the study. Therefore, recruitment of PwHNC was continued. The dropout rate was adjusted from 30% (N = 60) to 20% (N = 53, calculated sample size n = 42 PwHNC and 20% (n = 11) to dropout). Individualized home exercise programs in PwHNC in aftercare seem feasible. Consequently, the aim is now to evaluate the short and medium-term effects of individualized home exercise.

Resistance Training in Women Diagnosed with Breast Cancer: A Pilot Single Arm Pre-Post Intervention.

Background: Resistance training (RT) yields physical and psychological benefits for women living with and beyond breast cancer (WBC). This study examined the feasibility of a virtually delivered 8-week socially supportive RT intervention among WBC and assessed changes in physical activity and body image. Methods: A pilot single-arm 8-week pre-post intervention study design was implemented. Forty-one WBC were matched as exercise partners and asked to complete two RT sessions per week-one with a qualified exercise professional (QEP) and one with their peer. Data were collected at baseline (T1), post-intervention (T2), and 20 weeks post-baseline (T3). Results: The enrolment rate was 42%, the attendance rate for the QEP sessions was 63.8% and 40.0% for the peer sessions, and the retention rate was 87%. No adverse events were reported. Total weekly minutes of RT significantly (p < 0.05) increased by 42 minutes/week during the intervention and significantly decreased by 25 min/week at follow-up. Upper and lower body muscle strength increased (p < 0.01) during the intervention. Increased RT was associated with favorable activity self-perceptions. Conclusions: This pilot intervention study was feasible, safe, and demonstrated preliminary evidence for increasing RT time and strength among WBC. Virtually delivered socially supportive RT interventions can improve access for WBC.

HDL cholesterol efflux capacity and cholesterol loading capacity in long-term fasting: Evidence from a prospective, single-arm interventional study in healthy individuals

Background and aimsLong-term fasting (LF) is increasingly emerging as a non-pharmacological approach to modulate risk factors associated with the development of atherosclerotic cardiovascular diseases (ASCVD). However, protection from ASCVD is more tied to the functionality of high-density lipoprotein (HDL) than its plasma levels. Our prospective interventional study focuses on the functional properties of lipoproteins in modulating cholesterol homeostasis on peripheral cells and examines how LF may influence this and lipoprotein subclass composition. For that purpose, we investigated its impact on HDL-cholesterol efflux capacity (CEC), and on serum cholesterol loading capacity (CLC). MethodsForty healthy subjects (50 % females) underwent medically supervised 9-day fasting (250 kcal/day) in a specialised facility. Thirty-two subjects had a follow-up examination after one month of food reintroduction. ResultsLF was well tolerated and increased self-reported energy levels. Fasting reduced triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and HDL cholesterol (HDL-C). Very-low-density lipoprotein cholesterol (VLDL-C) and LDL3-C showed sustained reductions at follow-up. Only HDL-C, specifically HDL2-C levels, increased at follow-up. Total HDL-CEC decreased during LF and increased above baseline at follow-up. Fasting decreased ATP binding cassette (ABC)A1-mediated HDL-CEC whereas ABCG1-mediated HDL-CEC remained unaffected. Aqueous diffusion increased at follow up. LF decreased serum CLC and then returned to baseline levels. ConclusionsLF not only maintains lipoprotein functionality but also contributes to a favorable shift in the atherogenic risk profile, which persists even after food reintroduction. This further emphasizes the importance of considering HDL functionality alongside traditional lipid measurements to understand the potential for non-pharmacological interventions like LF to promote cardiovascular prevention and health. Trial registration numberNCT05031598.

Effect of skill-based educational training for ambulance personnel on neonatal transportfor newborn care in coastal South India - a single arm intervention study.

Education of '108' ambulance personnel involved in transporting neonates may improve outcomes. We assessed i) perceptions/practices of '108' ambulance personnel for transporting neonates, ii) clinical parameters of transported neonates at arrival, and iii) outcomes such as survival/mortality and NICU stay (before and after skill-based educational intervention). We conducted a single-arm intervention study (pre-and post) over 18 months. We assessed the perceptions and practices of 77 ambulance personnel on neonatal transport pre- versus post-intervention. Checklists assessed ambulance equipment availability/usage in both phases. We compared clinical parameters and outcomes of transported neonates between the pre-intervention (n=62) and post-intervention (n=53) phases. We analyzed data using SPSS version 25. Post-intervention, there was a significant reduction in the levels of hypothermia (p < 0.001), hypoglycemia (p=0.010), and prolonged capillary refill time (p=0.042), along with improvement in the use of intravenous fluids (p <0.001), a reduction in the positivity of umbilical swab growth (p=0.002) and in the duration of NICU stay (p = 0.001), significant improvement (p < 0.001) in the perceptions/practices of ambulance personnel towards neonatal transport. There was an improvement in the ambulance equipment availability/usage post-intervention. The perceptions and practices of the '108' ambulance towards transporting neonates had significantly improved post-educational intervention. Further, a significant decrease in hypothermia, hypoglycemia, and duration of NICU stay was seen in neonates transported post-intervention.

Endoscopic Membranectomy's Role in the Treatment of Nonhomogeneous Chronic Subdural Hematoma (EMiT-CSDH): Prospective Single-arm Interventional Pilot Study

Chronic subdural hematoma (CSDH) is a prevalent neurosurgical condition characterized by blood accumulation within the border cell layer. Despite various treatment options-medical, endovascular, and surgical-recurrence rates remain high. Our pilot study investigates the safety and efficacy of endoscopic membranectomy (EM) in reducing recurrence in nonhomogenous CSDH. This was a prospective single-arm interventional pilot study from March to June 2023. It included patients of all ages who presented with symptomatic nonhomogenous CSDH requiring surgical intervention. A total of 19 patients were enrolled in this study. The average age was 60.4 ± 10.4 years. The male:female ratio was 5.3:1. In this group, 73.7% (n= 14) of patients had a history of trauma. All patients presented with a history of altered sensorium and contralateral limb weakness. The most common type of CSDH was trabecular (42.1%), followed by gradient (21%), separated (15.8%), and laminar (15.8%). The average duration of surgery was 43.42 ± 10 minutes. CSDH may be thin or thick based on its tractability and has significance in EM technique. All patients started recovering within 24 hours. All patients were asymptomatic, without any neurologic deficit, at 2 weeks, and remained so at the 6-month review. In 17 patients, the 6-month follow-up computed tomography did not show any bleeding/recurrence. There were no postoperative seizures, wound-healing issues, or infections. There are multiple treatment options for CSDH at present. EM is a potentially safe and effective treatment for CSDH, with lower recurrence and faster recovery. Large-scale controlled studies on EM are required.

Subclinical leaflet thrombus in patients with severe aortic stenosis and atrial fibrillation -ENRICH-AF TAVI study

Subclinical leaflet thrombosis (SLT) can be one of the causes of transcatheter heart valve (THV) failure after transcatheter aortic valve implantation (TAVI). We sought to clarify the formation process of SLT and thrombogenicity during the perioperative period of TAVI. This multicenter, prospective, single-arm interventional study enrolled 26 patients treated with edoxaban for atrial fibrillation and who underwent TAVI for severe aortic stenosis between September 2018 and September 2022. We investigated changes in maximal leaflet thickness detected by contrast-enhanced computed tomography between 1 week and 3 months after TAVI in 18 patients and measured the thrombogenicity by Total Thrombus-formation Analysis System (T-TAS) and flow stagnation volume by computational fluid dynamics (CFD) (n = 11). SLT was observed in 16.7% (3/18) at 1 week, but decreased to 5.9% (1/17) at 3 months after TAVI. Patients with SLT at 1 week had a significantly decreased maximal leaflet thickness compared to those without SLT. Thrombogenicity assessed by T-TAS decreased markedly at 1 week and tended to increase at 3 months. The stagnation volume assessed by CFD was positively associated with a higher maximum leaflet thickness. This study showed the course of leaflet thrombus formation and visualization of stagnation in neo-sinus of THV in the acute phase after TAVI.

Efficacy of a non-pharmaceutical multimodal intervention program in a group setting for patients with mild cognitive impairment: A single-arm interventional study with pre-post and external control analyses

AimThis study aimed to evaluate the efficacy of a non-pharmaceutical multimodal intervention program consisting of physical exercise, cognitive stimulation, and health education in a group setting to slow the progression of mild cognitive impairment (MCI). MethodsA single-arm interventional study was conducted on 27 patients with MCI. To evaluate the efficacy of the intervention program, a pre-post analysis was performed using EuroQol-5 Dimension (EQ-5D), Mini-Mental State Examination (MMSE), Cognitive Function Instrument (CFI), 5 Cog test, depression, and physical performance before and after the 8-month intervention. Additionally, propensity score and the semi-Bayes analyses were performed to compare the intervention program with standard medical care, using the external control patients’ data for MMSE scores. ResultsTwenty-four patients completed the intervention program. During the study period, although EQ-5D and MMSE scores remained unchanged (mean change 0.02 [95 % confidence interval (CI): −0.004, 0.04], 0.5 [-0.2, 1.3]), CFI and the subcategories of 5Cog (attention and reasoning) improved (mean change −1.23 [-2.24, −0.21], 4.3 [0.9, 7.7], 3.0 [0.4, 5.6]). In the additional analysis comparing changes in MMSE scores, patients who underwent the intervention program had less decline than the external control patients (mean change −1.7 [-2.1, −1.3]) with an observed mean difference of 2.25 [1.46, 3.03], and propensity score-adjusted difference of 2.26 [1.46, 3.05]. The semi-Bayesian approach also suggested that the intervention slowed the progression of MCI. ConclusionA non-pharmaceutical multimodal intervention program could contribute to slowing cognitive decline in patients with MCI.

An App-Based Physical Activity Intervention in Community-Dwelling Chinese-, Tagalog-, and Vietnamese-Speaking Americans: Single-Arm Intervention Study.

Physical inactivity is associated with adverse health outcomes among Asian Americans, who exhibit the least adherence to physical activity guidelines compared with other racial and ethnic groups. Mobile app-based interventions are a promising approach to promote healthy behaviors. However, there is a lack of app-based interventions focused on improving physical activity among Asian Americans whose primary language is not English. This pilot study aimed to assess the feasibility and acceptability of a 5-week intervention using a culturally and linguistically adapted, evidence-based mobile phone app with an accelerometer program, to promote physical activity among Chinese-, Tagalog-, or Vietnamese-speaking Americans. Participants were recruited through collaborations with community-based organizations. The intervention was adapted from a 12-month physical activity randomized controlled trial involving the app and accelerometer for English-speaking adults. Sociodemographic characteristics, lifestyle factors, and physical measurements were collected at the baseline visit. A 7-day run-in period was conducted to screen for the participants who could wear a Fitbit One (Fitbit LLC) accelerometer and complete the app's daily step diary. During the 4-week intervention period, participants wore the accelerometer and reported their daily steps in the app. Participants also received daily messages to reinforce key contents taught during an in-person educational session, remind them to input steps, and provide tailored feedback. Feasibility measures were the percentage of eligible participants completing the run-in period and the percentage of participants who used the app diary for at least 5 out of 7 days during the intervention period. We conducted poststudy participant interviews to explore overall intervention acceptability. A total of 19 participants were enrolled at the beginning of the study with a mean age of 47 (SD 13.3; range 29-70) years, and 58% (n=11) of them were female. Of the participants, 26% (n=5) were Chinese, 32% (n=6) were Vietnamese, and 42% (n=8) were Filipino. All participants met the run-in criteria to proceed with the intervention. Adherence to the app diary ranged from 74% (n=14) in week 2 to 95% (n=18) in week 4. The daily average steps per week from accelerometers increased each week from 8451 (SD 3378) steps during the run-in period to 10,930 (SD 4213) steps in week 4. Participants reported positive experiences including an increased motivation to walk and the enjoyment of being able to monitor their physical activity. This is the first pilot study of a multicomponent intervention and evidence-based mobile phone app to promote physical activity among Asian Americans who use apps in traditional Chinese, Tagalog, or Vietnamese, which demonstrated high feasibility and acceptability. Future work focused on multilingual mobile apps to address disparities in physical inactivity among Asian Americans should be considered.

The effect of propofol versus thiopentone on APGAR score of babies delivered and recovery of pregnant mothers undergoing elective cesarean section

Background and objectives: The Apgar score is a vital indicator of the baby's well-being. This study aims to compare the effects of propofol and thiopental anesthetics on babies' Apgar scores and mothers' recovery times, this study was carried out. Methods: This single-arm interventional study was conducted in Zhyan and Soma Hospital in Sulaimani, Kurdistan Region of Iraq from February 2022 to July 2022. Separate doses of propofol and thiopental were given to 140 pregnant women who were candidates for elective cesarean section in two separate groups. Apgar scores at 1 and 5 minutes after birth, recovery time, and hemodynamic changes before and after the intervention were evaluated and compared. Results: The results of the diastolic pressure variable after the intervention and the hemodynamic variables were significantly different in each group before and after the intervention (P&lt;0.001). The mean recovery time in propofol and thiopental groups was 21.4 ± 2.4 and 26.0 ± 1.8 minutes, respectively, and they were statistically significantly different (p&lt;0.001). There was a statistically significant difference in the Apgar score at the 5th minute between the two groups (p=0.03). In terms of the need for resuscitation after the first minute, the results were in favor of the propofol group (p&lt;0.001). Conclusion: Propofol can be used more safely since patients who had anesthesia with it had better hemodynamics, quicker recovery times, neonates with higher Apgar scores, and less need for postpartum resuscitation.

Impact of Intergenerational Shokuiku (Food and Nutrition Education) Programs on Alleviating Loneliness in Japanese Communities across Ages.

As loneliness is a risk factor for mental and physical health problems in various age groups, this study aimed to explore the impact of the intergenerational Shokuiku (food and nutrition education) program (IGSP) on loneliness in a Japanese community. This single-arm intervention study conducted between 2022 and 2023 included children (n = 21), guardians (n = 16), university students (n = 3), and older adults (n = 6). The IGSP was a one-day program that included participants making and eating their own bread, butter, and sorbet. Loneliness was measured using the Five-item Loneliness Scale for Children (Five-LSC; Japanese) and the three-item UCLA Loneliness Scale (Japanese; for adults) with other direct questions. Social capital, including civic participation, social cohesion, and reciprocity, was assessed using a self-administered questionnaire. The Five-LSC score significantly decreased post-intervention (p = 0.04). There was a significant increase in adults who reported not feeling lonely (p = 0.001). However, the UCLA Loneliness Scale scores did not show any significant changes. A positive change in social cohesion, including community contribution (p = 0.001) and attachment (p = 0.002), was observed among adults. This study suggests that IGSPs have a positive impact on loneliness in children and a partly positive one in adults. These findings emphasize the potential of intergenerational programs to reduce loneliness in communities.

Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa.

We developed the Healthy Families-PrEP intervention to support HIV-prevention during periconception and pregnancy. We evaluated preexposure prophylaxis (PrEP) use with three objective measures. This single-arm intervention study enrolled women in KwaZulu-Natal, South Africa, who were HIV-uninfected, not pregnant, in a relationship with a partner with HIV or unknown-serostatus, and with pregnancy plans. PrEP was offered as part of a comprehensive HIV prevention intervention. Participants were followed for 12 months. We evaluated periconception PrEP uptake and adherence using quarterly plasma tenofovir concentrations. We modeled factors associated with PrEP uptake and high plasma tenofovir (past day dosing). Patterns of use were analyzed using electronic pillcap data. Dried blood spots to measure intracellular tenofovir product (past 2 months dosing) were analyzed for a subset of women. Three hundred thirty women with median age 24 (IQR: 22-27) years enrolled. Partner HIV-serostatus was unknown by 96% ( N = 316); 60% (195) initiated PrEP. High plasma tenofovir concentrations were seen in 35, 25, 22, and 20% of samples at 3, 6, 9, and 12 months, respectively. Similar adherence was measured by pillcap and dried blood spots. In adjusted models, lower income, alcohol use, and higher HIV stigma were associated with high plasma tenofovir. Eleven HIV-seroconversions were observed (incidence rate: 4.04/100 person-years [95% confidence interval: 2.24-7.30]). None had detectable plasma tenofovir. The Healthy Families-PrEP intervention supported women in PrEP use. We observed high interest in periconception PrEP and over one-third adhered to PrEP in the first quarter; one-fifth were adherent over a year. High HIV incidence highlights the importance of strategies to reduce HIV incidence among periconception women. NCT03194308.

Pulmonary rehabilitation: A cohort study assessing the effectiveness of a multi-professional nutrition intervention

BackgroundLimited benefit of pulmonary exercise rehabilitation has been associated with fulfilment of energy and protein requirements. ObjectivesThe aim was to enhance dietary intake towards requirements and to maintain changes after a pulmonary rehabilitation program. MethodsThis single arm intervention study included multidisciplinary focus on nutrition and three sessions of individual dietary counselling during a 10-week pulmonary exercise rehabilitation in five municipalities centers. Data were collected at baseline (P0), at the end of intervention (P1) and for two municipalities at three months post intervention (P2). ResultsOf the 111 included participants, (mean age 70.8 (±9)) 99 (89%) completed the rehabilitation including the three individual dietary counselling’s. A very large variation in body composition including body mass index and exercise abilities was found. Protein intake improved from 64 (±22 gram) (P0) to 88 (±25 gram) (P1) (p<0.001) and energy intake from 1676 (±505 kcal) (P0) to 1941 (±553 kcal) (p<0.001) (P1) and Muscle Mass Index increased from 10.6 (±3.2) (P0) to 10.9 (±3.2) (P1) (p=0.007); number of 30 second chair stand test improved from 10.9 (±2.8) repetitions (P0) to 14.1 (±4.3) repetitions (P1) (p<0.001), distance in six-minut walking test improved from 377.2 (±131.2 meters) (P0) to 404.1 (±128.6 meters) (P1) (p<0.001). Two municipalities completed the three months follow-up. For those, dietary improvements remained stable, including protein intake. ConclusionIncluding three sessions of dietary counselling in a multi-professional effort was associated with improved individualized dietary intake, as well as physical function. Benefits remained almost unchanged after three months. Improvements in function could not be fully explained by improved intakes.

Acceptability and Feasibility of Survivorship Group Medical Visits for Breast Cancer Survivors in a Safety Net Hospital.

Providing cost-effective, comprehensive survivorship care remains a significant challenge. Breast cancer survivors (BCS) who have limited income and are from marginalized racial and ethnic groups experience a worse quality of life and report higher distress. Thus, innovative care models are required to address the needs of BCSin low resource settings. Group medical visits (GMV), utilized in chronic disease management, are an excellent model for education and building skills. This single-arm intervention study was conducted at a public hospital in California. GMVs consisted of five 2-h weekly sessions focused on survivorship care planning, side effects of treatment and prevention, emotional health, sexual health, physical activity, and diet. The patient navigators recruited three consecutive GMV groups of six English-speaking BCS (N = 17). A multidisciplinary team delivered GMVs, and a patient navigator facilitated all the sessions. We used attendance rates, pre- and post-surveys, and debriefing interviews to assess the feasibility and acceptability of the intervention. We enrolled 18 BCS. One participant dropped out before the intervention started, 17 BCS consistently attended and actively participated in the GMV, and 76% (13) attended all planned sessions. Participants rated GMVs in the post-survey and shared their support for GMVs in debriefing interviews. The BCS who completed the post-survey reported that GMVs increased their awareness, confidence, and knowledge of survivorship care. GMVs were explicitly designed to address unmet needs for services necessary for survivorship care but not readily available in safety net settings. Our pilot data suggest that patient-navigator-facilitated GMVs are a feasible and acceptable model for integrating survivorship care in public hospitals.