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Conflicts of Interest | The authors declare no conflict of interest. | PMC10094525 | ||
Trial Registration | The study is registered at | PMC10094525 | ||
Abbreviations | CORONAVIRUS DISEASE 2019 | CI: confidence intervals; CON: Standard care; COVID-19: coronavirus disease 2019; EXE: Structured, supervised exercise training; GA: gestational age; MOT: Motivational counseling on physical activity; MVPA: Moderate-to-vigorous-intensity physical activity; PA: Physical activity; PSQI: Pittsburgh Sleep Quality Index; PPAQ: Pregnancy Physical Activity Questionnaire; RCT: Randomised controlled trial; SED: sedentary time; TST: total sleep time. | PMC10094525 | |
References | Baseline-constrained comparison between groups based on the means of the Pittsburgh Sleep Quality Index global score. Baseline, gestational age of maximum 15 weeks; CON (gray color), standard care; EXE (blue color), structured supervised exercise training; GA, gestational age; MOT (red color), motivational counseling on physical activity. * EXE compared to CON at GA week 28 (Baseline-constrained comparison between groups based on the means of sedentary time from the Pregnancy Physical Activity Questionnaire. Baseline, gestational age of maximum 15 weeks; CON (grey color), standard care; EXE (blue color), structured supervised exercise training; GA, gestational age; hr, hour; MOT (red color), motivational counseling on physical activity. * EXE compared to CON at GA week 28 (Baseline-constrained comparison between groups based on the activity tracker’s mean of total sleep and sedentary time. Baseline, gestational age of maximum 15 weeks; CON (gray color), standard care; EXE (blue color), structured supervised exercise training; GA, gestational age. h, hour; MOT (red color), motivational counseling on physical activity.Average and 95% confidence interval of total sleep time and sedentary time before COVID-19 [physical intervention only, participants (Differences in the total sleep time between the Pittsburgh Sleep Quality Index (PSQI) and the activity tracker vs. the average of sums at the gestational age of maximum 15 weeks (Outcomes from the Pittsburgh Sleep Quality Index and sedentary time from the Pregnancy Physical Activity Questionnaire.Comparison between groups on sleep outcomes from Pittsburgh Sleep Quality Index (PSQI) and sedentary time from the Pregnancy Physical Activity Questionnaire (PPAQ). A positive mean value indicates that the last-mentioned group has the highest mean. Bold Sleep and sedentary time from an activity tracker.Comparison between groups based on imputed activity tracker datasets (intention to treat analysis) from randomization (gestational age of maximum 15 weeks), GA week 28, GA week 34 and delivery, respectively. A positive mean value indicates that the last-mentioned group has the highest mean. CI, confidence interval; CON, standard care; EXE, structured supervised exercise training; GA, gestational age; h, hour; MOT, motivational counseling on physical activity. | PMC10094525 | ||
Background | bleeding, pneumonia, peritonitis | BLEEDING, PNEUMONIA, WOUND INFECTION, PERITONITIS, LEAKAGE, COMPLICATIONS | Percutaneous endoscopic gastrostomy (PEG) is commonly chosen for long-term enteral nutrition support. However, common complications of PEG include wound infection, leakage, obstruction, bleeding, dislodgement, pneumonia, peritonitis, and more. The anticipation of these complications by both patients and their family caregivers underscores the essential requirement of ongoing technical guidance for the daily care of PEG and the adoption of preventative strategies. | PMC10625096 |
Objective | COMPLICATIONS | This study aimed to establish and compare a health education program utilizing a tracking system for PEG using a mobile app (PEG app) and instant messaging software versus a paper-based health education program with instant messaging software. Their effectiveness in preventing complications, avoiding hospital readmissions, improving self-care practices, and enhancing quality of life outcomes was assessed. | PMC10625096 | |
Methods | A randomized controlled trial design was used, and the study sample consisted of patients from a medical center in central Taiwan who underwent thoracic surgery or gastroenterology procedures. Inclusion criteria were being a new case undergoing his or her first gastric tube insertion and having the ability to operate a smartphone. Exclusion criteria were cases requiring tube replacement or nasogastric tubes. A total of 74 participants were enrolled, with 37 participants in the experimental group and 37 participants in the control group. Data collection took place from hospitalization until 1 month after discharge. The experimental group received care using the gastric tube tracking system (PEG app) and the Line app that included phone, text, and photo capture capabilities, while the control group received routine nursing care and used the Line app. | PMC10625096 | ||
Results | COMPLICATIONS | The experimental group demonstrated a significant reduction in the occurrence of complications compared with the control group ( | PMC10625096 | |
Conclusions | COMPLICATIONS | Integration of the PEG app with instant messaging can enhance self-care ability, improve social aspects of quality of life, and reduce complications. The study results suggest that the PEG app could be used as an adjunct tool to promote patients’ self-directed management of their gastric tube at home, particularly for patients who have undergone their first PEG placement and are being discharged from the hospital. | PMC10625096 | |
Trial Registration | Chinese Clinical Trial Registry ChiCTR2300071271; https://tinyurl.com/4vvy584e | PMC10625096 | ||
Introduction | voice and visual information, bleeding, pneumonia, peritonitis | BLEEDING, PNEUMONIA, WOUND INFECTION, DISEASE, PERITONITIS, LEAKAGE, COMPLICATIONS | Percutaneous endoscopic gastrostomy (PEG) is a preferred method for long-term enteral nutrition support. Studies indicate that 5% to 7.8% of nursing home residents receive gastrostomy feeding [Common complications of PEG include wound infection (3%-50%), leakage (10%-42.3%), obstruction (8%-35%), bleeding (32%), dislodgement (14.3%), pneumonia, peritonitis (1%-18%), and buried bumper syndrome (1.5%-0.8%) [With the advancement of technology and the widespread use of smartphones, instant messaging apps, which can be downloaded for free on smartphones or computers via the internet, have transformed health education from static paper-based methods to dynamic audiovisual and video formats. These apps provide real-time voice and visual information, allowing one-on-one or group video chats; the exchange of photos, audio, and video; and real-time online question and answer functionality. However, despite the rapidity and convenience of instant messaging as a means of communication, when applied to disease prevention and health education campaigns, there is often a lack of standardized guidelines within the medical field [As a result, medical apps, including medical informatics apps, have emerged as a new educational approach. These apps offer advantages of standardization, privacy, data confidentiality, and systematic management [These effects result from integrating smartphone apps with technology that changes people’s lifestyles and behavior [Medical information apps have demonstrated effectiveness for privacy and confidentiality, self-health management, and enhancing self-care capabilities. We conducted a systematic literature review with specific search criteria combining the keywords “percutaneous endoscopic gastrostomy” and “mHealth application” using the Boolean operator “AND” and restricting the publication year range from 1995 to 2023. These criteria were applied to the following 4 databases: CINAHL, ProQuest, PubMed, and the Cochrane Library. Among the databases scrutinized, only ProQuest yielded 2 conference abstracts that were relevant to the convergence of PEG and mHealth apps within the specified publication year range. The literature search failed to uncover any articles specifically addressing the use of mHealth apps in the context of PEG procedures.As such, the aim of this study was to establish and compare the effectiveness of a mobile app for PEG integrated with real-time communication software with that of a paper-based health education program also integrated with real-time communication software. This study evaluated the implications on several key health-related outcomes, including complications and self-care, as well as perceived well-being in terms of quality of life. Additionally, the study assessed the impact on the use of health care services, specifically looking at hospital or emergency readmissions. | PMC10625096 |
Methods | PMC10625096 | |||
Study Design | This study used a randomized controlled trial design with a study period spanning from August 7, 2018, to December 31, 2022. Random allocation was achieved using computer-generated grouping, with numbers assigned and placed in sealed envelopes. Envelopes were drawn by cases at the time of enrollment to determine group allocation, continuing until the estimated sample size was reached, as illustrated in Flow of participants for the study of an app intervention for PEG. PEG: percutaneous endoscopic gastrostomy. | PMC10625096 | ||
Recruitment | death | COMPLICATIONS | A total of 82 patients underwent initial catheter placement. After excluding 6 patients who refused participation, 76 patients were randomized and assigned to respective groups, with 38 patients in each group for the study. During the 1-month follow-up period, there was 1 death owing to complications of chemotherapy in the experimental group, and 1 patient was lost to follow-up in the control group, resulting in 37 patients in each group who completed the study. | PMC10625096 |
Research Site and Participants | The study was conducted at a prestigious medical center located in the central region of Taiwan. Inclusion criteria for the study were as follows: (1) patients who were undergoing their first PEG placement; (2) patients who had access to mobile devices such as smartphones, tablets, or computers; (3) patients or their caregivers who were able to operate mobile devices; (4) patients who could upload data according to the designated schedule; and (5) patients who could communicate in English or Taiwanese. Exclusion criteria were as follows: (1) patients with nasogastric tubes and (2) patients who required replacement of gastrostomy or nasogastric tubes during the study period. | PMC10625096 | ||
Sample Size Estimation for Power Calculation | WOUND INFECTION, COMPLICATION | The sample size estimation for power calculation was grounded in the primary outcome measure, which focused on the most common complication—wound infection. This approach was inspired by the work of Pattison and Young [ | PMC10625096 | |
Randomization and Groups | redness, voice, swelling, pain | STERILE, EVENT, HEAT, COMPLICATIONS | The research tool involves the completion of a “Participant Consent Form” by the patient or their legal representative, followed by random allocation to either the intervention group or the control group through a drawing of lots. Patients in the intervention group had the mobile device app “Percutaneous Endoscopic Gastrostomy Tracking System (HTML 5)“ (PEG app) installed during their hospitalization.The intervention group received the PEG app and Line app (for instant messaging) for guidance. The protocol encompassed a teaching and feedback process administered by the principal investigator. This process involved daily changes of the wound dressing and applying sterile gauze, which were conducted by the patient or their caregiver postoperation. Additionally, the process included ongoing monitoring of the wound's condition and regular measurement of body temperature and body weight for a duration of 1 week. Patients were instructed to self-report any symptoms related to their wound, including but not limited to redness, swelling, heat, pain, discharge, and odor, using the designated mobile app. They were encouraged to upload daily wound photos until the completion of 1 week after the procedure. In addition to the aforementioned wound symptom reporting, patients were asked to complete a self-care knowledge questionnaire as a pretest. Furthermore, in the fourth week following tube placement, patients were instructed to complete questionnaires related to self-care knowledge, self-care ability, and their quality of life through the designated mobile app. In the event of an emergency, such as visits to the emergency department within 3 days or hospital readmissions within 14 days, patients or their family members were instructed to use the mobile app to report the situation on a daily basis. The data collected through the app were then accessed by the principal investigator through a designated website. The Line app (instant messaging) provided real-time communication for patients or family members to address any caregiving issues, including the ability to conduct voice or video calls and upload wound photos for immediate response.The control group received traditional paper-based gastric tube education handouts, which include information on the purpose, indications, daily care instructions, and complications. Additionally, for ethical consideration, the Line app (instant messaging) was used for real-time communication with patients or family members to address any caregiving issues, including immediate response through voice or video calls and uploading wound photos for prompt evaluation. | PMC10625096 |
Research Instruments and Assessment of Reliability and Validity | WOUND INFECTION, COMPLICATIONS, COMPLICATION | Regarding hardware, the mobile devices included smartphones, tablets, computers, a server, a thermometer, and a scale. Regarding software, the PEG tracking system was compatible with Android or iOS mobile devices or desktop computers with the Windows operating system, and the Line app allowed real-time communication. The research team installed the ”Active Server Pages (the Gastric Tube Monitoring Platform)“ through the Google browser, which automatically sent alerts to the platform regarding patients’ ”elevated body temperature“ and ”signs of wound infection.“ The assessment tools included basic patient information, physiological monitoring forms, wound assessment forms and complication reporting, self-care knowledge, self-care ability, and quality of life measures.The app interface (prototype) was designed based on a needs analysis of patients, family members, and clinical nurses. The researchers used draw.io software to create the interface, which included the login page, the home page, basic information, wound inspection form, temperature trend chart, gastric tube wound photography, recognition of complications, complications reporting, question-and-answer functionality, quality of life questionnaire, self-care knowledge questionnaire, and self-care ability questionnaire. | PMC10625096 | |
Outcome Measures | COMPLICATIONS | Data collection took place at 2 specific time points: initially, before the intervention began to gather demographic information and assess self-care knowledge. Subsequently, data collection occurred after the intervention, within 1 week of the completion of the 1-month study period, to assess complications, quality of life, self-care knowledge, and self-care ability. | PMC10625096 | |
Primary Outcomes | COMPLICATIONS | Following the health-social approach model, complications and quality of life were the primary outcome measures. | PMC10625096 | |
Complications | bleeding, pneumonia | BLEEDING, PNEUMONIA, WOUND INFECTION, LEAKAGE, COMPLICATIONS | Complications including wound infection, leakage, migration, pneumonia, granulation, bleeding, admission to the emergency department within 3 days, and hospital readmission within 14 days were assessed. | PMC10625096 |
World Health Organization Quality of Life Brief Version | In 1995, the World Health Organization (WHO) established a quality of life questionnaire (WHOQOL) that includes the following 4 major domains: psychological, physiological, social, and environmental. The domains use a 5-point Likert scale. A score of 1 represents ”very dissatisfied,“ 2 represents ”dissatisfied,“ 3 represents ”neutral,“ 4 represents ”satisfied,“ and 5 represents ”very satisfied“ [ | PMC10625096 | ||
Secondary Outcomes | PMC10625096 | |||
Self-Care Knowledge Assessment | COMPLICATIONS | The self-care knowledge assessment primarily evaluated the level of understanding by individuals or primary caregivers about self-care for gastric tubes, based on the following 4 dimensions: wound care, tube feeding, complications, and emergency medical care. A self-designed questionnaire with 10 items assessed self-care knowledge, with correct answers given a score of 1 and incorrect or unknown answers given a score of 0. A higher score indicates better self-care knowledge, with a total possible score of 10 and a minimum score of 0. The content validity index (CVI) during the first round of expert review was 0.58. Following semantic modifications to the eighth item, “emergency situations related to gastric tubes,” to remove compound options, as suggested by the experts, the second round of expert review yielded a CVI of 1. The internal consistency of the ”self-care knowledge scale“ was determined to be Cronbach α=.66. | PMC10625096 | |
Self-Care Ability | COMPLICATIONS | The self-designed questionnaire for self-care ability primarily assessed the level of competence in performing gastric tube care behaviors by patients or primary caregivers. It covers the following 3 dimensions: measures for tube feeding, prevention of complications, and observation of symptoms of complications. The self-designed questionnaire consists of 11 items, which are rated using a 5-point Likert scale, with response options of ”always“ (5 points), ”often“ (4 points), ”sometimes“ (3 points), ”rarely“ (2 points), and ”never“ (1 point). After revisions, the second round of expert review yielded a CVI of 0.98. The internal consistency reliability of the ”self-care ability scale“ was Cronbach α=.78. | PMC10625096 | |
Ethical Considerations | This study was approved by the Human Research Ethics Review Committee of Taichung Veterans General Hospital (on August 7, 2018; institutional review board number: CF18189A-1). | PMC10625096 | ||
Data Processing and Statistical Analysis | Descriptive analysis was performed using SPSS 26.0, while inferential statistical analysis involved chi-square tests, independent | PMC10625096 | ||
Discussion | PMC10625096 | |||
Principal Findings | esophageal cancer, redness, tumor, fever, swelling, shock, cancer, pain, infection, deterioration of wound infections | TUMOR, OESOPHAGEAL CANCER, SHOCK, CANCER, WOUND INFECTION, COMPLICATION, INFECTION, LEAKAGE, HEAT, COMPLICATIONS | The research findings demonstrated that using the PEG and Line apps can improve self-care behaviors, reduce complications, and enhance quality of life at the social level. The experimental group demonstrated significantly better self-care abilities than the control group. In terms of behavior change and habit formation, the experimental group utilized the app platform to proactively capture and report abnormal wound information, such as redness, swelling, heat, and pain, through daily wound photos, wound infection checks, and vital sign data feedback. Researchers received email notifications and were able to immediately observe changes in the patients' recent wound condition, particularly the quantity, color, and location of secretions, as well as slight fever symptoms indicated by body temperature, on the app platform. This early warning system enabled patients to increase the frequency of wound dressing changes and minimize further deterioration of wound infections. Both groups were knowledgeable about daily care and complication reporting, which is consistent with the findings by Ang et al [The experimental group experienced significantly fewer complications than the control group. Specifically, in the experimental group, there were 5 cases of complications (3 cases of infection and 2 cases of leakage) reported through daily wound checks and vital sign measurements. In comparison, the control group had 19 cases of complications (15 cases of leakage and 7 cases of infection, with 1 individual possibly experiencing 2 complications concurrently). The significant reduction in leakage complications in the experimental group can be attributed to the gastrostomy tube app platform, which primarily focused on medical care and allowed continuous uploading of daily data (wound symptoms, vital signs, complication reporting, and health care personnel's analysis of tube changes). In contrast, the control group relied on ad hoc communication to identify and report abnormalities, leading to intermittent photo uploads. The continuous uploading feature for the experimental group enabled a comparison of wound progression over time, facilitating timely detection of differences in care and adjustment of dressing change methods. Patients gained confidence in self-care through social support, changed their health behaviors, and developed a habit of daily reporting on their gastrostomy tube care. This early detection of leakage and prompt intervention helped reduce the risk of skin breakdown and physiological discomfort, such as pain. Furthermore, the lack of difference in wound infection rates between the 2 groups can be attributed to the small number of cases and the consistent use of antibiotics before and after surgery in both groups. Similarly, the lack of significant differences in emergency room visits and hospital readmissions in both groups can be attributed to the small number of cases, making it difficult to achieve statistically significant results. It is recommended that future research studies consider increasing the sample size to address this limitation.Regarding quality of life, there was no significant difference in total scores between the experimental and control groups. This is primarily because both groups had a comparable number of patients with esophageal cancer who underwent chemotherapy or radiotherapy, which has a significant physiological and psychological impact, as highlighted by Farrag et al [However, the experimental group had significantly higher scores in terms of quality of life at the social level than the control group. This could be attributed to the ”cost-benefit decision-making and self-efficacy in adopting healthy behaviors through the introduction of technologies such as health app usage, resulting in individual health and societal behavioral changes,” as indicated by Wong et al [When the tumor (cancer) was discovered, it was a sudden shock, with limited knowledge about health education and future treatment directions. Fortunately, the app helped record and take photos of the wound, etc. It helped me get through the toughest days. Recording on the app every day filled me with hope and confidence. With app management, we can discover overlooked steps and compare daily records.This implies that, with guidance from health care professionals and through recording and quality control, patients regain confidence and self-efficacy. This is consistent with the findings by Singh et al [This study confirms the behavior change theory of the PEG app, in which patients initially set the goal of wound healing and learn about gastric tube care knowledge through the app. On a daily basis, they self-report their gastric tube health, pay attention to complications, compare changes in their gastric tube, and make timely corrections for any oversights. The social resources of feedback, guidance, and clarification from health care providers facilitate changes in patients’ self-directed health behaviors.The lack of a significant difference in PEG knowledge between the experimental and control groups may be attributed to a couple of possible reasons. (1) Both groups had smartphones and could access PEG knowledge online and through patient support group chats, resulting in improved knowledge after intervention for both groups, and (2) both groups had instant messaging apps for immediate access to answers to questions, which could also be a contributing factor to the lack of a significant difference in knowledge. In terms of nursing application, the research findings demonstrate that the gastric tube action tracking system dynamically improved patients’ self-care knowledge, skills, and quality of life related to gastric tube management while reducing the incidence of complications and emergency department visits. Following the principle of a one-stop service, it is recommended to integrate the PEG app into the case management workflow of the hospital system, from inpatient to discharge, and expand it to cancer centers in parallel, achieving seamless integration of mHealth app information across hospital platforms, which brings substantial benefits to patients in terms of continuity of care, resulting in a win-win-win outcome. In terms of data collection, we suggest using big data approaches to collect wound evolution, vital signs, infection indicators, wound photos, and other features for early prediction of gastric tube wound infection through artificial intelligence algorithms. | PMC10625096 |
Limitations | In terms of research limitations, the participants knew to which group they belonged, which might have introduced potential biases and limitations to the objectivity of data collection, as blinding was not possible. Therefore, for future studies, it is recommended to involve personnel other than the researchers themselves in data collection to minimize researcher-related effects. With respect to research tools, considering the time and cost constraints, we suggest following the approach proposed by Cheng et al [ | PMC10625096 | ||
Conclusions | COMPLICATIONS | The group using the PEG app indicated significant improvements in self-care abilities, reduced complications, and better social support in terms of quality of life compared with the control group. These findings highlight the benefits of the PEG app for home-based postoperative care of patients with gastrostomy tubes. This study suggests that patients discharged after their first PEG placement should be assisted in using the PEG app to facilitate independent self-management of their gastrostomy tubes at home.The authors express our gratitude to Taichung Veterans General Hospital for permitting us to recruit research participants and conduct the study on their premises, as well as to the 5 clinical experts who offered their feedback on the instrument.Authors' Contributions: LCL and BLC contributed to the study design and implementation, data analysis, interpretation of the findings, and preparation of the manuscript. HCL and SSY contributed to the study design and identified the clinical cases. SCW contributed to data analysis and interpretation of the findings. HHC contributed to the study design.Conflicts of Interest: None declared.CONSORT-eHEALTH checklist (V 1.6.1). | PMC10625096 | |
Abbreviations | content validity indexmobile healthpercutaneous endoscopic gastrostomyWorld Health OrganizationWorld Health Organization Quality of Life Brief Version | PMC10625096 | ||
Background | Obesity, heterogenous asthma, asthma, CWP, weight loss | OBESITY, ASTHMA | Obesity is often associated with uncontrolled, difficult-to-treat asthma and increased morbidity and mortality. Previous studies suggest that weight loss may improve asthma outcomes, but with heterogenous asthma populations studied and unclear consensus on the optimal method of weight management. The Counterweight-Plus Programme (CWP) for weight management is an evidence-based, dietitian-led total diet replacement (TDR) program. | PMC10808069 |
Research Question | obesity, difficult-to-treat asthma, UC, asthma, CWP | OBESITY, ASTHMA | Can use of the CWP compared with usual care (UC) improve asthma control and quality of life in patients with difficult-to-treat asthma and obesity? | PMC10808069 |
Study Design and Methods | CWP, difficult-to-treat asthma | We conducted a 1:1 (CWP to UC) randomized, controlled single-center trial in adults with difficult-to-treat asthma and BMI of ≥ 30 kg/m | PMC10808069 | |
Results | Weight loss, CWP, UC | Thirty-five participants were randomized (36 screened) and 33 attended the 16-week follow-up (n = 17 in the CWP group, n = 16 in the UC group). Overall, mean ACQ6 score at baseline was 2.8 (95% CI, 2.4-3.1). Weight loss was greater in the CWP than UC group (mean difference, –12.1 kg; 95% CI, –16.9 to –7.4; | PMC10808069 | |
Interpretation | obesity, asthma, UC | OBESITY, ASTHMA | Using a structured weight management program results in clinically important improvements in asthma control and quality of life over 16 weeks compared with UC in adults with difficult-to-treat asthma and obesity. This generalizable program is easy to deliver for this challenging phenotype. Longer-term outcomes continue to be studied. | PMC10808069 |
Trial Registry | ClinicalTrials.gov; No.: NCT03858608; URL: | PMC10808069 | ||
Graphical Abstract | PMC10808069 | |||
Key Words | PMC10808069 | |||
Abbreviations | ASTHMA | Asthma Control Questionnaire 6Asthma Quality of Life QuestionnaireCounterweight-Plus Programmefractional exhaled nitric oxideinterquartile rangeminimal clinically important differencetotal diet replacementusual care
FOR EDITORIAL COMMENT, SEE | PMC10808069 | |
Study Design and Methods | obesity, UC, asthma, CWP, weight loss | OBESITY, ASTHMA | In this randomized, controlled, open-label, parallel study of a TDR weight loss program compared with usual care (UC) in individuals with difficult-to-treat asthma and obesity, participants were randomized 1:1 using a password-protected, online, third-party randomization service to CWP or UC. | PMC10808069 |
Participants | Eligible participants 18 to 75 years of age with BMI of ≥ 30.0 kg/m | PMC10808069 | ||
Measurements | Anxiety, asthma, dyspnea | THORACIC, ASTHMA, ASTHMA | Baseline demographics, asthma and other medical history, and medication information were obtained at visit 1. At all visits, the Asthma Control Questionnaire 6 (ACQ6) and Asthma Quality of Life Questionnaire (AQLQ) scores were recorded. The ACQ6 is a validated asthma control score comprising six questions,At all visits, other data collected included anthropomorphic measures, health-care use, Medical Research Council dyspnea scale score, Hospital Anxiety Depression scale score, blood sampling, spirometry (Vitalograph ALPHA spirometer) as per European Respiratory Society/American Thoracic Society standards, | PMC10808069 |
Counterweight-Plus Program | CWP, weight loss | The CWP consisted of three phases: TDR (0-12 weeks), food reintroduction (13-18 weeks), and weight loss maintenance (19-52 weeks) and was delivered by experienced dietitians with CWP training ( | PMC10808069 | |
Usual Care | asthma | DISEASE, ASTHMA, SECONDARY | Standard asthma care was continued in all participants in all groups. This included continuation of previously initiated asthma medication, but also modification of asthma treatment based on clinical need; those with worsening asthma received treatment escalation, whereas those with improving disease or lack of treatment efficacy underwent medication removal. All participants continued to be reviewed at their original secondary asthma clinic as part of standard care. All participants had the opportunity for weight management advice (ie, healthy eating and promoting exercise if in the UC group), inhaler technique, and asthma education as needed at each study visit. | PMC10808069 |
Primary Outcome | CWP, UC | The primary outcome was difference in change in ACQ6 score from baseline (visit 1) to 16 weeks (visit 2) between the CWP and UC groups. | PMC10808069 | |
Secondary Outcomes | CWP, UC | Secondary measures included difference in change in AQLQ score from baseline to 16 weeks between CWP and UC groups, overall and in each AQLQ domain (symptoms, activity, emotional, and environmental), and the difference in proportion of participants with ≥ 0.5 change (MCID in ACQ6 | PMC10808069 | |
Sample Size | CWP, UC | To demonstrate a difference of 0.5 between mean changes in ACQ6 score in CWP and UC groups from baseline to 16 weeks, based on an SD of 0.5 from a similar population, | PMC10808069 | |
Statistical Analysis | Participants attending visits 1 and 2 were included for intention-to-treat analysis. Continuous variables were described as mean (95% CI) or median (interquartile range [IQR]) based on distribution and compared using independent | PMC10808069 | ||
Results | PMC10808069 | |||
Participation and Baseline Characteristics | CWP, ABPA | ABPA, ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS, ASTHMA | Participants were recruited from August 2019 through August 2021, with 2-year follow-up scheduled to finish in August 2023. Sixteen-week follow-up visits continued until December 2021. Of 36 participants screened, one was ineligible (Consolidated Standards of Reporting Trials flow chart.Overall, mean age was 53 years, 63% were female sex, 54% were former smokers, and 43% were never smokers (Baseline CharacteristicsData are presented as No. (%), mean (95% CI) if parametric, or median (interquartile range) if nonparametric (the latter denoted by ∗). 6MWD = 6-min walk distance; ABPA = Allergic Bronchopulmonary Aspergillosis; ACQ6 = Asthma Control Questionnaire 6; AQLQ = Asthma Quality of Life Questionnaire; BD = bronchodilator; BDP = beclomethasone dipropionate; CWP = Counterweight-Plus Programme; DFB = dysfunctional breathing; FIndividuals in the CWP group were slightly older, had lower baseline peak expiratory flow rate and FEV | PMC10808069 |
Primary Outcome | CWP, UC | ASTHMA | Over 16 weeks, mean change in ACQ6 score was –0.45 (95% CI, –1.02 to 0.13) for the CWP group and 0.23 (95% CI, –0.17 to 0.63) for the UC group, with a mean difference of –0.69 (95% CI, –1.37 to –0.01; Intention-to-Treat Comparison of Asthma Control and Quality-of-Life Outcomes Between CWP and UC Groups Over 16 WeeksData are presented as mean (95% CI). ACQ6 = Asthma Control Questionnaire 6; AQLQ = Asthma Quality of Life Questionnaire; CWP = Counterweight-Plus Programme; UC = usual care.Comparison of mean difference using analysis of covariance with baseline variable as covariate.A-F, Graphs showing change in ACQ6 score (A), AQLQ overall score (B), AQLQ symptom domain score (C), AQLQ activity domain score (D), AQLQ emotional domain score (E), and AQLQ environmental domain score (F) between the CWP group and UC group at baseline (V1) and 16 weeks (V2). P value compares change in variable between CWP and UC groups with independent t test. ACQ6 = Asthma Control Questionnaire 6; AQLQ = Asthma Quality of Life Questionnaire; CWP = Counterweight-Plus Program; UC = usual care. | PMC10808069 |
Secondary Outcomes | CWP | Over 16 weeks, mean change in overall AQLQ score was 0.81 (95% CI, 0.28-1.35) for the CWP group and 0.08 (95% CI, –0.32 to 0.48) for the UC group, with a mean difference of 0.76 (95% CI, 0.18-1.34; Bar graph showing the proportion of participants achieving minimal clinically important difference in ACQ6 and AQLQ scores in the Counterweight-Plus Program group and usual care group over 16 weeks. Compared using χ | PMC10808069 | |
Other Outcomes | CWP, weight loss, UC | EVENTS | Mean weight loss was –13.5 kg (95% CI, –17.5 to –9.6) for the CWP group and –1.4 kg (95% CI, –3.2 to 0.4) for the UC group (mean difference, –12.1 kg; 95% CI, –16.9 to –7.4 kg; Intention-to-Treat Comparison of Other Outcomes Between CWP and UC GroupsData are presented as mean (95% CI) for parametric data or median (interquartile range) for nonparametric data (the latter denoted by ∗). Annualized health-care use variables compare change from baseline data (No. of events in prior 12 mo) to 16 wk ([No. of events × 365] / No. of d between visits). 6MWD = 6-min walk distance; BD = bronchodilator; CWP = Counterweight-Plus Programme; FComparison using independent | PMC10808069 |
Per-Protocol Analysis | CWP | Of the 33 participants attending visit 2, two participants did not tolerate CWP ( | PMC10808069 | |
Weight Loss Extent and Change in ACQ6 and AQLQ Scores | CWP, weight loss | ASTHMA | Post hoc analysis of changes in ACQ6 and AQLQ scores with CWP in groups based on extent of total body weight loss (< 10%, 10%-15%, and ≥ 15%) showed trends toward greater benefit with greater weight loss (Post Hoc Comparison of Asthma Control and Quality of Life With CWP by Percentage Weight LossData are presented as mean (95% CI). ACQ6 = Asthma Control Questionnaire 6; AQLQ = Asthma Quality of Life Questionnaire; CWP = Counterweight-Plus Programme.Comparison of mean difference using analysis of variance. | PMC10808069 |
Adverse Events | migraine, CWP, asthma, COVID-19 gastroenteritis | ADVERSE EVENTS, MIGRAINE, ASTHMA, COVID-19 PNEUMONITIS | No unexpected serious adverse events or intervention-related adverse events occurred during the trial. Overall, five participants were hospitalized during the 16-week period: three participants in the UC group (one participant with a ward level exacerbation of asthma, one participant with exacerbation of asthma requiring high dependency monitoring, one participant with COVID-19 pneumonitis) and two participants in the CWP group (one participant with COVID-19 gastroenteritis and one participant with migraine). | PMC10808069 |
Discussion | obesity, exertional breathlessness, difficult-to-treat asthma, obesity-associated asthma, UC, overweight, asthma, CWP, weight loss | OBESITY, ASTHMA | In this pragmatic open-label, randomized, controlled trial, we showed that delivery of a supported low-calorie total diet replacement program (Counterweight-Plus) to patients with difficult-to-treat asthma and obesity was safe and led to significant improvements in asthma control and quality of life compared with UC over 16 weeks. We demonstrated clinically significant improvements in favor of CWP for ACQ6 score, AQLQ score overall, and symptoms, activity, and environmental AQLQ domains. Comparison by percentage total body weight loss showed that > 10% loss is needed to gain clinically relevant benefits, although loss of > 15% likely imparts greater benefit. In addition, CWP showed favorable impacts on exertional breathlessness and anthropometric measures, the latter likely to have important consequences for other aspects of general health. These findings suggest that conservative treatment targeting substantial weight loss in patients with difficult-to-treat asthma and obesity is safe and can impact patient-centered outcomes favorably. Longer-term outcomes are awaited to determine whether benefits persist. This program can be administered in a primary care setting.A small number of trials have evaluated the impact of weight loss interventions in the population with obesity-associated asthma, with varying methodologies and outcomes. Freitas et alConversely, a study of 330 participants (of 2,022 screened) reported by Ma et alScott et alÖzbey et alGrandi Silva et alThis trial has several possible limitations. This proof-of-concept feasibility study was sufficient to detect significant effects, but a larger study is needed to generate definitive results. Small differences were observed between groups at baseline (age, peak expiratory flow rate, FEVLonger-term follow-up is required to determine whether weight loss is maintained and whether asthma-related benefits persist. Additionally, a future trial with a greater sample size is justified to generate definitive results. Further research should explore the factors associated with successful treatment outcome and efficacy in the overweight (BMI, 25.0-29.9 kg/m | PMC10808069 |
Interpretation | obesity, dyspnea, UC, asthma, CWP | OBESITY, ASTHMA | Compared with UC, use of the CWP weight management program with dietitian support improved asthma control and quality of life as well as dyspnea and anthropomorphic measures over 16 weeks in individuals with difficult-to-treat asthma and obesity. Further research is needed to confirm the longer-term outcomes and to identify predictors of treatment response. | PMC10808069 |
Funding/Support | This study was funded by an NHS Greater Glasgow and Clyde Endowment fund. | PMC10808069 | ||
Financial/Nonfinancial Disclosures | The authors have reported to | PMC10808069 | ||
References | PMC10808069 | |||
Supplementary Data | PMC10808069 | |||
e-Online Data | PMC10808069 | |||
Introduction | migraine, headache | MIGRAINE, HEART, ADVERSE EVENTS, PRIMARY IMMUNODEFICIENCY | Edited by: Francisco Javier Espinosa-Rosales, Fundación Mexicana para Niñas y Niños con Inmunodeficiencias (FUMENI), MexicoReviewed by: Marco Antonio Yamazaki-Nakashimada, National Institute of Pediatrics, Mexico; Soo Jin Cho, Hallym University Dongtan Sacred Heart Hospital, Republic of KoreaThis article was submitted to Primary Immunodeficiencies, a section of the journal Frontiers in ImmunologyHeadache and migraine adverse events are common concerns in the administration of intravenous immune globulins (IVIG). Trials of IVIG for primary immunodeficiency (PI) are typically small and have reported headache and migraine data inconsistently. | PMC9932595 |
Methods | migraine, headache | MIGRAINE | We analyzed headache and migraine in pooled data from three pivotal trials of Gammaplex | PMC9932595 |
Results | Headache, headaches, headache, migraines, migraine | MIGRAINE, MIGRAINES | In total, 1482 infusions were administered to 123 patients, with 94.6% of infusions achieving the maximum infusion rate. At least one product-related headache was reported in 6.1% (90/1482) of infusions. At least one product-related migraine was reported in 0.5% (7/1482) of infusions. Headache rates were higher for adults vs pediatric patients, females vs males, and 21-day vs 28-day dosing schedules, but were similar for the 5% and 10% IVIG products. Most headaches and migraines occurred during or within 72 hours of the infusion. Rates decreased after the first few infusions. | PMC9932595 |
Discussion | migraine, headache | MIGRAINE | Patients receiving this IVIG product on a 15-minute rate escalation protocol had low rates of headache and migraine for both the 5% and 10% formulations. | PMC9932595 |
Introduction | primary immunodeficiency disorders | Intravenous immune globulin (IVIG) is a standard therapy for the treatment of primary immunodeficiency disorders (GammaplexBecause PI is rare, trials of IVIG in patients with PI tend to be small, with most late-phase clinical trials of these agents involving 50 or fewer patients ( | PMC9932595 | |
Materials and methods | This was an exploratory retrospective analysis of data pooled from three pivotal trials of the IVIG products Gammaplex 5% and Gammaplex 10%, (immune globulin intravenous [human], Bio Products Laboratory, Elstree, UK) for the treatment of PI. Characteristics of the pooled trials (This retrospective pooled analysis did not directly engage any patients. All trials included in the analysis were approved by an institutional review board/ethics committee at each study center and obtained written informed consent from each participant (or their parent/guardian, if applicable) to participate in the study. Participants from the included studies agreed to have their results published. | PMC9932595 | ||
Statistical analysis | migraine, headaches, headache, migraines | ADVERSE EVENT, ADVERSE EVENT, MIGRAINES, MIGRAINE, EVENTS | Infusion and adverse event data were pooled across three Gammaplex studies (GMX01, GMX04, GMX07). Summaries of infusion protocol were generated to identify the proportion of infusions following the 15-minute rate escalation protocol and reaching the maximum infusion rate. Adverse events were documented based on direct observation during each infusion, interviews with the patient, and/or diary entries. Summaries of tolerability were generated to identify the proportion of infusions associated with product-related AEs. Product-related AEs were defined as those considered possibly, probably, or definitely related to administration of the product by the investigator. Infusion-associated AEs were defined as those occurring during or within 72 hours of the end of the infusion, specifically headaches and migraines. When assessing infusion protocol and tolerability, 95% confidence intervals for the proportion of infusions were calculated using the Clopper-Pearson (exact) method. Differences in tolerability across product formulation, dose categories, infusion order, and PI diagnosis were summarized using a 95% confidence interval for difference of proportions. All analyses were produced using SAS 9.4. All Exploratory subgroup analyses were conducted by gender (male vs female), age (adult vs pediatric), product formulation (5% IVIG vs 10% IVIG), infusion schedule (every 21 days vs every 28 days), and dose tertile (≤429 mg/kg, >429-≤526 mg/kg, and >526 mg/kg). Exploratory bivariate analyses were conducted for age and product formulation, age and gender, and gender and product formulation. Data were analyzed both by infusions and by patients to evaluate the extent to which a subset of patients accounted for headache and migraine events. | PMC9932595 |
Infusion rate | In all trials, infusion of the IVIG product was started at an initial infusion rate for 15 minutes (0.01 mL/kg/min for the IVIG 5% formulation, 0.005 mL/kg/min for the IVIG 10% formulation), then advanced every 15 minutes if tolerated to a maximum of 0.08 mL/kg/min, using the protocols shown in Infusion rate protocols ( | PMC9932595 | ||
Results | XLA, CVID | PRIMARY IMMUNODEFICIENCY, X-LINKED AGAMMAGLOBULINEMIA, DISEASE, COMMON VARIABLE IMMUNODEFICIENCY, CVID, DISEASE | The analysis included all Gammaplex infusions administered during the PI clinical trials (1482 infusions administered to 123 patients). Of these, 1234 infusions of the 5% IVIG formulation were administered to 108 patients and 248 infusions of the 10% IVIG formulation were administered to 47 patients. Both adult and pediatric patients participated in the 5% and 10% studies. Key patient, disease, and treatment characteristics for each trial are summarized in Patient Demographics, Disease Characteristics, and Infusion Parameters (CVID, common variable immunodeficiency; PI, primary immunodeficiency; XLA, X-linked agammaglobulinemia.*Three adults were premedicated for a total of five infusions of the 5% IVIG formulation and for five infusions of the 10% IVIG formulation. Six pediatric patients were premedicated for a total of 25 infusions of the 10% IVIG formulation. Given the small number of patients and infusions, the effects of premedication were not evaluated in this study. | PMC9932595 |
Achievement of the maximum infusion rate | The maximum infusion rate was achieved in 94.6% (1402/1482) of infusions (Percentage of infusions in which the maximum infusion rate was achieved, by subgroup. | PMC9932595 | ||
Percentage of infusions with reported product-related headache or migraine | migraine, headache | MIGRAINE | Product-related, infusion-associated headache was reported in 6.1% (90/1482) of all infusions (Percentage of infusions associated with product-related headache or migraine by subgroup.In the age-by-product breakdown, the percentage of infusions with at least one product-related, infusion-associated headache was similar for the 5% IVIG product and the 10% IVIG product in adults (7.1% vs 7.2%, Product-related, infusion-associated migraine was reported in 0.5% (7/1482) of all infusions ( | PMC9932595 |
Percentage of patients reporting at least one product-related headache or migraine | migraine, Headache, headache, migraines | MIGRAINE, MIGRAINES | Headache and migraine were reported by 28.5% (35/123) and 4.1% (5/123) patients, respectively. The percentage of patients reporting at least one product-related headache was similar for adults and pediatric patients (28.0% [23/82] vs 29.3% [12/41], The percentage of patients reporting at least one headache was lower for males than females (18.5% [12/65] vs 39.7% [23/58], At least one product-related migraine was reported by 4.1% (5/123) of patients. Of the seven reported migraines, six were reported by four adult female patients, with four migraines associated with infusion of the 5% IVIG formulation and two with the 10% IVIG formulation. The remaining migraine was reported by one male pediatric patient who was receiving the 10% IVIG formulation. The percentage of patients reporting at least one product-related migraine was significantly lower for males than females (0% [0/37] vs 8.9% [4/45], | PMC9932595 |
Timing of headache and migraine events | migraine, headache | MIGRAINE, EVENTS | Most headache events (77%, 96/125) and all migraine events (100%, 7/7) occurred within 72 hours of the start of the infusion (Timing of migraine and headache relative to the start of the infusion.Incidence of product-related headache and migraine by infusion number, number of events | PMC9932595 |
Discussion | migraine, Headache, IVIG-related headache, headache | MIGRAINE, ADVERSE EVENT | Headache is clearly associated with IVIG therapy for PI, but not with PI itself. In this retrospective analysis, we analyzed pooled data from three clinical trials of a single IVIG agent to confirm and extend our understanding of headache and migraine associated with IVIG infusions. Our analysis provides a systematic evaluation of infusion times and rates of headache and migraine in a large population of patients receiving IVIG treatment for PI. Pooled analyses can be used to reaffirm data present in individual trials or to understand new concepts that may be better represented in a larger data set (Almost all patients achieved the maximum infusion rate specified in the product labeling, utilizing an infusion protocol with 15-minute rate escalation increments. Recent trials of other IVIG products have reported achieving per-protocol infusion rates in >90% of infusions, but with longer rate escalation increments (30 minutes vs 15 minutes for the IVIG formulations used in this analysis) (The observed rates of product-related headache (6.1% of infusions, 28.5% of patients) and migraine (0.5% of infusions, 4.1% of patients) occurred with 94.6% of patients achieving the maximum infusion rate, and use of a 15-minute rate escalation protocol. To place these results in context, headache rates reported in recent studies of IVIG in PI range from 2% to 22% on a per-infusion basis, and from 8% to 50.8% on a per-patient basis (Despite short (15-minute) escalation increments in the infusion protocol, rates of product-related headache were not significantly different for the 5% and 10% formulations in the entire population, the adult subgroup, and the pediatric subgroup, whether calculated at the infusion level or on a per-patient basis. In contrast to our results, 10% IVIG formulations have historically been associated with increased adverse event rates compared to 5% IVIG formulations (With IVIG therapy, first doses have been associated with more reported AEs than subsequent doses (Product-related headache and migraine were concentrated in a minority of patients, and only a small proportion of the total number of infusions were preceded with premedications. This finding should serve as a reminder that many patients may tolerate these infusions without difficulty and without the need for premedications. Perhaps greater emphasis on selecting patients most at risk for AEs would result in more judicious use of premedication.Rapid IVIG infusion is generally considered to be a risk factor for IVIG-related headache (This pooled analysis is limited by the open-label design of the studies that were pooled for the analysis, the retrospective nature of the analysis, and the relatively small number of patients included, although the data set includes a large number of infusions. The pediatric patients included in trials GMX04 and GMX07 may not have reported their headache and migraine complaints appropriately. Lack of randomization increases the risk of bias in the subgroup analyses. In addition, the data are drawn from clinical trials rather than routine practice. Because of these limitations, the results should be considered suggestive rather than conclusive. However, the information presented here may help clinicians mitigate headache and migraine AEs in patients receiving IVIG infusions for PI.In summary, this retrospective data analysis found in patients being treated with IVIG for PI, rates of headache (6.1%) and migraine (0.5%) were low for adult and pediatric patients and for both the 5% and 10% formulations. A large majority of infusions (94.6%) achieved the maximum infusion rate. Either formulation of this IVIG product can be administered using a 15-minute rate escalation protocol without excessive rates of headache or migraine. | PMC9932595 |
Data availability statement | The datasets presented in this article are not readily available because the datasets generated during and/or analyzed during the current study are not publicly available because they containing information that could compromise research participant privacy/consent. Reasonable requests as appropriate and permissible will be considered by the corresponding author. Requests to access the datasets should be directed to Kim Clark, Kim.Clark@bpl.co.uk. | PMC9932595 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the institutional review board/ethics committee at each study center. The 3 trials each involved multiple centers. Participants from the included studies agreed to have their results published. Written informed consent to participate in this study was provided by each participant or the participants’ legal guardian/next of kin as applicable and appropriate. | PMC9932595 | ||
Author contributions | EW, KC, and BG contributed substantially to data collection, analysis, manuscript writing, and editing. ME conducted data analysis. All authors contributed to the manuscript and approved the submitted version. | PMC9932595 | ||
Acknowledgments | K. Baldwin | Medical writing and editorial support was provided by Medical Leverage, Edward K. Baldwin, PhD and Luiza Erthal, PhD. | PMC9932595 | |
Conflict of interest | EW and KC are employees of Bio Products Laboratory. ME is an employee of Atlantic Research Group, which contracted with Bio Products Laboratory to perform the data analysis for the study. BG is a consultant for BPL; a speaker and consultant for Takeda; a speaker and consultant for Grifols; a consultant for Koru; a consultant for ADMA Biologics; a consultant for Kedrion; a consultant for Pfizer; a speaker and advisor for Chiesi; and a speaker and consultant for Horizon, and has received clinical research support from Octapharma. | PMC9932595 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC9932595 | ||
References | PMC9932595 | |||
Background: | Obesity, obesity | OBESITY, OBESITY, DISEASES, INFLAMMATORY DISEASE | Obesity is classified as a low-grade chronic and systemic inflammatory disease and results from complicated interactions between genes and environmental factors, which leads to many diseases and affects the quality of life. There are growing interests in the effectiveness of probiotics as a supplementation to reduce obesity through regulating microbiota host metabolism. Probiotics may influence the interplays among gut, brain, adipose, and liver in a way leading to weight. Since limited studies have been conducted on human subjects, more investigation is needed in this field. Therefore, this study sheds light on the investigation of the anti-obesity effect of probiotic supplementation. | PMC10118337 |
Methods: | obese, ®, Saudi overweight | OBESE | Ninety adult Saudi overweight or obese adult will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics “MCP® BCMC® strains” for 12 weeks in a double-blind study. Biochemical markers will be measured through blood samples analyzed. Measurements and samples will be obtained at baseline and by the end of the study, at 12 weeks of treatment. | PMC10118337 |
Discussion: | This study expects that the multi-strain probiotic product will induce beneficial changes in gut microbiota (GM) including reduction in weight, especially the visceral fat, which leads to reduction in systemic inflammatory state associated with fat accumulation. | PMC10118337 | ||
1. Introduction | obesity, obese, overweight, human obesity | OBESITY, OBESE | The incidence of obesity has increased to be a major health concern in the twenty-first century. According to the World Health Organization, 39% of adults ages 18 years and over were overweight in 2016, and 13% were obese.Confirmed data in humans have shown an association between obesity and the gut microbial community structure.Based on the above, it is evident that a deep understanding of the GM functions helps to find appropriate solutions to control the increasing weight. In animal studies, physical and biochemical parameters, metabolic and inflammatory markers, and alterations in GM diversity revealed beneficial results against obesity whereas the results in humans are still rare. Alteration of the GM via applying natural or supplementation probiotic is considered as a new and promising therapeutic intervention treating human obesity. The present clinical trial aims to study the anti-obesity effects of multi-strain probiotic supplementation on overweight and obese adults. | PMC10118337 |
1.1. Aim of the study | obese, overweight | OBESE | Study the anti-obesity effect of consuming multi-strain probiotic supplementation on overweight and obese adults. | PMC10118337 |
1.2. Objectives | Evaluate the anti-obesity effect of multi-Strain probiotic supplementation.Investigate the effect of probiotics on reducing Lipopolysaccharides LPS.Determine the effect of probiotics on liver functions.Study the association between probiotics and food intake.Evaluate the role of gender difference in response to probiotic. | PMC10118337 | ||
2. Methods | gastrointestinal surgery, overweight or first-class obese | THYROID DISORDERS, RECRUITMENT, DISEASES, IMMUNE SYSTEM DISEASES | The study is a 12-week, a single center, double-blind, placebo-controlled, randomized, trial to be conducted at the occupational clinical of King Saud University Medical City, Riyadh, Saudi Arabia. Recruitment of subjects will be opened for all students and employees who from King Saud University. The study link will be sent to their email, also they can scan the study code from the banners which are in the active areas at the hospital. A total of 90 overweight or first-class obese subjects, males and females will be recruited and divided equally into 2 groups, a probiotics group, and a placebo group. To be included, a participant should be an adult male or females aged between 19 to 40 years with body mass index (BMI) from 25 to 35 kg/mSubjects who suffer from diseases and are on treatment, such as immune system diseases or thyroid disorders, pregnant women or who plan to be pregnant, those who had gastrointestinal surgery, hormone replacement therapy, on antibiotics and those who consume probiotic or prebiotic supplements regularly will be excluded. Figure Schematic diagram illustrated the methodology.The study has been approved by the Institutional Review Board of the College of Medicine in King Saud University (IRB E-20-5503). The study has also been registered in the Saudi Food and Drug Administration registry (SCTR number 21070702) as well as the US clinical trials registry (ClinicalTrials.gov Identifier: NCT05667038). | PMC10118337 |
2.1. Intervention | overweight or first-class obese | The study is a 12-week, double-blind, randomized, placebo-controlled clinical trial, 90 overweight or first-class obese subjects will be divided equally into 2 groups, a probiotics group, and a placebo group. A hypocaloric diet will be applied for both groups. Interventions will be performed in the first week and then continue to the twelfth week, in which all subjects will receive 3 boxes of either probiotics or placebo, all boxes are identical in color, weight, and shape. All subjects will be instructed to consume 2 sachets per day, first sachet is before the first meal by 10 minutes, and the other one before the last meal by ten minutes. For probiotics sachet, it contains granular powder with 6 microorganism strains (30 × 10 | PMC10118337 | |
2.2. Outcome measures | CREST | Medical history, including physical examination and vital signs, will be recorded before inclusion. Assessment of food frequency consumption for most probiotic and prebiotic food in Saudi culture by using a Food Frequency Questionnaire designed especially for this study. 24-hour dietary recall, all subjects will be asked to record 3 days for their daily intake of food before the intervention, and 3 days by the end of the intervention, in which 2 weekdays and 1 weekend. The first day will be done with a researcher in the clinic, then the other 2 days will be collected by phone call. Anthropometric measurements, the primary outcome of the present study is the relative change in waist circumference (WC) measurement from baseline to end-of-treatment. Other obesity-related outcomes included body weight, WC, and hip circumference. The anthropometrics included:Height will be measured using stadiometer to the nearest 0.5 cm. Subjects should remove shoes, any things cover their head, any cloths that may make it difficult to stand flat against the wall. Standing should be straight, on feet flat on the floor with keeping head, shoulders, and buttocks are touching the wall. The line of sight and chin should be parallel to the floor.Body weight will be recorded before breakfast, using a calibrated column scale to the nearest 0.1 kgWC will be measured at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest to the nearest 0.5 cm. To get an accurate waist size, the WC should be taken in a normal respiration situation, and after overnight fasting to reduce stomach contents which may affect the measurement.Hip circumference will be taken around the widest portion of the buttocks, with the tape parallel to the floor. Measuring waist and hip will be obtained by using 150 cm anthropometric measuring stretch-resistant tape ended with steel Hook. The tape should be held snugly around the body, but not in the constricted way. The subject should stand with closed feet, opened arms, with evenly distributing body weight, and should wear little clothing. Also, the subject should be relaxed to avoid any changing in the tension of the abdominal wall. To insure obtain right measuring, measurement should be repeated twice; if the difference is only 1 cm, the average should be counted. If the difference is more than 1 cm, the measurement should be repeated.Physical activity will be assessed at the beginning and the end of the study using the International Physical Activity Questionnaire (short form, last 7 days, self-administered format). Table Visits.This table shows the tasks to be accomplished for each participant visit. | PMC10118337 | |
2.3. Blinding | BLIND | The identity of probiotic and control treatments will not be known to investigators, research staff, or subjects. The following study procedures will be in place to ensure double-blind administration of study treatments:Access to the randomization code will be strictly controlled.Packaging and labeling of test and control treatments were coded, but shape, color, smell, and weight will be identical.Due to necessity of evaluate the activity of treatment product, both packages (with different letters) will be sent to microbiology lab to determine the activity of strains, the result will be blind without mention to any letter.Unblinding will be done on completion of the clinical study. During the study, the blind may be broken only in emergencies when knowledge of the subject treatment group is necessary for further subject management. In this case, the investigator should discuss the emergency with the Medical Monitor prior to unblinding. The principal investigator (PI) has a direct number-mobile to contact with the company personnel in charge of blinding. The product will be provided in sachets packed and coded as numbers. All subjects will be allocated in blocks according to their gender, age, and BMI. From those blocks, PI will make a list of pairs, each pair has 2 subjects. This list will be sent later to the collaborative members from inpatient pharmacy, who will allocate subjects (1:1) in 2 different groups. The randomization scheme will be computer generated using Excel sheet. After completing the intervention, a request letter will be sent to the company to unblind the study. Then the company lab will send an unblinding letter to inform us which alphabet is probiotic or placebo. | PMC10118337 | |
1.2.3. Implementation. | The roles of members in allocation process:First: PI:Give a unique number for each subject.Sign subjects in blocks according to their gender, age, and BMI.Make a list of pairs and send it the inpatient pharmacy.Second: Members from inpatient pharmacy:Allocate subjects (1:1) in 2 different groups.Make the randomization scheme by computer generated via Excel sheet. | PMC10118337 | ||
2.4. Sample size calculation and data analysis | The power calculation was based on the results of Gomes and his colleagues who used the G-Power software (version 3.0.10) to calculate the sample size. The primary outcome in that study is the difference in WC between groups. The power calculation requires 17 subjects in each group (95% power; 5% type I error) to detect a difference in WC. | PMC10118337 | ||
3. Discussion and conclusion | obesity, overweight, weight loss, diabetes | OBESITY, OBESE, CHRONIC DISEASES, INSULIN SENSITIVITY, DIABETES | There is a growing interest in the effectiveness of probiotics for treating chronic diseases. This study will evaluate the effects of multi-strain probiotics as an anti-obesity among overweight and obese Saudi adults. Regulating microbiota is considered a potential therapeutic avenue for obesity through many different mechanisms.The strains which have been used in this study are expected to beneficial effect on weight loss, however, any other results will still be interesting. Previous clinical trials in Saudi Arabia yielded positive results on the effects of multi-strain probiotics among patients with diabetes, specifically favorable outcomes in terms of improving insulin sensitivity. | PMC10118337 |
Acknowledgments | The authors acknowledge the research coordinators who are currently supporting the conduct of this trial. | PMC10118337 |
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