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Statistical analysis | To test for normality assumptions, the Kolmogorov–Smirnov test was performed, and the Levene test was used to test for equal variance assumptions (p < 0.05). The independent-sample t-test was conducted if normality was assumed for baseline comparisons between groups in age, weight, body fat, maximum strength, and muscl... | PMC10439966 | ||
Ethics declarations | The studies involving human participants were reviewed and approved by Experiment of Sports and Health Promotion Research Center, College of P.E and Sports, Beijing Normal University of ethics committee. Written informed consent to participate in this study was provided by the all participants. Written informed consent... | PMC10439966 | ||
Results | BBS | Table Baseline characteristics of participants (mean, standard deviation).Note: *independent-sample t-test, Perceive ratio and action score. Note. BBS, Barbell squat; BWS, Bodyweight squat; OMNI, OMNI-Resistance Exercise Scale (OMNI-RES) of perceived exertion; OMNI (leg 3), OMNI score of legs perceived exertion after c... | PMC10439966 | |
Within-group differences in changes in maximum strength, muscle thickness, and body fat | After 6 weeks, the barbell-back squat group showed a significant decrease in body fat percentage (t (7) = 2.54, Effects on lower limbs muscle thickness.Note: Pre- and Post-*Paired Sample T-test, Note: 1 was pre, 2 was post.In the barbell back squat group, Fig. Pre and post on isokinetic peak torque. Note. RCE, Right Kn... | PMC10439966 | ||
Between-group differences in changes in maximal strength, muscle thickness, and body fat | After 6 weeks, there were no significant differences in peak torque of knee extensor and flexor, as well as the H/Q ratio between the two groups (measured in N·m) (The D-value of isokinetic peak torque, H/Q ratio and body fat in two types of progressive resistance training.Note: D-value = post-test value-pre-test value... | PMC10439966 | ||
Discussion | double-leg barbell squats, muscle hypertrophy | The aim of this study was to compare the impact of two different progressive squat programs (bodyweight and barbell-back squat) on body fat, lower limb muscle thickness, and strength in sedentary women over a period of 6 weeks. It examined the specific effects of different postures and angles of bodyweight squats on lo... | PMC10439966 | |
Conclusion | lower extremity muscle circumference | Considering the importance of strength, particularly lower limb strength, for sedentary women, this randomized controlled trial provides evidence supporting the feasibility and effectiveness of progressive bodyweight squat training for improving knee joint strength and muscle circumference growth in sedentary young wom... | PMC10439966 | |
Practical implications | lower limb muscle strength | The progressive bodyweight squat program that was developed can be widely applied to the general population. It is also valuable for therapists and practitioners who have back problems, as it can improve lower limb muscle strength without placing additional burden on the back. This is particularly useful because back p... | PMC10439966 | |
Limitations and future research | muscle mass | Our study has some limitations that require attention. Firstly, while participants were instructed to maintain their regular diet, the lack of control over their diet could potentially influence the accretion of muscle mass and serve as a confounding factor. Secondly, it would be worthwhile to investigate the long-term... | PMC10439966 | |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-40319-x. | PMC10439966 | ||
Author contributions | W.W. | L.H. and W.W. conceived the and designed the study. W.W. and W.L.Z. did the literature review. W.W., J.X.Z., S.R. and R.H.S. did the initial data collection and analysis. L.H. and RHS wrote the first draft of the manuscript. J.X.Z., S.R., Y.K.J., W.L.Z., and L.H. critically edited the draft. All authors reviewed and ha... | PMC10439966 | |
Funding | This research was funded by a grant from National Natural Science Foundation of China Youth Science Foundation (81602869). | PMC10439966 | ||
Data availability | The datasets analyzed during the current study are available from the corresponding author on reasonable request. | PMC10439966 | ||
Competing interests | The authors declare no competing interests. | PMC10439966 | ||
References | PMC10439966 | |||
Methods | ulcerative colitis | REGRESSION, RECRUITMENT, ULCERATIVE COLITIS | Parallel controlled randomized clinical trial (1:1), approved by the ethics committee (No. 3.068.511/2018) and registered at The Brazilian Clinical Trials Registry (No. RBR-79dn4k). Non-adherent ulcerative colitis patients according to the Morisky-Green-Levine-test were included. Recruitment began in August 2019 until ... | PMC10752503 |
Results | ulcerative colitis, Pain | DISEASE, ULCERATIVE COLITIS | Forty-six and 49 participants were allocated in control and intervention groups, respectively. Two were excluded due to intervention refusal, and 4 and 6 were lost to follow-up in control and intervention groups. There was no post-intervention adherence rate difference, even after adjustment for type of non-adherence (... | PMC10752503 |
Conclusions | The intervention program was not able to produce a significant medication adherence rate difference between comparative groups, however, there was a significant improvement in quality of life. Study limitations may include: sample size calculated to identify differences of 30%, leading to a possible insufficient power;... | PMC10752503 | ||
Data Availability | All relevant data are within the manuscript and its | PMC10752503 | ||
1. Introduction | IBD, chronic inflammatory bowel disease, infections, UC | INFLAMMATORY BOWEL DISEASES, MINOR, INFECTIONS, CHRONIC DISEASES, ADVERSE EFFECTS, ULCERATIVE COLITIS | Low adherence to drug treatment has been identified as a serious public health problem with a magnitude ranging from 15% to 93% for patients with chronic diseases, with an estimated average of 50%, depending on the method applied, characterized as an "invisible epidemic" [Ulcerative colitis is a chronic inflammatory bo... | PMC10752503 |
2. Materials and methods | The protocol for this trial and CONSORT checklist are available as supporting information; see | PMC10752503 | ||
2.1. Study location | IBD, UC | The study was carried out at a public outpatient pharmacy unit (POP) responsible for dispensing medications to patients with different health conditions, including patients with IBD. The study site was in the city of Salvador, capital of the state of Bahia, Brazil. At that time UC patients had access exclusively to ora... | PMC10752503 | |
2.2. Study design | It was a randomized, pragmatic parallel group clinical trial with two arms (1:1), in which attention was paid to preserve routine conditions of care and service.The research protocol was registered in the Brazilian Registry of Clinical Trials with primary identifier number RBR-79dn4k. | PMC10752503 | ||
2.3. Target population | coronavirus disease, UC | The target population were patients diagnosed with UC in the state of Bahia assisted by physician from public system and pharmacist assistance from POP. Routinely, patients returned monthly to acquire their medications. However, due to the pandemic caused by the 2019 new coronavirus disease (COVID-19), there was an eff... | PMC10752503 | |
2.4. Inclusion criteria | IBD, UC | DISEASE, RECRUITMENT | The study included patients diagnosed with UC who, during the recruitment phase, irrespective of the disease activity met all the following criteria: had at least three months of active registration at POP; prescribed with at least one medication to treat UC; aged 18 or over; able to answer the research instruments; wh... | PMC10752503 |
2.5. Exclusion criteria | Participants who were adherent according to MGLT. Lost to follow-up was defined as three unsuccessful attempts to contact the participant via phone calls in different working days occurred and/or there was refusal to be interviewed within the Visit 2 interval period. | PMC10752503 | ||
2.6. Recruitment | RECRUITMENT | The study started with the recruitment stage since August 2019 until August 2020, while follow-up began at February 2020 until March 2021. The identification of patients eligible to participate in the research was carried out as they presented themselves at POP, according to information contained in their medical recor... | PMC10752503 | |
Trial flow diagram. | UC | RECRUITMENT | According to the sample calculation, number of interviewers and flow of patients with UC at POP, a period of recruitment of 4 months was initially estimated. However, there was an extension of this period, since there was a significant percentage of patients’ representatives. Next, COVID-19 pandemic status was declared... | PMC10752503 |
2.7. Randomization | RECRUITMENT | The simple randomization process was used, generating a list of 108 allocation positions prior to participants recruitment through an online tool ( | PMC10752503 | |
2.8. Participant’s allocation | UC | After signing the Informed Consent Form (ICF), participants were interviewed in person and if they were considered adherent to drug treatment for UC according to MGLT, the interview was interrupted, and they were not allocated. Non-adherent respondents were fully interviewed on visit 1, and then allocated according to ... | PMC10752503 | |
2.9. Data collection | ’s behavior | Data collection was carried out by qualified interviewers that attended to the Good Clinical Practices course (Instruments validated in the Brazilian reality were used, such as the MGLT [“The extent to which a person’s behavior ‐ taking medication, following a diet and / or making lifestyle changes ‐ corresponds to the... | PMC10752503 | |
2.10. Blinding | RECRUITMENT, BLIND | The participants received a unique code to identify all the instruments and forms of the research, with the omission of their names. The blinding of those involved was difficult, since the application of the intervention program automatically reveals to the participants in which group, they were allocated, making maski... | PMC10752503 | |
2.12. Data categorization | UC | Sociodemographic and economic variables (sex, age, ethnicity/color, origin, marital status, monthly income, education) and pharmacotherapeutic variables (drugs in use for UC and comorbidities, number of dosage units in use for the treatment of UC, UC treatment schemes, medication adherence of drugs for UC, according to... | PMC10752503 | |
2.13. Sample calculation and selection | RECRUITMENT | Based on the results of a study published in Brazil [Due to the difficulties already reported for recruitment, the research team decided to end the recruitment stage in September 2020. | PMC10752503 | |
2.14. Endpoints | UC | SECONDARY | The primary endpoint was pre-specified as adherence to medication for UC according to MGLT.The QoL scores were pre-specified as secondary outcomes according to the SF-36 Brazil instrument. | PMC10752503 |
2.15. Statistical analysis | REGRESSION, SECONDARY, REGRESSION | Data was entered into a database built with the Statistical Package for the Social Sciences®, version 21.0. The analysis plan was finalized and approved prior to the data lock for the final analysis. Quantitative variables were described as means (standard deviation), and non-normal quantitative variables were summariz... | PMC10752503 | |
2.16. Ethical considerations | VIRUS | The study was approved at December 2018 by the Research Ethics Committee of the Universidade do Estado da Bahia (No. 3.068.511/2018). The written ICF was presented and signed by all participants. All study procedures followed Brazilian ethical legislation and the trial has been sent to registry at The Brazilian Clinica... | PMC10752503 | |
3. Results | During the study period, 325 approaches were made to POP users considered for eligibility, and 95 were allocated to the research from August 2019 to October 2020, randomly assigned to groups CG and IG, 46 and 49, respectively. Two were excluded due to intervention refusal, and 4 and 6 were lost to follow-up in control ... | PMC10752503 | ||
Selection, recruitment and allocation of research participants, Salvador, BA (2019–2021). | PMC10752503 | |||
3.1. Participants baseline characteristics | Socio-demographic and economic baseline participants’ characteristics, distributed by allocation group are shown at | PMC10752503 | ||
3.2. Impact of interventions on primary outcome | It was observed that there were no significant differences in adherence (classified according to MGLT), when compared by allocation groups. The descriptive data on adherence before and after interventions are shown in | PMC10752503 | ||
Descriptive data of primary outcome (adherence according to MGLT) before and after intervention program according to group allocation, Salvador, BA (2019–2021). | PMC10752503 | |||
3.3. Impact of interventions on secondary outcome | Pain | The comparative analysis of the differences in mean scores at Visit 2 and 1, using paired and independent Student’s t-test, revealed that there was a significant improvement in three QoL domains for the IG compared to the CG: “Pain” and “Vitality” and an improvement trend for the “Emotional aspects” domain ( | PMC10752503 | |
4. Discussion | Pain, IBD, intentional behavior, UC | CORONAVIRUS, DISEASE, CROSS, CHRONIC DISEASES | The intervention program was not able to produce significant differences for the primary outcome (medication adherence), but was able to improve three QoL domains.The need to include non-adherent patients in clinical trials had previously been signaled as a strategy to improve the quality of published studies [Most par... | PMC10752503 |
5. Conclusion | chronic disease, Pain, UC | CHRONIC DISEASE | Exposure to the proposed intervention program was not able to produce a significant difference between comparative groups in medication adherence for non-adherent patients with UC. We suggest that in future studies, outcome differences of lesser magnitude for sample calculation, shorter intervals for measuring adherenc... | PMC10752503 |
Supporting information | PMC10752503 | |||
Protocol. | (DOCX)Click here for additional data file. | PMC10752503 | ||
CONSORT checklist. | (DOC)Click here for additional data file. | PMC10752503 | ||
CONSERVE checklist. | (DOCX)Click here for additional data file. | PMC10752503 | ||
Minimal data set. | (XLSX)Click here for additional data file.We acknowledge the Bahia Health State Department for allowing the study to be carried out at FIMAE. | PMC10752503 | ||
References | PMC10752503 | |||
Methods | depression, anxiety | In this unblinded cluster RCT, 540 participants from two high schools in China were randomly assigned to the Coping Camp intervention (n = 6 classes; 275 students) or treatment as usual (n = 5 classes; 265 students) at the class level. Coping Camp was an automated self-help app, consisting of 11 sessions delivered over... | PMC10681230 | |
Results | depression, anxiety | At post-intervention and follow-up assessments, 75.4% and 81.7% of participants respectively attended. On average, participants logged in for 8.56 out of 11 sessions. Compared to the control group, the intervention group had significant reductions in levels of perceived stress (p = 0.01, d = 0.15 at T1; p < 0.001, d = ... | PMC10681230 | |
Conclusions | The Coping Camp is feasible, acceptable and effective in stress management among Chinese school adolescents. | PMC10681230 | ||
Data Availability | We are not able to share the data set in publicly available data repertoires, because it has been stated in the ethics application and participant information sheet that only aggregated data will be reported publicly. Depositing dataset publicly will violate the ethics approval requirements and the consent that partici... | PMC10681230 | ||
Introduction | Adolescence is an important transitional period when adolescents experience diverse physical, psychological and social changes. The changes, including puberty, seeking independence, building peer relationships, and meeting academic and transition demands, all constitute acute or chronic stressors for adolescents. Stres... | PMC10681230 | ||
Methods | We followed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) [ | PMC10681230 | ||
Study design | This study was a two-arm cluster randomised controlled trial. Participants were randomised by classes (i.e., clusters) on a 1:1 ratio to either the intervention group or the control group (see | PMC10681230 | ||
CONSORT diagram. | Notes: Data was collected by gathering participating students in an auditorium and providing them with time to complete the assessment. Missing participants fall into two categories: drop-out participants and absent participants. Drop-out participants occurred when they informed the intervention implementer of their wi... | PMC10681230 | ||
Settings | RECRUITMENT | The participants were recruited from two high schools in Mianyang City of Sichuan province in China. The recruitment was conducted in September 2021. One was a private high school and the other was a public high school. The schools were anonymised due to confidentiality. The private school had a student population of a... | PMC10681230 | |
Participant recruitment | RECRUITMENT | Participation in this study was voluntary. After consulting school administrators, only students who enrolled in grades 10 and 11 were available. The reason provided was that grade 12 students were preparing for the national college entrance examination, therefore, involving them was not practical. The recruitment stra... | PMC10681230 | |
Participant eligibility criteria | ideation, psychiatric, a mental disorder | RECRUITMENT | Our inclusion criteria included: (1) own a smartphone and be permitted by parents and teachers to use the smartphone; (2) be enrolled in grades 10 and 11 of high school at the time of intervention. The exclusion criteria included: (1) students should not have suicidal ideation; (2) and should not be diagnosed with a me... | PMC10681230 |
Random allocation | The randomization was conducted by a research assistant who was independent of our research group. This research assistant was also blinded of which group was intervention group and which group was control group. An online randomizer ( | PMC10681230 | ||
Blinding | BLIND | Given the nature of the intervention, it was not possible to blind either the participants or the intervention implementer. However, the outcome assessors and the researcher who conducted the randomization were blinded to the students’ condition. | PMC10681230 | |
Procedures | During the screening stage, 575 students interested in participating were invited by the first author to complete a short questionnaire to confirm their eligibility in the auditoriums at the schools. This took place on two separate weekdays during moral education class where students were engaged in non-academic activi... | PMC10681230 | ||
Intervention condition | Participants assigned to the intervention group (IG) received a QR code to download the Coping Camp application, which had two versions: Android and IOS versions to suit different students. After downloading the Coping Camp, students were required to create a personal account, which they must use to log into the Coping... | PMC10681230 | ||
Example pages of the app prototype. | PMC10681230 | |||
Control group | Participants who were allocated to a control group (CG) attended their regular moral education classes as arranged by the schools. | PMC10681230 | ||
Measures | All the participants in the intervention or control group were assessed at three timepoints: baseline (T0; prior to intervention), post-intervention (T1; 11 weeks after the baseline), and follow-up (T2; 19 weeks after the baseline). The measures included demographic variables and study outcomes. Demographic variables w... | PMC10681230 | ||
Perceived stress | The primary outcome was perceived stress which was assessed by Perceived Stress Scale-10 Items (PSS-10). The PSS-10 is a self-reported scale comprising ten items used to evaluate respondents’ global level of perceived stress [ | PMC10681230 | ||
Depression and anxiety | depression, Depression, Anxiety, anxiety | SECONDARY | The Depression, Anxiety and Stress Scale (DASS-21) was used to measure symptoms of anxiety and depression as secondary outcomes. The DASS-21 is a 21-item scale that rates the degree to which each statement applies to participants over the past week on a four-point Likert scale from 0 to 3. Total scores range from 0 to ... | PMC10681230 |
Mental health wellbeing | Mental health wellbeing was measured using the four-item self-report instrument called the Outcome Rating Scale (ORS-4). The ORS-4 assesses the perceived change in three areas of client functioning: individual (or symptomatic) functioning, interpersonal relationships, and social role performance (work adjustment, quali... | PMC10681230 | ||
Coping behaviours | Stress coping behaviours were measured using the short form of the Coping Inventory for Stressful Situations (CISS-SFC), which is a 21-item scale that measures task-oriented coping, emotion-oriented coping, and avoidance-oriented coping. Task-oriented coping was regarded as maladaptive coping, and emotion- and avoidanc... | PMC10681230 | ||
Negative events | EVENTS | To measure the negative effects of the intervention on a universal sample of school students, we defined negative events as any significant unfavorable changes perceived by participants in their life and study, rather than solely as significant changes in their mental condition during the intervention period. Serious n... | PMC10681230 | |
Acceptability | Acceptability of the intervention was measured through feedbacks at the end of each session which was assessed using a short satisfaction survey. The survey had two questions: the first was a quantitative question asking participants to rate the usefulness of Coping Camp on a 5-point scale, with 1 indicating "not usefu... | PMC10681230 | ||
Sample size calculation | stress reduction | According to a meta-analysis on internet interventions on stress reduction [ | PMC10681230 | |
Statistical analysis | Statistical analyses were conducted using software R version 4.2.2 (the R Foundation for Statistical Computing, Vienna, Austria). The accepted level of significance for this study was set at 95%. To determine baseline differences between the intervention group and control group, independent t-tests were performed on co... | PMC10681230 | ||
Missing participants and missing data handling | Data was collected by gathering participating students in an auditorium and providing them with time to complete the assessment. Therefore, missing participants fall into two categories: drop-out participants and absent participants. Drop-out participants occurred when they informed the intervention implementer of thei... | PMC10681230 | ||
Ethical review | Ethics approvals were obtained from two institutions: the Human Ethics Office at The University of Queensland in Australia (approval number: 2021/HE000791) and the Research Ethics Office at Tianjin Normal University in China (approval number: 2021041901). Informed written consent forms were obtained offline from both t... | PMC10681230 | ||
Trial registration | This randomised controlled trial was registered via Australian New Zealand Clinical Trials Registry (ANZCTR). Registration number: 380316. Link to the trial registration: | PMC10681230 | ||
Results | PMC10681230 | |||
Study participation | A flowchart of the study participants is shown in | PMC10681230 | ||
Demographic and baseline characteristics of trial participants (N = 540). | Note:*p<0.05**p<0.01 | PMC10681230 | ||
Program attrition and program use | During the 11-week program, the number of login times per student varied from 2 to 24 times (mean = 8.56, SD = 5.12). Each session lasted between 25 and 50 minutes. | PMC10681230 | ||
Adherence | Adherence was defined as the frequency of sessions completed by students, ranging from 0 to 11. Out of 275 students, 19 students (6.9%) did not complete any sessions, 43 students (15.6%) completed 1–3 sessions, 92 students (33.5%) completed 4–7 sessions, and 121 students (44%) completed 8–11 sessions. | PMC10681230 | ||
Intervention effects | Intent-to-treat analyses were conducted using linear mixed models (LMM) with random intercepts for students and classes to examine the effects of Coping Camp on all study outcomes. The final models for each study outcome are shown in | PMC10681230 | ||
Changes of outcome variables across three timepoints. | PMC10681230 | |||
Stress (PSS-10) | timepoint*group | The final mixed model for perceived stress, measured by PSS-10, included timepoint, group, and timepoint*group as fixed effects, along with the significant covariate gender. Results of the LMM analysis ( | PMC10681230 | |
Acceptability | Participants rated all 11 sessions on a 5-point scale, with average ratings ranging from 4.06 (SD = 0.89) to 4.49 (SD = 0.76), indicating high levels of perceived helpfulness. Qualitative feedback echoed these findings, with most participants reporting that Coping Camp was "great" (n = 69; 57%) and "helpful" (n = 21; 1... | PMC10681230 | ||
Negative events | EVENTS | Out of 221 intervention group participants and 278 control group participants, 56 (25.34%) and 129 (46.40%) respectively reported negative events in response to an open-ended question. Six students (2.71%) in the intervention group and 5 students (1.80%) in the control group did not respond. The difference was not sign... | PMC10681230 | |
Discussion | PMC10681230 | |||
Principal findings | depression | This study tested the efficacy of Coping Camp, a stress-managing app based on stress inoculation training (SIT), among Chinese school adolescents. The primary objective was to determine whether 11 weeks of use reduced stress levels. Secondary objectives included assessing acceptability in high school settings, reducing... | PMC10681230 | |
Perceived stress | To our knowledge, this study was one of the first to demonstrate the stress-reducing effects of a mobile app based on stress inoculation training (SIT) in a universal sample of Chinese school adolescents. The results showed that the use of the Coping Camp significantly reduced the perceived stress level both at post-in... | PMC10681230 | ||
Depression and anxiety | Our study found that Coping Camp significantly reduced DASS-21 score at both post-intervention ( | PMC10681230 | ||
Mental health wellbeing (ORS-4) | We found that Coping Camp was not effective in improving mental health well-being. This finding is similar to previous similar studies [ | PMC10681230 | ||
Stress coping behaviours (CISS-SFC) | At the time of writing, there is limited number of studies examining the evidence on online and app-based mental health interventions’ effects on coping behaviour changes. Our study is one of the first to provide evidence on this subject and found that the use of an app-based mental health intervention, the Coping Camp... | PMC10681230 | ||
Acceptability | The results of this study showed that the Coping Camp was acceptable to Chinese high school students and the use of Coping Camp was feasible in Chinese high school settings. The rates of the Coping Camp were ranged from 4.05 to 4.49 across sessions, which was above the cut-off score of “useful”. This rating was similar... | PMC10681230 | ||
Strength, limitations and implications for policymakers | depression, anxiety | To our best knowledge, this study is the first randomized controlled trial to investigate the efficacies of an app, the Coping Camp, which was developed for Chinese high school students and reflects the real-world effect of mobile intervention. This study showed that the use of the Coping Camp significantly reduced the... | PMC10681230 | |
Conclusions | This study showed that the use of an app-based intervention, the Coping Camp, which was developed for managing stress among Chinese high school students was feasible, acceptable and effective, which provides an alternative for Chinese high schools where there are lack of mental health professionals and students experie... | PMC10681230 | ||
Supporting information | PMC10681230 |
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