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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 muscle thickness. The Mann–Whitney U test was conducted if normality was not assumed. For changes in all outcomes within the groups, a paired-sample t-test was used if normality and equal variance were assumed. If pre-test values were significantly different between groups at baseline, analysis of covariance (ANCOVA) was applied to test differences in post-test values between groups, including pretest values as a covariate, the posttest variable and the difference were taken as dependent variables respectively. Otherwise, the independent-sample t-test was conducted. The statistical analyses were performed using SPSS version 26 (SPSS, Inc., Chicago, IL, USA). The level of significance was set at p < 0.05, and all values are presented as mean ± standard deviation (SD). | 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 was obtained from the individuals for the publication of any potentially identifiable images or data included in this article. | 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 completing 3 sets; OMNI (leg 6), OMNI score of legs perceived exertion after completing 6 sets; OMNI (leg 6), OMNI score of whole body perceived exertion after completing 6 sets. | 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 Knee Concentric Peak Torque of Extensor; RCF, Right Knee Concentric Peak Torque of Flexor; REE, Right Knee Eccentric Peak Torque of Extensor; REF, Right Knee Eccentric Peak Torque of Flexor; LCE, Left Knee Concentric Peak Torque of Extensor; LCF, Left Knee Concentric Peak Torque of Flexor; LEE, Left Knee Eccentric Peak Torque of Extensor; LEF, Left Knee Eccentric Peak Torque of Flexor; Nm, Newton meter; RCHQ, The Mean Concentric Peak torque of Hamstring-to-Quadriceps Ratio in Right Knee; LCHQ, The Mean Concentric Peak Torque of Hamstring-to-Quadriceps Ratio in Left Knee; 1 was pre, 2 was post.Effects of maximal strength, H/Q ratio and body fat in two types of progressive resistance training.Note: Pre- and Post-*Paired Sample T-test, In the group performing bodyweight squats, there were changes observed in the isokinetic torque of the right knee. Specifically, the concentric peak torque of the flexor (RCF) showed a statistically significant difference of t (6) = − 3.73 ( | 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; Pre and Post-*Paired Sample T-test, Pre and post of two groups on muscle thickness. Note: 1 was pre, 2 was post. | 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 lower limb muscle strength compared to barbell-back squats. Despite the fact that the number of training repetitions for both groups remained essentially the same, the training mode that increases the level of movement difficulty as the load intensity was found to be just as effective as gradually increasing the barbell weight as the load intensity, which can help increase knee muscle strength and muscle hypertrophy levels for the subject. The study’s main findings revealed that both groups exhibited similar increases in lower limb isokinetic peak torque and muscle thickness, but changes in body fat differed between the two groups.Previous studies have shown that bodyweight squat mode, which focuses on increasing the number of repetitions, can improve the total training volume by increasing the number of repetitions under constant load intensity (bodyweight)With regard to muscle strength, both groups of untrained women experienced comprehensive improvements, including in right knee concentric peak torque of flexor, right knee eccentric peak torque of extensor, and left knee concentric peak torque of extensor. This study further proved that bodyweight squats, using body-weight as the load intensity and focusing on multiple unilateral squats combinations, can achieve a similar increase in knee joint strength as double-leg barbell squats with 60–80% 1RM in short term. Results about the bodyweight squat in this study were also consistent with those of previous studies, which showed that various leg squats can significantly stimulate the quadriceps and hamstringsMeanwhile, previous evidence have shown significant differences in H/Q ratios between dominant and non-dominant legs in young womenIn terms of muscle hypertrophy, early studies generally agree that neural adaptation plays a dominant role during the first 6–7 weeks of training, while muscle hypertrophy changes very little during this periodMuscle cross-sectional areas had a significant relationship with strength-velocity characteristics of the whole muscle and greater force productionFinally, participants in the barbell-back squat group experienced a significant reduction in body fat percentage without a change in body weight, consistent with previous findings that resistance training can lead to rapid decreases in body fat in untrained women | 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 women over a 6-week period. These findings extend existing research on lower extremity strength promotion in the general population through strength training methods. Based on the resistance training methods that incorporate different unilateral squat positions using bodyweight, it may have short-term effects on the development of strength and the muscular system, from knee strength to lower extremity muscle circumference. Therefore, we suggest that bodyweight squat training can be used as an alternative to traditional resistance training for sedentary young women. | 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 problems are often accompanied by reduced strength in the lower limbs. | 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 effects of the two training sessions on body fat, muscle strength, and thickness by conducting studies with longer training periods. Thirdly, the small number of participants in our study limits the generalizability of the results, and further research is needed to investigate the training effects on a larger sample size. Additionally, it would be beneficial to examine the impact of bodyweight squat on the stability of core and lower limb joints, which could be a valuable area for future research. | 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 had final approval of the submitted and published versions. | 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 August 2020, with 6-month follow-up. All participants received standard usual care, and additionally the intervention group received educational (video, educational leaflet, verbal guidance) and behavioral interventions (therapeutic scheme, motivational and reminder type short message services). Researchers were blinded for allocation prior to data collection at Visits 1 and 2 (0 and 6 months). Primary outcome: 180-day adherence rate, with relative risk 95%CI. Secondary outcome: 180-day quality of life according to SF-36 domains, using Student’s t test. Variables with p<0.20 were selected for regression. Analysis included data from August/2019 to May/2021. | 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 (unintentional/both/intentional) as confounder, or if considered as adherent the intervention group participants lost in follow-up. Interventions promoted better quality of life scores even after multivariate analysis for “Pain”, when adjusted for ulcerative colitis severity, sex, and marital status (β = 18.352, p = 0.004), “Vitality”, when adjusted for ulcerative colitis severity (β = 10.568, p = 0.015) and “Emotional Aspects”, when adjusted for disease severity, income, and education (β = 24.907, p = 0.041). | 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; non blinded participants, exposing the results to the risk of performance bias; outcomes based on self-reported data. | 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 bowel disease that requires continuous drug treatment for its control, therefore, the lack of adherence constitutes a barrier to the achievement of therapeutic goals [Nieuwlaat In March 2020, the World Health Organization declared a pandemic, bringing with it several direct and indirect consequences. A systematic review investigated the impact on medication adherence with oral and biological medications for patients with Inflammatory Bowel Diseases (IBD) in this period. Major or minor impacts on adherence to treatment were identified for patients with IBD according to geographic regions. In addition, the result may have varied as a result of what each study considered as low or high adherence and the methods for measuring it. The results point to the following reasons for non-adherence: concern of patients and the health team regarding the safety of the treatment (risk of infections and adverse effects) and difficulties in accessing health services and medication due to social distancing and lockdown [The aim of the present study was to evaluate the impact of an intervention program on adherence rates and QoL in patients with UC who do not adhere to drug treatment. | 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 oral (mesalamine, sulfasalazine, azathioprine, cyclosporine) and rectal treatment (mesalamine). In 2019, the unit had 855 patients with UC registered for care, including 590 users assisted by physicians from the public health system and 265 from the complementary health system. | 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 effort to assist them with a greater amount of medication, to reduce exposure and contribute to social distancing. | 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; who were assisted by the IBD outpatient clinics at two reference centers; who had a cell phone; and were classified as non-adherent according to Morisky-Green-Levine Test (MGLT). | 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 records. Then, the service user was approached by an investigator to identify whether it was the patient himself, as well as to present the research and confirm his eligibility. See | 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, which also contributed to reduce the number of patients presented at the pharmacy. | 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 information contained in the numbered envelope and opened consecutively, resulting from the randomization process. This procedure aimed to reduce interviewer’s bias during data collection at visit 1. Participants were allocated to the Intervention Group (IG) or Control Group (CG) and the allocation secrecy was preserved, as the researchers who performed the interventions were different from those who measured the outcomes. Both CG and IG received the standard care offered at POP, and the IG was also exposed to the intervention program (see | 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 recommendations agreed with a caregiver” [The MGLT has four questions, and those who answered “no” to all questions were considered adherent, whereas those who answered “yes” to at least one question, were classified as non-adherent. When one or two questions were answered affirmatively, the respondent’s behavior was classified as moderately adherent. An affirmative answer to three or four questions was classified as having low adherence. When answering affirmatively to the first two questions of the MGLT, the behavior was considered “unintentional”, when answering affirmatively to the last two questions of the MGLT, the behavior was considered “intentional” [For participants’ health-related QoL assessment, the Brazil Short Form Health Survey 36 (SF-36) was used [The Lichtiger Index [ | 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 masking impossible.The research team was divided into the following dedicated activities: a) recruitment, data collection at visit 1, allocation and execution of the intervention program for the IG (non-blind researchers); b) database feeding (non-blind researchers); c) data collection at visit 2 (blind researcher); d) analysis of the database (non-blind researchers).When participants entered the survey and prior to the final data collection, they were asked not to disclose to other participants or the research team which group they had been allocated to. | 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 the MGLT [ | 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 summarized by median (IQR). Qualitative variables were described with measures of absolute and percentage frequency. To compare intervention and control groups in relation to qualitative variables, Pearson’s chi-square test or Fischer’s exact test was used, when recommended. The comparison of quantitative variables between groups was performed by applying the Student’s t test for unpaired samples or ANOVA, if indicated, the non-parametric Mann-Whitney test or Kruskal Wallis test.The occurrence of the primary study outcome (adherence) was calculated by the ratio between the total number of participants who achieved adherence to treatment and the total number of participants in the group, multiplied by 100, calculated separately for the intervention and comparative groups, in times 0 and 6 months. The calculation was carried out either considering maximum adherence (those at baseline who had low or moderate adherence and after 6 months they became adherent) or improvement in adherence (those who at baseline had low adherence and after 6 months became adherent or reached moderate adherence, as well as who in the baseline had moderate adherence and after 6 months became adherent).For primary outcomes, the relative risk with the respective 95% CI was used as a measure of effectiveness, obtained from the ratio between the adherence of the intervention group and the adherence of the comparative group, at times 0 and 6 months after application of the intervention program. For adjustments for potential confounders, Logistic Regression was used to estimate the adjusted ORs with the respective 95% CI. Associations with p values less than 0.05 were considered significant. The analysis was made per protocol.The analysis of QoL (secondary outcome) was performed by comparing the mean differences of the 8 domains of the SF-36 score between Visit 2 and Visit 1 with the paired t-test calculated, separately for the CG and IG. The variables that showed differences of p <0.20 were included in the construction of the regression models. For adjustments for potential confounders, Multiple Linear Regression was used to adjust the effect of the intervention by confounding variables. | 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 Clinical Trials Registry (REBEC) since February 2019. All adjustments and information required by REBEC had no ethical or methodological implications and were made accordingly. The approval was updated online as January 2020 (No. RBR-79dn4k).The COVID-19 pandemic was declared in March 11Expansion of the data collection window on Visit 2 to 1 month before and 1 month after the 180 days counted from the date of Visit 1;Optional conduction of final interview (Visit 2) via phone call, registered on a file containing telephone number, date and time of interview. This modification was important to preserve isolation during peak phases of the virus dissemination, while maintaining the study’s feasibility. | 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 and intervention groups Eighty-three participants completed the research protocol, thus, the final sample analyzed was 40 in the CG and 43 in the IG ( | 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 participants were women, with an average age of 47 years, black or mixed race, residing in urban area. It seems that in Latin America there is a predominance of women and residents in urban areas [As for the clinical status for UC, most of them had active disease at baseline, comparable to the proportion of patients with moderate to severe UC in Brazil [Most participants used oral and/or rectal amino salicylates. Findings converge with previously published results, where the largest proportion of patients were using salicylates for UC [It is necessary to emphasize that rectal medication use for IBD treatment has been considered a risk factor for low adherence when compared to the oral route. This is possibly due to the discomfort related to administration, difficulty in use during working hours or on trips, as well as the lack of adherence in these cases has been associated with intentional behavior [At baseline, significant differences were observed in the distribution of types of non-adherence between groups. Studies with similar objectives that used MGLT, with patients diagnosed with UC, did not show baseline distribution of this variable, therefore, we could not compare how this variable behaved in other studies [The intervention program proposed by this research is considered to be multicomponent, as it contains multiple strategies, educational, behavioral and motivational [The multicomponent approach can be complex, as it involves different combinations of interventions with regard to type, frequency, intensity and quality [In the present study, educational measures were carried out in a single moment, while motivational and reminder messages were repeated. It is possible that the most immediate result of these interventions was not captured due to the time elapsed until data collection at visit 2 (after 6 months), therefore, an increase on the frequency of educational intervention and instruments application to measure adherence would be desirable. In a meta-analysis it was found that the longer the follow-up time, the smaller the differences for the outcome of adherence between comparative groups [It is possible that the intervention program of this research did not have a greater impact because it did not include changes in the interaction routine between participants and health professionals. Multiple interventions through a virtual platform have already been proposed, in which, in addition to educational approach and reminders, the data entered by patients were analyzed using a pre-defined automatic protocol, and if necessary, the assistance team was activated for appropriate measures. Del Hoyo As for QoL, in this research there was an improvement in the scores of the domains “Pain” and “Vitality” in the IG when compared to the CG, a result maintained after adjustment for confounders. Other studies have already found the impact of multicomponent interventions with an improvement in QoL. Although Cross According to observed results in the present research, multicomponent interventions may contribute to improve QoL for UC patients, despite no significant impact for medication adherence having been found. Other clinical trials aiming to improve adherence to chronic diseases have shown improvement in QoL [Some limitations of the present study may have interfered with the observed results. The sample size was calculated to identify differences of 30% in the primary outcome, therefore, it is possible that statistical differences in adherence between the comparative groups were not observed due to insufficient power. It is suggested that in future designs, differences of lesser magnitude of the outcome should be considered for the sample calculation. Another point was the impossibility of blinding the participants regarding the allocation, exposing the results to the risk of performance bias, eventually improving the provision of usual attention perceived by the CG participants, which may have attenuated the differences between the groups [We must discuss the atypical moment experienced during the execution of the research after declaring the state of emergency due to the new coronavirus, which may have affected participants’ QoL and adherence to treatment. A recent study identified that stress due to the pandemic was reported by 22% of IBD patients as high and 38% as moderate. In addition, 62% of the patients had concern about medications increasing the risk of developing COVID-19. Additionally, 14% of patients considered discontinuing, while 11% effectively discontinued treatment because of pandemic [ | 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 adherence using more than one method, higher frequency of educational interventions and inclusion of new forms of interaction between patient and care team should be considered.In this research, the intervention program demonstrated a significant improvement for QoL, specifically for the domains of "Pain", "Vitality" and "Emotional aspects". This result is extremely important for UC patients, as it is a chronic disease with a recognized negative impact on QoL. | 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 11 weeks, with primary outcomes including perceived stress, depression, anxiety, stress-coping behaviours, and mental health well-being. All outcomes were assessed at baseline, post-intervention (11 weeks), and follow-up (19 weeks), with efficacy analysed using linear mixed models and feasibility/acceptability measured by a 5-point Likert scale and qualitative feedback. | 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 = 0.18 at T2), anxiety (p = 0.11; d = 0.08 at T1; p = 0.01; d = 0.13 at T2) and depression (p = 0.04, d = 0.11 at T1; p = 0.05, d = 0.10 at T2) but did not have a greater increase in stress-coping behaviours (p = 0.10 at T1; p = 0.97 at T2) or mental health wellbeing (p = 0.93 at T1; p = 0.08 at T2). The average ratings for each session were above 4, and qualitative feedback showed that most participants found the intervention to be “great,” “good,” and “useful.” | 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 participants gave us. As per ethical guidelines of the University of Queensland, all research data were kept in an online data management system—Research Data Manager (RDM). Only investigators have access to the data in this project. However, if it is available upon request to individual researcher who are interested. Here is the contact information for the University of Queensland Human Research Ethics Committee: Dr Tamara Periera Human Research Ethics Coordinator Phone: +61 7 344 31656 Email: | 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. Stress, China has an adolescent population of 146 million and 87% are enrolled in schools [Online mental health services may provide a solution to these issues of access and quality. Globally, mental health services have been increasingly delivered via internet such as videoconference, mobile apps and portable devices. Evidence suggest that these online mental health interventions enable patients who reside in remote areas to access services while saving time and money for traveling [ | 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 withdrawal from the study. If they did not complete the post-intervention assessment (T1), they were also missing from the follow-up assessment (T2). Absent participants were those who were not present at school on the day of assessment. Therefore, participants who were missing from the post-intervention assessment (T1) might be present at T2 and completed the follow-up assessment (T2). Therefore, the number of lost participants at T2 were counted in comparison to the baseline participants. | 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 around 3400. The public school had a student population of around 6000. Mianyang City is a moderately sized city located in southwest China. | 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 strategies involved advertisement, posters, and announcements. | 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 mental disorder at the time of recruitment; (3) and not be taking psychiatric medications and (4) they should not be receiving regular mental health counselling services. The eligibility criteria were assessed via self-reported questionnaires. | 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 activities (e.g., students watched news on TV or head teachers discussed daily affairs of the class). The participant information sheets were handed out to students to read information about the study, and they were given a chance to ask questions. After screening, 35 students were deemed ineligible (see | 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 Camp.The intervention was based on Stress Inoculation Training (SIT) [The Coping Camp comprised 11 sessions ( | 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 were collected at baseline. We collected gender, year of birth, class, grade, name of the school, residence (rural or urban), and guardians for demographic information. Study outcomes were introduced in below sections. Data were collected via online questionnaires in the app and in the classrooms. | 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 42, with higher scores indicating more severe symptoms. Subscale scores were also utilized in the study. The DASS-21 has been validated in Chinese adolescent populations and has satisfactory psychometric properties [ | 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, quality of life). The ORS-4 has been found to have adequate reliability and validity [ | 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 avoidance-oriented coping were regarded as maladaptive coping [ | 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 negative events were defined as mortality, hospitalization, suicide, or suicide attempts. Short questionnaires with open-ended questions were used to measure negative events. Data related to negative events was collected at the end of the intervention period (T1). | 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 useful at all" and 5 indicating "most useful." The second question was qualitative, asking participants to provide comments about each session. | 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 continuous baseline variables (e.g., age, PSS-10, DASS-21, ORS-4, CISS-SFC, MER), and Chi-squared tests were performed on categorical or nominal variables (e.g., gender, home location, guardian, etc.). To evaluate the efficacy of the intervention, intention-to-treat (ITT) analyses were conducted separately for each outcome [ | 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 their withdrawal from the study. Except for one class (n = 48) students who withdrew from the study due to one subject teacher believed that the students should spend more time studying, after two weeks from the start of the intervention, there were no more students or classes who withdrew. In this case, they did not complete the post-intervention assessment (T1) or follow-up assessment (T2). Absent participants also occurred when they were not present at school on the day of assessment. Therefore, participants who were missing from the post-intervention assessment (T1) might be present at T2 and completed the follow-up assessment (T2). Therefore, the number of lost participants at T2 were counted in comparison to the baseline participants.Missing data occurred in two different scenarios. The first scenario was when participants dropped out of the intervention or were not present on the day of assessment. At time point 1, there were 133 missing participants. Of those, 116 were from the intervention group, with 48 dropping out of the intervention and 68 not being present on the assessment day, while 17 were from the control group. At time point 2, there were 99 missing participants, with 17 from the control group and 82 from the intervention group. For the missing participants from the intervention group at time point 2, 48 had already dropped out at time point 1, and 34 were not present on the day of assessment at time point 2. Even though some participants did not complete all the time points, their data was still used in the analyses. The participants who dropped out did not differ significantly from those who remained in the trial regarding participant characteristics and study outcomes.The second scenario was when a single participant skipped questions on a questionnaire such as PSS-10 or DASS-21. In this case, the missing data points were coded as NA and treated as missing in our analysis in R. Any participants with missing data for given outcomes were removed from the analysis of those outcomes. Missing data were not significantly associated with participants’ characteristics or study outcomes. To test the robustness of our results, we compared LMM results of including only those with complete data with results of including all the participants and found that the two results remained almost unchanged. | 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 the participants and their guardians as most of the participants were under the age of 18 at the time of the trial. Participation was voluntary, and all students were informed that their answers would remain confidential. Only the first author had access to identifiable information during and after data collection. All participants were anonymized prior to data analysis. | 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; 17%). However, a small number of participants reported difficulty mastering and relating to the app’s content (n = 11; 9%). | 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 significant (P = .91). The most common negative events reported were decreased monthly academic exam scores and conflicts with teachers, parents, and friends. No serious negative events were reported in either group. | 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 negative mental health outcomes, improving mental health wellbeing, and changing stress coping strategies. Results showed a significant reduction in levels of stress and depression. However, Coping Camp was not effective in improving mental health wellbeing or changing stress coping strategies. | 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-intervention and 19-week follow-up. The effect sizes were Cohen’s d = 0.15 at post-intervention and 0.18 at 19-week follow-up. The effect sizes were small as compared with previous online interventions among adolescents and young adults [ | 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, was not effective in changing stress coping strategies. This finding is in line with several studies that suggested face-to-face interventions were not effective in changing stress coping strategies among adolescents [Notably, we found that gender had significant effects on stress and coping behaviours. First, compared with male, females were under significantly more stress. Second, gender had significant effects on the coping styles. Compared with males, female participants used significantly more emotion- and avoidance-oriented coping strategies. Also, female participants used less task-oriented coping strategies. These findings are in line with previous research [ | 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 to previous online interventions that was conducted in school settings [ | 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 stress levels, anxiety and depression among Chinese high school students and was feasible and acceptable among Chinese high school students. This has important implications for policymakers and educators. They can make use of internet resources (e.g., webpages and apps) as a mode to deliver psychoeducation and training about stress and coping where there is a lack of human resources in mental health professions. Several limitations should be noted. First, the sample was recruited from a moderate city in China, the results should be generated to big cities and remote/rural areas with caution. Second, as this is the first app that was developed for Chinese high school students, improvements should be made before it can be used for larger population. Third, participants were allocated randomly to two groups within the same school, which allowed for information sharing and cell phone exchanges. This might introduce contamination bias. | 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 experience excessive stress. | PMC10681230 | ||
Supporting information | PMC10681230 |
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