scholarly journals Qualitative Contributions to a Randomized Controlled Trial Addressing HIV/AIDS-Stigma in Medical Students

2015 ◽  
Author(s):  
Melissa Marzán-Rodríguez ◽  
Nelson Varas-Diaz ◽  
Torsten Neilands
Keyword(s):  
Medical Students ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Intervention Group ◽  
Deep Understanding ◽  
Structural Factors ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Related Stigma ◽  
Hiv Aids

Specialized training for healthcare professionals (HCP) in order to reduce HIV/AIDS related stigma must be part of a public health model for HIV/AIDS. Tested interventions to reduce HIV/AIDS related stigma among HCP have been mostly absent from these efforts. A qualitative approach was used to assess stigma reduction within a traditional randomized controlled design in order to better understand how our current stigma intervention worked and was understood by 2nd year medical students. After conducting a quantitative follow up survey one-year post intervention we conducted 20 in-depth qualitative interviews with a subsample of our intervention group participants as part of the overall evaluation process. Once the interviews were finished, we transcribed them and used NVivo (v.8) to organized the qualitative data. In the process of analyzing the qualitative data we identified core intervention areas participants described as useful for their training and development: (1) acquiring more HIV/AIDS-related knowledge, (2) increased skills for management of high stigma situations, and (3) the ability to identify socio-structural factors that foster HIV infection among clients. The gathered information is important in order to have a deep understanding of how attitudinal change happens as part of our intervention strategies.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

scholarly journals Exploring the feasibility and acceptability of a mixed-methods pilot randomized controlled trial testing a 12-week physical activity intervention with adolescent and young adult cancer survivors

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Amanda Wurz ◽  
Jennifer Brunet
Keyword(s):  
Physical Activity ◽  
Cancer Survivors ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Physical Activity Behaviour ◽  
Adolescent And Young Adult ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Activity Behaviour

Abstract Background Adolescent and young adult (AYA) cancer survivors (i.e. individuals diagnosed with cancer between 15 and 39 years and who completed treatment) may benefit from physical activity. Yet, few researchers have explored the effects of physical activity on physical and psychological outcomes among AYA cancer survivors. A pilot study exploring the feasibility and acceptability of a physical activity intervention and proposed trial methods to inform a definitive randomized controlled trial (RCT) is therefore necessary to fill this gap. Methods A two-arm, mixed-methods pilot RCT was conducted. Participants were randomized to a wait-list control group or a 12-week physical activity intervention comprised of 4 weekly aerobic and strength training sessions (intervention group). Feasibility measures included: number of AYA cancer survivors referred/self-referred, eligible, and recruited, retention to the trial (i.e. assessment completion), adherence to the physical activity intervention, and percentage of missing data for baseline (week 0), mid- (week 6), and post-intervention assessments (week 12). The acceptability of trial methods (all participants) and the intervention (intervention group only) was assessed via qualitative interviews post-intervention. Results Over a 12-month period, 31 AYA cancer survivors were referred/self-referred and 16 were eligible and consented to participate. Retention to the trial was 94% and adherence to the physical activity intervention ranged from 50 to 92%. With the exception of the assessment of aerobic capacity and directly measured physical activity behaviour, there were no missing data. Participants generally reported being satisfied with the trial methods and intervention; however, issues related to delivery of the physical activity intervention were identified. Conclusions The methods and intervention piloted require modification and further pilot testing in advance of a definitive RCT. Recruitment strategies identifying a greater number of younger AYA cancer survivors who have different types of cancers and who lack motivation to participate in physical activity-based studies should be explored. Refining the assessments of directly measured physical activity behaviour and aerobic capacity and incorporating behavioural support into the intervention may improve feasibility and acceptability. This study highlights the value of doing pilot work and provides critically useful data that can be used to refine studies seeking to assess causation and optimize physical activity interventions for AYA cancer survivors. Trial registration clinicaltrials.gov, NCT03016728. Registered January 11, 2017.

scholarly journals Pharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zeenat Fatima Chatha ◽  
Usman Rashid ◽  
Sharon Olsen ◽  
Fakhar ud Din ◽  
Amjad Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
People Living With Hiv ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cell Counts ◽  
Cd4 Cell

Abstract Background Pakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH). Methods Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire. Results Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001). Conclusions The findings support the improvement in ART adherence and HIV management. Trial registration The trial is registered with Australian New Zealand Clinical Trials Registry (ACTRN12618001882213). Registered 20 November 2018.

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

Evaluation of My Stress Control, a web-based stress management program for persons experiencing work-related stress: A randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Caroline Eklund ◽  
Anne Söderlund ◽  
Magnus L Elfström
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Management ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Wait List ◽  
Post Intervention ◽  
Web Based ◽  
Stress Control ◽  
Randomized Controlled

BACKGROUND Stress is one of the most common reasons for sick leave. Web-based interventions have the potential to reach an unlimited number of users at a low cost and have been shown effective at addressing several health-related problems. To handle stress on an individual level is about behavior change. To support behavior change in stress management My Stress Control (MSC) was developed. The development of MSC was based on several health psychology theories and models but central in the development was Social Cognitive Theory, Theory of Reasoned Action, Theory of Planned Behavior, Transactional Theory of Stress and Coping and the Transtheoretical Model and Stages of Change. MSC is a fully automated program. The program is tailored to the user's specific need for stress management and behavior change. OBJECTIVE The aim of this study was to conduct a randomized controlled trial to evaluate the extent to which MSC affected perceived stress in persons experiencing work-related stress. METHODS This study was conducted as a randomized controlled trial with two arms. Study participants were recruited by visiting worksites and workplace meetings. Participants were assigned to intervention or wait list group. Web-based questionnaires were used pre- and post-intervention to collect data. Perceived stress measured with the Perceived Stress Scale (PSS-14) was the primary outcome measurement. Analyses were conducted for both between- and within-group changes. RESULTS A total of 92 participants were included in this study, 48 in intervention group and 44 in waitlist group. Twelve participants in the intervention group and 19 participants in the waitlist group completed the post intervention assessment. There were no significant effects on perceived stress between the intervention and wait list groups or within the groups. A small effect size (dCohen=0.25) was found when comparing mean change over time on the primary outcome measure between the intervention and wait list groups. Additionally, a small effect size was found between pre- and post-intervention assessment within the intervention group (dCohen=0.38) as well as within the wait list group (dCohen=0.25). CONCLUSIONS It is still uncertain what effect My Stress Control (MSC) may have on perceived stress. Because adherence was low in the intervention group, elements or features that facilitate adherence must be further developed before firmer conclusions of the effect of MSC can be studied. CLINICALTRIAL This RCT was registered at clinicaltrials.gov, protocol record 2015/0646.

Enhancing adoptive parenting: A randomized controlled trial

2010 ◽  
Vol 15 (4) ◽  
pp. 529-542 ◽  
Author(s):  
Alan Rushton ◽  
Elizabeth Monck ◽  
Morven Leese ◽  
Paul McCrone ◽  
Jessica Sharac
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Adoptive Parents ◽  
Control Group ◽  
Parenting Interventions ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Significant Difference

The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a “services as usual” group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference ( p < 0.007) was found for “satisfaction with parenting” in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters’ satisfaction with parenting in the intervention group compared to the routine service group.

scholarly journals Exploring Effects of Interprofessional Education on Undergraduate Students Behaviour: A Randomized Controlled Trial

2010 ◽  
Vol 1 (3) ◽  
Author(s):  
Johannes Maximilian Just ◽  
Martin W Schnell ◽  
Maren Bongartz ◽  
Christian Schulz
Keyword(s):  
Randomized Controlled Trial ◽  
Medical Students ◽  
Undergraduate Students ◽  
Interprofessional Education ◽  
Nursing Student ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Team Approach ◽  
Randomized Controlled

Background: One way to improve the quality of palliative care for elderly patients is to use an interprofessional team approach, which may be encouraged through interprofessional education (IPE). However, the effectiveness of IPE interventions has yet to be proven. We therefore designed a randomized controlled trial using a simulated practice setting to measure the effects of an IPE intervention on medical students’ clinical behaviour.Methods: Undergraduate nursing (N = 20) and medical (N = 20) students were evenly assigned to either an intervention or a control group. Students in the intervention group received interprofessional curriculum (12 teaching units), and the control group was given written material containing the content of the IPE curriculum. Using a pre-post design, clinical behaviour of matched pairs of nursing and medical students was analyzed for qualitative (care objectives) and quantitative aspects of communication (initiation, interruptions, speaking time, and exchanged information items). Statistical analyses included chi-square, Fisher’s exact, and t-tests, where appropriate.Results: Care objective scores improved in both groups (categories N = 6, p-range = intervention group: .001–.630; control group: .001–.888). Interruptions and speaking time showed no change between or within groups, while the number of nursing student-initiated contacts increased (p = .0007). The number of information items exchanged increased significantly in both the intervention group (Pre: M = 9.65, SD = 1.79; Post: M = 12.35, SD = 1.87; p = .001) and the control group (Pre: M = 8.75, SD = 2.59; Post: M = 11.75, SD = 2.22; p = .001).Conclusions:We found a moderate effect of IPE on a change in interprofessionalcommunication style.

scholarly journals Weekly group tummy time classes are feasible and acceptable to mothers with infants: a pilot cluster randomized controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Lyndel Hewitt ◽  
Samantha Stephens ◽  
Abbe Spencer ◽  
Rebecca M. Stanley ◽  
Anthony D. Okely
Keyword(s):  
Randomized Controlled Trial ◽  
Motor Development ◽  
Group Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Time Duration ◽  
Randomized Controlled ◽  
Tummy Time

Abstract Background The World Health Organization recommends 30 min of tummy time daily for improved motor development and reduced likelihood of plagiocephaly. As only 30% of infants meet this recommendation, parents require strategies and support to increase this proportion. Methods The aim of this study was to determine the feasibility, acceptability, and potential efficacy of a group intervention to promote tummy time. The design is a cluster randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Five groups of healthy infants (N = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother’s groups (Australia) were randomly allocated to the intervention or control group. The intervention group received group tummy time classes in addition to usual care. The control group received usual care with their child and family health nurse. Primary outcomes were intervention feasibility and acceptability. Secondary outcomes were tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development. Measures were taken at baseline, post-intervention, and when infants were 6 months of age. Analyses were by linear mixed models and Cohen’s d statistic. Results Recruitment, retention, and collection of objective data met feasibility targets. Acceptability was also met with intervention mothers reporting the information, goal planning, and handouts significantly more useful and relevant than control group mothers (p < 0.01). Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen’s d = 0.5). Limitations were the small sample size, 4-week intervention, limited accelerometer use, and a homogenous sample of participants. Conclusion Group tummy time classes delivered in a mother’s group setting were shown to be feasible and acceptable. A larger randomized controlled trial is warranted. Trial registration ANZCTR, ACTRN12617001298303p. Registered 11 September 2017

scholarly journals Promoting the Quality of Teacher-Toddler Interactions: A Randomized Controlled Trial of “Thrive by Three” In-Service Professional Development in 187 Norwegian Toddler Classrooms

2021 ◽  
Vol 12 ◽  
Author(s):  
Elisabet Solheim Buøen ◽  
Ratib Lekhal ◽  
Stian Lydersen ◽  
Turid Suzanne Berg-Nielsen ◽  
May Britt Drugli
Keyword(s):  
Professional Development ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Differences ◽  
Control Group ◽  
Post Intervention ◽  
Significant Group ◽  
Randomized Controlled ◽  
Service Professional

The effectiveness of the Thrive by Three intervention, a 10-month, multicomponent, in-service professional development model to promote the quality of caregiver-toddler interactions (i.e., process quality), was tested utilizing a clustered randomized controlled design. Eighty childcare centers with 187 toddler classrooms in Norway were randomly assigned to either the Thrive by Three intervention group (n=87) or a usual-activity wait list control group (n=100). Interactional quality was assessed with the Toddler version of the Classroom Assessment Scoring System (CLASS-Toddler) at three timepoints: pre-, mid-, and post-intervention. There were significant group differences in change in quality during the intervention period in both CLASS domains, Emotional and Behavioral Support (EBS), and Engaged Support for Learning (ESL), with greater overall differences in the ESL domain. Quality increased in the intervention groups, but quality decreased in the control group from baseline to post-intervention. There were significant group differences in quality at baseline. The Thrive by Three intervention had a positive effect on teacher-toddler interactions in both the EBS and ESL domains. Results need to be replicated preferably in more diverse samples.Clinical Trial Registration:ClinicalTrials.gov #NCT03879733.

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