Contemporary Clinical Trials Communications最新文献

{"title":"A character-strengths based coaching intervention to improve wellbeing of rural community health workers in Madhya Pradesh, India: Protocol for a single-blind randomized controlled trial","authors":"Ameya P. Bondre ,&nbsp;Azaz Khan ,&nbsp;Abhishek Singh ,&nbsp;Spriha Singh ,&nbsp;Ritu Shrivastava ,&nbsp;Narendra Verma ,&nbsp;Aashish Ranjan ,&nbsp;Jyotsna Agrawal ,&nbsp;Seema Mehrotra ,&nbsp;Rahul Shidhaye ,&nbsp;Anant Bhan ,&nbsp;John A. Naslund ,&nbsp;Steve D. Hollon ,&nbsp;Deepak Tugnawat","doi":"10.1016/j.conctc.2024.101377","DOIUrl":"10.1016/j.conctc.2024.101377","url":null,"abstract":"<div><h3>Background</h3><div>There is scarce knowledge on the use of structured positive psychology interventions for reducing work-stress and improving wellbeing of rural community health workers in India, particularly the Accredited Social Health Activists (ASHAs) who are village-level (resident women, incentivised) lay health workers. This trial will test the effectiveness of a ‘character-strengths’ based coaching intervention compared to routine supervision on wellbeing (‘authentic happiness’) of ASHAs.</div></div><div><h3>Methods</h3><div>This protocol is for a single-blind, parallel group randomized controlled trial comparing the effectiveness of a five-day residential workshop focusing on the use of character-strengths and subsequent 8- to 10-week remote telephonic coaching (weekly) to individually support ASHAs to improve their wellbeing, against routine health system support. The arms are intervention added to routine ASHA supervision (weekly, by the ASHA supervisor), and routine supervision alone (control arm). The target sample comprises 330 rural ASHAs in Madhya Pradesh, India. The primary outcome of mean Authentic Happiness Inventory (AHI) scores will be compared between arms at 3-month follow-up. Secondary outcomes will include an assessment of ASHA's self-reported affect, self-efficacy, flourishing, burnout, motivation, physical health symptoms, quality of life, and routine work performance indicators, and the consequent patient-level outcomes [e.g., service satisfaction and depression remission rates after receiving brief psychological treatment by trained ASHAs]. We will also evaluate the costs of developing and delivering the intervention.</div></div><div><h3>Discussion</h3><div>This trial will determine whether a character-strengths based coaching intervention is an effective and scalable approach for reducing work-stress and improving wellbeing of rural ASHAs in low-resource settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101377"},"PeriodicalIF":1.4,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recruitment issues in a multicenter randomized controlled trial about the effect of the Cultural Formulation Interview on therapeutic working alliance","authors":"Alma M. Brand ,&nbsp;Simon P.N. Groen ,&nbsp;Samrad Ghane ,&nbsp;Nathalie Destoop ,&nbsp;Hannah E. Jongsma ,&nbsp;Bernard G.C. Sabbe ,&nbsp;Özlem Becan ,&nbsp;Dhiya Alyan ,&nbsp;Mario H. Braakman","doi":"10.1016/j.conctc.2024.101373","DOIUrl":"10.1016/j.conctc.2024.101373","url":null,"abstract":"<div><div>This short communication concerns recruitment issues in a multicenter randomized controlled trial. An overview of anticipated and unexpected recruitment issues at various organizational levels is discussed as encountered in this trial. These experiences are shared to assist researchers in avoiding similar experiences, prevent wasting valuable research resources, and justify the time and energy committed by enrolled participants.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101373"},"PeriodicalIF":1.4,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Concomitant heparin use promotes skin graft donor site healing by basic fibroblast growth factor: A pilot prospective randomized controlled study","authors":"Keishi Kohyama ,&nbsp;Hisakazu Kato ,&nbsp;Hideshi Okada ,&nbsp;Takuma Ishihara ,&nbsp;Yuji Yasue ,&nbsp;Ryo Kamidani ,&nbsp;Kodai Suzuki ,&nbsp;Takahito Miyake ,&nbsp;Hiroshi Okuda ,&nbsp;Hirofumi Shibata ,&nbsp;Hiroyuki Tomita ,&nbsp;Takenori Ogawa","doi":"10.1016/j.conctc.2024.101375","DOIUrl":"10.1016/j.conctc.2024.101375","url":null,"abstract":"<div><div>Owing to its mitogenic and angiogenic characteristics, the use of basic fibroblast growth factor (bFGF) to promote wound healing has been investigated. However, its clinical efficacy has fallen short of expectations due to its instability. Heparin has been reported to stabilize bFGF. Therefore, we hypothesized that the combination of these agents would more effectively promote wound healing than bFGF alone; a single-center, two-arm parallel, single-blind, and a prospective randomized controlled pilot study was therefore performed involving 12 patients who underwent split-thickness skin graft harvesting. To ensure a feasible clinical treatment model, commercially available agents were used. The patients were randomly assigned to either the control group treated with bFGF (n = 6) or the intervention group treated with bFGF and heparin (n = 6) in a 1:1 ratio. The wound area and the wound area variation was assessed each week postoperatively, as was the number of days required for epithelialization. As a supplementary analysis, the least-squares means were calculated using a linear mixed-effects model. The results of this study indicate that the combination of bFGF and heparin may more effectively promote wound healing than bFGF alone, consistent with our hypothesis. A multicenter trial based on these data is ongoing.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101375"},"PeriodicalIF":1.4,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142323200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A roadmap for improving representation in clinical trials","authors":"Amanda F. Petrik ,&nbsp;Nora B. Henrikson ,&nbsp;Gloria D. Coronado ,&nbsp;Erin Keast ,&nbsp;Matthew P. Banegas","doi":"10.1016/j.conctc.2024.101374","DOIUrl":"10.1016/j.conctc.2024.101374","url":null,"abstract":"<div><div>Clinical trials continue to struggle with recruiting diverse participants that include historically underrepresented and minoritized patients, who are typically patients in non-white racial and ethnic groups and have low income (Medicaid). Enrolling diverse participants will benefit the health sciences by providing more generalizable findings. The Cancer Financial Experience project (CAFÉ) study sought to improve financial distress by providing financial navigation for newly diagnosed cancer patients, and intentionally recruited diverse participants. All diverse participants consented at slightly higher rates than non-diverse participants (21.3 % vs. 20.1 %). Spanish-speaking patients consented at a much higher rate than non-Spanish speakers (36.4 % vs. 20.2 % respectively). Here we discuss how we increased our recruitment of diverse participants. Obtaining diverse participation is achievable and will provide more meaningful findings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101374"},"PeriodicalIF":1.4,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142319478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches: A double-blinded randomized control study protocol","authors":"K. Jobin ,&nbsp;C. Campbell ,&nbsp;S.M. Schabrun ,&nbsp;K.J. Schneider ,&nbsp;A. Smith ,&nbsp;C.T. Debert","doi":"10.1016/j.conctc.2024.101370","DOIUrl":"10.1016/j.conctc.2024.101370","url":null,"abstract":"<div><h3>Background</h3><div>Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. Conservative therapies such as ET (ET) and physiotherapy combined with injection-based therapies are cornerstones of treatment for CGH but have shown limited efficacy. Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has shown promise in treating other chronic pain conditions. The primary aim of this trial is to evaluate the feasibility and safety of tDCS when combined with ET for the treatment of CGH.</div></div><div><h3>Methods</h3><div>Adults (aged 18–65), blinded to treatment arm, will be randomized into one of two groups: active tDCS followed by ET or sham tDCS followed by ET. Transcranial direct current stimulation will be applied over M1 three times per week for 6-weeks and ET will be performed daily. The primary outcomes of this trial will be the feasibility and safety of the intervention. Feasibility will be defined as greater than 30 % recruitment, 70 % protocol adherence, and 80 % retention rate. Safety will be defined as no severe adverse events. Secondary exploratory outcomes will assess improvement in pain, strength, function, and quality of life.</div></div><div><h3>Conclusions</h3><div>This trial aims to demonstrate the safety and feasibility of tDCS in combination with ET for the treatment of CGH. Cervicogenic headaches can be difficult to treat contributing to significant impairments function and quality of life. Transcranial direct current stimulation is a potential novel treatment to improve health outcomes in these patients.</div></div><div><h3>Registration</h3><div>ClinicalTrials.gov-NCT05582616.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101370"},"PeriodicalIF":1.4,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142357614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Constricting Gaps: Protocol development, implementation challenges and lessons learned for the reality map of unmet needs for Palliative Care Interventions in advanced cancer patients study in Romania and Switzerland","authors":"Kalbermatten Natalie ,&nbsp;Curca Razvan ,&nbsp;Grigorescu Alexandru ,&nbsp;Mosoiu Daniela ,&nbsp;Pop Florina ,&nbsp;Poroch Vladimir ,&nbsp;Rosiu Ariana ,&nbsp;Achimas-Cadariu Patriciu ,&nbsp;Strasser Florian ,&nbsp;Swiss-Romanian Partnership IZERZO","doi":"10.1016/j.conctc.2024.101360","DOIUrl":"10.1016/j.conctc.2024.101360","url":null,"abstract":"<div><h3>Background</h3><p>Patients with advanced cancer experience many symptoms and needs requiring a Palliative Care Intervention (PCI). Identifying gaps between needs for PCIs and experienced delivery may improve health care, furthermore the association of gaps with quality indicators (QI). The multicentre Romanian (RO)-Swiss (CH) reality map study implemented a novel protocol based on needs concepts and culturally adapted quality indicators (QI).</p></div><div><h3>Methods</h3><p>An interactive mapping guide measuring unmet needs for PCIs monthly over six months, patient characteristics (cognition, EAPC basic data set, Cofactors) and QI (Inappropriate Anticancer Treatment, High Symptom Burden [IPOS, EQ5D], Repeated ER Admissions, Aggressive End-of-Life Care, and Quality of Death-and-Dying) were developed, applying swiss standards for quality assurance. A composite endpoint (QI, cofactors) was planned. Finally, local solutions responding to gaps were piloted.</p></div><div><h3>Results</h3><p>From 308 patients (RO: 262, CH: 46, age 62j [mean], 74 % ECOG PS 1&amp;2, 81 % current anticancer treatment) baseline and first follow-up data revealed main gaps (symptom management, spiritual needs, family support), country differences (e.g. illness understanding, spiritual needs) and a significant association of the number of gaps with depression. Later data become less, and data quality on QI variable, revealing gaps in research conduct competences, resources, and applicability of over-sophisticated quality assurance tools. Nevertheless, the unmet needs data promoted local initiatives, 81 patients participated in feasibility studies. Finally, the joint experience stimulated academic developments and national integration of palliative care into oncology.</p></div><div><h3>Conclusions</h3><p>Pairing motivation and enthusiasm with more modest aims, feasibility testing of all outcomes and investment in research competences may disperse gaps.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101360"},"PeriodicalIF":1.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001078/pdfft?md5=b74ce7b1dbbe5bda766e9f8e34705576&pid=1-s2.0-S2451865424001078-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach","authors":"Jillian E. Urban ,&nbsp;Justin B. Moore ,&nbsp;Madison E. Marks ,&nbsp;Ty D. Holcomb ,&nbsp;Robert Patterson ,&nbsp;Alexis McCoy ,&nbsp;Christopher M. Miles ,&nbsp;Joel D. Stitzel ,&nbsp;Kristie L. Foley","doi":"10.1016/j.conctc.2024.101371","DOIUrl":"10.1016/j.conctc.2024.101371","url":null,"abstract":"<div><p>Subconcussive, repetitive head impacts sustained in collision sports may negatively affect brain health. American football practices are controlled environments amenable to intervention. Engaging community members is essential for successful development, implementation, and sustainability of viable interventions. The objective of this study is to develop and pilot test an evidence-based intervention to reduce head impact exposure in youth American football (i.e., football), using a community-engaged approach. This manuscript describes the co-design of the intervention and associated implementation plan and the study protocol for evaluating the effectiveness and feasibility of the intervention and implementation plan. In the first part of this study, focus groups with parents and coaches, and individual interviews with organizational leaders associated with two teams at the middle school level were conducted. An anonymous survey assessing beliefs and perceptions of non-concussive head impacts was given to parents, coaches, and organizational leaders within the local youth football league. Following the football season, qualitative and quantitative data describing determinants of head acceleration events in football were shared with 12 stakeholders of coaches, league and school administrators, parents, an athletic trainer, and local university player development director. Together, we co-designed COACH (COmmunities Aligned to reduce Concussion and Head impact exposure) and implementation plan using a strategic planning approach. The preliminary effectiveness and feasibility were assessed in the second part of this study. Youth football players participating on the teams in year 1 (control teams) were fitted with mouthpiece-based head kinematic sensors which measure head acceleration events (HAEs). HAEs were collected and quantified during team activities. Preliminary effectiveness of the intervention to reduce HAEs was measured among two new teams pilot testing COACH with mouthpiece-based sensors, while simultaneously monitoring implementation of the intervention. We report our study design and evaluation, and opportunities and challenges with our approach. The results will inform a future full-scale pragmatic trial to assess the implementation and effectiveness of the intervention program.</p><p>NCT04908930.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101371"},"PeriodicalIF":1.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001182/pdfft?md5=83c04fcea6ccc6dcb01c52415fa91438&pid=1-s2.0-S2451865424001182-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment effects of two pharmaceutical skin care creams for xerotic feet among persons with diabetes: Rationale and design of a two-armed double blind randomized controlled trial","authors":"Anna Ericsson ,&nbsp;Karin Borgström ,&nbsp;Christine Kumlien ,&nbsp;Magdalena Gershater Annersten ,&nbsp;Tautgirdas Ruzgas ,&nbsp;Johan Engblom ,&nbsp;Petri Gudmundsson ,&nbsp;Victoria Lazer ,&nbsp;Skaidre Jankovskaja ,&nbsp;Eva Lavant ,&nbsp;Sophia Ågren-Witteschus ,&nbsp;Sebastian Björklund ,&nbsp;Saman Salim ,&nbsp;Mikael Åström ,&nbsp;Stefan Acosta","doi":"10.1016/j.conctc.2024.101372","DOIUrl":"10.1016/j.conctc.2024.101372","url":null,"abstract":"<div><h3>Introduction</h3><p>To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator creams.</p></div><div><h3>Methods</h3><p>Two-armed double-blind RCT, registered in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: NCT06427889. With 80 % power, two-tailed significance of 2.5 % in each arm, 39 study persons is needed in each arm, total 78 persons, 98 including dropouts, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal®lipid cream), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28.</p></div><div><h3>Discussion</h3><p>This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101372"},"PeriodicalIF":1.4,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001194/pdfft?md5=f48333f5855f1319b1cce6062b04605d&pid=1-s2.0-S2451865424001194-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142272608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility and effectiveness of cardiac telerehabilitation for older adults with coronary heart disease: A pilot randomized controlled trial","authors":"Jing Jing Su ,&nbsp;Arkers Kwan Ching Wong ,&nbsp;Xi-Fei He ,&nbsp;Li-ping Zhang ,&nbsp;Jie Cheng ,&nbsp;Li-Juan Lu ,&nbsp;Lan Lan ,&nbsp;Zhaozhao Wang ,&nbsp;Rose S.Y. Lin ,&nbsp;Ladislav Batalik","doi":"10.1016/j.conctc.2024.101365","DOIUrl":"10.1016/j.conctc.2024.101365","url":null,"abstract":"<div><h3>Background</h3><p>Cardiac rehabilitation is a beneficial multidisciplinary treatment of exercise promotion, patient education, risk factor management, and psychosocial counseling for people with coronary heart disease (CHD) that is underutilized due to substantial disparities in access, referral, and participation. Empirical studies suggest that cardiac telerehabilitation (CTR) have safety and efficacy comparable to traditional in-person cardiac rehabilitation, however, older adults are under-reported with effectiveness, feasibility, and usability remains unclear.</p></div><div><h3>Methods</h3><p>The study randomized 43 older adults (84 % males) to the 12-week CTR intervention or standard of care. Guided by Social Cognitive Theory, participants received individualized in-person assessment and e-coaching sessions, followed by CTR usage at home. Data were collected at baseline (T0), six-week (T1), and 12-week (T2).</p></div><div><h3>Results</h3><p>Participants in the CTR intervention group showed significant improvement in daily steps (T1: β = 4126.58, p = 0.001; T2: β = 5285, p = 0.01) and health-promoting lifestyle profile (T1: β = 23.26, <em>p</em> &lt; 0.001; T2: β = 12.18, <em>p</em> = 0.008) across study endpoints. Twenty participants completed the intervention, with 40 % used the website for data-uploading or experiential learning, 90 % used the pedometer for tele-monitoring. Improving awareness of rehabilitation and an action focus were considered key facilitators while physical discomforts and difficulties in using the technology were described as the main barriers.</p></div><div><h3>Conclusions</h3><p>The CTR is feasible, safe and effective in improving physical activity and healthy behaviors in older adults with CHD. Considering the variation in individual cardiovascular risk factors, full-scale RCT with a larger sample is needed to determine the effect of CTR on psychological symptoms, body weight and blood pressure, and quality of life.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101365"},"PeriodicalIF":1.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001121/pdfft?md5=1325af129481d86f6693d6c3df596e65&pid=1-s2.0-S2451865424001121-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Get BusActive!: Protocol of a single-blinded randomised controlled trial incentivising public transport use for physical activity gain among young people and adults","authors":"Melanie J. Sharman ,&nbsp;Oliver Stanesby ,&nbsp;Kim A. Jose ,&nbsp;Stephen Greaves ,&nbsp;Anna Timperio ,&nbsp;Elizabeth Reid ,&nbsp;Lisa Stafford ,&nbsp;Petr Otahal ,&nbsp;Verity J. Cleland","doi":"10.1016/j.conctc.2024.101367","DOIUrl":"10.1016/j.conctc.2024.101367","url":null,"abstract":"<div><h3>Background</h3><p>Population level physical activity generally does not meet recommended targets. Compared with private motor vehicle users, public transport users tend to be more physically active and financial incentives may encourage more public transport use, but these relationships are under-investigated. This paper describes the protocol of a randomised controlled trial that aimed to determine the effect of financially incentivising public transport use on physical activity in a regional Australian setting.</p></div><div><h3>Methods</h3><p><em>Get BusActive!</em> is a 9.5-month single-blinded randomised controlled trial. A convenience sample of Tasmanians aged ≥15 years will be randomised to a 14-week incentive-based intervention (bus trip target attainment rewarded by bus trip credits and weekly supportive text messages) or an active control following baseline measures and will be followed up ∼24 weeks later (maintenance phase). Both groups will receive written physical activity guidelines. The primary outcome is change in accelerometer-measured steps/day from baseline to immediately post intervention phase and maintenance phase. Secondary outcomes are change in: smartcard-measured bus trips/week; measured and self-reported minutes/week of physical activity and sitting; transport-related behaviour (using one-week travel diary), perspectives (e.g. enablers/barriers) and costs; health. Linear mixed model regression will determine group differences. Participant-level process evaluation will be conducted and intervention cost to the public transport provider determined.</p></div><div><h3>Conclusion</h3><p><em>Get BusActive!</em> will fill an important knowledge gap about the causal relationship between financially incentivised public transport use and physical activity—the findings will benefit health and transport-related decision makers.</p></div><div><h3>Trial registration</h3><p>ACTRN12623000613606.</p></div><div><h3>Universal trial number</h3><p>U1111-1292-3414.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101367"},"PeriodicalIF":1.4,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001145/pdfft?md5=6483b4bf1d4bcaa6983ccc7970f77d98&pid=1-s2.0-S2451865424001145-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}