Contemporary clinical trials最新文献

{"title":"Ketamine treatment in youth for fast reduction of suicidality and engagement in psychotherapy: A randomized placebo-controlled trial protocol","authors":"Noreen A. Reilly-Harrington ,&nbsp;Tatiana Falcone ,&nbsp;David A. Jobes ,&nbsp;Christina Deisz ,&nbsp;Claire Flannery ,&nbsp;Amber Wolf ,&nbsp;Bo Hu ,&nbsp;Amit Anand","doi":"10.1016/j.cct.2024.107777","DOIUrl":"10.1016/j.cct.2024.107777","url":null,"abstract":"<div><h3>Background</h3><div>Suicide is a leading cause of death in young persons. While ketamine has demonstrated rapid anti-suicidal effects, its safety and efficacy in youth has not been fully investigated. The Collaborative Assessment and Management of Suicidality (CAMS), a suicide-focused treatment shown to decrease suicidal ideation and symptom distress, has never been studied in combination with ketamine.</div></div><div><h3>Objectives</h3><div>This study investigates whether ketamine infusion, as compared to placebo, rapidly reduces severe suicidality in youth and young adults and enhances effectiveness of CAMS to decrease suicidality after acute treatment and at 3-month follow-up. We explore whether participants who receive ketamine, as compared to placebo, have decreased suicidality, suicide attempts, emergency department visits for suicidality, and psychiatric readmissions over 3-month follow-up.</div></div><div><h3>Methods</h3><div>This randomized controlled trial is enrolling 140 participants (ages 14–30) hospitalized with severe suicidal ideation or after attempted suicide. While hospitalized, participants are randomized to receive up to 6 treatments of either ketamine or placebo. Concurrently, participants engage in CAMS sessions, starting while inpatient and continuing post-discharge for up to 12 sessions via telehealth or until resolution of suicidality criteria are met. Monthly follow-up assessments are conducted for 3 months.</div></div><div><h3>Discussion</h3><div>Historically, hospital admissions have not decreased suicidal behavior following discharge. We hypothesize that ketamine, as compared to placebo, will lead to rapid improvement in suicidality and enhance engagement in CAMS, requiring significantly fewer sessions to resolve high-risk suicidality after discharge. We hypothesize that the ketamine group will have decreased suicidality, suicide attempts, and readmissions compared to the placebo group over 3-month follow-up.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107777"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized clinical trial protocol of an app-based intervention to prevent postpartum depression","authors":"Ellen Poleshuck ,&nbsp;Debra Fox ,&nbsp;Beau Abar ,&nbsp;Daniel Maeng ,&nbsp;Tamara Bilinski ,&nbsp;Lauren Beers ,&nbsp;Jules Rosen ,&nbsp;Caron Zlotnick","doi":"10.1016/j.cct.2024.107800","DOIUrl":"10.1016/j.cct.2024.107800","url":null,"abstract":"<div><h3>Purpose</h3><div>To develop and evaluate the effectiveness of an asynchronously delivered app, InBloom, for postpartum depression (PPD) prevention relative to an evidence-based synchronously delivered in-person intervention, ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) for depression and return on investment via a prospective randomized controlled trial and quasi-experimental cohort analyses.</div></div><div><h3>Background</h3><div>PPD affects 1 in 7 gestational parents in the US, causing emotional distress, consequences for infant development and child adjustment, disruptions in family relationships, and financial burden. ROSE is an evidence-based intervention administered as four in-person group sessions plus one postpartum booster session. Despite ROSE's demonstrated effectiveness, pragmatic barriers impact disseminating an in-vivo group intervention broadly to people at risk for PPD. If effective, an app may help overcome implementation barriers.</div></div><div><h3>Design</h3><div>We will develop an app based on the ROSE intervention, recruit 152 pregnant people ≥18 years, 17–32 weeks' gestation, and with risk factors for PPD, and randomize participants either to InBloom or ROSE. Primary outcomes are depression and return on investment (ROI). Hypothesized mechanisms are perceived access, engagement, and satisfaction with the intervention. Control groups include historical control subjects from the largest ROSE trial for depression outcomes and Electronic Health Record (EHR) data on concurrent patients from the same clinics not offered InBloom or ROSE for ROI outcomes.</div></div><div><h3>Conclusion</h3><div>At the end of the trial, we will know if InBloom is a viable alternative to ROSE, allowing further implementation studies of an easy, low-cost distribution app to reduce risk of PPD.</div><div><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span> <strong>Registration Identifier:</strong> <span><span>NCT05518162</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107800"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical decision support to improve primary care obesity management in adults with diabetes: Clinic-randomized study design","authors":"MarySue Beran,&nbsp;Heidi L. Ekstrom,&nbsp;A. Lauren Crain,&nbsp;Stephanie A. Hooker,&nbsp;Lilian Chumba,&nbsp;Deepika Appana,&nbsp;Kay Kromrey,&nbsp;Gopikrishna Kunisetty,&nbsp;Zeke M. McKinney,&nbsp;Nicolaas P. Pronk,&nbsp;Rashmi Sharma,&nbsp;Jennifer Vesely,&nbsp;Patrick J. O'Connor","doi":"10.1016/j.cct.2025.107830","DOIUrl":"10.1016/j.cct.2025.107830","url":null,"abstract":"<div><h3>Background</h3><div>To promote use of lifestyle, pharmacologic, and surgical weight management options for adults with body mass index (BMI) ≥35 kg/m² and type 2 diabetes (T2D), this project implements and evaluates a weight loss clinical decision support (WL-CDS) intervention that provides patient-specific estimates of the risks and benefits of evidence-based obesity management options to primary care clinicians (PCCs) and patients at primary care clinical encounters.</div></div><div><h3>Methods</h3><div>We randomize 38 primary care clinics to either (a) usual care (UC), or (b) the WL- CDS intervention that provides patients and PCCs recommendations for lifestyle changes and patient-specific obesity management options and estimates of benefits and risks of weight loss medications, or metabolic bariatric surgery (MBS) when indicated.</div></div><div><h3>Primary endpoints</h3><div>Outcomes assessed at 18-months after a patient-specific index date are (a) referral of eligible patients for MBS evaluation; (b) initiation or active management of FDA-approved medications for weight loss; and (c) weight trajectory. Outcomes measured within 1 month of index date are patient-reported (d) shared decision making about weight loss options, and (e) intention to engage in weight loss.</div></div><div><h3>Conclusion</h3><div>This study will deepen our understanding of how patients and PCCs use WL-CDS generated information to inform selection of obesity care options for adults with T2D and BMI ≥35 kg/m².</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107830"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing vaccine research in Africa: A comprehensive analysis of vaccine clinical trials landscape","authors":"Lindi Mathebula ,&nbsp;Thobile Malinga ,&nbsp;Chinwe Iwu-Jaja ,&nbsp;Duduzile Ndwandwe","doi":"10.1016/j.cct.2024.107779","DOIUrl":"10.1016/j.cct.2024.107779","url":null,"abstract":"<div><div>This study presents an in-depth analysis of vaccine clinical trials in Africa, emphasising the significance of local investments to address the continent's healthcare requirements. The research scrutinises vaccine trials across various African nations, focusing on trial distribution, phases, funding sources, recruitment sites, recruitment statuses, and age group participation.</div><div>The findings suggest substantial trial activity in countries like Kenya, Ghana, and Gambia, whereas nations like the Democratic Republic of the Congo and Tunisia exhibit minimal representation. Notably, COVID-19, HIV, and Yellow Fever vaccines prominently feature in the trials, with Phase 3 trials being the most prevalent. The presence of “Not Applicable” trials indicates adopting adaptive trial designs.</div><div>Analysis of funding patterns reveals substantial international and local support, reflecting an escalating commitment to vaccine research in Africa. Nevertheless, concerns persist regarding disparities in trial distribution and age group participation, underscoring the necessity for robust regulatory frameworks and augmented local R&amp;D capacity. Addressing these disparities can enhance the efficacy of vaccine research and elevate health outcomes across the African continent.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107779"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of fermented and fiber-rich foods on maternal & offspring microbiome study (FeFiFo-MOMS) — Study design and methods","authors":"Catherine P. Ward ,&nbsp;Dalia Perelman ,&nbsp;Lindsay R. Durand ,&nbsp;Jennifer L. Robinson ,&nbsp;Kristen M. Cunanan ,&nbsp;Sailendharan Sudakaran ,&nbsp;Roujheen Sabetan ,&nbsp;Maggie J. Madrigal-Moeller ,&nbsp;Christopher Dant ,&nbsp;Erica D. Sonnenburg ,&nbsp;Justin L. Sonnenburg ,&nbsp;Christopher D. Gardner","doi":"10.1016/j.cct.2025.107834","DOIUrl":"10.1016/j.cct.2025.107834","url":null,"abstract":"<div><h3>Background</h3><div>Recent research underscores the crucial role of the gut microbiota in human health, particularly during states of altered homeostasis, including pregnancy. Additionally, it is not well understood how dietary changes during pregnancy affect the development of microbiomes of both mother and child.</div></div><div><h3>Methods</h3><div>Here, we describe the study design and methods for our randomized controlled trial, the fermented and fiber-rich foods on maternal and offspring microbiome study (FeFiFo-MOMS). We enrolled 135 women during early pregnancy, randomizing them to one of four diet arms: increased fiber, increased fermented foods, increase in both, and no dietary intervention as a comparator arm. Samples were collected across pregnancy continuing to 18 months post-birth for clinical, microbiome, and immune marker analysis.</div></div><div><h3>Results</h3><div>Our trial design intended to investigate the effects of dietary interventions—specifically, increased intake of high-fiber and fermented foods—on maternal gut microbiota diversity and its subsequent transmission to infants.</div></div><div><h3>Conclusion</h3><div>The FeFiFo-MOMS trial was designed to provide valuable insights into the modifiable dietary factors that could influence maternal and infant health through microbiota-mediated mechanisms and examine the broader implications of diet on pregnant mothers' and infants' health and disease.</div><div><span><span><strong>Clinicaltrials.gov</strong></span><svg><path></path></svg></span> <strong>ID:</strong> <span><span>NCT05123612</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107834"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving weight loss and cardiometabolic risk in black patients with diabetes or pre-diabetes: Rationale and protocol for a digital medicine hybrid type 1 implementation trial","authors":"Peter T. Katzmarzyk ,&nbsp;Eboni G. Price-Haywood ,&nbsp;John W. Apolzan ,&nbsp;Kara D. Denstel ,&nbsp;Kimberly L. Drews ,&nbsp;Elise Farris ,&nbsp;Jewel Harden-Barrios ,&nbsp;Larry R. Hearld ,&nbsp;Emily F. Mire ,&nbsp;Corby K. Martin ,&nbsp;Robert L. Newton ,&nbsp;Maria Pisu","doi":"10.1016/j.cct.2024.107806","DOIUrl":"10.1016/j.cct.2024.107806","url":null,"abstract":"<div><h3>Background</h3><div>The goal of the PROPEL-IT study is to conduct an effectiveness-implementation (hybrid type 1) study to 1) test the effectiveness of a digital technology focused 24-month, patient-centered precision public health approach to weight-loss, facilitated by an electronic medical record (EMR) in Black patients with obesity and type 2 diabetes mellitus or prediabetes, and 2) better understand the external validity and context for implementation.</div></div><div><h3>Methods</h3><div>Patients in the Intensive Lifestyle Intervention (ILI) participate in a high-intensity behavioral intervention to facilitate weight loss through reducing dietary intake and increasing physical activity. The ILI is delivered by health coaches in the digital medicine program of a large health care organization facilitated by the patient portal of their EMR. Patients in the usual care (UC) group continue to receive routine medical care from their health care team. The primary outcome is percent weight change from baseline. Study implementation is guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) evaluative framework.</div></div><div><h3>Results</h3><div>Patient recruitment began on August 31, 2022 and was completed on January 22, 2024. During the ∼17-month recruitment period, 352 patients were recruited and randomized (176 to ILI; 176 to UC).</div></div><div><h3>Conclusion</h3><div>The results of this study will provide evidence on the effectiveness of a remotely delivered high-intensity weight loss program within a large health care organization, and provide important information regarding its implementation in a digital medicine setting.</div><div><strong>Clinical Trials Registration Number:</strong> <span><span>NCT05523375</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107806"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons with chronic kidney disease","authors":"Jesse C. Christensen ,&nbsp;Shuchi Anand ,&nbsp;Glenn M. Chertow ,&nbsp;Kate Lyden ,&nbsp;Amara Sarwal ,&nbsp;Terrence Bjordahl ,&nbsp;Robert Boucher ,&nbsp;Azeem Mohammed ,&nbsp;Evan G. Oro ,&nbsp;Farahnaz Akramimoghaddam ,&nbsp;Niharika Katkam ,&nbsp;Augustine Takyi ,&nbsp;George Bissada ,&nbsp;Akhil Ramanujam Chakravartula ,&nbsp;Edison Lee ,&nbsp;Ann Zheng ,&nbsp;Guo Wei ,&nbsp;Tom Greene ,&nbsp;Srinivasan Beddhu","doi":"10.1016/j.cct.2024.107766","DOIUrl":"10.1016/j.cct.2024.107766","url":null,"abstract":"<div><h3>Background</h3><div>Sedentary behavior is highly prevalent and associated with morbidity and mortality in chronic kidney disease (CKD). A Sit Less, Interact and Move More (SLIMM) sedentary activity coaching intervention can reduce sedentary duration among persons with CKD, but preliminary data suggest that effects may not persist. Prior studies have suggested that moderate/vigorous intensity physical activities are not sustainable in persons with CKD. Therefore, we aimed to determine whether guided resistance training ± oral semaglutide co-intervention improves adherence and/or persistence of the SLIMM intervention.</div></div><div><h3>Method/design</h3><div>The SLIMM-2 is a two-center study designed with a 3-month sedentary activity coaching (SLIMM) followed by a 9-month randomized controlled trial with three arms: SLIMM + standard of care resistance training + oral placebo, SLIMM + guided resistance training + oral placebo, or SLIMM + guided resistance training + oral semaglutide. The study is recruiting persons with CKD (eGFR 20 to ≤60 ml/min/1.73 m²). ActivPAL, a wearable tri-axial accelerometer, is used to assess outcomes including sedentary duration (primary outcome), stepping duration and the average number of steps per day. Additional outcomes include 6-min walk distance and body fat percentage. Persons randomized to standard of care resistance training will be encouraged to maintain individualized physical activity goals; those randomized to guided resistance training will attend guided sessions per month and be prescribed daily independent exercises.</div></div><div><h3>Results</h3><div>Enrollment, interventions, and follow-up are ongoing.</div></div><div><h3>Conclusions</h3><div>Results from the SLIMM-2 study are expected to inform clinical practice, with the potential to enhance physical health and functioning among persons with CKD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107766"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving colonoscopy quality in the national VA healthcare system","authors":"Andrew J. Gawron ,&nbsp;Travis Bailey ,&nbsp;Rachel Codden ,&nbsp;Jason Dominitz ,&nbsp;Samir Gupta ,&nbsp;Christian Helfrich ,&nbsp;Charles Kahi ,&nbsp;Lila Krop ,&nbsp;Carmel Malvar ,&nbsp;Grace McKee ,&nbsp;Morgan Millar ,&nbsp;Ashley Mog ,&nbsp;Tiffany Nguyen-Vu ,&nbsp;Olga Patterson ,&nbsp;Angela P. Presson ,&nbsp;Sameer Saini ,&nbsp;Mary Whooley ,&nbsp;Yiwen Yao ,&nbsp;Susan Zickmund ,&nbsp;Tonya Kaltenbach","doi":"10.1016/j.cct.2024.107784","DOIUrl":"10.1016/j.cct.2024.107784","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) prevention is a Veterans Affairs (VA) priority. Colonoscopy quality, especially adenoma detection rate (ADR), is critical for effective screening. Our research indicates considerable variation in ADR among VA providers. Even a slight increase in ADR can reduce fatal CRC rates, and audit and feedback strategies have improved ADR in other settings. A recent report identified deficiencies in VA colonoscopy quality, highlighting the need for standardized documentation and reporting. To address this, we developed the VA Endoscopy Quality Improvement Program (VA-EQuIP), which aims to improve colonoscopy quality through benchmarking and collaborative learning, aligning with VA's modernization priorities and HSR&amp;D and QUERI goals of accelerating evidence-based implementation.</div></div><div><h3>Methods</h3><div>We will conduct a stepped wedge cluster randomized trial to evaluate whether VA-EQuIP improves provider ADR compared to usual care, the implementation of VA-EQuIP, site-level factors associated with colonoscopy quality improvement, and components of provider behavior change. Using mixed methods our study will measure outcomes like reach, implementation, adoption, maintenance of VA-EQuIP, and provider behavior change. The analysis will include primary and secondary outcomes, such as overall and screening ADR, cecal intubation rate, and bowel preparation quality, using mixed effects generalized linear models and interrupted time-series analyses. Adoption and implementation will be evaluated through usage statistics, surveys, and qualitative interviews to identify factors influencing success.</div></div><div><h3>Discussion</h3><div>This study will assess the impact of VA-EQuIP on colonoscopy quality metrics and factors associated with effective implementation. VA-EQuIP infrastructure allows for national-scale implementation and evaluation of quality reporting with minimal manual labor, guiding future quality improvement efforts to ensure optimal patient care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107784"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of the Positive Outcomes through Supported Transition (POST) opioid preventive intervention for youth in the legal system: Study protocol for a sequential multiple assignment randomized trial","authors":"Ahnalee M. Brincks ,&nbsp;Kevin P. Haggerty ,&nbsp;Alexandria Kolberg ,&nbsp;Katie M. Albertson ,&nbsp;Carolyn A. McCarty ,&nbsp;Margaret R. Kuklinski ,&nbsp;Ted Ryle ,&nbsp;Kym R. Ahrens","doi":"10.1016/j.cct.2024.107782","DOIUrl":"10.1016/j.cct.2024.107782","url":null,"abstract":"<div><div>Adolescents and young adults in the legal system (AYALS) are at high risk for opioid use disorder (OUD). Effective, efficient interventions to prevent OUD that support youth as they transition to the community are needed. The Positive Outcomes through Supported Transition intervention trial is designed to identify the optimal intensity and sequence of behavioral skills and case management components for OUD prevention.</div><div>This sequential, multiple assignment randomized trial addresses three research questions: 1.whether to begin with a high-intensity, broad-scope intervention (Enhanced Adolescent Community Reinforcement Approach; <em>E</em>-ACRA) or a lower intensity intervention (Assertive Community Support; ACS), 2. whether to continue with <em>E</em>-ACRA or step-down to ACS after release, and 3. whether to step-up to E-ACRA or continue ACS for youth reporting problematic substance use after release.</div><div>Youth committed to state custody will be recruited prior to their release and randomized to <em>E</em>-ACRA or ACS. At five weeks post-release, E-ACRA participants will be re-randomized to <em>E</em>-ACRA or ACS. ACS participants reporting problematic substance use at five weeks will be re-randomized to <em>E</em>-ACRA or ACS. Primary analyses will test the effects of initial intervention (E-ACRA vs. ACS); secondary analyses will test the effects of second-stage interventions. Cost-effectiveness analysis will determine whether the additional resources deployed to <em>E</em>-ACRA are justified economically by the outcomes achieved.</div><div>Prevention is critical for this population. High-intensity interventions can be burdensome for participants (and agencies) and costly to deliver. This study examines how best to sequence high and low intensity interventions to maximize beneficial outcomes for the most youth.</div><div>This study's design was pre-registered with <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (<span><span>NCT04901312</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107782"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol of an adaptive mobile health intervention for the management of gestational weight gain: The LEAP cluster randomized controlled trial","authors":"Sneha B. Sridhar ,&nbsp;Assiamira Ferrara ,&nbsp;Susan D. Brown ,&nbsp;Charles P. Quesenberry ,&nbsp;Fei Xu ,&nbsp;Emily Liu ,&nbsp;Tali Sedgwick ,&nbsp;Page Kissel ,&nbsp;Hillary D. Serrato Bandera ,&nbsp;Cheryl Albright ,&nbsp;Monique M. Hedderson","doi":"10.1016/j.cct.2024.107781","DOIUrl":"10.1016/j.cct.2024.107781","url":null,"abstract":"<div><h3>Background</h3><div>More than half of pregnant patients with overweight or obesity exceed national gestational weight gain (GWG) guidelines, increasing their risk of adverse outcomes. There is an urgent need to develop effective and scalable interventions to improve GWG.</div></div><div><h3>Objective</h3><div>To describe the protocol of <u><strong>L</strong></u>ifestyle, <u><strong>E</strong></u>ating, and <u><strong>A</strong></u>ctivity in <u><strong>P</strong></u>regnancy (LEAP), a cluster randomized controlled trial evaluating a mobile health (mHealth) intervention promoting appropriate GWG in an integrated healthcare system.</div></div><div><h3>Methods</h3><div>LEAP is a cluster randomized trial with randomization at the clinician level. Patient eligibility includes a pre-pregnancy BMI of 25.0–40.0 kg/m² and singleton pregnancy. Consented patients receive standard care or standard care plus mHealth intervention per their clinician's randomization. The patient adaptive intervention provides personalized, automated feedback on GWG and physical activity using 1) a smartphone application, 2) a Wi-Fi scale and activity tracker; 3) weekly educational topics; and 4) step-wise support (added when GWG is &gt;75th percentile of the GWG guidelines). Intervention clinicians receive newsletters with motivational interviewing tips to facilitate discussing GWG. Primary outcomes are total GWG (last measured weight – pre-pregnancy weight) and weekly rate of GWG (total GWG/gestational weeks at delivery) as continuous variables and categorized per the IOM GWG guidelines. Secondary outcomes include trimester-specific rate of GWG, GWG trajectory, diet and physical activity, postpartum weight retention, birthweight, infant size for gestational age, and infant growth to 12 months.</div></div><div><h3>Conclusions</h3><div>LEAP addresses gaps in the implementation of GWG interventions in healthcare settings. The adaptive and mHealth nature of the intervention may enhance scalability.</div><div>Trial Registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT03880461</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"149 ","pages":"Article 107781"},"PeriodicalIF":2.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}