Pub Date : 2025-12-04DOI: 10.1016/j.cct.2025.108180
Michael Hollifield , Charles Brock , Kelvin Lim , Paul Holtzheimer , Michael Alkire , Franz Macedo , Michelle J. Bovin , Tyler Smith , Jennifer Romesser , Michael Messina , Tanja Jovanovic , Seth Norrholm , Anastasia Krajec
Posttraumatic Stress Disorder (PTSD) is a debilitating disorder characterized by re-experiencing aspects of the original trauma, avoidance of trauma reminders, negative alterations in cognition and mood, and hyperarousal. Current evidence-based treatments for PTSD have both value and limitations, most notably slow response and high withdrawal rates. The field is searching for more rapid and highly effective interventions. The Stellate Ganglion Block (SGB), which has historically been used to treat regional pain syndromes, causalgia (nerve injury), and intractable angina, has support for being a rapid and highly effective intervention from multiple case series. However, one of two published RCTs was negative and the other had limitations. A larger more definitive study is necessary to provide the evidence needed to determine if SGB is an effective intervention. This paper describes the background, theory and methods of a multi-site triple-blind placebo-controlled trial about the efficacy and safety of the SGB for PTSD. Elements that make this a more definitive study include using and describing a reliably conducted sham, using a standard dose of anesthetic, including an untreated group, rigorously assessing side-effects and safety, and evaluating durability, enhanced dosing, and an objective physiological outcome measure (fear-potentiated startle) to evaluate treatment response in addition to the clinical effect. The strengths and limitations of this research are also presented.
Clinical trial registration
This study is registered on ClinicalTrials.gov ID NCT05169190
{"title":"Efficacy and safety of the stellate ganglion block for posttraumatic stress disorder in veterans: Rationale for and methods of a multisite trial","authors":"Michael Hollifield , Charles Brock , Kelvin Lim , Paul Holtzheimer , Michael Alkire , Franz Macedo , Michelle J. Bovin , Tyler Smith , Jennifer Romesser , Michael Messina , Tanja Jovanovic , Seth Norrholm , Anastasia Krajec","doi":"10.1016/j.cct.2025.108180","DOIUrl":"10.1016/j.cct.2025.108180","url":null,"abstract":"<div><div>Posttraumatic Stress Disorder (PTSD) is a debilitating disorder characterized by re-experiencing aspects of the original trauma, avoidance of trauma reminders, negative alterations in cognition and mood, and hyperarousal. Current evidence-based treatments for PTSD have both value and limitations, most notably slow response and high withdrawal rates. The field is searching for more rapid and highly effective interventions. The Stellate Ganglion Block (SGB), which has historically been used to treat regional pain syndromes, causalgia (nerve injury), and intractable angina, has support for being a rapid and highly effective intervention from multiple case series. However, one of two published RCTs was negative and the other had limitations. A larger more definitive study is necessary to provide the evidence needed to determine if SGB is an effective intervention. This paper describes the background, theory and methods of a multi-site triple-blind placebo-controlled trial about the efficacy and safety of the SGB for PTSD. Elements that make this a more definitive study include using and describing a reliably conducted sham, using a standard dose of anesthetic, including an untreated group, rigorously assessing side-effects and safety, and evaluating durability, enhanced dosing, and an objective physiological outcome measure (fear-potentiated startle) to evaluate treatment response in addition to the clinical effect. The strengths and limitations of this research are also presented.</div></div><div><h3>Clinical trial registration</h3><div>This study is registered on <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID <span><span>NCT05169190</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108180"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681683","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}
This paper outlines the study protocol for an evaluation of the Let's Connect® (LC) parenting program. LC is a trauma-responsive, emotion-focused parenting program that teaches parents/caregivers to identify and respond to children's emotional needs and behaviors in a way that builds connection and warmth and promotes children's emotional competence, mental and behavioral health, and overall well-being. In a randomized controlled trial (RCT), this project will evaluate the efficacy of LC in a virtual delivery format with families who are at-risk for or have experienced trauma, violence, and/or other adverse life events.
Methods
We will recruit up to 200 parent-child dyads (children ages 4–14 years) and randomize them to the 14-week LC intervention condition or waitlist control condition. Primary outcomes include parent well-being, parenting practices, child well-being, and child social-emotional competencies. Outcomes will be assessed using parent and child report questionnaires, parent interview, and observational data at three time points: baseline (T1), posttest (T2; ∼14 weeks after baseline), and follow-up (T3; 6-months after posttest). Intent-to-treat analyses will be used to estimate intervention effects across the three assessment points.
Conclusion
This study is the first RCT of the LC parenting intervention that will evaluate its efficacy and will contribute to evidence of innovative and culturally responsive, emotion-focused parenting interventions in a sustainable delivery format. This trial is preregistered on the Open Science Framework (https://osf.io/xd5he/).
{"title":"Study protocol for a randomized controlled trial of the Let's Connect® intervention: A trauma-responsive, emotion-focused parenting skills program","authors":"Marcela Torres Pauletic, Kimberly Shipman, Christine M. Steeger, Megan Holton, Jill Trammell","doi":"10.1016/j.cct.2025.108177","DOIUrl":"10.1016/j.cct.2025.108177","url":null,"abstract":"<div><h3>Background</h3><div>This paper outlines the study protocol for an evaluation of the Let's Connect® (LC) parenting program. LC is a trauma-responsive, emotion-focused parenting program that teaches parents/caregivers to identify and respond to children's emotional needs and behaviors in a way that builds connection and warmth and promotes children's emotional competence, mental and behavioral health, and overall well-being. In a randomized controlled trial (RCT), this project will evaluate the efficacy of LC in a virtual delivery format with families who are at-risk for or have experienced trauma, violence, and/or other adverse life events.</div></div><div><h3>Methods</h3><div>We will recruit up to 200 parent-child dyads (children ages 4–14 years) and randomize them to the 14-week LC intervention condition or waitlist control condition. Primary outcomes include parent well-being, parenting practices, child well-being, and child social-emotional competencies. Outcomes will be assessed using parent and child report questionnaires, parent interview, and observational data at three time points: baseline (T1), posttest (T2; ∼14 weeks after baseline), and follow-up (T3; 6-months after posttest). Intent-to-treat analyses will be used to estimate intervention effects across the three assessment points.</div></div><div><h3>Conclusion</h3><div>This study is the first RCT of the LC parenting intervention that will evaluate its efficacy and will contribute to evidence of innovative and culturally responsive, emotion-focused parenting interventions in a sustainable delivery format. This trial is preregistered on the Open Science Framework (<span><span>https://osf.io/xd5he/</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108177"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696078","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}
Pub Date : 2025-12-04DOI: 10.1016/j.cct.2025.108178
Tamara Blickisdorf , Lisa G. Wood , Sarah R. Valkenborghs , Anne E. Dixon , Jay C. Horvat , Natasha A. Weaver , Serene Yoong , Bronwyn S. Berthon , Evan J. Williams , Alexandra C. Brown , Christine R. Jenkins , Meagan L. Morrissey , Peter A. Wark , Katie Wynne , Christopher L. Grainge , Emad M. El-Omar , Lily M. Williams , John D. Brannan , Liang De Wang , Siu Ling Wong , Hayley A. Scott
Background
Obesity is associated with more severe asthma symptoms, more frequent exacerbations, and more frequent asthma-related hospitalisations compared to adults without obesity. Because the origins and expression of obesity varies between individuals, a one-size-fits-all approach to obesity management will not address the underlying cause(s), increasing the risk of treatment failure. We hypothesise that obesity-related asthma is driven by excess adiposity, poor diet quality, physical inactivity, and poor metabolic health, while an individualised obesity management intervention, utilising medical nutrition therapy and personalised physical activity prescription, will result in better asthma control.
Methods
The Individualised Diet and Exercise Intervention for Optimising Asthma Control and Lung Function (IDEAL) Study will test the first individualised obesity management approach for people with asthma. In this 16-week randomised controlled trial with 12-month follow-up, 102 adults with obesity and uncontrolled asthma will be randomised to either the IDEAL program or control group. Participants will be assessed for outcomes at baseline, 16 and 52 weeks. Participants randomised to the IDEAL Program will attend five sessions with a dietitian and physiotherapist/exercise physiologist during the 16-week intervention period. We will test the intervention effect on asthma (asthma control, lung function), inflammatory (e.g. sputum cell counts, plasma IL-6) and non-asthma outcomes (e.g. diet quality, physical activity levels, metabolic health), as well as the acceptability and cost of the intervention.
Conclusion
This trial aims to provide people living with asthma and obesity an effective and sustainable way to help control their asthma symptoms and will assess mechanisms responsible for any improvements observed.
{"title":"Personalising the management of obesity-related asthma using medical nutrition therapy and physical activity prescription: The IDEAL study protocol","authors":"Tamara Blickisdorf , Lisa G. Wood , Sarah R. Valkenborghs , Anne E. Dixon , Jay C. Horvat , Natasha A. Weaver , Serene Yoong , Bronwyn S. Berthon , Evan J. Williams , Alexandra C. Brown , Christine R. Jenkins , Meagan L. Morrissey , Peter A. Wark , Katie Wynne , Christopher L. Grainge , Emad M. El-Omar , Lily M. Williams , John D. Brannan , Liang De Wang , Siu Ling Wong , Hayley A. Scott","doi":"10.1016/j.cct.2025.108178","DOIUrl":"10.1016/j.cct.2025.108178","url":null,"abstract":"<div><h3>Background</h3><div>Obesity is associated with more severe asthma symptoms, more frequent exacerbations, and more frequent asthma-related hospitalisations compared to adults without obesity. Because the origins and expression of obesity varies between individuals, a one-size-fits-all approach to obesity management will not address the underlying cause(s), increasing the risk of treatment failure. We hypothesise that obesity-related asthma is driven by excess adiposity, poor diet quality, physical inactivity, and poor metabolic health, while an individualised obesity management intervention, utilising medical nutrition therapy and personalised physical activity prescription, will result in better asthma control.</div></div><div><h3>Methods</h3><div>The Individualised Diet and Exercise Intervention for Optimising Asthma Control and Lung Function (IDEAL) Study will test the first individualised obesity management approach for people with asthma. In this 16-week randomised controlled trial with 12-month follow-up, 102 adults with obesity and uncontrolled asthma will be randomised to either the IDEAL program or control group. Participants will be assessed for outcomes at baseline, 16 and 52 weeks. Participants randomised to the IDEAL Program will attend five sessions with a dietitian and physiotherapist/exercise physiologist during the 16-week intervention period. We will test the intervention effect on asthma (asthma control, lung function), inflammatory (e.g. sputum cell counts, plasma IL-6) and non-asthma outcomes (e.g. diet quality, physical activity levels, metabolic health), as well as the acceptability and cost of the intervention.</div></div><div><h3>Conclusion</h3><div>This trial aims to provide people living with asthma and obesity an effective and sustainable way to help control their asthma symptoms and will assess mechanisms responsible for any improvements observed.</div></div><div><h3>Ethics/Registrations</h3><div><strong>NSW REGIS ETHICS Reference:</strong> 2023/ETH00833.</div><div><strong>UoN IBC Reference No:</strong> SP-23-92.</div><div><strong>ANZCTR Reference No:</strong> ACTRN12623000979651.</div><div><strong>Universal Trial Number</strong>: U1111–1291–8501.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108178"},"PeriodicalIF":1.9,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696106","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}
Pub Date : 2025-12-01DOI: 10.1016/j.cct.2025.108072
Thomas G. Travison , Edward Pham , Karen Donelan , Stephen J. Bartels , Jocelyn A. Carter , Kathryn Corelli , Steven R. Counsell , Maggie Crean , Ellen Flaherty , Carie Michael , Daniel S. Moran , Harvey J. Murff , Jennifer Perloff , Christine S. Ritchie
Older adults with complex health and social care needs comprise some 5% of the United States population but contribute roughly half of healthcare costs. Patient and caregiver perspectives in qualitative studies emphasize care fragmentation in traditional care delivery models. The need for more streamlined and personalized care for these older adults is acute, particularly in value-based care systems such as Accountable Care Organizations (ACOs). Prior studies suggest that older adults with complex health needs are best cared for through person-centered care plans conducted by interdisciplinary teams of healthcare professionals, but adoption remains suboptimal. In this study, we compare two different geriatric-focused approaches to care for older adults: Annual Wellness Visits (AWV) and/or AWV augmented with GRACE (Geriatric Resources for Assessment and Care of Elders). AWVs are a Medicare benefit with a brief geriatric assessment; GRACE is a geriatric model of care that uses a home-based geriatric assessment, structured protocols, team-based care planning and primary care co-management to support older adults with complex care needs. The two-phase study includes a Phase 1 feasibility pilot, conducted in two primary care practices in one health system; and a Phase 2 cluster-randomized trial conducted in 32 primary care practices in four ACOs. Phase 2 assesses the comparative effectiveness of AWVs vs. AWV with GRACE, with primary outcomes of hospitalizations and patient experience, and secondary outcomes of caregiver strain and clinician professional fulfillment. Results will help inform personalized care among older adults with complex health needs.
{"title":"Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study","authors":"Thomas G. Travison , Edward Pham , Karen Donelan , Stephen J. Bartels , Jocelyn A. Carter , Kathryn Corelli , Steven R. Counsell , Maggie Crean , Ellen Flaherty , Carie Michael , Daniel S. Moran , Harvey J. Murff , Jennifer Perloff , Christine S. Ritchie","doi":"10.1016/j.cct.2025.108072","DOIUrl":"10.1016/j.cct.2025.108072","url":null,"abstract":"<div><div>Older adults with complex health and social care needs comprise some 5% of the United States population but contribute roughly half of healthcare costs. Patient and caregiver perspectives in qualitative studies emphasize care fragmentation in traditional care delivery models. The need for more streamlined and personalized care for these older adults is acute, particularly in value-based care systems such as Accountable Care Organizations (ACOs). Prior studies suggest that older adults with complex health needs are best cared for through person-centered care plans conducted by interdisciplinary teams of healthcare professionals, but adoption remains suboptimal. In this study, we compare two different geriatric-focused approaches to care for older adults: Annual Wellness Visits (AWV) and/or AWV augmented with GRACE (Geriatric Resources for Assessment and Care of Elders). AWVs are a Medicare benefit with a brief geriatric assessment; GRACE is a geriatric model of care that uses a home-based geriatric assessment, structured protocols, team-based care planning and primary care co-management to support older adults with complex care needs. The two-phase study includes a Phase 1 feasibility pilot, conducted in two primary care practices in one health system; and a Phase 2 cluster-randomized trial conducted in 32 primary care practices in four ACOs. Phase 2 assesses the comparative effectiveness of AWVs vs. AWV with GRACE, with primary outcomes of hospitalizations and patient experience, and secondary outcomes of caregiver strain and clinician professional fulfillment. Results will help inform personalized care among older adults with complex health needs.</div><div><span><span>NCT06287801</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108072"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999810","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}
Pub Date : 2025-11-29DOI: 10.1016/j.cct.2025.108170
Simone Baldi , Francesca Cuffaro , Edda Russo , Kate Porter , William Cheung , Maria Magdalena Coman , Marco Garcia Vaquero , Thomas Lingner , Maria Cristina Verdenelli , Gwendolyn Barceló-Coblijn , Iain Brownlee , Stefano Fumagalli , Amedeo Amedei
Background and aims
Atrial fibrillation (AF), heart failure (HF), and undernutrition represent a complex triad with major clinical and socioeconomic consequences in older adults, often predisposing to frailty. Undernutrition often remains underdiagnosed due to a reliance on weight-based measures and limited awareness of inflammation-related cachexia. The AMBROSIA study aims to fill these gaps by exploring the response of the microbiota–inflammation–brain axis to a targeted, fortified food product-based intervention, with comprehensive outcome assessments, alongside mechanistic/exploratory -omics analyses and gut microbiota (GM) functional profiling.
Methods and results
This single-center, prospective, parallel-group randomized controlled trial aims to enroll 120 older adults with confirmed AF and/or HF. Participants will be randomized 1:1 into an intervention group (n = 60) or control group (n = 60). All participants receive individualized dietary counseling; the intervention group additionally consumes one AMBROSIA nutritional bar daily for six months. The bar contains hydrolyzed proteins, inulin, CoQ₁₀, and probiotics (L. rhamnosus IMC 501® and L. paracasei IMC 502®) in a flavonoid-rich chocolate matrix. Clinical, cognitive, and nutritional data, along with blood, saliva, urine, and stool samples, will be collected at baseline, 3, and 6 months. The primary endpoint is the change in skeletal muscle mass, physical function and frailty, while secondary endpoints include changes in nutritional status, inflammation, GM, metabolomics, and quality of life.
Conclusion
By integrating cutting-edge omics tools and a multidimensional nutritional strategy, AMBROSIA aims to uncover mechanisms driving undernutrition and identify biomarkers to support personalized interventions for older patients with AF and HF.
{"title":"Assessment of a novel functional food modulating the microbiota-inflammation-brain axis in patients with heart failure and/or /atrial fibrillation patients (the AMBROSIA study): Protocol for a randomized controlled trial","authors":"Simone Baldi , Francesca Cuffaro , Edda Russo , Kate Porter , William Cheung , Maria Magdalena Coman , Marco Garcia Vaquero , Thomas Lingner , Maria Cristina Verdenelli , Gwendolyn Barceló-Coblijn , Iain Brownlee , Stefano Fumagalli , Amedeo Amedei","doi":"10.1016/j.cct.2025.108170","DOIUrl":"10.1016/j.cct.2025.108170","url":null,"abstract":"<div><h3>Background and aims</h3><div>Atrial fibrillation (AF), heart failure (HF), and undernutrition represent a complex triad with major clinical and socioeconomic consequences in older adults, often predisposing to frailty. Undernutrition often remains underdiagnosed due to a reliance on weight-based measures and limited awareness of inflammation-related cachexia. The AMBROSIA study aims to fill these gaps by exploring the response of the microbiota–inflammation–brain axis to a targeted, fortified food product-based intervention, with comprehensive outcome assessments, alongside mechanistic/exploratory -omics analyses and gut microbiota (GM) functional profiling.</div></div><div><h3>Methods and results</h3><div>This single-center, prospective, parallel-group randomized controlled trial aims to enroll 120 older adults with confirmed AF and/or HF. Participants will be randomized 1:1 into an intervention group (<em>n</em> = 60) or control group (n = 60). All participants receive individualized dietary counseling; the intervention group additionally consumes one AMBROSIA nutritional bar daily for six months. The bar contains hydrolyzed proteins, inulin, CoQ₁₀, and probiotics (<em>L. rhamnosus</em> IMC 501® and L. <em>paracasei</em> IMC 502®) in a flavonoid-rich chocolate matrix. Clinical, cognitive, and nutritional data, along with blood, saliva, urine, and stool samples, will be collected at baseline, 3, and 6 months. The primary endpoint is the change in skeletal muscle mass, physical function and frailty, while secondary endpoints include changes in nutritional status, inflammation, GM, metabolomics, and quality of life.</div></div><div><h3>Conclusion</h3><div>By integrating cutting-edge omics tools and a multidimensional nutritional strategy, AMBROSIA aims to uncover mechanisms driving undernutrition and identify biomarkers to support personalized interventions for older patients with AF and HF.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108170"},"PeriodicalIF":1.9,"publicationDate":"2025-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145654007","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}
Pub Date : 2025-11-27DOI: 10.1016/j.cct.2025.108171
Jennifer A. Campbell, Rebekah J. Walker, Leonard E. Egede
Background
Monetary interventions, such as cash transfers, have emerged as important intervention approaches to address the complex determinants at the structural and individual level impacting diabetes outcomes.
Methods
This NIH funded (K01DK131319), pilot randomized controlled trial (RCT) is an ongoing 5 year study to evaluate the efficacy of two diabetes-tailored cash transfer interventions in low-income adults in which 1) cash transfers are conditional on participating in nurse-led, telephone-delivered diabetes education/skills training and stress/coping intervention delivered every 2 weeks for 6 months (DM-CCT); or 2) cash transfers are unconditional (DM-UCT), on clinical outcomes (HbA1c and blood pressure), and quality of life among 100 African Americans aged 18+ years with T2DM and HbA1c ≥8 %. Assessments will be conducted at baseline, 3-, and 6-months with primary outcome at 6 months post-randomization.
Discussion
Recruitment began in March 2023 and was completed in February 2024. Average age was 51 years. Most participants were women (71.0 %). Mean HbA1c was 10.1±1.8 for DM-CCT group and 10.2±1.8 for DM-UCT group. Mean systolic and diastolic blood pressure was 128.0±22.7 mmHg and 80.2±13.7 mmHg for DM-CCT group and 133.5±22.2 mmHg and 83.7±13.7 mmHg for DM-UCT group. Mean BMI was 36.2±10.3 kg/m2 for DM-CCT and 35.7±9.2 kg/m2 for DM-UCT. This pilot RCT represents a promising intervention to address the underlying poverty driven social risk factors while simultaneously addressing diabetes specific behaviors to improve outcomes. Findings from this study will provide preliminary evidence on efficacy of cash transfer interventions to improve clinical outcomes in low-income adults with poorly controlled T2DM.
{"title":"Pilot randomized trial of cash transfer interventions to improve health outcomes in low income adults with poorly controlled type 2 diabetes: Study protocol and baseline characteristics","authors":"Jennifer A. Campbell, Rebekah J. Walker, Leonard E. Egede","doi":"10.1016/j.cct.2025.108171","DOIUrl":"10.1016/j.cct.2025.108171","url":null,"abstract":"<div><h3>Background</h3><div>Monetary interventions, such as cash transfers, have emerged as important intervention approaches to address the complex determinants at the structural and individual level impacting diabetes outcomes.</div></div><div><h3>Methods</h3><div>This NIH funded (K01DK131319), pilot randomized controlled trial (RCT) is an ongoing 5 year study to evaluate the efficacy of two diabetes-tailored cash transfer interventions in low-income adults in which 1) cash transfers are conditional on participating in nurse-led, telephone-delivered diabetes education/skills training and stress/coping intervention delivered every 2 weeks for 6 months (DM-CCT); or 2) cash transfers are unconditional (DM-UCT), on clinical outcomes (HbA1c and blood pressure), and quality of life among 100 African Americans aged 18+ years with T2DM and HbA1c ≥8 %. Assessments will be conducted at baseline, 3-, and 6-months with primary outcome at 6 months post-randomization.</div></div><div><h3>Discussion</h3><div>Recruitment began in March 2023 and was completed in February 2024. Average age was 51 years. Most participants were women (71.0 %). Mean HbA1c was 10.1±1.8 for DM-CCT group and 10.2±1.8 for DM-UCT group. Mean systolic and diastolic blood pressure was 128.0±22.7 mmHg and 80.2±13.7 mmHg for DM-CCT group and 133.5±22.2 mmHg and 83.7±13.7 mmHg for DM-UCT group. Mean BMI was 36.2±10.3 kg/m<sup>2</sup> for DM-CCT and 35.7±9.2 kg/m<sup>2</sup> for DM-UCT. This pilot RCT represents a promising intervention to address the underlying poverty driven social risk factors while simultaneously addressing diabetes specific behaviors to improve outcomes. Findings from this study will provide preliminary evidence on efficacy of cash transfer interventions to improve clinical outcomes in low-income adults with poorly controlled T2DM.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108171"},"PeriodicalIF":1.9,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630892","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}
Pub Date : 2025-11-26DOI: 10.1016/j.cct.2025.108167
Terrence M. Riley , Camila Weschenfelder , Eric Ravussin , Jennifer C. Rood , Frank Greenway , Sarah Taff , Robert C. Hickner , Hongyuan Cao , Angelina R. Sutin , Gregory Todd , Stephen R. Hennigar , Claire E. Berryman
Background
Diet and exercise are the cornerstone of obesity prevention and treatment. However, a substantial number of individuals are non-responsive to existing weight-loss interventions and obesity rates continue to rise. Daily exposure to low-oxygen conditions may aid in current weight-loss strategies by increasing resting metabolic rate and decreasing appetite. Whether in-home, overnight, normobaric hypoxic exposure promotes body weight loss in adults with obesity remains unknown.
Methods
Fifty adults with obesity (BMI: 30–39.9 kg/m2) will complete this double-blind, parallel-arm, randomized, controlled-feeding clinical trial. Participants will be provided with a weight maintenance diet for 2 weeks while undergoing baseline measurements. Following the weight maintenance phase, an energy restricted diet (500 kcal/day below weight maintenance needs) will be provided in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% oxygen, elevation ∼2,640 m) or normoxia (8 h/night, 21% oxygen, elevation ∼60 m), using a commercially available, in-home tent system, for 8 weeks. The primary outcome is the difference in body weight change between interventions. Secondary outcomes include measures of body composition, total and resting energy expenditure, energy intake from an ad libitum meal, insulin sensitivity and glycemic control, sympathetic tone, iron absorption and indicators of iron status, stool microbial diversity and composition, appetite, psychosocial factors, and sleep quantity and quality.
Discussion
Chronic, overnight, low oxygen exposure may provide a novel intervention to supplement current weight-loss strategies, inform new strategies to accelerate weight loss, and aid long-term weight management efforts in adults with obesity.
{"title":"Effects of daily low oxygen exposure on weight status, body composition, and metabolic health in adults with obesity: protocol for a randomized, double-blind, controlled-feeding study","authors":"Terrence M. Riley , Camila Weschenfelder , Eric Ravussin , Jennifer C. Rood , Frank Greenway , Sarah Taff , Robert C. Hickner , Hongyuan Cao , Angelina R. Sutin , Gregory Todd , Stephen R. Hennigar , Claire E. Berryman","doi":"10.1016/j.cct.2025.108167","DOIUrl":"10.1016/j.cct.2025.108167","url":null,"abstract":"<div><h3>Background</h3><div>Diet and exercise are the cornerstone of obesity prevention and treatment. However, a substantial number of individuals are non-responsive to existing weight-loss interventions and obesity rates continue to rise. Daily exposure to low-oxygen conditions may aid in current weight-loss strategies by increasing resting metabolic rate and decreasing appetite. Whether in-home, overnight, normobaric hypoxic exposure promotes body weight loss in adults with obesity remains unknown.</div></div><div><h3>Methods</h3><div>Fifty adults with obesity (BMI: 30–39.9 kg/m<sup>2</sup>) will complete this double-blind, parallel-arm, randomized, controlled-feeding clinical trial. Participants will be provided with a weight maintenance diet for 2 weeks while undergoing baseline measurements. Following the weight maintenance phase, an energy restricted diet (500 kcal/day below weight maintenance needs) will be provided in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% oxygen, elevation ∼2,640 m) or normoxia (8 h/night, 21% oxygen, elevation ∼60 m), using a commercially available, in-home tent system, for 8 weeks. The primary outcome is the difference in body weight change between interventions. Secondary outcomes include measures of body composition, total and resting energy expenditure, energy intake from an ad libitum meal, insulin sensitivity and glycemic control, sympathetic tone, iron absorption and indicators of iron status, stool microbial diversity and composition, appetite, psychosocial factors, and sleep quantity and quality.</div></div><div><h3>Discussion</h3><div>Chronic, overnight, low oxygen exposure may provide a novel intervention to supplement current weight-loss strategies, inform new strategies to accelerate weight loss, and aid long-term weight management efforts in adults with obesity.</div></div><div><h3>Clinical trial registration</h3><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT05289310</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108167"},"PeriodicalIF":1.9,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615978","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}
Pub Date : 2025-11-26DOI: 10.1016/j.cct.2025.108168
Catherine E. Mosher , Eileen H. Shinn , Elizabeth L. Addington , Wei Wu , Jonathan B. Bricker , Paul R. Helft , Anita A. Turk , Laura B. Vater , Ashiq Masood , Shadia I. Jalal , Patrick J. Loehrer Sr. , Victoria L. Champion , Shelley A. Johns
Fatigue's interference with activities, mood, and cognition is one of the most prevalent and distressing problems of patients with advanced gastrointestinal cancer. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing demands. Evidence-based interventions for patient fatigue interference and caregiver burden are lacking in advanced gastrointestinal cancer. In a pilot trial, telephone-based Acceptance and Commitment Therapy (ACT) showed potential for reducing patient fatigue interference and caregiver burden in this population. The current Phase II trial seeks to determine the efficacy of this intervention for patients with advanced gastrointestinal cancer and moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 244 dyads are randomly assigned to either the ACT intervention or an education/support control. Participants in both conditions attend six weekly 50-min telephone sessions, four of which involve both dyad members, and a 30-min booster session. The primary aim is to test the effects of telephone-delivered ACT on patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. This trial also examines whether increased psychological flexibility, defined as mindful acceptance of present experiences, including challenges, while pursuing actions aligned with personal values, mediates ACT's effects on primary outcomes. Our ability to demonstrate ACT's efficacy will support its adoption in cancer care. Findings will also inform future ACT trials for dyads coping with other serious illnesses.
{"title":"Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer","authors":"Catherine E. Mosher , Eileen H. Shinn , Elizabeth L. Addington , Wei Wu , Jonathan B. Bricker , Paul R. Helft , Anita A. Turk , Laura B. Vater , Ashiq Masood , Shadia I. Jalal , Patrick J. Loehrer Sr. , Victoria L. Champion , Shelley A. Johns","doi":"10.1016/j.cct.2025.108168","DOIUrl":"10.1016/j.cct.2025.108168","url":null,"abstract":"<div><div>Fatigue's interference with activities, mood, and cognition is one of the most prevalent and distressing problems of patients with advanced gastrointestinal cancer. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing demands. Evidence-based interventions for patient fatigue interference and caregiver burden are lacking in advanced gastrointestinal cancer. In a pilot trial, telephone-based Acceptance and Commitment Therapy (ACT) showed potential for reducing patient fatigue interference and caregiver burden in this population. The current Phase II trial seeks to determine the efficacy of this intervention for patients with advanced gastrointestinal cancer and moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 244 dyads are randomly assigned to either the ACT intervention or an education/support control. Participants in both conditions attend six weekly 50-min telephone sessions, four of which involve both dyad members, and a 30-min booster session. The primary aim is to test the effects of telephone-delivered ACT on patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. This trial also examines whether increased psychological flexibility, defined as mindful acceptance of present experiences, including challenges, while pursuing actions aligned with personal values, mediates ACT's effects on primary outcomes. Our ability to demonstrate ACT's efficacy will support its adoption in cancer care. Findings will also inform future ACT trials for dyads coping with other serious illnesses.</div><div>Trial Registration ID: <span><span>NCT06532877</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108168"},"PeriodicalIF":1.9,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630889","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}
Pub Date : 2025-11-26DOI: 10.1016/j.cct.2025.108172
Erin E. Bonar , Jason E. Goldstick , Meredith L. Philyaw-Kotov , Carrie A. Bourque , Susan J. Woolford , Ken Resnicow , Joanna Quigley , Golfo Tzilos Wernette , Sana Ahmed , Debra M. Langlois , Maureen A. Walton
Prevention of alcohol use and misuse among adolescents is a public health priority. A health care visit provides an opportunity for screening for alcohol use and delivery of early interventions. Digital intervention delivery may reduce barriers to implementation in these settings. Herein, we describe the protocol from an ongoing comparative effectiveness study testing digital interventions to prevent escalation of alcohol use among adolescents (ages 12–19) connected to pediatric healthcare. Adolescents screening positive for past-year alcohol use are eligible to participate. Enrolled participants complete a baseline survey and are randomly assigned [stratified by sex and age group (12–14; 15–17; 18–19)] to an interactive, ∼45-min computerized brief intervention (CBI) alone or combined with 8 weeks of text messages. Outcomes are assessed at 3-, 6-, 9-, and 12-months post-baseline. Primary outcomes include past 3-month alcohol consumption. Secondary outcomes include alcohol and drug consequences, illicit and prescription drug misuse, and depression symptoms. In parallel, caregivers are also invited to participate, which involves referral to download the app “Talk. They Hear You.” and completing surveys at baseline, 3-, 6-, 9- and 12- months to report their use of the app. A novel aspect of this study is that we partnered with adolescents, caregivers, and health care staff and clinicians throughout the study to enhance relevance, effectiveness, and potential for future dissemination. This study will provide critical data to inform implementation of digital interventions for pediatric patients with the potential to prevent negative health outcomes and promote adolescent well-being.
{"title":"Comparison of digital behavioral interventions to prevent alcohol misuse among adolescents ages 12 to 19: A randomized clinical trial protocol","authors":"Erin E. Bonar , Jason E. Goldstick , Meredith L. Philyaw-Kotov , Carrie A. Bourque , Susan J. Woolford , Ken Resnicow , Joanna Quigley , Golfo Tzilos Wernette , Sana Ahmed , Debra M. Langlois , Maureen A. Walton","doi":"10.1016/j.cct.2025.108172","DOIUrl":"10.1016/j.cct.2025.108172","url":null,"abstract":"<div><div>Prevention of alcohol use and misuse among adolescents is a public health priority. A health care visit provides an opportunity for screening for alcohol use and delivery of early interventions. Digital intervention delivery may reduce barriers to implementation in these settings. Herein, we describe the protocol from an ongoing comparative effectiveness study testing digital interventions to prevent escalation of alcohol use among adolescents (ages 12–19) connected to pediatric healthcare. Adolescents screening positive for past-year alcohol use are eligible to participate. Enrolled participants complete a baseline survey and are randomly assigned [stratified by sex and age group (12–14; 15–17; 18–19)] to an interactive, ∼45-min computerized brief intervention (CBI) alone or combined with 8 weeks of text messages. Outcomes are assessed at 3-, 6-, 9-, and 12-months post-baseline. Primary outcomes include past 3-month alcohol consumption. Secondary outcomes include alcohol and drug consequences, illicit and prescription drug misuse, and depression symptoms. In parallel, caregivers are also invited to participate, which involves referral to download the app “Talk. They Hear You.” and completing surveys at baseline, 3-, 6-, 9- and 12- months to report their use of the app. A novel aspect of this study is that we partnered with adolescents, caregivers, and health care staff and clinicians throughout the study to enhance relevance, effectiveness, and potential for future dissemination. This study will provide critical data to inform implementation of digital interventions for pediatric patients with the potential to prevent negative health outcomes and promote adolescent well-being.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108172"},"PeriodicalIF":1.9,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630817","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}
Pub Date : 2025-11-25DOI: 10.1016/j.cct.2025.108166
Soohyun Nam , Guangyu Tong , Joanne Iennaco , Debbie Humphries , Monica Ordway , Minjung Lee , Siobhan Thompson , Milagrosa Seguinot , Fernando Morales , Kwasheba Harriot , Nilda Paris , Katurah A. Bryant , Kristine Weidner , Taneha Edwards , Robin Whittemore
Black women in the U.S. disproportionately suffer from insomnia and related cardiometabolic health burdens. However, there is a lack of sleep intervention and implementation research specifically targeting Black women. The aim of this study is to co-design and evaluate equity-focused, community-engaged implementation strategies for an online, group-based mindfulness-based therapy for insomnia (MBTI) tailored for Black women, and to test the effectiveness of MBTI. The study will utilize trained registered nurses to deliver the online MBTI sessions and integrate community health workers (CHWs) to address social determinants of health. This two-phase, study includes: (1) qualitative individual interviews with Black women, CHWs, and clinicians to identify barriers/facilitators to online MBTI (N = 10–40) (2) the development of equity-focused implementation strategies through community engagement process with the Community Advisory Board (clinicians, CHWs, social workers, and community-based organization members), and (3) a Hybrid Type 1 randomized controlled trial comparing online group-based MBTI to a waitlist control (N = 340). Implementation outcomes include acceptability (mean summary score ≥ 3.5 out of 5-point Likert scale), feasibility (≥ 80 %), fidelity (≥ 85 %), cost, and contextual factors; effectiveness outcomes include changes in Insomnia Severity Index scores (≥ 7-point reduction post-intervention) and actigraphy-measured sleep (an increase in total sleep time 20–40 min post-intervention). This study addresses the urgent need for equity-focused intervention and implementation research in sleep health. The study will evaluate how tailoring evidence-based interventions to community needs, leveraging CHWs, and embedding community partnership throughout the process improves access, uptake, and outcomes in Black women with insomnia.
{"title":"Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women","authors":"Soohyun Nam , Guangyu Tong , Joanne Iennaco , Debbie Humphries , Monica Ordway , Minjung Lee , Siobhan Thompson , Milagrosa Seguinot , Fernando Morales , Kwasheba Harriot , Nilda Paris , Katurah A. Bryant , Kristine Weidner , Taneha Edwards , Robin Whittemore","doi":"10.1016/j.cct.2025.108166","DOIUrl":"10.1016/j.cct.2025.108166","url":null,"abstract":"<div><div>Black women in the U.S. disproportionately suffer from insomnia and related cardiometabolic health burdens. However, there is a lack of sleep intervention and implementation research specifically targeting Black women. The aim of this study is to co-design and evaluate equity-focused, community-engaged implementation strategies for an online, group-based mindfulness-based therapy for insomnia (MBTI) tailored for Black women, and to test the effectiveness of MBTI. The study will utilize trained registered nurses to deliver the online MBTI sessions and integrate community health workers (CHWs) to address social determinants of health. This two-phase, study includes: (1) qualitative individual interviews with Black women, CHWs, and clinicians to identify barriers/facilitators to online MBTI (<em>N</em> = 10–40) (2) the development of equity-focused implementation strategies through community engagement process with the Community Advisory Board (clinicians, CHWs, social workers, and community-based organization members), and (3) a Hybrid Type 1 randomized controlled trial comparing online group-based MBTI to a waitlist control (<em>N</em> = 340). Implementation outcomes include acceptability (mean summary score ≥ 3.5 out of 5-point Likert scale), feasibility (≥ 80 %), fidelity (≥ 85 %), cost, and contextual factors; effectiveness outcomes include changes in Insomnia Severity Index scores (≥ 7-point reduction post-intervention) and actigraphy-measured sleep (an increase in total sleep time 20–40 min post-intervention). This study addresses the urgent need for equity-focused intervention and implementation research in sleep health. The study will evaluate how tailoring evidence-based interventions to community needs, leveraging CHWs, and embedding community partnership throughout the process improves access, uptake, and outcomes in Black women with insomnia.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT06348082</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108166"},"PeriodicalIF":1.9,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615981","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}
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