Contemporary clinical trials最新文献_第4页

Increasing parent help-seeking for child mental health: A study protocol for the growing minds check-in, an online universal screening tool 增加父母对儿童心理健康的帮助：一项关于成长中的心理检查的研究协议，一种在线普遍筛查工具。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107801

Talia Carl , Lucy A. Tully , Rebecca K. McLean , Mark R. Dadds , David J. Hawes , Cathrine Mihalopoulos , Mary Lou Chatterton , Frank Oberklaid , Allison M. Waters , Dianne Shanley , Marie B.H. Yap , Warren G. Cann , Thomas Carlick , Jaimie C. Northam

Background

Early identification and intervention for mental health (MH) problems in childhood offers lifelong benefits. Many children with MH problems do not receive appropriate help. To address this need, an online universal MH screening tool, the Growing Minds Check-In for parents/caregivers (GMCI-P), was developed to provide feedback to parents on their children's MH, identify children at risk of MH problems, and link parents to evidence-based online programs/information, with the goal of facilitating parent help-seeking, and ultimately reducing the prevalence of child MH problems.

Methods/design

A randomised controlled trial (RCT) with 440 parents/caregivers will be conducted to 1) examine the efficacy of GMCI-P for increasing parent help-seeking; 2) explore acceptability; and 3) cost-effectiveness. Participants will be Australian parents/caregivers with a child aged from birth to 17 years, 6 months, who will be randomly allocated to GMCI-P (intervention) or waitlist control (WLC) group, and complete baseline measures. The intervention group will complete the GMCI-P immediately, the post-GMCI-P intervention questions, a three-month and six-month follow-up. The WLC group will receive access to GMCI-P after their three-month follow-up but will not be followed up further. The primary outcome is parent help-seeking behaviour for child MH, and secondary outcomes include child MH, parenting, parent wellbeing, acceptability, cost-effectiveness, and unintended negative effects.

Discussion

The results from this study will provide efficacy, acceptability and cost-effectiveness data on a universal online, parent-report child MH Check-In. These results can be used to inform public policy on universal screening for child MH.

Trial registration: ACTRN12624000098538

背景：早期识别和干预儿童心理健康（MH）问题提供终身受益。许多有MH问题的儿童没有得到适当的帮助。为了满足这一需求，开发了一种在线通用的MH筛查工具，即家长/照料者成长心理检查（GMCI-P），向家长提供关于其子女MH的反馈，识别有MH问题风险的儿童，并将家长与基于证据的在线项目/信息联系起来，目的是促进家长寻求帮助，并最终减少儿童MH问题的发生率。方法/设计：对440名家长/照顾者进行随机对照试验（RCT），以1)检验GMCI-P对增加家长求助的效果；2)探索可接受性；3)成本效益。参与者将是澳大利亚的父母/照顾者，他们的孩子年龄从出生到17 岁，6 个月，他们将被随机分配到GMCI-P（干预）组或等候名单对照组（WLC）组，并完成基线测量。干预组将立即完成GMCI-P， GMCI-P后的干预问题，三个月和六个月的随访。WLC组将在三个月的随访后获得GMCI-P，但不会进一步随访。主要结果是父母为儿童MH寻求帮助的行为，次要结果包括儿童MH、养育、父母福祉、可接受性、成本效益和意想不到的负面影响。讨论：本研究的结果将提供一个普遍的在线，家长报告儿童MH登记的有效性，可接受性和成本效益数据。这些结果可用于为儿童mh普遍筛查的公共政策提供信息。试验注册：ACTRN12624000098538。

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引用次数: 0

Corrigendum to “Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial” [Contemp Clin Trials 2024 Apr:139:107456, pgs 1–11]

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107767

James D. Ralston , Melissa Anderson , Janet Ng , Ayat Bashir , Kelly Ehrlich , Dena Burns-Hunt , Meredith Cotton , Laurel Hansell , Clarissa Hsu , Helen Hunt , Andrew J. Karter , Shaula M. Levy , Evette Ludman , Lawrence Madziwa , Emily M. Omura , Kristine Rogers , Brandie Sevey , James A.M. Shaw , Susan M. Shortreed , Umesh Singh , Laura Yarborough

引用次数: 0

Preterm-birth-prevention with Lactobacillus crispatus oral probiotics: Protocol for a double blinded randomised placebo-controlled trial (the PrePOP study) 用 Crispatus 乳杆菌口服益生菌预防早产：双盲随机安慰剂对照试验（PrePOP 研究）方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107776

Gillian A. Corbett , Siobhan Corcoran , Conor Feehily , Benedetta Soldati , Anthony Rafferty , David A. MacIntyre , Paul D. Cotter , Fionnuala M. McAuliffe

Introduction

Effective spontaneous preterm birth (sPTB) prevention is an urgent unmet clinical need. Vaginal depletion of Lactobacillus crispatus is linked to sPTB. This trial will investigate impact of an oral Lactobacillus spp. probiotic product containing an L. crispatus strain with other Lactobacilli spp., on the maternal vaginal and gut microbiome in pregnancies high-risk for sPTB.

Methods

A double-blind, placebo-controlled, randomised trial will be performed at the National Maternity Hospital Dublin, Ireland. Inclusion criteria are women with history of sPTB or mid-trimester loss, cervical surgery (cone biopsy or two previous large-loop-excision-of-transformation-zone) or uterine anomaly. The intervention is oral supplementation for twelve weeks with probiotic or identical placebo. The probiotic will contains:

◦ 4 billion CFU Lactobacillus crispatus Lbv 88(2x10⁹CFU/Capsule)

◦ 4 billion CFU Lactobacillus rhamnosus Lbv 96(2x10⁹CFU/Capsule)

◦ 0.8 billion CFU Lactobacillus jensenii Lbv 116(0.4x10⁹CFU/Capsule)

◦ 1.2 billion CFU Lactobacillus gasseri Lbv 150(0.6x10⁹CFU/Capsule).

Investigators and participants will be blinded to assignment.

Results

The primary outcome is detectable L. crispatus in the vaginal microbiome after twelve weeks of treatment, measured using high-throughput DNA sequencing. A total of 126 women are required to detect a 25 % increase in detectable L. crispatus. Secondary outcomes include impact of intervention on the gut microbiome and metabolome, rate of sPTB and mid-trimester loss, neonatal outcomes and maternal morbidity.

Conclusions

This randomised trial will investigate ability of an oral probiotic containing L. crispatus to increase its abundance in the vaginal microbiome, both directly by horizontal transfer and indirectly via microbiome and metabolome of the gut.

前言：有效预防自发性早产（sPTB）是一项迫切的未满足的临床需求。阴道中criscrisus乳杆菌的缺失与sPTB有关。本试验将研究含有一种crispatus菌株和其他乳酸菌的口服乳杆菌益生菌产品对sPTB高危妊娠孕妇阴道和肠道微生物群的影响。方法：一项双盲、安慰剂对照、随机试验将在爱尔兰都柏林国家妇产医院进行。纳入标准为有sPTB病史或妊娠中期流产、宫颈手术（宫颈锥活检或两次大环切除转化区）或子宫异常的妇女。干预是口服补充益生菌12周或相同的安慰剂。该益生菌将包含：◦40亿CFU crispatus Lbv 88（2x109CFU/Capsule）◦40亿CFU鼠李糖乳杆菌Lbv 96（2x109CFU/Capsule）◦8亿CFU jensenii Lbv 116（0.4 × 109cfu /Capsule）◦12亿CFU gasseri Lbv 150（0.6x109CFU/Capsule）研究者和参与者将对分配进行盲法。结果：主要结果是在治疗12周后阴道微生物组中检测到crispatus，使用高通量DNA测序进行测量。总共需要126名妇女检测到可检测的crispatus增加了25% %。次要结局包括干预对肠道微生物组和代谢组的影响，sPTB和中期妊娠损失率，新生儿结局和孕产妇发病率。结论：这项随机试验将研究含有葡萄球菌的口服益生菌通过直接水平转移和间接通过肠道微生物组和代谢组增加阴道微生物组丰度的能力。

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引用次数: 0

Multi-domain Online Therapeutic Investigation Of Neurocognition (MOTION) – A randomized comparative-effectiveness study of two remotely delivered mind-body interventions for older adults with cognitive decline 神经认知（运动）的多领域在线治疗研究——一项针对老年认知衰退患者的两种远程身心干预的随机比较有效性研究。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2025.107811

Linda L. Chao , Deborah E. Barnes , Margaret A. Chesney , Wolf E. Mehling , Jennifer A. Lee , Cynthia Benjamin , Helen Lavretsky , Linda Ercoli , Prabha Siddarth , Katherine L. Narr

Background

Research suggest that mind-body movement programs have beneficial effects on cognitive outcomes for older adults with cognitive decline. However, few studies have directly compared specific approaches to mind-body movement or studied the impact of remote program delivery.

Methods

In a 3-arm randomized controlled trial (RCT) for older adults with cognitive impairment, we are comparing a multidomain mind-body program that emphasizes movement, body awareness, personal meaningfulness, and social connection, and a traditional Chinese mind-body exercise (Tai Chi) to a health and wellness education control condition. All 3 interventions are delivered remotely two times per week (onehour per session) for 12 weeks. The two active interventions are live-streamed. Outcomes are assessed prior to, after, and 6-months after the interventions. The co-primary outcomes are changes on the Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-cog) and brain functional connectivity in the Default Mode Network (DMN). Secondary outcomes include measures of specific cognitive domains (e.g., executive function, attention), mobility, and self-report measures of general well-being, quality of life, social engagement, self- and attention-regulation.

Conclusion

This RCT will directly compare the effects of two mind-body movement programs versus an education control delivered remotely over 12 weeks on cognitive, neuroimaging, and participant-reported outcomes. If successful, these programs may provide scalable strategies for slowing cognitive decline, which could potentially delay dementia onset in some individuals.

Trial registration ID: NCT05217849

背景：研究表明，身心运动项目对认知能力下降的老年人的认知结果有有益的影响。然而，很少有研究直接比较身心运动的具体方法或研究远程节目传递的影响。方法：在一项针对认知障碍老年人的三组随机对照试验（RCT）中，我们比较了强调运动、身体意识、个人意义和社会联系的多领域身心计划，以及中国传统的身心锻炼（太极）与健康教育对照条件。所有三种干预措施每周远程提供两次（每次一小时），持续12周 。这两个积极的干预是直播的。在干预之前、之后和干预后6个月评估结果。共同的主要结果是阿尔茨海默病评估量表-认知子量表（ADAS-cog）和默认模式网络（DMN）中脑功能连通性的变化。次要结果包括特定认知领域的测量（例如，执行功能，注意力），流动性和一般幸福感，生活质量，社会参与，自我和注意力调节的自我报告测量。结论：这项随机对照试验将直接比较两种身心运动方案与远程教育控制在认知、神经成像和参与者报告结果方面的影响，时间超过12 周。如果成功，这些项目可能为减缓认知能力下降提供可扩展的策略，这可能会延迟某些人的痴呆症发病。试验注册id: NCT05217849。

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引用次数: 0

Ketamine treatment in youth for fast reduction of suicidality and engagement in psychotherapy: A randomized placebo-controlled trial protocol 氯胺酮治疗可快速减轻青少年的自杀倾向并帮助其接受心理治疗：随机安慰剂对照试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107777

Noreen A. Reilly-Harrington , Tatiana Falcone , David A. Jobes , Christina Deisz , Claire Flannery , Amber Wolf , Bo Hu , Amit Anand

Background

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.

Objectives

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.

Methods

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.

Discussion

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.

背景：自杀是年轻人死亡的主要原因。虽然氯胺酮已显示出快速的抗自杀效果，但其在青少年中的安全性和有效性尚未得到充分调查。自杀行为的协同评估和管理（CAMS）是一种以自杀为重点的治疗方法，显示可以减少自杀意念和症状困扰，但从未与氯胺酮联合研究。目的：本研究探讨与安慰剂相比，氯胺酮输注是否能迅速降低青少年和年轻人的严重自杀率，并在急性治疗后和3个月随访时提高CAMS降低自杀率的有效性。我们探讨在3个月的随访中，与安慰剂相比，接受氯胺酮治疗的参与者是否降低了自杀率、自杀未遂率、因自杀而急诊就诊率和再入院率。方法：本随机对照试验纳入140名有严重自杀意念或自杀未遂住院的参与者（14-30岁）。在住院期间，参与者随机接受多达6种氯胺酮或安慰剂治疗。与此同时，参与者参加CAMS会议，从住院时开始，出院后通过远程保健继续进行最多12次会议，或直到满足自杀标准的解决。每月随访评估3个 月。讨论：历史上，住院并没有减少出院后的自杀行为。我们假设，与安慰剂相比，氯胺酮将导致自杀率的快速改善，并增强CAMS的参与，在出院后需要更少的疗程来解决高风险自杀。我们假设在3个月的随访中，与安慰剂组相比，氯胺酮组的自杀率、自杀未遂率和再入院率都有所下降。

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引用次数: 0

Randomized clinical trial protocol of an app-based intervention to prevent postpartum depression 基于app干预预防产后抑郁的随机临床试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107800

Ellen Poleshuck , Debra Fox , Beau Abar , Daniel Maeng , Tamara Bilinski , Lauren Beers , Jules Rosen , Caron Zlotnick

Purpose

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.

Background

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.

Design

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.

Conclusion

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.

ClinicalTrials.gov Registration Identifier: NCT05518162

目的：通过前瞻性随机对照试验和准实验队列分析，开发和评估异步交付应用InBloom在预防产后抑郁症（PPD）方面的有效性，以及基于证据的同步交付现场干预ROSE （Reach Out, Stay Strong, Essentials for the mothers of neonatal）对抑郁症的治疗效果和投资回报。背景：在美国，产后抑郁症影响了七分之一的妊娠父母，造成情绪困扰，影响婴儿发育和儿童适应，破坏家庭关系，并造成经济负担。ROSE是一种基于证据的干预措施，包括四次面对面的小组会议和一次产后加强会议。尽管ROSE证明了其有效性，但实际障碍影响了将体内组干预广泛传播给PPD风险人群。应用程序可能有助于克服实现障碍。设计：我们将在ROSE干预的基础上开发一款app，招募年龄≥18 岁，妊娠17-32 周，且存在PPD危险因素的孕妇152名，随机分为InBloom组和ROSE组。主要结果是抑郁和投资回报率（ROI）。假设的机制是感知到的介入、参与和对干预的满意度。对照组包括来自最大的抑郁症结果ROSE试验的历史对照受试者和来自同一诊所的并发患者的电子健康记录（EHR）数据，这些患者没有提供InBloom或ROSE的ROI结果。结论：在试验结束时，我们将知道InBloom是否是ROSE的可行替代方案，从而允许进一步实施研究一个简单，低成本的分销应用程序，以降低PPD的风险。临床试验：gov注册标识符：NCT05518162。

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引用次数: 0

Clinical decision support to improve primary care obesity management in adults with diabetes: Clinic-randomized study design

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2025.107830

MarySue Beran, Heidi L. Ekstrom, A. Lauren Crain, Stephanie A. Hooker, Lilian Chumba, Deepika Appana, Kay Kromrey, Gopikrishna Kunisetty, Zeke M. McKinney, Nicolaas P. Pronk, Rashmi Sharma, Jennifer Vesely, Patrick J. O'Connor

Background

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.

Methods

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.

Primary endpoints

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.

Conclusion

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.

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引用次数: 0

Advancing vaccine research in Africa: A comprehensive analysis of vaccine clinical trials landscape 推进非洲的疫苗研究：疫苗临床试验前景综合分析。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107779

Lindi Mathebula , Thobile Malinga , Chinwe Iwu-Jaja , Duduzile Ndwandwe

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.

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.

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&D capacity. Addressing these disparities can enhance the efficacy of vaccine research and elevate health outcomes across the African continent.

本研究对非洲的疫苗临床试验进行了深入分析，强调了当地投资对满足非洲大陆医疗保健需求的重要意义。研究仔细考察了非洲各国的疫苗试验，重点关注试验分布、阶段、资金来源、招募地点、招募状况和参与年龄组。研究结果表明，肯尼亚、加纳和冈比亚等国的试验活动非常活跃，而刚果民主共和国和突尼斯等国的试验活动则很少。值得注意的是，COVID-19、HIV 和黄热病疫苗在试验中占有突出地位，其中以 3 期试验最为普遍。不适用 "试验的出现表明采用了适应性试验设计。对资助模式的分析表明，国际和当地都提供了大量支持，这反映出对非洲疫苗研究的投入在不断增加。然而，试验分布和参与年龄组的差异仍然令人担忧，这凸显了建立健全的监管框架和提高当地研发能力的必要性。解决这些差距可以提高疫苗研究的效率，改善整个非洲大陆的健康状况。

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引用次数: 0

Effects of fermented and fiber-rich foods on maternal & offspring microbiome study (FeFiFo-MOMS) — Study design and methods

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2025.107834

Catherine P. Ward , Dalia Perelman , Lindsay R. Durand , Jennifer L. Robinson , Kristen M. Cunanan , Sailendharan Sudakaran , Roujheen Sabetan , Maggie J. Madrigal-Moeller , Christopher Dant , Erica D. Sonnenburg , Justin L. Sonnenburg , Christopher D. Gardner

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Clinicaltrials.gov ID: NCT05123612

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引用次数: 0

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 改善黑人糖尿病或糖尿病前期患者的体重减轻和心脏代谢风险：数字医学混合1型实施试验的基本原理和方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107806

Peter T. Katzmarzyk , Eboni G. Price-Haywood , John W. Apolzan , Kara D. Denstel , Kimberly L. Drews , Elise Farris , Jewel Harden-Barrios , Larry R. Hearld , Emily F. Mire , Corby K. Martin , Robert L. Newton , Maria Pisu

Background

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.

Methods

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.

Results

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).

Conclusion

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.

Clinical Trials Registration Number: NCT05523375

背景：PROPEL-IT研究的目的是进行一项有效性-实施（混合型1）研究，以1)测试数字技术为重点的24个月、以患者为中心的精确公共卫生减肥方法的有效性，该方法由电子病历（EMR）促进，适用于黑人肥胖和2型糖尿病或前驱糖尿病患者；2)更好地了解实施的外部有效性和背景。方法：强化生活方式干预（Intensive Lifestyle Intervention， ILI）患者参与高强度行为干预，通过减少饮食摄入和增加身体活动来促进体重减轻。ILI由大型医疗保健组织的数字医学项目的健康教练提供，由其电子病历的患者门户网站提供便利。常规护理（UC）组的患者继续接受其卫生保健团队的常规医疗护理。主要结果是与基线相比体重变化的百分比。研究实施由实施研究综合框架（CFIR）和覆盖、有效性、采用、实施和维护（RE-AIM）评估框架指导。结果：患者招募于2022年8月31日开始，2024年1月22日完成。在17个月的招募期内，352例患者被招募并随机分配(176例为ILI；176至UC)。结论：本研究的结果将为大型医疗机构内远程交付高强度减肥计划的有效性提供证据，并为其在数字医疗环境中的实施提供重要信息。临床试验注册号：NCT05523375。

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