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2.
J Med Internet Res ; 26: e50330, 2024 Mar 28.
Article in English | MEDLINE | ID: mdl-38416574

ABSTRACT

BACKGROUND: The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care. OBJECTIVE: This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers. METHODS: Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point. RESULTS: We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points). CONCLUSIONS: In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-6926-7.


Subject(s)
Digital Health , Ethnicity , Adult , Humans , Minority Groups , Weight Gain , Obesity/prevention & control , Weight Loss , Community Health Centers
3.
Am J Public Health ; 114(S1): S69-S73, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38207261

ABSTRACT

We aimed to disseminate reliable COVID-19 information to the Black and Latino communities of Baltimore City, Maryland, between July 2020 and December 2022. With community partners, we disseminated evidence-based COVID-19 information via grassroots and digital strategies, including Hopkins Opportunity for Participant Engagement, and connected volunteers to COVID-19 research. Using a multimodal approach facilitated dissemination of reliable information and raised awareness of research; evaluation of trust is ongoing. Robust, multimodal strategies are needed to foster trust and equity among diverse communities. (Am J Public Health. 2024;114(S1):S69-S73. https://doi.org/10.2105/AJPH.2023.307492).


Subject(s)
COVID-19 , Information Dissemination , Humans , Baltimore , Hispanic or Latino , Trust , Black or African American
4.
Curr Cardiol Rep ; 25(10): 1189-1210, 2023 10.
Article in English | MEDLINE | ID: mdl-37787858

ABSTRACT

PURPOSE OF REVIEW: We review under-representation of key demographic groups in cardiovascular clinical trials, focusing on lipid-lowering trials. We outline multilevel strategies to recruit and retain diverse populations in cardiovascular trials. RECENT FINDINGS: Barriers to participation in trials occur at the study, participant, health system, sponsor, and policy level, requiring a multilevel approach to effectively increase participation of under-represented groups in research. Increasing the representation of marginalized and under-represented groups in leadership positions in clinical trials can ensure that their perspectives and experiences are considered. Trial design should prioritize patient- and community-indicated needs. Women and individuals from racially/ethnically diverse populations remain under-represented in lipid-lowering and other cardiovascular clinical trials relative to their disease burden in the population. This limits the generalizability of trial results to the broader population in clinical practice. Collaboration between community stakeholders, researchers, and community members can facilitate shared learning about trials and build trust.


Subject(s)
Clinical Trials as Topic , Patient Selection , Female , Humans , Lipids
5.
J Clin Transl Sci ; 7(1): e96, 2023.
Article in English | MEDLINE | ID: mdl-37125060

ABSTRACT

Introduction: The electronic health record (EHR) and patient portal are used increasingly for clinical research, including patient portal recruitment messaging (PPRM). Use of PPRM has grown rapidly; however, best practices are still developing. In this study, we examined the use of PPRM at our institution and conducted qualitative interviews among study teams and patients to understand experiences and preferences for PPRM. Methods: We identified study teams that sent PPRMs and patients that received PPRMs in a 60-day period. We characterized these studies and patients, in addition to the patients' interactions with the PPRMs (e.g., viewed, responded). From these groups, we recruited study team members and patients for semi-structured interviews. A pragmatic qualitative inquiry framework was used by interviewers. Interviews were audio-recorded and analyzed using a rapid qualitative analysis exploratory approach. Results: Across ten studies, 35,037 PPRMs were sent, 33% were viewed, and 17% were responded to. Interaction rates varied across demographic groups. Six study team members completed interviews and described PPRM as an efficient and helpful recruitment method. Twenty-eight patients completed interviews. They were supportive of receiving PPRMs, particularly when the PPRM was relevant to their health. Patients indicated that providing more information in the PPRM would be helpful, in addition to options to set personalized preferences. Conclusions: PPRM is an efficient recruitment method for study teams and is acceptable to patients. Engagement with PPRMs varies across demographic groups, which should be considered during recruitment planning. Additional research is needed to evaluate and implement recommended changes by study teams and patients.

7.
BMC Public Health ; 23(1): 695, 2023 04 14.
Article in English | MEDLINE | ID: mdl-37060053

ABSTRACT

BACKGROUND: Clinical trial implementation continues to shift toward pragmatic design, with the goal of increasing future adoption in clinical practice. Yet, few pragmatic trials within clinical settings have qualitatively assessed stakeholder input, especially from those most impacted by research implementation and outcomes, i.e., providers and staff. Within this context, we conducted a qualitative study of the implementation of a pragmatic digital health obesity trial with employees at a Federally qualified health center (FQHC) network in central North Carolina. METHODS: Participant recruitment was conducted through purposive sampling of FQHC employees from a variety of backgrounds. Two researchers conducted semi-structured qualitative interviews and collected demographic data. Interviews were digitally recorded, professionally transcribed and double-coded by two independent researchers using NVivo 12. Coding discrepancies were reviewed by a third researcher until intercoder consensus was reached. Responses were compared within and across participants to elucidate emergent themes. RESULTS: Eighteen qualitative interviews were conducted, of whom 39% provided direct medical care to patients and 44% worked at the FQHC for at least seven years. Results illuminated the challenges and successes of a pragmatically designed obesity treatment intervention within the community that serves medically vulnerable patients. Although limited time and staffing shortages may have challenged recruitment processes, respondents described early buy-in from leadership; an alignment of organizational and research goals; and consideration of patient needs as facilitators to implementation. Respondents also described the need for personnel power to sustain novel research interventions and considerations of health center resource constraints. CONCLUSIONS: Results from this study contribute to the limited literature on pragmatic trials utilizing qualitative methods, particularly in community-based obesity treatment. To continue to merge the gaps between research implementation and clinical care, qualitative assessments that solicit stakeholder input are needed within pragmatic trial design. For maximum impact, researchers may wish to solicit input from a variety of professionals at trial onset and ensure that shared common goals and open collaboration between all partners is maintained throughout the trial. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT03003403) on December 28, 2016.


Subject(s)
Obesity , Weight Gain , Humans , Attitude of Health Personnel , Community Health Centers , Obesity/prevention & control , Qualitative Research
8.
J Clin Transl Sci ; 7(1): e22, 2023.
Article in English | MEDLINE | ID: mdl-36755547

ABSTRACT

Introduction: Pragmatic trials are needed to establish evidence-based obesity treatment in primary care settings, particularly in community health centers (CHCs) that serve populations at heightened risk of obesity. Recruiting a representative trial sample is a critical first step to informing care for diverse communities. We described recruitment strategies utilized in a pragmatic obesity trial and assessed the sociodemographic characteristics and odds of enrollment by recruitment strategy. Methods: We analyzed data from Balance, a pragmatic trial implemented within a network of CHCs. We recruited participants via health center-based and electronic health record (EHR)-informed mail recruitment. We analyzed associations between sociodemographic characteristics and the return rate of patient authorization forms (required for participation) from EHR-informed mail recruitment. We also compared sociodemographic characteristics and randomization odds by recruitment strategy after returning authorization forms. Results: Of the individuals recruited through EHR-informed mail recruitment, females were more likely than males to return authorization forms; however, there were no differences in rates of return by preferred language (English/Spanish) or age. Females; underrepresented racial and ethnic groups; Spanish speakers; younger adults; and those with lower education levels were recruited more successfully in the health center. In contrast, their counterparts were more responsive to mail recruitment. Once authorization forms were returned, the odds of being randomized did not significantly differ by recruitment method. Conclusion: Health center-based recruitment was essential to meeting recruitment targets in a pragmatic weight gain prevention trial, specifically for Hispanic and Spanish-speaking communities. Future pragmatic trials should consider leveraging in-person recruitment for underrepresented groups in research.

9.
JMIR Form Res ; 6(9): e38262, 2022 Sep 06.
Article in English | MEDLINE | ID: mdl-36066936

ABSTRACT

BACKGROUND: The use of digital technologies and software allows for new opportunities to communicate and engage with research participants over time. When software is coupled with automation, we can engage with research participants in a reliable and affordable manner. Research Electronic Data Capture (REDCap), a browser-based software, has the capability to send automated text messages. This feature can be used to automate delivery of tailored intervention content to research participants in interventions, offering the potential to reduce costs and improve accessibility and scalability. OBJECTIVE: This study aimed to describe the development and use of 2 REDCap databases to deliver automated intervention content and communication to index participants and their partners (dyads) in a 2-arm, 24-month weight management trial, Partner2Lose. METHODS: Partner2Lose randomized individuals with overweight or obesity and cohabitating with a partner to a weight management intervention alone or with their partner. Two databases were developed to correspond to 2 study phases: one for weight loss initiation and one for weight loss maintenance and reminders. The weight loss initiation database was programmed to send participants (in both arms) and their partners (partner-assisted arm) tailored text messages during months 1-6 of the intervention to reinforce class content and support goal achievement. The weight maintenance and reminder database was programmed to send maintenance-related text messages to each participant (both arms) and their partners (partner-assisted arm) during months 7-18. It was also programmed to send text messages to all participants and partners over the course of the 24-month trial to remind them of group classes, dietary recall and physical activity tracking for assessments, and measurement visits. All text messages were delivered via Twilio and were unidirectional. RESULTS: Five cohorts, comprising 231 couples, were consented and randomized in the Partner2Lose trial. The databases will send 53,518 automated, tailored text messages during the trial, significantly reducing the need for staff to send and manage intervention content over 24 months. The cost of text messaging will be approximately US $450. Thus far, there is a 0.004% known error rate in text message delivery. CONCLUSIONS: Our trial automated the delivery of tailored intervention content and communication using REDCap. The approach described provides a framework that can be used in future behavioral health interventions to create an accessible, reliable, and affordable method for intervention delivery and engagement that requires minimal trial-specific resources and personnel time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03801174; https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174.

10.
J Cardiovasc Nurs ; 37(5): 475-481, 2022.
Article in English | MEDLINE | ID: mdl-35467561

ABSTRACT

BACKGROUND: The Dietary Approaches to Stop Hypertension eating plan is an evidence-based treatment of hypertension; however, adherence to the Dietary Approaches to Stop Hypertension is low. To improve adherence to the Dietary Approaches to Stop Hypertension among adults with hypertension, we designed Nourish, a 2-arm, 12-month randomized controlled trial. The COVID-19 pandemic necessitated a change from in-person to remotely delivered visits, requiring substantial protocol modifications to measure blood pressure accurately and safely for secondary outcome data. PURPOSE: The purpose of this article is to describe the implementation of an at-home blood pressure measurement protocol for the Nourish trial. CONCLUSION: Our investigator team and study staff developed and implemented a robust and feasible blood pressure measurement protocol to be executed within an at-home format. CLINICAL IMPLICATIONS: The described blood pressure measurement protocol provides a framework for use in future clinical trials and clinical settings in which a remote visit is preferred or required.


Subject(s)
COVID-19 , Hypertension , Adult , Blood Pressure , Humans , Hypertension/diagnosis , Hypertension/therapy , Pandemics/prevention & control , Randomized Controlled Trials as Topic , SARS-CoV-2
11.
Fam Community Health ; 45(3): 206-213, 2022.
Article in English | MEDLINE | ID: mdl-35385415

ABSTRACT

Evidence suggests that socioenvironmental stressors, such as discrimination, may serve as determinants of the ongoing obesity epidemic and persisting disparities in obesity prevalence. The objectives of these analyses were to examine whether perceived discrimination was associated with body mass index (BMI) trajectory and whether this relationship differed by race or sex. Data for these analyses came from the Healthy Aging in Neighborhoods of Diversity across the Life Span study, a prospective cohort study in Baltimore City. Mixed-effects linear regression was used in a sample of 1962 African American and white adults to test our hypotheses. We found that race was an effect modifier in the relationship between perceived discrimination and BMI trajectory (B = 0.063, P = .014). Specifically, higher baseline perceived discrimination was associated with positive BMI trajectory in African American adults (B = 0.031, P = .033) but not in white adults (B = -0.032 P = .128). In this longitudinal study of African American and white adults, the relationship between perceived discrimination and BMI trajectory differed by race. Future research should be conducted in diverse samples to understand the risk socioenvironmental stressors pose on the development and progression of overweight and obesity, in addition to how these differ in subgroups.


Subject(s)
Black or African American , White People , Adult , Body Mass Index , Humans , Longitudinal Studies , Obesity/epidemiology , Perceived Discrimination , Prospective Studies
12.
Ethn Health ; 27(6): 1345-1357, 2022 08.
Article in English | MEDLINE | ID: mdl-33550838

ABSTRACT

OBJECTIVE: To examine the association between social determinants of health, hypertension, and diabetes among African immigrants. METHODS: The African Immigrant Health Study was a cross-sectional study of the health of African immigrants in the Baltimore-Washington Metropolitan Area. The outcomes of interest were self-reported diagnoses of hypertension and diabetes. Logistic regression was used to examine the relationship between educational status, employment, income, social support, health insurance, and self-reported diagnoses of hypertension and diabetes, adjusting for age, sex, and length of stay in the U.S. RESULTS: A total of 465 participants with mean (±SD) age 47 (±11.5) years were included. Sixty percent were women, 64% had a college degree or higher, 83% were employed, 67% had health insurance, and 70% were married/cohabitating. Over half (60%) of the participants had lived in the United States for ≥ 10 years, and 84% were overweight/obese. The overall prevalence of hypertension and diabetes was 32% and 13%, respectively. The odds of diabetes was higher (aOR: 5.00, 95% CI: 2.13, 11.11) among those who were unemployed than among those who were employed, and the odds of hypertension was higher among those who had health insurance (aOR:1.73, 95% CI: 1.00, 3.00) than among those who did not. CONCLUSIONS: Among African immigrants, those who were unemployed had a higher likelihood of a self-reported diagnosis of diabetes than those who were employed. Also, people who had health insurance were more likely to self-report a diagnosis of hypertension. Additional studies are needed to further understand the influence of social determinants of health on hypertension and diabetes to develop health policies and interventions to improve the cardiovascular health of African immigrants.


Subject(s)
Diabetes Mellitus , Emigrants and Immigrants , Hypertension , Cross-Sectional Studies , Diabetes Mellitus/epidemiology , Female , Humans , Hypertension/epidemiology , Male , Middle Aged , Risk Factors , Social Determinants of Health , United States/epidemiology
13.
J Nurs Manag ; 30(1): 226-233, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34590765

ABSTRACT

AIMS: The purpose of this study is to determine the prevalence of posttraumatic stress disorder among U.S. nurses and to examine how severity of posttraumatic stress disorder symptoms are associated with their role. BACKGROUND: The lifetime prevalence of posttraumatic stress disorder is estimated at 6.8%. Loss of workdays, inability to perform at full capacity, and loss of fulfillment are a few of the issues associated with an individual diagnosed with posttraumatic stress disorder. Untreated consequences include early retirement, loss of job, disability, and suicide. METHOD: Participants completed an online survey that included the 20-item posttraumatic stress disorder checklist-5. RESULTS: Severity of posttraumatic stress disorder symptoms among nurses estimates that 28.4% have a probable diagnosis of posttraumatic stress disorder with 15.4% experiencing severe symptoms. The impact of stress was negative job performance impacting mental fatigue and workplace attrition. Coping skills included mindfulness and utilizing social networks. CONCLUSIONS: Nurses are exposed to traumatic experiences, which has an impact on their mental health and well-being and ability to successfully perform their jobs. The impact of these experiences is not differentiated by demographic correlates. IMPLICATIONS FOR NURSING MANAGEMENT: This highlights multiple modifiable factors that impact the severity of stressful experiences. Addressing environmental, organizational, and intrapersonal changes are key components in alleviating the negative impact experienced by nurses.


Subject(s)
Mindfulness , Stress Disorders, Post-Traumatic , Adaptation, Psychological , Humans , Mental Health , Prevalence , Stress Disorders, Post-Traumatic/epidemiology , United States/epidemiology
14.
AJPM Focus ; 1(2): 100037, 2022 Dec.
Article in English | MEDLINE | ID: mdl-37791242

ABSTRACT

Introduction: The Dietary Approaches to Stop Hypertension dietary pattern is a proven way to manage hypertension, but adherence remains low. Dietary tracking applications offer a highly disseminable way to self-monitor intake on the pathway to reaching dietary goals but require consistent engagement to support behavior change. Few studies use longitudinal dietary self-monitoring data to assess trajectories and predictors of engagement. We used dietary self-monitoring data from participants in Dietary Approaches to Stop Hypertension Cloud (N=59), a feasibility trial to improve diet quality among women with hypertension, to identify trajectories of engagement and explore associations between participant characteristics. Methods: We used latent class growth modeling to identify trajectories of engagement with a publicly available diet tracking application and used bivariate and regression analyses to assess the associations of classifications of engagement with participant characteristics. Results: We identified 2 latent classes of engagement: consistent engagers and disengagers. Consistent engagers were more likely to be older, more educated, and married or living with a partner. Although consistent engagers exhibited slightly greater changes in Dietary Approaches to Stop Hypertension score, the difference was not significant. Conclusions: This study highlights an important yet underutilized methodologic approach for uncovering dietary self-monitoring engagement patterns. Understanding how certain individuals engage with digital technologies is an important step toward designing cost-effective behavior change interventions. Trial registration: This study is registered at www.clinicaltrials.gov NCT03215472.

15.
JMIR Res Protoc ; 10(11): e31307, 2021 Nov 25.
Article in English | MEDLINE | ID: mdl-34842549

ABSTRACT

BACKGROUND: Weight bias internalization, also known as weight self-stigma, is a serious health concern for individuals with higher body weight. Weight bias internalization is associated with the greater avoidance of health care and health-promoting activities, disordered eating, social isolation, and weight gain. Elevated weight bias internalization has been associated with low self-compassion, yet few investigations have explored self-compassion as a potential mechanism for reducing internalized weight bias. OBJECTIVE: Ruby is a 2-arm randomized controlled trial that was designed to test the efficacy of a 4-week digital self-compassion intervention to reduce internalized weight bias compared with a wait-list control. METHODS: Adults with elevated internalized weight bias and a BMI of >30 kg/m2 (N=80) were recruited. Ruby is a standalone digital trial that will be delivered entirely via a smartphone and will involve web-based data collection and text messages. The intervention content will include psychoeducation and daily mindfulness practices with a focus on self-compassion and body concerns. We will use intent-to-treat analyses to examine changes in weight bias internalization throughout time by treatment arm. The analyses will be conducted by using one-way analysis of covariance models and linear mixed models. RESULTS: The protocol was designed in May 2020 and approved in December 2020. Data collection is currently underway. CONCLUSIONS: Ruby will be the first digital standalone, self-compassion-based intervention designed to reduce internalized weight bias. Owing to its standalone digital delivery, Ruby may be a highly scalable treatment for internalized weight bias that can be delivered on its own or combined with other treatments. We expect Ruby to be accessible to many, as participants can access the digital intervention at times of the day that are the most convenient in their schedule and are not burdened by in-person time commitments, which can be a barrier for participants with competing demands on their time and resources. If efficacious, Ruby will be poised to expand a burgeoning body of literature related to psychological intervention in this area. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678973; https://clinicaltrials.gov/ct2/show/NCT04678973. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31307.

16.
Contemp Clin Trials ; 111: 106598, 2021 12.
Article in English | MEDLINE | ID: mdl-34653651

ABSTRACT

INTRODUCTION: Online tools are increasingly utilized in clinical trial recruitment. A/B testing is an effective technology used in political campaigns and commercial marketing to improve contributions or sales. However, to our knowledge, A/B has not been described in the context of clinical trial recruitment. METHODS: Two A/B testing experiments were implemented on the recruitment website of the Study To Understand Fall Reduction and Vitamin D in You (STURDY), a response-adaptive, two-stage, randomized controlled trial. Commercial A/B platforms randomized web-users to different versions of the trial's website landing page; Experiment 1 included two infographic versions and Experiment 2 included three video versions. We compared web-user engagement metrics between each version and the original landing page. We determined the effect of each version compared to the original landing page on the likelihood of a web-user to (1) request more information about the trial, (2) complete a screening visit, or (3) enroll in the trial. RESULTS: A total of 2605 and 374 web-users visited the trial's website during Experiment 1 and 2, respectively. Response to the online interest form significantly differed by infographic version in Experiment 1. The number of individuals who engaged with website content and pages significantly differed by video in Experiment 2. CONCLUSION: In a pilot study implementing A/B testing of a clinical trial recruitment website, different versions of the website led to differences in web-user engagement and interest in the trial. A/B testing tools offer a promising approach to test the effectiveness of clinical trial recruitment materials and to optimize recruitment campaigns. CLINICAL TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov. The trial registration number is NCT02166333. The URL is: https://clinicaltrials.gov/ct2/show/NCT02166333 Trial Registration Number: NCT02166333 Trial Register: ClinicalTrials.gov.


Subject(s)
Vitamin D , Vitamins , Accidental Falls , Aged , Humans , Pilot Projects
17.
Contemp Clin Trials ; 109: 106539, 2021 10.
Article in English | MEDLINE | ID: mdl-34400362

ABSTRACT

INTRODUCTION: Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. METHODS: The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120-159 mmHg; a diastolic blood pressure of 80-99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. DISCUSSION: Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875.


Subject(s)
Hypertension , Adult , Behavior Therapy , Blood Pressure , Diet , Feeding Behavior , Humans , Hypertension/drug therapy , Randomized Controlled Trials as Topic
18.
J Am Heart Assoc ; 10(17): e021108, 2021 09 07.
Article in English | MEDLINE | ID: mdl-34431310

ABSTRACT

Background Although disproportionately affected by cardiovascular disease, Black adults remain underrepresented in clinical trials. The National Institutes of Health recommends that studies define goals for recruitment of underrepresented populations. However, the extent to which cardiovascular trials incorporate evidence-based recruitment strategies in their protocols is understudied. Methods and Results We systematically reviewed National Institutes of Health-funded cardiovascular clinical trials registered in ClinicalTrials.gov between 2000 and 2019. Based on publicly available or requested protocols, we focused on enrollment of Black adults as well as the following recruitment strategies: community-based, electronic medical record-based, and provider-based recruitment. A total of 100 clinical trials focused on cardiovascular disease were included in our analysis, of which 62% had published protocols, and 46% of trials had enrolled populations that were <25% Black. In our analysis of available trial protocols, 21% of trials defined a recruitment target for underrepresented groups; however, only one study reported achieving its enrollment goal. While 13% of trial protocols referenced community-based recruitment strategies, 5% explicitly mentioned involving community members in the trial design process. Defining recruitment targets was associated with higher enrollment of Black participants. Conclusions Black adults are underrepresented in National Institutes of Health-funded cardiovascular trials, and the majority of these trials did not specify a Black enrollment target, did not meet targets, and largely did not report specific plans to enroll Black adults in their studies. Future interventions should target trial design and planning phases before study initiation to address these enrollment disparities.


Subject(s)
Black People , Cardiovascular Diseases , Clinical Trials as Topic , Patient Selection , Adult , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/therapy , Humans , Motivation
19.
PLoS One ; 16(6): e0252747, 2021.
Article in English | MEDLINE | ID: mdl-34157025

ABSTRACT

BACKGROUND: Health inequities remain a public health concern. Chronic adversity such as discrimination or racism as trauma may perpetuate health inequities in marginalized populations. There is a growing body of the literature on trauma informed and culturally competent care as essential elements of promoting health equity, yet no prior review has systematically addressed trauma informed interventions. The purpose of this study was to appraise the types, setting, scope, and delivery of trauma informed interventions and associated outcomes. METHODS: We performed database searches- PubMed, Embase, CINAHL, SCOPUS and PsycINFO-to identify quantitative studies published in English before June 2019. Thirty-two unique studies with one companion article met the eligibility criteria. RESULTS: More than half of the 32 studies were randomized controlled trials (n = 19). Thirteen studies were conducted in the United States. Child abuse, domestic violence, or sexual assault were the most common types of trauma addressed (n = 16). While the interventions were largely focused on reducing symptoms of post-traumatic stress disorder (PTSD) (n = 23), depression (n = 16), or anxiety (n = 10), trauma informed interventions were mostly delivered in an outpatient setting (n = 20) by medical professionals (n = 21). Two most frequently used interventions were eye movement desensitization and reprocessing (n = 6) and cognitive behavioral therapy (n = 5). Intervention fidelity was addressed in 16 studies. Trauma informed interventions significantly reduced PTSD symptoms in 11 of 23 studies. Fifteen studies found improvements in three main psychological outcomes including PTSD symptoms (11 of 23), depression (9 of 16), and anxiety (5 of 10). Cognitive behavioral therapy consistently improved a wide range of outcomes including depression, anxiety, emotional dysregulation, interpersonal problems, and risky behaviors (n = 5). CONCLUSIONS: There is inconsistent evidence to support trauma informed interventions as an effective approach for psychological outcomes. Future trauma informed intervention should be expanded in scope to address a wide range of trauma types such as racism and discrimination. Additionally, a wider range of trauma outcomes should be studied.


Subject(s)
Trauma and Stressor Related Disorders/epidemiology , Health Equity/statistics & numerical data , Humans , Psychotherapy/methods , Psychotherapy/statistics & numerical data , Randomized Controlled Trials as Topic , Trauma and Stressor Related Disorders/therapy
20.
J Psychosom Res ; 146: 110434, 2021 07.
Article in English | MEDLINE | ID: mdl-33810863

ABSTRACT

OBJECTIVE: The objective of the paper is to critically review the current state of the literature on the association between discrimination and allostatic load (AL) in adults and determine whether this association differs by sociodemographic characteristics. METHODS: An extensive literature search was conducted in PubMed, CINAHL, PsycINFO, and Embase to identify studies that investigated the association between discrimination and AL. The search was limited to the English language, articles that were peer-reviewed and articles that were published within the last 10 years. RESULTS: A total of 11 studies met the eligibility criteria for this review, 8 of which were cross-sectional and 3 of which were longitudinal. There was heterogeneity in the type of discrimination measured, the composition of AL summary score, and the analytic approach utilized to examine the relationship of interest. Nine studies found a significant, positive association between discrimination and AL. The types of discrimination found to be positively associated with AL included lifetime discrimination, childhood racial discrimination, everyday discrimination, and everyday weight discrimination. One study found that this association differed by educational attainment. CONCLUSION: There is evidence that discrimination is associated with AL. Longitudinal studies with diverse samples are needed to further explore this association and how it differs based on sociodemographic characteristics.


Subject(s)
Allostasis , Racism , Adult , Child , Educational Status , Humans , Longitudinal Studies
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