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Preliminary trial findings from Harvest Share: a cost-offset community supported agriculture model to improve diet in New York City

LeCroy, Madison N; Cardenas, Luisa; Chan, Sze Wan Celine; Scherer, Maya; Dolotina, Brett; Lanza, Dalila Victoria; Dowd, Rhyden; Hughes, Michelle; Mei, Steve; Barth, Kathleen; Gregoire, Mayssa; Rodriguez Gil, Ana I; DeDominicis, Marisa; Acevedo, Maria; Rodriguez, Alina; Kourousias, Lorena; Cheng, Mary; Wu, Mitchel; Guzman, Jairo; Belli, Hayley M; Barajas-Gonzalez, R Gabriela; Đoàn, Lan N; Yi, Stella S
BACKGROUND:Community-supported agriculture (CSA) programs are an evidence-based approach to increase fruit and vegetable (F&V) intake while also strengthening the local farming economy and social bonds. However, uptake has been limited due to payment structures and/or CSA offerings not reflecting local community preferences. To address this need, we developed the Harvest Share program, which centers a cost-offset CSA tailored to local communities in New York City. Here, our objective is to conduct a mixed-methods evaluation of year one of Harvest Share to evaluate its preliminary impact on diet and social outcomes. METHODS:Harvest Share participants (n = 542; n = 153 CSA and n = 389 comparison community [CC] participants) completed surveys and Veggie Meter readings-an objective measure of F&V intake-at the start and end of the 20-week growing season (~ June-October 2023). Qualitative interviews were conducted with n = 23 participants to understand program experiences. Mixed effect linear regression models were used to examine the impact of Harvest Share on primary (Veggie Meter score) and secondary outcomes (diet and social variables). Significant associations were based on the group (CSA vs. CC) by time (pre vs. post) interaction term. Descriptive, thematic analysis was used to analyze interviews. RESULTS:Across CSA and CC participants, individuals were, on average, 44 years old; female (80%); Asian (48%) or Hispanic/Latino (37%); and of lower socioeconomic status (55% with annual household income <$50,000). Change in Veggie Meter scores (p = 0.02), F&V consumption (p < 0.0001), and F&V knowledge (p = 0.0004) significantly differed between CSA and CC participants. Veggie Meter scores trended downwards in both groups, but the decline was non-significant among CSA participants (CSA: -7.43 [95%CI: -21.30, 6.44]; CC: -27.29 [95%CI: -36.27, -18.30]). CSA participation was associated with an increased number of different types of F&V consumed (CSA: 3.74 [95%CI: 2.94, 4.53]; CC: 0.05 [95%CI: -0.48, 0.57]) and decreased number of F&V that individuals did not know how to prepare (CSA: -1.60 [95%CI: -2.28, -0.93]; CC: -0.13 [95%CI: -0.57, 0.32]). Qualitative interviews indicated the CSA also promoted family and community connection and improved physical and mental health. CONCLUSIONS:A cost-offset, tailored CSA can improve diet and social outcomes using a model that supports farmers. TRIAL REGISTRATION/BACKGROUND:Registered on ClinicalTrials.gov as NCT05381766 (registration date: May 19, 2022).
PMID: 42436486
ISSN: 1479-5868
CID: 6064492

Provider comments reveal barriers to EHR nudge effectiveness: process evaluation of a null deprescribing trial

Viswanadham, Ratnalekha V N; Belli, Hayley M; Martinez, Tiffany Rose; Wong, Christina; Blecker, Saul B; Troxel, Andrea B; Mann, Devin M
BACKGROUND:De-implementation-reducing low-value or harmful care-is critical but difficult in clinical practice. Clinical decision support (CDS) "nudges" in electronic health records (EHRs) aim to promote guideline-concordant deprescribing, but effects are inconsistent. In a pragmatic randomized controlled trial across a large health system, we tested a suite of EHR-based CDS nudges to support Choosing Wisely-aligned deprescribing of glycemic medications in older adults with type 2 diabetes. Although a prior pilot showed modest improvement in guideline concordance (5.1%), the full trial found no significant changes in prescribing; this process evaluation examines clinicians' comments on alerts to explain why. METHODS:We conducted a mixed-methods process evaluation of comments within EHR-based alerts from a null-result RCT that promoted Choosing Wisely deprescribing for older adults with type 2 diabetes. Among 66,634 alerts firing across EHR encounters (December 2016-July 2023), providers commented on 764 (1.2%). Two researchers independently coded comments using reflexive thematic analysis, identifying four themes (three negative). Exploratory logistic and multinomial regressions examined predictors of commenting, valence, and themes among acknowledged firings, adjusting for patient, provider, and encounter factors. RESULTS:Thematic analysis of comments revealed three barriers to deprescribing: (1) disagreement with Choosing Wisely guidelines (308 comments, e.g., perceived low overtreatment risk); (2) workflow misalignment (203 comments, e.g., wrong provider responsibility); and (3) patient preferences (69 comments). Logistic regression showed multiple concurrent OPAs reduced action odds by 31.6% (OR 0.684, 95% CI 0.560-0.835); comments were 2.57 times more likely to be negative than positive (OR 2.565, 95% CI 1.637-4.018). Disparities in engagement were found, with female providers, patients, and socially vulnerable individuals less likely to comment. CONCLUSION/CONCLUSIONS:This process evaluation demonstrates scalable real-time feedback for clinical decision support refinement in de-implementation, with regressions identifying context-specific predictors. Provider disagreement, alert firings misaligned to workflows, and patient resistance hinder effectiveness. Future work should refine clinical decision support design to address complexity, enhance guideline explainability to build provider concordance, align with provider roles and workflows, and include patient-centered approaches. TRIAL REGISTRATION/BACKGROUND:The NYU School of Medicine Institutional Review Board (i17-01308) approved the trial, which has the clinicaltrials.gov ID NCT04181307 (https://clinicaltrials.gov/study/NCT04181307), with a first record date of November 26, 2019.
PMID: 42251456
ISSN: 2662-2211
CID: 6044892

Healthcare Professionals' Perspectives on Addressing Patients' Medication Adherence in Primary Care Settings

Martinez, Tiffany R; Schoenthaler, Antoinette M; Mann, Devin M; Belli, Hayley; Bearnot, Harris R; Lustbader, Ian; Blecker, Saul
BACKGROUND:Medication nonadherence is a common issue among patients with hypertension. Healthcare professionals often overlook medication nonadherence due to limited tools, time constraints, and competing demands. Integrating pharmacy medication fill data into electronic health records (EHRs) presents an opportunity to enhance medication adherence measurement and monitoring in real-time. This study identified facilitators and barriers to addressing adherence to antihypertensive medications by Medical Assistants (MAs), Registered Nurses (RNs), and Primary Care Providers (PCPs) in primary care settings. METHODS:We conducted a qualitative study with, 15 healthcare professionals (5 MAs, 5 RNs, and 5 PCPs) caring for patients with hypertension. Semi-structured interviews, guided by the Consolidated Framework for Implementation Research (CFIR), explored barriers and facilitators related to screening and addressing medication non-adherence during primary care clinical encounters. Thematic analysis and deductive coding were used to analyze the data. RESULTS:Four major themes emerged: motivation, work infrastructure, capability, and opportunity. MAs and PCPs were motivated to discuss medication adherence and build relationships. Capability varied; RNs were confident in their counseling skills based on their training and patient trust, and PCPs described adherence counseling as part of their role, particularly through motivational interviewing. Work infrastructure presented structural hurdles due to RN workflow limitations and MA role constraints. Opportunity to address non-adherence were constrained by tight schedules and competing clinical demands during brief visits. CONCLUSIONS:RNs and PCPs felt capable in their ability to address medication adherence but cited time and competing demands as significant barriers; conversely, MAs reported motivation but were limited by their role. These findings suggest opportunities for effective management of medication adherence in practice settings through a more coordinated strategy across multiple healthcare professionals. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov; NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422.
PMID: 41308044
ISSN: 1365-2753
CID: 5968612

Medication Adherence in Hypertension: A Cluster Randomized Clinical Trial

Blecker, Saul; Mann, Devin M; Martinez, Tiffany R; Belli, Hayley M; Zhao, Yunan; Ahmed, Aamina; Fitchett, Cassidy; Wong, Christina; Bearnot, Harris R; Voils, Corrine I; Schoenthaler, Antoinette M
IMPORTANCE/UNASSIGNED:Medication nonadherence is present in nearly half of patients with hypertension but is underrecognized in clinical care. Data linkages between electronic health records and pharmacies have created opportunities for scalable assessment of medication adherence at the point of care. OBJECTIVE/UNASSIGNED:To test the effectiveness of a multicomponent intervention that identified patients with uncontrolled hypertension and medication nonadherence using linked electronic health record-pharmacy data combined with team-based care to address adherence barriers. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:TEAMLET (Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence) was a pragmatic, 2-arm, cluster randomized clinical trial conducted between October 2022 and November 2024 in 10 primary care sites in New York. The study included adults with uncontrolled hypertension and low medication adherence, defined as proportion of days covered (PDC) less than 80%. Data analysis was performed from November 2024 to January 2025. INTERVENTION/UNASSIGNED:The intervention consisted of the following: (1) automated identification of patients with medication nonadherence at the time of the visit; (2) prompting of medical assistants to screen for barriers to adherence; (3) clinical decision support alerting the primary care physicians and nurse practitioners to barriers to adherence; and (4) adherence discussion between the primary care physician or nurse practitioner and the patient. The comparator was usual care. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was change in PDC from baseline to 12 months. RESULTS/UNASSIGNED:Among 1726 patients (mean [SD] age, 67.2 [13.9] years; 887 [51.4%] female), the mean (SD) baseline PDC was 33.2% (30.5%) overall (32.4% [30.4%] in the intervention group and 34.0% [30.6%] in the control group). The mean (SD) PDC at 12 months was 51.1% (39.5%) for the intervention group and 53.1% (39.6%) for the control group. No difference was found in the change in PDC from baseline to 12 months between the intervention and control groups (mean [SD] absolute change in PDC, 18.5 [41.1] vs 18.2 [40.9] percentage points, respectively; adjusted difference, -0.15 percentage point; 95% CI, -4.06 to 3.76 percentage points). Change in systolic blood pressure and patients who became adherent (PDC ≥80%) at 12 months were also similar between groups. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this pragmatic trial, an intervention that combined team-based primary care with automated identification of patients with antihypertensive medication nonadherence did not lead to improvements in adherence or blood pressure. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT05349422.
PMCID:12242813
PMID: 40632527
ISSN: 2380-6591
CID: 5890882

The two-dose MVA-BN mpox vaccine induces a nondurable and low avidity MPXV-specific antibody response

Oom, Aaron L; Wilson, Kesi K; Yonatan, Miilani; Rettig, Stephanie; Youn, Heekoung Allison; Tuen, Michael; Shah, Yusra; DuMont, Ashley L; Belli, Hayley M; Zucker, Jane R; Rosen, Jennifer B; Herati, Ramin Sedaghat; Samanovic, Marie I; Duerr, Ralf; Kottkamp, Angelica C; Mulligan, Mark J; ,
UNLABELLED:The 2022 global outbreak of clade IIb mpox was the first major outbreak of mpox outside of African nations. To control the outbreak, public health officials began vaccination campaigns using the third-generation orthopoxvirus vaccine modified vaccinia Ankara from Bavarian Nordic (MVA-BN). Prior to this outbreak, the durability of monkeypox virus (MPXV)-specific immunity induced by MVA-BN was poorly understood. In 2022, we launched the New York City Observational Study of Mpox Immunity (NYC OSMI, NCT05654883), a longitudinal study of 171 participants comprising MVA-BN vaccines and mpox convalescent individuals. Peripheral blood sampling was performed at intervals including prior to vaccination, after one dose, and after the second dose. MVA-BN vaccinees with and without a history of smallpox vaccination demonstrated detectable MPXV-specific memory B cells at 1-year post-vaccination. Additionally, MVA-BN increased MPXV neutralizing titers in smallpox vaccine-naïve vaccinees, with a comparable maximum titer reached in naïve and smallpox vaccine-experienced vaccinees. However, neutralizing titers returned to baseline within 5-7 months for naïve individuals, while remaining elevated in those with prior smallpox vaccination. Both naïve and experienced individuals generated robust IgG responses against MPXV H3 and A35, but naïve vaccinees' IgG responses showed lower avidity than experienced vaccinees. These data highlight a low avidity antibody response elicited by MVA-BN that is short-lived in naïve vaccinees. This work supports the need for long-term studies on protection induced by MVA-BN, including the potential need for booster doses as well as the development of next-generation orthopoxvirus vaccines. IMPORTANCE/OBJECTIVE:The ongoing outbreaks of mpox demonstrate the continuing threat of orthopoxviruses to global health. While previous orthopoxvirus vaccines generated lifelong antibody and cellular immunity, we show here that the current mpox vaccine, MVA-BN or JYNNEOS, fails to induce durable antibody immunity in individuals with no prior smallpox vaccination. This raises the important question of whether MVA-BN vaccinees have long-term protection from mpox. Our work highlights the need for further studies into the durability of protection generated by MVA-BN as well as whether subsequent booster doses are necessary to maintain protection.
PMID: 40162783
ISSN: 1098-5514
CID: 5818712

Diabetes distress among immigrants of south Asian descent living in New York City: baseline results from the DREAM randomized control trial

Mohsin, Farhan; Wyatt, Laura; Belli, Hayley; Ali, Shahmir; Onakomaiya, Deborah; Misra, Supriya; Yusuf, Yousra; Mammen, Shinu; Zanowiak, Jennifer; Hussain, Sarah; Zafar, Haroon; Lim, Sahnah; Islam, Nadia; Ahmed, Naheed
BACKGROUND:Type 2 diabetes (T2D) disproportionately affects individuals of South Asian descent. Additionally, diabetes distress (DD) may lead to complications with diabetes management. This study examines the prevalence of DD among foreign-born individuals of South Asian descent in New York City (NYC) and its association with sociodemographic and clinical factors. METHODS:Baseline data was collected from the Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, an intervention designed to reduce hemoglobin A1c (HbA1c) among South Asian individuals with uncontrolled T2D at primary care practices in NYC. The Diabetes Distress Scale (DDS) measured DD, and Core Healthy Days Measures assessed physical and mental healthy days. Sociodemographic variables were analyzed using descriptive statistics, Chi-square tests assessed categorical variables, and Wilcoxon Rank Sum tests evaluated continuous variables (Type I error rate = 0.05). Logistic regression models examined associations between HbA1c, mental health, and other covariates with dichotomized DD subscales. RESULTS:Overall, 414 participants completed the DDS at baseline (median age = 55.2 years; SD = 9.8). All were born outside of the US; the majority were born in Bangladesh (69.8%) followed by India, Pakistan, and Nepal (24.7%) and Guyana and Trinidad and Tobago (5.5%). High emotional burden, regimen-related distress and physician-related distress were reported by 25.9%, 21.9%, and 6.2% of participants, respectively. In adjusted analyses, individuals with ≥ 1 day of poor mental health had higher odds of overall distress (OR:3.8, p = 0.013), emotional burden (OR:4.5, p < 0.001), and physician-related distress (OR:4.6, p = 0.007) compared to individuals with no days of poor mental health. Higher HbA1c (OR:1.45, p = < 0.001) was associated with regimen-related distress; and lower emotional support was associated with overall distress (OR:0.92, p < 0.001) and regimen-related distress (OR:0.95, p = 0.012). Individuals born in Bangladesh had significantly lower odds of overall distress, emotional burden, and regimen-related distress compared to individuals born in Guyana and Trinidad and Tobago. CONCLUSIONS:Findings highlight the rate and risk factors of DD among individuals of South Asian descent living in NYC. Screening for DD in patients with prediabetes or diabetes should be integrated to address mental and physical health needs. Future research can benefit from a longitudinal analysis of the impact of DD on diabetes self-management and health outcomes. TRIAL REGISTRATION/BACKGROUND:This study uses baseline data from "Diabetes Management Intervention for South Asians" (NCT03333044), which was registered with clinicaltrials.gov on 6/11/2017.
PMID: 39894868
ISSN: 1471-2458
CID: 5783582

Spatial arrangement of the whiskers of harbor seals ( Phoca vitulina ) compared to whisker arrangements of mice ( Mus musculus ) and rats ( Rattus norvegicus )

Graff, Matthew M; Belli, Hayley M; Wieskotten, Sven; Bresee, Chris S; Krüger, Yvonne; Janssen, Thomas L; Dehnhardt, Guido; Hartmann, Mitra J Z
Most mammals have specialized facial hairs known as vibrissae (whiskers), sensitive tactile structures that subserve both touch and flow sensing. Different animals have different numbers and geometric arrangements of whiskers, and it seems nearly self-evident that these differences would correlate with functional and behavioral use. To date, however, cross-species comparisons of three-dimensional (3D) whisker array geometry have been limited because standard morphometric techniques cannot be applied. Our laboratory recently developed a novel approach to enable quantitative, cross-species vibrissal array comparisons. Here we quantify the 3D morphology of the vibrissal array of the harbor seal ( Phoca vitulina ), construct a CAD model of the array, and compare array morphologies of harbor seals, mice ( Mus musculus ) and rats ( Rattus norvegicus ). In all three species whisker arclength decreases from caudal to rostral, whisker curvature increases from caudal to rostral, and whiskers emerge from the face in smooth orientation gradients. Two aspects of whisker orientation are strikingly consistent across species: the elevation angle is constant within a row, and the twist of the whisker about its own axis varies smoothly in a diagonal gradient across the array. We suggest that invariant whisker elevation within a row may aid localization behaviors, while variable twist-orientation may help the animal sense stimulus direction. We anticipate this work will serve as a starting point for quantitative comparisons of vibrissal arrays across species, help clarify the mechanical basis by which seal vibrissae enable efficient wake detection and following, and enable the creation of whole-body biomechanical models for neuroscience and robotics.
PMCID:10827100
PMID: 38293081
CID: 5664422

Characterizing Technology Use and Preferences for Health Communication in South Asian Immigrants With Prediabetes or Diabetes: Cross-Sectional Descriptive Study

Hu, Lu; Wyatt, Laura C; Mohsin, Farhan; Lim, Sahnah; Zanowiak, Jennifer; Mammen, Shinu; Hussain, Sarah; Ali, Shahmir H; Onakomaiya, Deborah; Belli, Hayley M; Aifah, Angela; Islam, Nadia S
BACKGROUND:Type 2 diabetes disproportionately affects South Asian subgroups. Lifestyle prevention programs help prevent and manage diabetes; however, there is a need to tailor these programs for mobile health (mHealth). OBJECTIVE:This study examined technology access, current use, and preferences for health communication among South Asian immigrants diagnosed with or at risk for diabetes, overall and by sex. We examined factors associated with interest in receiving diabetes information by (1) text message, (2) online (videos, voice notes, online forums), and (3) none or skipped, adjusting for sociodemographic characteristics and technology access. METHODS:We used baseline data collected in 2019-2021 from two clinical trials among South Asian immigrants in New York City (NYC), with one trial focused on diabetes prevention and the other focused on diabetes management. Descriptive statistics were used to examine overall and sex-stratified impacts of sociodemographics on technology use. Overall logistic regression was used to examine the preference for diabetes information by text message, online (videos, voice notes, or forums), and no interest/skipped response. RESULTS:The overall sample (N=816) had a mean age of 51.8 years (SD 11.0), and was mostly female (462/816, 56.6%), married (756/816, 92.6%), with below high school education (476/816, 58.3%) and limited English proficiency (731/816, 89.6%). Most participants had a smartphone (611/816, 74.9%) and reported interest in receiving diabetes information via text message (609/816, 74.6%). Compared to male participants, female participants were significantly less likely to own smartphones (317/462, 68.6% vs 294/354, 83.1%) or use social media apps (Viber: 102/462, 22.1% vs 111/354, 31.4%; WhatsApp: 279/462, 60.4% vs 255/354, 72.0%; Facebook: Messenger 72/462, 15.6% vs 150/354, 42.4%). A preference for receiving diabetes information via text messaging was associated with male sex (adjusted odds ratio [AOR] 1.63, 95% CI 1.01-2.55; P=.04), current unemployment (AOR 1.62, 95% CI 1.03-2.53; P=.04), above high school education (AOR 2.17, 95% CI 1.41-3.32; P<.001), and owning a smart device (AOR 3.35, 95% CI 2.17-5.18; P<.001). A preference for videos, voice notes, or online forums was associated with male sex (AOR 2.38, 95% CI 1.59-3.57; P<.001) and ownership of a smart device (AOR 5.19, 95% CI 2.83-9.51; P<.001). No interest/skipping the question was associated with female sex (AOR 2.66, 95% CI 1.55-4.56; P<.001), high school education or below (AOR 2.02, 95% CI 1.22-3.36; P=.01), not being married (AOR 2.26, 95% CI 1.13-4.52; P=.02), current employment (AOR 1.96, 95% CI 1.18-3.29; P=.01), and not owning a smart device (AOR 2.06, 95% CI 2.06-5.44; P<.001). CONCLUSIONS:Technology access and social media usage were moderately high in primarily low-income South Asian immigrants in NYC with prediabetes or diabetes. Sex, education, marital status, and employment were associated with interest in mHealth interventions. Additional support to South Asian women may be required when designing and developing mHealth interventions. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT03333044; https://classic.clinicaltrials.gov/ct2/show/NCT03333044, ClinicalTrials.gov NCT03188094; https://classic.clinicaltrials.gov/ct2/show/NCT03188094. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:RR2-10.1186/s13063-019-3711-y.
PMCID:11087851
PMID: 38669062
ISSN: 2561-326x
CID: 5664432

A Cluster-Randomized Study of Technology-Assisted Health Coaching for Weight Management in Primary Care

Jay, Melanie R; Wittleder, Sandra; Vandyousefi, Sarvenaz; Illenberger, Nicholas; Nicholson, Andrew; Sweat, Victoria; Meissner, Paul; Angelotti, Gina; Ruan, Andrea; Wong, Laura; Aguilar, Adrian D; Orstad, Stephanie L; Sherman, Scott; Armijos, Evelyn; Belli, Hayley; Wylie-Rosett, Judith
PURPOSE/OBJECTIVE:We undertook a trial to test the efficacy of a technology-assisted health coaching intervention for weight management, called Goals for Eating and Moving (GEM), within primary care. METHODS:). The primary outcome (weight change at 12 months) and exploratory outcomes (eg, program attendance, diet, physical activity) were analyzed according to intention to treat. RESULTS:= .48). There were no statistically significant differences in secondary outcomes. Exploratory analyses showed that the GEM arm had a greater change than the EUC arm in mean number of weekly minutes of moderate to vigorous physical activity other than walking, a finding that may warrant further exploration. CONCLUSIONS:The GEM intervention did not achieve clinically important weight loss in primary care. Although this was a negative study possibly affected by health system resource limitations and disruptions, its findings can guide the development of similar interventions. Future studies could explore the efficacy of higher-intensity interventions and interventions that include medication and bariatric surgery options, in addition to lifestyle modification.
PMCID:11419716
PMID: 39313341
ISSN: 1544-1717
CID: 5738742

Antibody Titers against Mpox Virus after Vaccination [Letter]

Kottkamp, Angelica C; Samanovic, Marie I; Duerr, Ralf; Oom, Aaron L; Belli, Hayley M; Zucker, Jane R; Rosen, Jennifer B; Mulligan, Mark J; ,
PMID: 38091537
ISSN: 1533-4406
CID: 5589312