bluuebunny/crossref_metadata_2025 huggingface dataset:
Abstract P043: A Framework For The Evaluation Of Digital Tools
Authors: Danawi Hadi , Dunn Patrick
Published: April 2022

Digital health tools encompass a wide range of technologies that have been used in healthcare services including mobile applications, health information technology, smart wearable devices, remote monitoring and treatment, and health platforms. These tools walk a fine line between lifestyle consumer products and medical devices. Sleep applications can be used by consumers as a fun gadget to track sleep, but it may also be used as a medical tool to collect information concerning serious sleep disorders. The fast proliferation of these tools has put pressure on concerned stakeholders to make sense of this group of technologies. Various questions have been raised within this realm: What counts as medical as opposed to a lifestyle device? Which devices require regulation and under what standards? Which devices are allowed to be used in the medical context? And which are not? And under what conditions? Social scientists have highlighted the complexity of digital health tools that (include both medical and lifestyle characteristics and the difficulties accompanied with classifying these tools for regulatory purposes. In an attempt to do so, several regulatory bodies including the US Food and Drug Administration (FDA) have revised their existing standards to accommodate the regulation of digital health tools. As such, the FDA published a guidance document on Mobile Medical Applications; this led to various concerns questioning the boundaries between lifestyle and medical digital technologies that were defined by the FDA guidelines, which left a significant number of technologies that were considered to be low-risk, completely out of the FDA oversight and with no required compliance/quality control/effectiveness checks. This prompted many companies to develop hundreds of products that belong to the low-risk category, granting them the ability to ignore FDA regulations. Consequently, there remains considerable concern regarding the quality and safety of these digital health technologies that are being used within the medical context. Clear and well-defined regulation processes are needed to control the development and design of these tools, especially that many lack scientific evidence and data privacy. The framework ought to include a risk-based approach to classify devices for regulation in a way to ensure the safety and effectiveness of all digital health tools throughout their life cycle, even those classified as low-risk. The framework and regulatory process also need to take into consideration the rapid change in digital product development, as processes that extend for a long period of time may become obsolete in supporting decisions about these tools. As these digital health tools become more sophisticated, accessible, widespread, and cheaper, the need for classifying and regulating the sector becomes important, especially with the rapid evolution of these technologies.
Abstract P044: A Novel Digital Therapeutic Program Is Feasible For Patients With Peripheral Artery Disease
Authors: Oddsson Saemundur , Wahlgren Carl , Nordanstig Joakim , Gottsäter Anders , Gunnarsdottir Thrudur , Ulfsdottir Hildigunnur , Gudmundsson Elias , Bjornsdottir Agusta , Thorgeirsson Tryggvi
Published: April 2022

Introduction:
Patients with peripheral artery disease (PAD) are at increased risk for adverse cardiovascular and limb events and impaired quality of life. Lifestyle factors, such as patient physical activity levels and dietary habits, are known risk factors. Limited data is available on the feasibility and efficacy of tailored PAD digital therapeutic programs, focused on improving lifestyle (e.g. physical activity levels, dietary habits, sleep, stress, energy levels) and medication adherence.

Hypothesis:
We assessed the hypothesis that a digital therapeutic program is feasible among elderly patients with PAD.

Methods:
Patients were recruited from two vascular surgery specialty clinics in Sweden. Fourteen patients signed informed consent forms and started a four-week intervention based on the first weeks of the SK-111 digital program (Sidekick Health). Questionnaires were administered at baseline and at the end of the intervention. Data on in-app activity was collected throughout the intervention.

Results:
Out of the 14 patients (8 men, 6 women) who started the intervention, 11 stayed active within the platform from week 1 through 4. The 11 active participants performed a median of 7.1 activities in the app/day (IQR=3.4-12.9) and logged a median number of 4500 steps/day (IQR=2700-6455). The amount of physical activity logged/day went up from a mean of 21 (SD=39) min/day to 33 (SD=54) min/day from week 1 to week 4 (p=0.201). Seven participants (median age=72, IQR=69-73 years) answered both pre and post questionnaires. No changes were observed from pre to post intervention for either the walking distance domain of the Walking Impairment Questionnaire: 22.7 (SD=0.1) and 24.3 (SD=0.1), (p=0.499) or the Vascular Quality of Life Questionnaire sum score: 15.4 (SD=3.2) and 15.6 (SD=3.4), (p=0.864). For the pre-post medication adherence question (“During the last week, did you ever forget to take your PAD medication?” Rated from 0-10), ratings went down from 2.0 (SD=3.6) before to 0.1 (SD=0.4) after intervention (p=0.048). A post-program question asking whether using the platform helped them remember to take their medication, 5/7 (71%) patients considered it helpful. When asked how likely patients would be to recommend the PSP to others, the average score was 83/100.

Conclusions:
The findings from this feasibility study indicate that a PAD digital therapeutic program is feasible for elderly patients with PAD. A multicenter RCT is currently ongoing, where the clinical effectiveness of the full SK-111 will be further explored in this patient group.
Abstract P045: Self-reported Anxiety And Patient Activation Among Smartwatch Users Monitored For Atrial Fibrillation Post-stroke: The Pulsewatch Study
Authors: Paul Tenes J , Tran Khanh-van T , Mehawej Jordy , Lessard Darleen , Filippaios Andreas , Ding Eric , Joshi Shiksha , Mensah Otabil Edith , Noorishirazi Kamran , Naeem Syed , Soni Apurv , Saczynski Jane , McManus David D
Published: April 2022

Introduction:
Wearable devices such as smartwatches are emerging as convenient and accurate means of post-stroke atrial fibrillation (AF) detection, however little is known about how the use of smartwatches for this purpose affects patients’ anxiety or engagement with their medical care.

Hypothesis:
Use of a smartwatch for atrial fibrillation monitoring will not significantly increase anxiety or affect engagement with medical care in post-stroke patients.

Methods:
We analyzed data from a randomized controlled trial, the Pulsewatch study, which included patients (>=50 years) who presented to the UMass Memorial Health system with an ischemic stroke in the past decade, and/or had a CHA2DS2-VASc score >2, with no contraindications to anticoagulation. Participants were randomized to either wear a Samsung smartwatch for AF monitoring (intervention) or not wear a smartwatch (control) for 30 days. Participants completed the General Anxiety Disorder-7 (GAD7) and the Consumer Health Activation Index (CHAI), which examined anxiety and patient activation (i.e. personal healthcare knowledge and management ability), prior to and after the 30-day period. Logistic regression was used to examine the association between smartwatch use and changes in anxiety and patient activation before and after the 30-day period.

Results:
Participants in the control group (N=56) had a mean age of 66, were 43% female, and 88% white, compared to the intervention group (N=54) which had a mean age of 64, were 41% female, and 91% white. There were no significant differences in baseline levels of anxiety (control 15% vs intervention 20%, P=0.3) and patient activation (control 12% vs intervention 10%, P=0.7) between the groups. After 30 days of rhythm monitoring, smartwatch users, as opposed to participants without a smartwatch, did not have a higher odd of having increased anxiety (38.9% vs 29.1%; aOR 1.37; 95% CI 0.45-4.15) or patient activation (20.4% vs 35.7%; aOR 0.62; 95% CI 0.18-2.17), adjusting for baseline anxiety, patient activation, valvular disease, diabetes, beta blocker use, and anticoagulant use.

Conclusion:
To the best of our knowledge, this is among the first studies to demonstrate a lack of difference in anxiety or patient activation in older stroke survivors who were prescribed a smartwatch for AF monitoring as compared to controls. Further studies are needed to elucidate the benefits and pitfalls related to the use of wearables as an alternative for post-stroke arrhythmia monitoring.
Abstract P046: Psychosocial Measures In Relation To Smartwatch Device Alerts For Atrial Fibrillation Detection Post Stroke: The Pulsewatch Study
Authors: Filippaios Andreas , Tran Khanh-van T , Mehawej Jordy , Ding Eric , Saczynski Jane , Lessard Darleen , Paul Tenes , Mensah Otabil Edith , Noorishirazi Kamran , Naeem Syed , Joshi Shiksha , Soni Apurv , McManus David D
Published: April 2022

Background:
Atrial fibrillation (AF) is a major stroke risk factor and rhythm monitoring post stroke is recommended. Wearable smartwatches with different device alert systems have been increasingly popular. Anxiety and perceived confidence in physicians, particularly in older stroke survivors, in relation to alerts delivered from AF detection devices remain to be elucidated.

Objectives:
Assess the associations between smartwatch alerts for detected atrial fibrillation in older post stroke patients and self-reported anxiety and perceived confidence in physicians.

Methods:
Data were used from Phase I of the Pulsewatch study, a randomized controlled trial, which enrolled patients (≥50 years) from the UMass Memorial Health System with a history of a stroke or transient ischemic attack (TIA), CHA
2
DS
2
-VASc ≥ 2 and no contraindications to anticoagulation. Intervention participants wore a cardiac patch monitor, a smartwatch, and were given a smartphone installed with the Pulsewatch applications, while control participants only wore the cardiac patch monitor for 14 days. Intervention participants were grouped into those receiving at least one alert versus those who did not receive any alerts from the smartwatch. Generalized Anxiety Disorder-7 Scale and Perceived Efficacy in Patient-Physician Interactions Questionnaire were utilized at baseline and 14 days to assess anxiety and perceived confidence in physicians, respectively. Logistic regression was used to examine anxiety and perceived confidence in physicians in relation to alerts amongst smartwatch users.

Results:
A total of 68 participants (on average 65.2 ± 9.2 years of age, 41.2% [28 of 68] were women, 83.8% [57 of 68] were non-Hispanic white) were included in the intervention arm; 10 of which received at least one alert. Reception of alerts was not significantly associated with increased anxiety (adjusted OR [aOR] 0.98, 95% CI 0.13 - 7.6) or decreased perceived confidence in physicians (aOR 1.86, 95% CI 0.26 - 13.4), adjusting for the corresponding baseline outcome.

Conclusions:
Our study shows that smartwatch devices prescribed for AF detection in stroke survivors are not significantly associated with increased anxiety or decreased perceived confidence in physicians. Further studies are needed to explore their potential as methods for AF monitoring in older patients post stroke.
Abstract P051: Healthy For Life: A Shift To Virtual Nutrition Education To Improve Confidence And Dietary Behaviors
Authors: Gavras Heather , Jones Olivia , Poudel Remy
Published: April 2022

Introduction:
Less than 10% of U.S. adults meet the guidelines for whole grains, fruits, and vegetables each day. The Healthy for Life community-based program aims to change confidence and health behaviors, by equipping individuals with new skills for healthy living. As a result of the COVID-19 pandemic in 2020 and 2021, the program pivoted from in-person to a virtual implementation model. This required more advanced planning due to additional logistics to ensure a skills-based learning environment.

Objectives:
To examine the effectiveness of the Healthy for Life program over time, specifically: o Changes in participant confidence in the preparation of healthy foods at home o Changes in participant consumption of fruits, vegetables, and whole grains o Changes in participant frequency of healthy shopping habits

Methods:
A community engagement program was implemented and evaluated in 17 community centers in 2020-2021 to measure changes in participant confidence to prepare healthy meals at home, consumption of fruits, vegetables and whole grains, and frequency of healthy shopping habits. Community center facilitators administered the same pre/post survey to participants at the first educational experience, and then again at the final experience. Facilitators entered the participant data into an online survey portal. Analysis was conducted with 235 participants who completed both pre and post surveys. Two-way repeated ordinal regression was used to assess changes in key metrics over time.

Results:
Participants were predominately female (90.6%), about two-thirds (65.2%) were between 25-55 years old, and most identified as non-Hispanic White/Caucasian (42.6%) or Black/African American (35.7%). Close to half (45.9%) of participants had a college degree or higher, over a quarter (28.1%) received benefits from SNAP and/or WIC, and more than two-thirds (63.8%) indicated they are the only person in their household preparing meals. Almost half (49.3%) of respondents attended the suggested minimum of 4 educational experiences. On average, respondents statistically significantly increased their daily fruit & vegetable consumption by 1.21 serving(s). In addition, over one-third (34%) of respondents increased their level of confidence to prepare healthy meals at home and (37%) respondents increased their level of confidence to substitute healthier cooking and food preparation methods. Close to half (47.2%) respondents reported increased frequency of reading food labels and checking the nutritional values when purchasing food.

Conclusions:
Despite the shift to virtual implementation, the Healthy for Life community education program, was still effective in improving participant confidence and dietary behaviors over time. However, additional research studies are required to further assess whether virtual implementation of this type of intervention will continue to be effective.
Abstract P054: Plant-based Nutrition And Lifestyle Intervention To Improve Dietary Behaviors Among Black Adults In The South
Authors: Sterling Samara , Bowen Shelly-Ann
Published: April 2022

Background:
Plant-based diets may reduce risk of cardiovascular disease (CVD) and help with weight management, particularly in communities where the burden of chronic disease is high. However, little research has been done on plant-based diet implementation in rural Black communities that are disproportionately affected with obesity/CVD. Since dietary behaviors are closely linked to cultural identity in this community, intervention strategies are needed to preserve cultural traditions while addressing lifestyle behaviors that reduce CVD risk.

Methods:
The Veggie & Soul pilot program was a 12-week plant-based nutrition and lifestyle intervention implemented in 2020 to prioritize and educate Black adults in rural Georgia about the benefits of a healthy diet and encourage increased consumption of fruits, vegetables, and whole grains. Weekly nutrition education sessions were implemented, in addition to support groups and cooking classes. Multiple instruments for dietary assessment were collected at baseline and 12 weeks including: (1) food frequency questionnaire; (2) food behavior survey, and (3) two 24-hour dietary recalls (1 weekend and 1 weekday). Paired t-tests explored differences between baseline and 12-week measurements.

Results:
Twenty-four participants (22 women, 2 men) completed the intervention. Participants doubled their daily servings of fruit from baseline to 12 weeks (1.3 vs. 2.6 servings respectively; p<.001) and reported a 76% increase in daily vegetable servings (1.7 vs. 3.0 servings respectively; p<.001). There was also a 90% increase in daily servings of whole grain (1 vs. 1.9 servings respectively; p=0.014). Further, results showed a significant reduction in intake of nutrients to limit including cholesterol (-83%; p<.001), saturated fat (-42%; p<.001), sodium (-28%; p=.004), and added sugars (-54%; p-.002). At baseline, 46% of participants agreed or strongly agreed that “a diet without meat is satisfactory and nutritious.” At 12 weeks, 95% of participants agreed or strongly agreed with this statement (p<.001). There was a significant increase in participant confidence in preparing healthy meals by the end of the intervention (p=.03). Median weight change was 9.6 lbs, with a decrease in both body mass index and waist circumference (p<.001). Waist-hip ratio reductions were also mildly significant (p=0.058).

Conclusion:
Implementing a 12-week nutrition and lifestyle intervention among Black adults in the rural South improved reported dietary behaviors that may impact obesity and cardiovascular risk. Long-term interventions are needed that will promote permanent behavior changes to improve health in similar communities.
Abstract P055: Reweighting Diet Quality Score Components Strengthens All-cause Mortality Risk Associations
Authors: Parker Haley W , Oaks Brietta , Buchanan Ashley , Vadiveloo Maya
Published: April 2022

Introduction:
The Dietary Patterns Methods Project concluded that various high-quality diets comparably reduce mortality, but it is unclear whether some individual components are more integral to risk reduction than reflected in current indexes. Thus, we examined mortality risk associated with standard vs. modified diet quality weighting schemes.

Hypothesis:
High scores on a data-driven (vs. standard) diet quality weighting scheme will be associated with stronger mortality risk reduction.

Methods:
National Health and Nutrition Examination and Survey III (1988-94) data from 10,789 non-pregnant adults ≥20 yrs. with valid mortality and dietary data were analyzed. Diet quality was scored from a single 24-hr recall with the Healthy Eating Index (HEI)-2015. The standard HEI 9 adequacy and 4 moderation components were reweighted creating: 1) the Key Facets HEI with fruits, vegetables, whole grains, and plant proteins equally weighted, emphasizing components present in virtually all diet quality indexes; and 2) the Machine Learning (ML)-weighted HEI where data-driven LASSO models determined relative component contribution to all-cause mortality associations. For all 3 HEIs, energy-residualized scores were ranked and assigned to quintiles (Q); covariate-adjusted sex-stratified Cox models with attained age as the timescale assessed all-cause and CVD mortality risk associations across HEI Qs.

Results:
In all 3 HEIs, high (Q5 vs. Q1) scores were associated with reduced all-cause mortality risk, ranging from 16% to 38%. The ML-weighted HEI had the strongest risk reduction (38% in women, 23% in men), 7 to 8% lower than standard HEI scores. Key Facets (vs. standard) scores yielded equivalent risk in men (16%) and 2% greater risk reduction in women. There was no association between any of the HEI scores and CVD mortality.

Conclusions:
All-cause mortality risk associations were 7-8% stronger in the ML-weighted vs. standard HEI. Findings suggest data-driven diet quality weighting schemes warrant further examination.
Abstract P057: Proteomic Signature Of Healthy Dietary Patterns And Risk Of Cardiovascular Disease In The Framingham Heart Study
Authors: Walker Maura E , Xanthakis Vanessa , Lin Honghuang , Jacques Paul , Ramachandran Vasan S
Published: April 2022

Background:
Identifying circulating proteins associated with healthy dietary patterns may offer novel insights into the key biological processes underlying diet-related chronic disease. As a first step toward achieving this goal, we examined the relations between a proteomic score of healthy dietary patterns and the risk of cardiovascular disease (CVD).

Methods:
We evaluated up to 1713 Framingham Offspring Study participants (1991-1995, mean age 54yr, 55% women) who had plasma proteins assayed using the SomaLogic platform and diet assessed using a validated food frequency questionnaire. We regressed three healthy dietary pattern indices (Alternative Healthy Eating Index, Dietary Approaches to Stop Hypertension [DASH], and Mediterranean-style diet) on 103 diet-related proteins using elastic net regression (separate model for each diet index) with a 10-fold cross-validation (CV). Protein selection was based on the minimum mean CV error. A proteomic score was created by summing (concentration*β coefficient) of selected proteins, and validated in 862 Framingham Third Generation Cohort participants (2008-2011, mean age 46yr, 56% women). We used multivariable Cox proportional hazard models to relate the proteomic score and dietary pattern indices (separate models) to CVD in participants free of CVD (n=2459). All models adjusted for age, sex, smoking, and lipid medication use. Additional models adjusted for 1) both the proteomic score and dietary pattern indices and 2) body mass index, total cholesterol to high-density lipoprotein cholesterol ratio, triglycerides, diabetes mellitus, and hypertension.

Results:
Across three dietary patterns, 11 proteins characterized the proteomic score. Partial correlations of the proteomic score with the healthy dietary patterns ranged from r=0.33-0.36 (adjusted for age, sex, and total energy) in the validation sample, with the strongest correlation for the DASH index. Over a mean follow-up of 20 years, 510 participants developed CVD. Adjusting for age, sex, smoking, and lipid medication, a 1-SD unit increase in the proteomic score was associated with a 22% lower risk of CVD (hazard ratio [95% CI] 0.78 [0.72, 0.84]) and a 1-SD unit increase in the DASH index was associated with a 15% lower risk of CVD (hazard ratio 0.85 [0.77, 0.93). In mutually-adjusted models, relations of the proteomic score with CVD (0.80 [0.73, 0.87]), and of the DASH index with CVD were maintained (0.89 [0.82, 0.97]). Upon further adjustment for metabolic risk factors, relations of the proteomic score and CVD were attenuated (0.96 [0.87, 1.05]), but relations of the DASH index with CVD were unchanged (0.89 [0.80, 0.98]).

Conclusion:
We characterized a distinct proteomic score of healthy dietary patterns in a community-based cohort of adults. A healthy diet proteomic score may represent variation in the proteome that influences CVD risk.
Abstract P058: Comparative Effects Of Different Dietary Patterns On Biomarkers Of Non-Communicable Diseases: A Systematic Review And Network Meta-Analysis
Authors: Liang Shuang , Mijatovic Jovana , Li Ang , Nasir Reeja , Toniutti Clemence , Bell-Anderson Kim , O'Leary Fiona , Skilton Michael
Published: April 2022

Each year, there are millions non-communicable diseases (NCDs) related deaths that are attributed to dietary risk factors. Dietary pattern describes the overall combination of dietary components, therefore is a more proximate representation of real-world dietary intake. The comparisons of different dietary patterns have been largely limited by the traditional pair-wise meta-analysis. We conducted a systematic review and network meta-analysis of randomised trials with healthy participants to compare major dietary patterns in NCD prevention, using biomarkers of NCDs as outcomes. For each biomarker outcome, a random effects network meta-analysis was conducted to estimate all possible pair-wise relative effects and to obtain a relative ranking of the dietary patterns in a connected network. The relative effects were estimated by calculating the summary mean differences (MD) with corresponding 95% CI. The relative ranking was assessed using the distribution of the ranking probabilities and the surface under the cumulative ranking curves (SUCRA). Of the 4008 records identified from the systematic literature search, 72 articles met our inclusion criteria and 68 were included in the quantitative synthesis. We compared up to 11 dietary patterns (Mediterranean diet, DASH diet, Paleo diet, dietary guidelines-based diet, low GI / GL diet, plant based diet, low fat diet, low carbohydrate high fat diet, traditional Mexican diet, high GI / GL diet and western habitual diet) for their effects on 11 NCD biomarkers (HDL, TG, LDL, TC, glucose, insulin, hsCRP, apoB, apoA1, HOMA-IR, and IL-6). Compared to western habitual diet, the Mediterranean diet, DASH diet, dietary guidelines based diet, plant based diet and low fat diet reduced LDL, TC, and apoB (MD range: -0.29 to -0.17 mmol/L, -0.36 to -0.24 mmol/L, and -0.11 to -0.07 g/L, respectively, all p<0.05); the Paleo diet, plant based diet and dietary guidelines based diet reduced HOMA-IR (MD range: -0.95 to -0.35, all p<0.05). While no dietary pattern ranked consistently highest across all NCD biomarkers, the Mediterranean diet was best to improve lipid profile (LDL, HDL, TC, TG, apoB and apoA1 combined average SUCRA: 63.1%); low carbohydrate high fat diet was best for glycaemic control (glucose, insulin and HOMA-IR combined average SUCRA: 66.4%); and Paleo diet was best in inflammation reduction (hsCRP and IL-6 combined average SUCRA: 87.0%). The Paleo diet had the highest all-outcomes-combined ranking (average SUCRA: 63.1%), followed by the Mediterranean diet (58.9%) and DASH diet (58.8%), while the western habitual diet (37.8%) and high GI / GL diet (38.5%) received the lowest all-outcomes-combined SUCRAs. Our findings suggest that the Paleo diet may provide potential health benefit and warrants further consideration for NCD prevention.
Abstract P059: Effects Of Saturated Fatty Acid On Lipoprotein(a): A Systematic Review And Meta-analysis
Authors: Riley Terrence , Sapp Philip , Petersen Kristina , Kris-Etherton Penny M
Published: April 2022

Background:
Elevated lipoprotein(a) [Lp(a)] is a significant contributor to residual CVD risk. Replacement of saturated fatty acids (SFA) with mono- and polyunsaturated fatty acids (MUFA and PUFA), carbohydrates (CHO) has established effects on traditional lipid parameters related to CVD; however, the evidence for Lp(a) is inconsistent. Moreover, some evidence suggests replacing SFA with other macronutrients increases Lp(a).

Objective:
The aim was to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the effect of replacing SFA with MUFA, PUFA, trans fatty acids (TFA) and CHO on Lp(a).

Methods:
PubMed, Cochrane Central, ClinicalTrials.gov, and Web of Science were searched for RCTs with a duration of ≥13 days that included healthy adults ages 20-65 y and examined the effect of diets differing in SFA, MUFA, PUFA, or CHO on Lp(a). Exclusion criteria included changes in protein/alcohol and >10% weight loss in last 6 months. Diet comparisons were extracted from trials to assess the effect of substitution of SFA for other macronutrients. Data are presented as weighted means. Data were analyzed using a mixed model approach (SAS 9.4).

Results:
Twenty-seven articles met criteria for inclusion and data were available for analysis for 15 articles. There were 39 comparisons between SFA and other macronutrients. Lp(a) was measured by macra, polyclonal, or sandwich enzyme linked immunosorbent assay (ELISA), particle enhanced turbidimetric immunoassay, or radioimmunoassay. SFA was substituted for TFA (
k
=6), MUFA (
k
=9), and PUFA (
k
=3). Five trials compared a high SFA diet with a high CHO diet. A total of 539 adults (44.7
+
31.6 y) were included in the pooled sample. Overall, the mean displacement of SFA for other macronutrients was 6.7% of kcals. Mean Lp(a) across the included studies was 100.5
+
100.3 mg/dl. Replacement of SFA with MUFA, PUFA or CHO did not significantly affect Lp(a). Lp(a) was 6.1 mg/dl (p=0.021; 95% CI: -11.3, -0.9) lower when SFA replaced TFA.

Conclusions:
Overall, substitution of SFA for other macronutrients did not impact Lp(a) concentrations. Lower levels of Lp(a) were observed when 5% of kcals from TFA were replaced with SFA, although the clinical relevance of this finding is unclear. Further research examining the effect of SFA replacement on Lp(a) is needed due to the methodological quality of the available data and heterogeneity in Lp(a) measurement methods utilized.
Abstract P060: The Association Of Lean Mass With Type 2 Diabetes: The Coronary Artery Risk Development In Young Adults (CARDIA) Study
Authors: Booker Robert , Alexandria Shaina , Bancks Michael , Chow Lisa , Lewis Cora E , Schreiner Pamela , Wong Mandy , Carnethon Mercedes R
Published: April 2022

Introduction:
Body mass index (BMI) does not capture tissue composition and thus is unable to assess the contribution of each tissue type to cardiometabolic health. This limitation of BMI may explain the paradoxical association of BMI-weight status with mortality for those with type 2 diabetes (T2D), and merits investigation of individual tissues. We assessed the relationship between body composition and incident T2D and assessed for differences by BMI-weight status. We hypothesized that greater lean mass (LM) would be associated with lower risk for T2D for all BMI groups.

Methods:
Black and White participants from CARDIA without T2D in 2005-06 (baseline) were included in this longitudinal analysis (
N
=2,473). LM and fat mass (FM) were assessed via dual-energy X-ray absorptiometry. Incident T2D was defined using American Diabetes Association cut points for fasting and post-load glucose, glycated hemoglobin, and diabetes medication use. We used Cox proportional hazards regression to estimate hazard ratios (HR) for incident T2D over 10 years according to 1-standard deviation (SD) increment in LM (1 SD=1g) and assessed for potential effect measure modification (EMM) of this association by weight status. We assessed a secondary exposure, LM:FM ratio, in relation to incident T2D.

Results:
Mean baseline age was 45.2±3.6 years (57% White and 57% female). The cumulative incidence of T2D was 7.2% (178 events, total person years=21,421.7). Before and after adjustment, neither LM nor LM:FM were significantly associated with T2D (Table), and we did not observe evidence for EMM by weight status for any association.

Conclusions:
LM in middle adulthood does not appear to be associated with T2D risk. Whether incorporation of data for other tissue depots is informative to T2D risk merits evaluation.
Abstract P062: Migration-related Weight Changes Among African Immigrants In The United States
Authors: Byiringiro Samuel , Turkson-ocran Ruth-alma N , Baptiste Diana , Koirala Binu , Ogungbe Oluwabunmi B , Dennison Himmelfarb Cheryl , Commodore-Mensah Yvonne
Published: April 2022

Introduction:
People who migrate from low to high-income countries are at an increased risk of weight gain and excess weight is a risk factor for cardiovascular diseases. Little is known about changes in BMI categories pre-and post-migration. We assessed changes in BMI pre-and post-migration and associated risk factors.

Methods:
We performed a cross-sectional analysis of data from the African Immigrant Health Study which included African immigrants in the Baltimore, Washington D.C. metropolitan area. BMI category change was the outcome and was categorized as healthy BMI change, unhealthy BMI maintenance, and unhealthy BMI change. We explored the following potential factors: age at migration, percentage of life in the US, physical activity, diet, depression, country of origin, and reasons for migration. We used multinomial logistic regression adjusting for age, sex, employment, education, income, and marital status.

Results:
Among 300 participants, the mean (SD) age was 47.6 (11.7) years, and 167 (55.6%) were females. Also, 14.0% had healthy BMI change, 25.7% had unhealthy BMI maintenance, and 60.3% had unhealthy BMI change. Individuals who migrated at age 40-49 years were six times likely to maintain unhealthy BMI than immigrants at age 20-29 years (OR = 6.55, 95% CI: 1.53, 28.04). Immigrants from Sierra Leone had the lowest odds of unhealthy BMI change compared to Ghanaians (OR: 0.05, 95% CI: 0.01, 0.33). Migrating for employment or economy (OR: 0.11, 95% CI: 0.03, 0.46), and family (OR: 0.10, 95% CI: 0.02, 0.43) was associated with lower odds of unhealthy BMI change than migrating for educational reasons. Spending 25% or more of life in the US was associated with a 3-fold higher odds of unhealthy BMI change (OR: 3.03, 95% CI: 1.30, 8.38) (Table).

Conclusion:
Majority of African immigrants had unhealthy BMI change upon migrating to the US. Tailored interventions that consider acculturation, country of origin and reasons for migration are needed to prevent obesity in this population.
Abstract P064: Metabolic Risk Transitions In Obesity With The Incidence Of Heart Failure And Coronary Heart Disease: The Atherosclerosis Risk In Communities (aric) Study
Authors: Commodore-Mensah Yvonne , Zhang Sui , Echouffo Tcheugui Justin , Florido Roberta , Nambi Vijay , Michos Erin D , Post Wendy S , Gerstenblith Gary , Blumenthal Roger S , Ballantyne Christie M , Selvin Elizabeth , Ndumele Chiadi E
Published: April 2022

Introduction:
Obesity is associated with a varying spectrum of metabolic risk, from the metabolically healthy obesity (MHO) phenotype, to metabolically unhealthy obesity (MUO) with the development of metabolic syndrome (MetS) and diabetes (DM). The longitudinal association of metabolic risk with CVD phenotypes (CHD, HF) has not been well characterized.

Hypothesis:
Persistent MHO is independently associated with heart failure (HF) but not coronary heart disease (CHD), and regression from MUO to MHO mitigates CVD risk.

Methods:
We conducted a prospective analysis of 10,011 Visit 4 (1996-98) ARIC participants free of HF and CHD (mean age 63, 21% Black, 56% female). Metabolic risk among those with obesity (BMI ≥ 30 kg/m
2
) was categorized as MHO (no MetS or DM), MUO (MetS present) and MUO with DM, with same categorizations among those without obesity. We used Cox regression models to estimate associations of cross-categories of metabolic risk status at Visit 2 (1990-92) and Visit 4 with risk of HF and CHD after Visit 4 through 12/21/19. (Reference: persistent metabolically healthy normal weight).

Results:
Between Visits 2 and 4, 56% of those with MHO transitioned to MUO. There were 2212 HF and 1648 CHD events, median follow-up of 20.5 years. Persistent MHO status was associated with increased risk for HF (HR:1.59, 95% CI: 1.19-2.13) but not CHD (HR: 1.08, 95% CI: 0.74-1.58) (Table). Persistent MUO with DM had the highest risk for HF (HR: 5.30, 95% CI: 4.38-6.41) and CHD (HR: 3.77, 95% CI: 3.00-4.74). Among those with MUO at Visit 2, progression to MUO with DM at Visit 4 was linked to greater risk for HF and CHD, while regression to MHO was associated with an attenuated risk for CVD. Similar patterns were seen for those without obesity (data not shown).

Conclusions:
Transitions in metabolic risk status are common and associated with divergent patterns of CVD risk. Progression from MHO to MUO and even persistent MHO are linked to HF risk, whereas regression from MUO to MHO may attenuate CVD risk. Primordial prevention of obesity is warranted to stave off HF.
Abstract P077: Midlife Physical Activity Is Associated With Gut Microbial Species And Metabolic Pathways: Coronary Artery Risk Development In Young Adults Study
Authors: Lulla Anju , Gabriel Kelley P , Puterman Eli , Ingram Katherine H , Petrosino Joseph , Shikany James M , Meirelles Osorio , Launer Lenore J , Meyer Katie
Published: April 2022

Background:
Behavioral factors for cardiometabolic outcomes have been shown to influence the composition and function of the gut microbiota, which has been associated with cardiometabolic outcomes. Observational studies have documented associations between physical activity and gut microbial composition using 16S rRNA sequencing data, but there is a paucity of data on functional measures, which can be generated from whole-metagenomics sequencing (WMS).

Methods:
Data are from 480 CARDIA participants who attended the Year 30 follow-up exam (2015-2016, ages 48-60, 47:53 Black:White race, 47:53 male:female gender). Physical activity (exercise units) was estimated from reported frequency and duration of 13 activity types of at least moderate intensity during the previous year. Species, metabolic pathways, and enzyme families were assigned using standard reference databases. Multivariate measures of beta-diversity (between-person) was assessed with principal coordinates analysis (PCoA) and tested with PERMANOVA. Multivariable-adjusted linear regression was used to test associations between distinct microbial features and physical activity, adjusting for false discovery rate (FDR).

Results:
Sequence data mapped to 105 species 1,307 enzyme families, and 318 metabolic pathways. Beta-diversity of species, but not for enzyme families or metabolic pathways, was significantly differentiated according to physical activity. In analysis of distinct microbial features, 7 species, 15 enzyme families, and 3 metabolic pathways were significantly associated with physical activity at an FDR-adjusted p-value of 0.10 (Table).

Conclusion:
These findings support associations between gut microbial features and physical activity in a middle-aged, bi-race population-based cohort. Although temporality cannot be established from these cross-sectional analyses, our results are consistent with data suggesting that physical activity may influence composition and function of the gut microbiota.
Abstract P085: Plasma Pro-enkephalin A And Incident Cognitive Impairment In The Regards Cohort
Authors: Short Samuel A , Wilkinson Katherine , Schulte Janin , Arce Miguel , Manly Jennifer , Cheung Katharine L , Nicoli Charles D , Howard Virginia J , Cushman Mary
Published: April 2022

Background:
Cardiovascular disease is a major risk for cognitive impairment. The opioid precursor peptide pro-enkephalin A (PENK-A) is a circulating hormone associated with several cardiovascular diseases and possibly vascular dementia. The objective of this study was to test the association of plasma PENK-A with incident cognitive impairment and describe potential differences by age, race, and sex.

Methods:
REGARDS is a prospective population-based cohort of 30,239 Black and White adults. Baseline plasma PENK-A was measured in 462 participants who developed cognitive impairment over a median 4.7 years and 556 who did not develop this. PENK-A’s association with incident cognitive impairment was assessed by logistic regression models adjusted for confounders. We tested for differences by age, sex, and race with interaction terms.

Results:
PENK-A concentration was comparable between cases and controls, but higher with White race, female sex, greater age, coronary artery disease, and chronic kidney disease. Categorical and linear models did not reveal an association with cognitive impairment. Spline plots showed a non-linear association with decreased odds at very high PENK-A values (adjusted OR for 95
th
vs 50
th
percentiles 0.66, 95% CI 0.46-0.95). This association was only apparent after final adjustment for kidney function. Interaction testing showed substantial interactions by each age and sex (all P
<
0.06). In subgroup analyses, shapes of association differed but no independent trends were discernable (Figure).

Conclusions:
Circulating PENK-A was not particularly associated with cognitive impairment odds. High levels may be protective; this finding could be spurious. Differences by sex and age may exist, expanding upon prior findings in REGARDS of differing non-linear associations with stroke by sex and race. Further work is needed to characterize the importance of endogenous opioid pathways to cardiovascular health and differences by demographic factors.
Abstract P089: N-terminal Pro-B-type Natriuretic Peptide And Incident Metabolic Syndrome And Its Components In REGARDS
Authors: Nicoli Charles D , Plante Tim B , Long Leann , McClure Leslie A , Judd Suzanne E , Carson April P , Cushman Mary
Published: April 2022

Introduction:
Natriuretic peptides are released in response to cardiomyocyte stretch and are markers of atriopathy and heart failure. Lower N-terminal pro-B-type natriuretic peptide (NT-proBNP) has been associated with greater risk for diabetes mellitus (DM) in prospective studies, but associations of B-type natriuretic peptides with incident metabolic syndrome (MetS) have not been evaluated.

Hypothesis:
Higher baseline NT-proBNP is associated with lower risk for incident metabolic syndrome and its components.

Methods:
We included 2,144 Black and white participants from the REasons for Geographic And Racial Differences in Stroke (REGARDS) study without MetS at baseline (2003-2007). These participants had baseline plasma NT-proBNP measured by immunoassay and underwent follow-up in 2013-2016. Those with NT-proBNP >100 pg/mL were excluded. Incident MetS was defined as ≥3 harmonized criteria at follow-up: high systolic blood pressure, increased waist circumference, dysglycemia, high triglycerides, and low high-density lipoprotein. Three sequential logistic regression models estimated odds ratios of incident MetS and for individual MetS criteria, incorporating demographic factors, metabolic risk factors, and laboratory markers related to insulin resistance.

Results & Conclusions:
Over mean 9.4 (SD 1.0) years follow up, 426 participants (mean [SD] age 60.7 [0.4] years, 193 (45%) Black race, 228 (54%) women) developed MetS. Median [IQR] plasma NT-proBNP was 34 [16-58] pg/mL. No significant association of NT-proBNP with incident MetS was observed (Table). There were no observed interactions of this association by race (P=0.22), age (P=0.15), or sex (P=0.60). Each 1-SD higher log NT-proBNP was associated with lower risk of incident dysglycemia, but not other MetS components. The metabolic implications of B-type natriuretic peptides may be limited to glycemic homeostasis.
Abstract P091: Performance Of Glycated Albumin As A Marker Of Hyperglycemia During Pregnancy: Results From The National Health And Nutrition Examination 1999-2004
Authors: Rooney Mary R , Zhang Sui , Minhas Anum A , Fang Michael , Echouffo Tcheugui Justin , Grams Morgan , Christenson Robert H , Selvin Elizabeth
Published: April 2022

Background:
Glycated albumin (GA) is FDA-cleared for use as a short-term (2-3 week) marker of glycemia. HbA1c is not recommended for use during pregnancy due to its lack of sensitivity and suboptimal performance due to alterations in blood volume and decreases in hemoglobin. It is unclear if GA has a role for monitoring hyperglycemia in pregnancy.

Objective:
We evaluated the performance of GA as a measure of hyperglycemia in pregnant women without pre-gestational diabetes and compared our results to those in a sample of similarly-aged non-pregnant women.

Methods:
We used data from 555 pregnant women aged 20-40 years with measurements of glycemic markers (GA, HbA1c, glucose) without pre-gestational diabetes who participated in the 1999-2004 NHANES. We used Pearson’s correlations and linear regression and evaluated the area under the curve (AUC) for GA to detect elevated glucose or HbA1c. Results were compared to 1607 NHANES women aged 20-40 who were not pregnant.

Results:
In pregnant women in the US, 1.9% had elevated HbA1c (≥5.7%), 4.4% had elevated glucose (≥100 mg/dL) and 1.9% had elevated GA (≥16.5%). The correlation of HbA1c and glucose was 0.21 in pregnant women and was 0.62 in the non-pregnant women. GA was poorly correlated with HbA1c (r=0.08) and glucose (r=0.17) in pregnant women and modestly associated with HbA1c (r=0.31) and glucose (r=0.35). In pregnancy, BMI was positively associated with HbA1c (r=0.33) and glucose (r=0.25) but was inversely associated with GA (r=-0.27). GA had poor discrimination for detecting mild hyperglycemia in pregnant women, defined as either HbA1c ≥5.7% (AUC=0.538) or glucose ≥100 mg/dL (AUC=0.499) (
Figure
). Similar patterns were observed in women who were not pregnant.

Conclusions:
Our results suggest that GA is not a useful marker to identify or monitor mild hyperglycemia in pregnancy. GA appears to be strongly affected by adiposity. Weight gain during pregnancy may explain the poor concordance of GA with traditional measures of glycemia in pregnant women.
Abstract P092: Cell Adhesion Molecules And Incident Hypertension In Black And White Adults: The REasons For Geographic And Racial Differences In Stroke (REGARDS) Study
Authors: Harkness Tyler A , Wilkinson Katherine , Loo Ying , Howard George , Howard Virginia J , Cushman Mary , Zakai Neil A , Cheung Katharine L , Judd Suzanne E , Plante Timothy B
Published: April 2022

Background:
High C-reactive protein (a nonspecific inflammatory biomarker) is a risk factor for incident hypertension. The role of specific inflammation pathways in hypertension’s origins are unresolved. E-selectin, ICAM-1, and VCAM are cell adhesion molecules expressed by endothelial cells that aid leukocyte adhesion during inflammation. Their association with incident hypertension is unclear.

Objective:
To determine risk of incident hypertension by level of E-selectin, ICAM-1, and VCAM.

Methods:
REGARDS enrolled 30,239 Black and White US adults aged ≥45 years from across the continental US in 2003-2006, with a second exam in 2013-2016. The Biomarkers as Mediators of Racial Disparities in Risk Factors (BioMedioR) study included 4,400 REGARDS participants who attended both exams. We excluded participants with hypertension or missing biomarkers of interest at baseline. Hypertension was defined using a 140/90 mm Hg threshold or self-reported use of blood pressure (BP) lowering medications. Modified Poisson regression estimated relative risk (RR) of incident hypertension by baseline E-Selectin, ICAM-1, and VCAM.

Results:
Among 1,923 normotensive participants (mean [SD] age 71 [8] years, 36% Black race, 51% women) with 9 years median follow up, 37% developed hypertension. Baseline E-selectin and ICAM-1 but not VCAM were higher among Black participants and obese participants. In multivariable adjusted models, higher E-selectin was associated with greater risk of incident hypertension among White but not Black adults (P
interaction
= 0.05) in all but the final model (
Table
). Higher ICAM-1 and VCAM were not associated with risk of hypertension in any model.

Conclusion:
In a prospective study of Black and White US adults, E-selectin was associated with incident hypertension among White adults except when adjusting for medical comorbidities, including baseline systolic BP. Modification of E-selectin through behavioral interventions or medical therapies might be tested to lower risk of hypertension development.