Strengths and opportunities to clinical trial enrollment among BIPOC, rural dwelling patients in the northwest United States: a retrospective study

Introduction: Clinical trials investigating the safety and efficacy of experimental drugs and devices are the cornerstone of medicinal advancement. Enrolling sufficient participants in these trials is vital to ensure adequate statistical power and generalizability. Clinical trial participation is particularly low among certain populations, including medically underserved communities (i.e., rural areas) and Black, Indigenous, and People of Color (BIPOC).Methods: A retrospective study design was used to understand patient outcomes and access/barriers to clinical trial participation in the rural northwest United States. A quantitatively focused retrospective chart review was conducted for adult participants enrolled in at least one clinical trial in a single northwest health system between 1999 and 2022. Descriptive and inferential statistical analyses were performed to assess trial outcomes at a significance level 0.05.Results: The retrospective chart review yielded 833 clinical trial records with 753 individual enrolled participants. The all-cause relative frequency of death at last known follow-up amongst clinical trial participants was 8.90% (n = 67). Based on logistic regression, the death was significantly associated with the participants’ age at initial trial screening (β = 0.09, p-value <0.001), those that resided in non-metro areas (β = −0.86, p-value = 0.045), and those that lived in Northeastern Montana (β = 1.27, p-value = 0.025). Additionally, death at last known follow-up was significantly associated with enrollment in 2021–2022 (β = −1.52, p-value <0.001), enrolled in more than one study (β = 0.84, p-value = 0.023), in internationally sponsored trials (β = −2.08, p-value <0.001), in Phase I (β = 5.34, p-value <0.001), in Phase II trials (β = 1.37, p-value = 0.013), diabetes as a primary trial target (β = −2.04, p-value = 0.003).Conclusion: As decentralized trial design and remote or virtual elements of traditional trials become normative, representation of rural and frontier populations is imperative to support the generalizability of trial data encouraged by the FDA

Evaluation of acceptability, functionality, and validity of a passive image-based dietary intake assessment method in adults and children of Ghanaian and Kenyan origin living in London, UK

BACKGROUND: Accurate estimation of dietary intake is challenging. However, whilst some progress has been made in high-income countries, low- and middle-income countries (LMICs) remain behind, contributing to critical nutritional data gaps. This study aimed to validate an objective, passive image-based dietary intake assessment method against weighed food records in London, UK, for onward deployment to LMICs. METHODS: Wearable camera devices were used to capture food intake on eating occasions in 18 adults and 17 children of Ghanaian and Kenyan origin living in London. Participants were provided pre-weighed meals of Ghanaian and Kenyan cuisine and camera devices to automatically capture images of the eating occasions. Food images were assessed for portion size, energy, nutrient intake, and the relative validity of the method compared to the weighed food records. RESULTS: The Pearson and Intraclass correlation coefficients of estimates of intakes of food, energy, and 19 nutrients ranged from 0.60 to 0.95 and 0.67 to 0.90, respectively. Bland-Altman analysis showed good agreement between the image-based method and the weighed food record. Under-estimation of dietary intake by the image-based method ranged from 4 to 23%. CONCLUSIONS: Passive food image capture and analysis provides an objective assessment of dietary intake comparable to weighed food records

I2N: image to nutrients, a sensor guided semi-automated tool for annotation of images for nutrition analysis of eating episodes

INTRODUCTION: Dietary assessment is important for understanding nutritional status. Traditional methods of monitoring food intake through self-report such as diet diaries, 24-hour dietary recall, and food frequency questionnaires may be subject to errors and can be time-consuming for the user. METHODS: This paper presents a semi-automatic dietary assessment tool we developed - a desktop application called Image to Nutrients (I2N) - to process sensor-detected eating events and images captured during these eating events by a wearable sensor. I2N has the capacity to offer multiple food and nutrient databases (e.g., USDA-SR, FNDDS, USDA Global Branded Food Products Database) for annotating eating episodes and food items. I2N estimates energy intake, nutritional content, and the amount consumed. The components of I2N are three-fold: 1) sensor-guided image review, 2) annotation of food images for nutritional analysis, and 3) access to multiple food databases. Two studies were used to evaluate the feasibility and usefulness of I2N: 1) a US-based study with 30 participants and a total of 60 days of data and 2) a Ghana-based study with 41 participants and a total of 41 days of data). RESULTS: In both studies, a total of 314 eating episodes were annotated using at least three food databases. Using I2N's sensor-guided image review, the number of images that needed to be reviewed was reduced by 93% and 85% for the two studies, respectively, compared to reviewing all the images. DISCUSSION: I2N is a unique tool that allows for simultaneous viewing of food images, sensor-guided image review, and access to multiple databases in one tool, making nutritional analysis of food images efficient. The tool is flexible, allowing for nutritional analysis of images if sensor signals aren't available

Effects of Meal Frequency on Metabolic Profiles and Substrate Partitioning in Lean Healthy Males

The daily number of meals has an effect on postprandial glucose and insulin responses, which may affect substrate partitioning and thus weight control. This study investigated the effects of meal frequency on 24 h profiles of metabolic markers and substrate partitioning.Twelve (BMI:21.6 ± 0.6 kg/m(2)) healthy male subjects stayed after 3 days of food intake and physical activity standardization 2 × 36 hours in a respiration chamber to measure substrate partitioning. All subjects randomly received two isoenergetic diets with a Low meal Frequency (3 ×; LFr) or a High meal Frequency (14 ×; HFr) consisting of 15 En% protein, 30 En% fat, and 55 En% carbohydrates. Blood was sampled at fixed time points during the day to measure metabolic markers and satiety hormones.Glucose and insulin profiles showed greater fluctuations, but a lower AUC of glucose in the LFr diet compared with the HFr diet. No differences between the frequency diets were observed on fat and carbohydrate oxidation. Though, protein oxidation and RMR (in this case SMR + DIT) were significantly increased in the LFr diet compared with the HFr diet. The LFr diet increased satiety and reduced hunger ratings compared with the HFr diet during the day.The higher rise and subsequently fall of insulin in the LFr diet did not lead to a higher fat oxidation as hypothesized. The LFr diet decreased glucose levels throughout the day (AUC) indicating glycemic improvements. RMR and appetite control increased in the LFr diet, which can be relevant for body weight control on the long term.ClinicalTrials.gov NCT01034293

Dining-out behaviors of residents in Chuncheon city, Korea, in comparison to the Korean National Health and Nutrition Survey 2001

Dining-out behavior is associated not only with socio-demographic characteristics such as gender, education, occupation, residence, and marital status, but also with individual preferences, such as eating-out activities, interests, and opinions. We investigated dining-out behaviors and their associated factors. Announcements by health practioners and the Chief of Dong Office were used to recruit 739 residents (217 males and 522 females) in Chuncheon, Korea. Information on the frequency and reasons for eating out, the standards for meal selection, and the overall satisfaction with restaurants, based on taste, nutrition, amount, price, service, sanitation, and subsidiary facilities of restaurants, was obtained through personal interviews with a structured questionnaire. Among all respondents, 46.3% of subjects ate outside of the home once or twice a month, and 33.8% reported that they ate out only a few times a year, or never. This was much higher than the national average of 52.0% as reported by the Korean National Health and Nutrition Survey (KNHNS) in 2001. The frequency of eating out differed significantly according to age (p=0.001), family income (p<0.001), residential area (p<0.001), and educational level (p<0.001). The most common reasons for dining out were meetings (46.7%), followed by special celebrations (15.4%), and enjoyment (11.2%). Korean food (55.3%) was the most frequently selected type of meal when eating out, and food was most often selected based on personal preferences (41.4%) and taste (29.8%); only 5.5% and 7.7% of subjects considered nutrition or other factors (e.g., sanitation), respectively. The results showed that the frequency of eating out for Chuncheon residents was much lower than the national average; in addition, eating-out behaviors depended on the residents' socio-demographic and personal characteristics

Why do women invest in pre-pregnancy health and care? A qualitative investigation with women attending maternity services

Background Despite the importance attributed to good pre-pregnancy care and its potential to improve pregnancy and child health outcomes, relatively little is known about why women invest in pre-pregnancy health and care. We sought to gain insight into why women invested in pre-pregnancy health and care. Methods We carried out 20 qualitative in-depth interviews with pregnant or recently pregnant women who were drawn from a survey of antenatal clinic attendees in London, UK. Interviewees were purposively sampled to include high and low investors in pre-pregnancy health and care, with variation in age, partnership status, ethnicity and pre-existing medical conditions. Data analysis was conducted using the Framework method. Results We identified three groups in relation to pre-pregnancy health and care: 1) The “prepared” group, who had high levels of pregnancy planning and mostly positive attitudes to micronutrient supplementation outside of pregnancy, carried out pre-pregnancy activities such as taking folic acid and making changes to diet and lifestyle. 2) The “poor knowledge” group, who also had high levels of pregnancy planning, did not carry out pre-pregnancy activities and described themselves as having poor knowledge. Elsewhere in their interviews they expressed a strong dislike of micronutrient supplementation. 3) The “absent pre-pregnancy period” group, had the lowest levels of pregnancy planning and also expressed anti-supplement views. Even discussing the pre-pregnancy period with this group was difficult as responses to questions quickly shifted to focus on pregnancy itself. Knowledge of folic acid was poor in all groups. Conclusion Different pre-pregnancy care approaches are likely to be needed for each of the groups. Among the “prepared” group, who were proactive and receptive to health messages, greater availability of information and better response from health professionals could improve the range of pre-pregnancy activities carried out. Among the “poor knowledge” group, better response from health professionals might yield greater uptake of pre-pregnancy information. A different, general health strategy might be more appropriate for the “absent pre-pregnancy period” group. The fact that general attitudes to micronutrient supplementation were closely related to whether or not women invested in pre-pregnancy health and care was an unanticipated finding and warrants further investigation.This report is independent research commissioned and funded by the Department of Health Policy Research Programme Pre-Pregnancy Health and Care in England: Exploring Implementation and Public Health Impact, 006/0068

Comparison of air displacement plethysmography to hydrostatic weighing for estimating total body density in children

BACKGROUND: The purpose of this study was to examine the accuracy of total body density and percent body fat (% fat) using air displacement plethysmography (ADP) and hydrostatic weighing (HW) in children. METHODS: Sixty-six male and female subjects (40 males: 12.4 ± 1.3 yrs, 47.4 ± 14.8 kg, 155.4 ± 11.9 cm, 19.3 ± 4.1 kg/m(2); 26 females: 12.0 ± 1.9 yrs, 41.4 ± 7.7 kg, 152.1 ± 8.9 cm, 17.7 ± 1.7 kg/m(2)) were tested using ADP and HW with ADP always preceding HW. Accuracy, precision, and bias were examined in ADP with HW serving as the criterion method. Lohman's equations that are child specific for age and gender were used to convert body density to % fat. Regression analysis determined the accuracy of ADP and potential bias between ADP and HW using Bland-Altman analysis. RESULTS: For the entire group (Y = 0.835x + 0.171, R(2 )= 0.84, SEE = 0.007 g/cm(3)) and for the males (Y = 0.837x + 0.174, R(2 )= 0.90, SEE = 0.006 g/cm(3)) the regression between total body density by HW and by ADP significantly deviated from the line of identity. However in females, the regression between total body density by HW and ADP did not significantly deviate from the line of identity (Y = 0.750x + 0.258, R(2 )= 0.55, SEE = 0.008 g/cm(3)). The regression between % fat by HW and ADP for the group (Y = 0.84x + 3.81, R(2 )= 0.83, SEE = 3.35 % fat) and for the males (Y = 0.84x + 3.25, R(2 )= 0.90, SEE = 3.00 % fat) significantly deviated from the line of identity. However, in females the regression between % fat by HW and ADP did not significantly deviate from the line of identity (Y = 0.81x + 5.17, R(2 )= 0.56, SEE = 3.80 % fat). Bland-Altman analysis revealed no bias between HW total body density and ADP total body density for the entire group (R = 0.-22; P = 0.08) or for females (R = 0.02; P = 0.92), however bias existed in males (R = -0.37; P ≤ 0.05). Bland-Altman analysis revealed no bias between HW and ADP % fat for the entire group (R = 0.21; P = 0.10) or in females (R = 0.10; P = 0.57), however bias was indicated for males by a significant correlation (R = 0.36; P ≤ 0.05), with ADP underestimating % fat at lower fat values and overestimating at the higher % fat values. CONCLUSION: A significant difference in total body density and % fat was observed between ADP and HW in children 10–15 years old with a potential gender difference being detected. Upon further investigation it was revealed that the study was inadequately powered, thus we recommend that larger studies that are appropriately powered be conducted to better understand this potential gender difference

GPS-determination of along-strike variation in Cascadia margin kinematics: Implications for relative plate motion, Subduction zone coupling, and permanent deformation

High‐precision GPS geodesy in the Pacific Northwest provides the first synoptic view of the along‐strike variation in Cascadia margin kinematics. These results constrain interfering deformation fields in a region where typical earthquake recurrence intervals are one or more orders of magnitude longer than the decades‐long history of seismic monitoring and where geologic studies are sparse. Interseismic strain accumulation contributes greatly to GPS station velocities along the coast. After correction for a simple elastic dislocation model, important residual motions remain, especially south of the international border. The magnitude of northward forearc motion increases southward from western Washington (3–7 mm/yr) to northern and central Oregon (∼9 mm/yr), consistent with oblique convergence and geologic constraints on permanent deformation. The margin‐parallel strain gradient, concentrated in western Washington across the populated Puget Lowlands, compares in magnitude to shortening across the Los Angeles Basin. Thus crustal faulting also contributes to seismic hazard. Farther south in southern Oregon, north‐westward velocities reflect the influence of Pacific‐North America motion and impingement of the Sierra Nevada block on the Pacific Northwest. In contrast to previous notions, some deformation related to the Eastern California shear zone crosses northernmost California in the vicinity of the Klamath Mountains and feeds out to the Gorda plate margin

The SNAPSHOT study protocol : SNAcking, Physical activity, Self-regulation, and Heart rate Over Time

Peer reviewedPublisher PD