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INTRODUCTION: The Cancer Health Assessments Reaching Many study seeks to reduce disparities in genomic care. Two patient advisory committees (PACs) were formed, 1 of English speakers and 1 of Spanish speakers, to vet study processes and materials. Stakeholder engagement in research is relatively new, and we know little about how stakeholders view their engagement. We wanted to learn how patient stakeholders viewed the process, to inform future patient engagement efforts. METHODS: Patients at 2 study sites were invited to serve on 2 PACs. We used an iterative engagement process to solicit and incorporate patient feedback. Much of the PAC feedback on study materials and processes was incorporated. Using surveys and exit interviews, we evaluated stakeholders’ experiences as PAC members. RESULTS: Nearly all PAC members felt satisfied and included in the study decisions, but surveys and exit interviews suggested the need to improve communications. DISCUSSION: Although most believed their feedback was used, and most felt included in study decisions, some said they did not know whether their opinions were used to modify materials or approaches. This suggests the need to explain to patient stakeholders the extent to which their feedback was used and to inform them about the impact that other stakeholders, such as institutional review boards, have on decisions. CONCLUSION: Our evaluation highlights the value of dedicating resources to stakeholder engagement. Although gathering patient feedback on study materials and processes introduced time constraints and complexity to our study, adaptations to materials and processes furthered study goals.

Lynch syndrome (LS) is the most common inherited cause of colorectal and endometrial cancers. Identifying individuals at risk for LS without personal cancer history requires detailed collection and assessment of family health history. However, barriers exist to family health history collection, especially in historically underserved populations. To improve LS risk assessment in historically underserved populations, we adapted the provider-facing PREdiction Model for gene Mutations (PREMM5™ model), a validated LS risk assessment model, into a patient-facing electronic application through an iterative development process involving expert and patient stakeholders. We report on preliminary findings based on the first 500 individuals exposed to the adapted application in a primary care population enriched for low-literacy and low-resource patients. Major adaptations to the PREMM5™ provider module included reduction in reading level, addition of interactive literacy aids, incorporation of family history assessment for both maternal and paternal sides of the family, and inclusion of questions about individual relatives or small groups of relatives to reduce cognitive burden. In the first 500 individuals, 90% completed the PREMM5™ independently; of those, 94% did so in 5 min or less (ranged from 0.2 to 48.8 min). The patient-facing application was able to accurately classify 84% of patients as having clinically significant or not clinically significant LS risk. Our preliminary results suggest that in this diverse study population, most participants were able to rapidly, accurately, and independently complete an interactive application collecting family health history assessment that accurately assessed for Lynch syndrome risk.

BACKGROUND: Clinical genomic implementation studies pose challenges for informed consent. Consent forms often include complex language and concepts, which can be a barrier to diverse enrollment, and these studies often blur traditional research-clinical boundaries. There is a move toward self-directed, web-based research enrollment, but more evidence is needed about how these enrollment approaches work in practice. In this study, we developed and evaluated a literacy-focused, web-based consent approach to support enrollment of diverse participants in an ongoing clinical genomic implementation study. METHODS: As part of the Cancer Health Assessments Reaching Many (CHARM) study, we developed a web-based consent approach that featured plain language, multimedia, and separate descriptions of clinical care and research activities. CHARM offered clinical exome sequencing to individuals at high risk of hereditary cancer. We interviewed CHARM participants about their reactions to the consent approach. We audio recorded, transcribed, and coded interviews using a deductively and inductively derived codebook. We reviewed coded excerpts as a team to identify overarching themes. RESULTS: We conducted 32 interviews, including 12 (38%) in Spanish. Most (69%) enrolled without assistance from study staff, usually on a mobile phone. Those who completed enrollment in one day spent an average of 12 minutes on the consent portion. Interviewees found the information simple to read but comprehensive, were neutral to positive about the multimedia support, and identified increased access to testing in the study as the key difference from clinical care. CONCLUSIONS: This study showed that interviewees found our literacy-focused, web-based consent approach acceptable; did not distinguish the consent materials from other online study processes; and valued getting access to testing in the study. Overall, conducting empirical bioethics research in an ongoing clinical trial was useful to demonstrate the acceptability of our novel consent approach but posed practical challenges.

Hispanic women are at high risk for type 2 diabetes (T2D), with obesity and unhealthy eating being important contributing factors. A cross-sectional design was used in this study to identify dietary patterns and their associations with diabetes risk factors. Participants completed a culturally adapted Food Frequency Questionnaire capturing intake over the prior 3 months. Overweight/obese Hispanic women (n = 191) with or at risk for T2D were recruited from a community clinic into a weight loss intervention. Only baseline data was used for this analysis. Dietary patterns and their association with diabetes risk factors (age, body mass index, abdominal obesity, elevated fasting blood glucose [FBG], and hemoglobin A1c). An exploratory factor analysis of dietary data adjusted for energy intake was used to identify eating patterns, and Pearson correlation coefficient (r) to assess the association of the eating patterns with the diabetes risk factors. Six meaningful patterns with healthful and unhealthful traits emerged: (1) sugar and fat-laden, (2) plant foods and fish, (3) soups and starchy dishes, (4) meats and snacks, (5) beans and grains, and (6) eggs and dairy. Scores for the “sugar and fat-laden” and “meats and snacks” patterns were negatively associated with age (r = − 0.230, p = 0.001 and r = − 0.298, p

PURPOSE: There is a critical need for genomic medicine research that reflects and benefits socioeconomically and ancestrally diverse populations. Disparities in research populations persist, however, highlighting that traditional study designs and materials may be insufficient or inaccessible to all groups. New approaches can be gained through collaborations with patient/community stakeholders. Although some benefits of stakeholder engagement are recognized, routine incorporation into design and implementation of genomics research has yet to be realized. METHODS: The NIH-funded Clinical Sequencing Evidence-Generating Research (CSER) consortium required stakeholder engagement as a dedicated project component. Each CSER project planned and carried out stakeholder engagement activities with differing goals and expected outcomes. Examples were curated from each project to highlight engagement strategies and outcomes throughout the research lifecycle from development through dissemination. RESULTS: Projects tailored strategies to individual study needs, logistical constraints, and other challenges. Lessons learned include starting early with engagement efforts across project stakeholder groups and planned flexibility to enable adaptations throughout the project lifecycle. CONCLUSION: Each CSER project utilized more than one approach to engage with relevant stakeholders, resulting in numerous adaptations and tremendous value-added throughout the full research lifecycle. Incorporation of community stakeholder insight improves the outcomes and relevance of genomic medicine research.

This study aimed to evaluate the laboratory-related outcomes of participants who were offered genomic testing based on cancer family history risk assessment tools.Patients from clinics that serve populations with access barriers, who are screened at risk for a hereditary cancer syndrome based on adapted family history collection tools (the Breast Cancer Genetics Referral Screening Tool and PREMMOf all the participants, 87% successfully returned a saliva kit. Overall, 5% had a pathogenic/likely pathogenic cancer risk variant and 1% had a secondary finding. Almost all (14/15, 93%) participants completed recommended consultations with nongenetics providers after an average of 17 months. The recommended actions (eg, breast magnetic resonance imaging) were completed by 17 of 25 participants. Participant personal history of cancer and PREMMThis accessible model of hereditary cancer risk assessment and genetic testing yielded results that were often acted upon by patients and physicians.

Hereditary cancer syndromes result from germline genetic alterations predisposing individuals to higher lifetime cancer risk than the general population. Hereditary cancer syndromes account for 5%-10% of all malignancies and are characterized by early-onset, aggressive tumors affecting multiple tissue types.1 For example, patients with hereditary breast and ovarian cancer syndrome (HBOC) have high lifetime risk of breast (41%-90%) and ovarian (8%-62%) cancers and elevated risk for several other cancers.2 Similarly, patients with Lynch syndrome (LS) have high lifetime risk of colorectal (12%-52%) and endometrial (0%-57%) cancers, as well as other cancers.3 Reduced cost of genetic technologies4 and new guidance on collecting family history in primary care5 have enabled better detection of these syndromes, providing opportunities to reduce cancer risk. CONTEXT Key Objective Individuals with hereditary cancer syndromes are predisposed to higher lifetime cancer risk than the general population. Early diagnosis of these syndromes can lead to downstream care that greatly reduces cancer morbidity and mortality. In this narrative review, we explore the factors affecting uptake of and adherence to hereditary cancer risk reduction strategies and how these factors interact with systemic barriers to care in medically marginalized populations. Knowledge Generated We identified factors at the health system, clinician, and patient levels that interact to affect downstream hereditary cancer care and have implications for health equity. We found that several interventions designed to improve downstream care utilization did not address systemic barriers affecting marginalized populations and suggest strategies to address these barriers in future intervention design. Relevance Our review creates a template for the design of more equitable interventions to improve downstream hereditary cancer care.

Aim: To increase Spanish speakers' representation in genomics research, accessible study materials on genetic topics must be made available in Spanish. Materials & methods: The Clinical Sequencing Evidence-Generating Research consortium is evaluating genome sequencing for underserved populations. All sites needed Spanish translation of recruitment materials, surveys and return of results. Results: We describe our process for translating site-specific materials, as well as shared measures across sites, to inform future efforts to engage Spanish speakers in research. Conclusion: In translating and adapting study materials for roughly 1000 Spanish speakers across the USA, and harmonizing translated measures across diverse sites, we overcame numerous challenges. Translation should be performed by professionals. Studies must allocate sufficient time, effort and budget to translate and adapt participant materials.

BACKGROUND: Overweight Hispanic women are at high risk for type 2 diabetes. A clinical diagnosis of hyperglycemia is often necessary to access interventions. We examined the prevalence of undiagnosed hyperglycemia among a group of low-income overweight or obese Hispanic women, who were receiving care at a Federally Qualified Health Center (FQHC). METHODS: Among 196 overweight or obese Hispanic women (mean age 44 ± 10 years, mean weight 86.8 ±16.5 kg, mean Body Mass Index [BMI] 36.5 ± 6.4 kg/m(2)) enrolled in a randomized clinical weight loss trial, we compared A1C and fasting blood glucose (FBG) obtained at baseline with women’s existing diabetes and prediabetes diagnoses in the medical record. RESULTS: According to the information in participants’ medical records, 36% (70/196) had diagnosed diabetes, 20% (39/196) had a diagnosis of prediabetes, and the remaining 44% (87/196) had neither diagnosis. Among participants without a diagnosis of diabetes or prediabetes during the baseline screening for our study, 63% (55/87) had a least one test in the pre-diabetes range (baseline A1C and FBG were in pre-diabetes range for 39 and 55 participants, respectively), and 13% (11/87) had at least one test in the diabetic range (baseline A1C and FBG values in diabetes range for 3 and 11 participants, respectively). DISCUSSION: We found substantial prevalence of undiagnosed hyperglycemia among a sample of overweight and obese Hispanic women. It is possible that limited awareness of diabetes risk may be a barrier to patient compliance with screening recommendations.

BackgroundThe Diabetes Prevention Program (DPP) and Look AHEAD studies demonstrated that modest weight loss and increased physical activity can significantly reduce the incidence of diabetes among overweight individuals with prediabetes. However, these studies involved costly interventions, all of which are beyond the reach of most real-world settings serving high-risk, low-income populations. Our project, De Por Vida, implemented a diabetes risk-reduction intervention for Hispanic women in a Federally Qualified Health Center and assessed the program’s efficacy. This report describes the methodology used to develop and implement De Por Vida, the cultural adaptations made, the community–academic partnership formed to carry out this program, and the barriers and challenges encountered through the implementation process.MethodsOur goal was to translate the DPP and Look AHEAD programs into an intervention to prevent diabetes and reduce diabetes complications among high-risk Hispanic women at a federally qualified health center in Hillsboro, Oregon, where more than half of clinic patients are Spanish-speaking, and nearly all live in poverty. This randomized clinical trial targeted overweight Spanish-speaking women at risk for, or diagnosed with, type 2 diabetes. We developed a 12-month behavioral diabetes risk-reduction intervention that was responsive to the cultural practices of the Hispanic population and that could be implemented in low-income clinical settings. Study planning and implementation involved close collaboration among the clinic leadership, a research team from the Kaiser Permanente Center for Health Research, and Arizona State University.DiscussionCreating a fully informed partnership between research and clinical institutions is the first step in successful cooperative research projects. The adoption of a bidirectional, rather than a top-down, approach to communication between researchers and health-care providers, and between clinic management and the clinic frontline staff, gave the research study team crucial information about barriers, constraints, and needs that clinic staff experienced in implementing the program. This allowed clinic management and front-line clinic staff to play an active role in study implementation, identifying problem areas, and collaborating in finding practical solutions.Clinical Trial Registrationwww.clinicaltrials.gov, NCT03113916.

Lynch syndrome (LS) is the most common inherited cause of colorectal and endometrial cancers. Identifying individuals at risk for LS without personal cancer history requires detailed collection and assessment of family health history. However, barriers exist to family health history collection, especially in historically underserved populations. To improve LS risk assessment in historically underserved populations, we adapted the provider-facing PREdiction Model for gene Mutations (PREMM

Purpose of Review Latin America is the scenario of great inequalities where about 32 million human beings live with diabetes. Through this review, we aimed at describing the current state of the prevalence, awareness, treatment, and control of diabetes mellitus and completion of selected guidelines of care across Latin America and identify opportunities to advance research that promotes better health outcomes. Recent Findings The prevalence of diabetes mellitus has been consistently increasing across the region, with some variation: higher prevalence in Mexico, Haiti, and Puerto Rico and lower in Colombia, Ecuador, Dominican Republic, Peru, and Uruguay. Prevalence assessment methods vary, and potentially underestimating the real number of persons with diabetes. Diabetes unawareness varies widely, with up to 50% of persons with diabetes who do not know they may have the disease. Glycemic, blood pressure, and LDL-C control and completion of guidelines to prevent microvascular complications are not consistently assessed across studies, and the achievement of control goals is suboptimal. On the other hand, multiple interventions, point-of-care/rapid assessment tools, and alternative models of health care delivery have been proposed and tested throughout Latin America. Summary The prevalence of diabetes mellitus continues to rise across Latin America, and the number of those with the disease may be underestimated. However, some local governments are embedding more comprehensive diabetes assessments in their local national surveys. Clinicians and public health advocates in the region have proposed and initiated various multi-level interventions to address this enormous challenge in the region.

Introduction Racial/ethnic and socioeconomic disparities in diabetes prevalence and management persist. Unmet basic needs such as food insecurity and unstable housing interfere with optimal diabetes self-management. Bridge to Health/Puente a la Salud is a randomized pilot trial designed to examine the feasibility of testing the effectiveness of addressing unmet basic needs via navigation services versus navigation plus diabetes self-management support (DSMS) on improving diabetes-related outcomes among racial/ethnic minority and low-income patients with uncontrolled diabetes. Material and methods We recruited and randomized 110 African American, Hispanic, and Medicaid patients (any race/ethnicity) with diabetes and recent hemoglobin A1C ≥ 8% to one of two 6-month interventions: 1) Navigation only; or 2) Navigation + DSMS. In both arms, practice-embedded patient navigators help participants navigate social services and community-based resources to address unmet basic needs. In Navigation + DSMS, participants are also assigned to a community health worker (CHW) embedded in a local community-based organization who provides additional navigation support and delivers DSMS. A1C and unmet basic needs data are collected via routine lab and survey, respectively, at baseline and 6-month follow-up. Qualitative interviews with participants, health system leaders, CHWs, and patient navigators are conducted to explore intervention acceptability and determinants of implementation in a health care setting. Discussion Findings from this pilot feasibility study will enhance understanding about acceptability, preliminary clinical effectiveness, and facilitators and barriers to implementation of the Navigation only and Navigation + DSMS interventions and inform refinements of the overall study design for the larger, randomized clinical trial.

Hispanic women are at high risk for type 2 diabetes (T2D), with obesity and unhealthy eating being important contributing factors. A cross-sectional design was used in this study to identify dietary patterns and their associations with diabetes risk factors. Participants completed a culturally adapted Food Frequency Questionnaire capturing intake over the prior 3 months. Overweight/obese Hispanic women (n = 191) with or at risk for T2D were recruited from a community clinic into a weight loss intervention. Only baseline data was used for this analysis. Dietary patterns and their association with diabetes risk factors (age, body mass index, abdominal obesity, elevated fasting blood glucose [FBG], and hemoglobin A1c). An exploratory factor analysis of dietary data adjusted for energy intake was used to identify eating patterns, and Pearson correlation coefficient (r) to assess the association of the eating patterns with the diabetes risk factors. Six meaningful patterns with healthful and unhealthful traits emerged: (1) sugar and fat-laden, (2) plant foods and fish, (3) soups and starchy dishes, (4) meats and snacks, (5) beans and grains, and (6) eggs and dairy. Scores for the "sugar and fat-laden" and "meats and snacks" patterns were negatively associated with age (r = - 0.230, p = 0.001 and r = - 0.298, p 0.001, respectively). Scores for "plant foods and fish" were positively associated with FBG (r = 0.152, p = 0.037). Being younger may be an important risk factor for a diet rich in sugar and fat; this highlights the need to assess dietary patterns among younger Hispanic women to identify traits potentially detrimental for their health.

Advances in the application of genomic technologies in clinical care have the potential to increase existing healthcare disparities. Studies have consistently shown that only a fraction of eligible patients with a family history of cancer receive recommended cancer genetic counseling and subsequent genetic testing. Care delivery models using pre-test and post-test counseling are not scalable, which contributes to barriers in accessing genetics services. These barriers are even more pronounced for patients in historically underserved populations. We have designed a multimodal intervention to improve subsequent cancer surveillance, by improving the identification of patients at risk for familial cancer syndromes, reducing barriers to genetic counseling/testing, and increasing patient understanding of complex genetic results. We are evaluating this intervention in two large, integrated healthcare systems that serve diverse patient populations (NCT03426878). The primary outcome is the number of diagnostic (hereditary cancer syndrome) findings. We are examining the clinical and personal utility of streamlined pathways to genetic testing using electronic medical record data, surveys, and qualitative interviews. We will assess downstream care utilization of individuals receiving usual clinical care vs. genetic testing through the study. We will evaluate the impacts of a literacy-focused genetic counseling approach versus usual care genetic counseling on care utilization and participant understanding, satisfaction, and family communication. By recruiting participants belonging to historically underserved populations, this study is uniquely positioned to evaluate the potential of a novel genetics care delivery program to reduce care disparities.

Background. Young adulthood is often associated with poor dietary habits that may increase risk of obesity and chronic diseases. As independence grows, little is known about strategies to help balance social, work, and education commitments that may override desires to incorporate healthful food choices. Objective. In advance of a randomized trial to test an online intervention targeting young adults, we sought to identify views and experiences with healthy eating, and specifically, eating more fruits and vegetables. Methods. We conducted 13 focus groups with 68 young adults in metropolitan Detroit (Henry Ford Health System) and rural Pennsylvania (Geisinger Health System). Randomly selected adults aged 21 to 30 years, using health system automated data, were sent recruitment letters. Questions were grounded in social cognitive theory and self-determination theory. Audiotapes were transcribed, content themes identified, coded, verified for reliability, and analyzed qualitatively. Results. Young adults’ efforts to eat healthfully included three major themes of (1) motivations to create a healthy lifestyle, teach by example, feel better, and manage weight and future health problems; (2) learning to eat well from childhood, independent living, and peers; and (3) strategies to eat better through planning, tracking, and commitment. Discussion. We uncovered theory-based factors that facilitate healthy dietary behavior change among young adults, including managing their behavior through self-monitoring, goal-setting, small steps, meaningful reinforcements, and social opportunities. Conclusions. Targeted interventions encouraging reflection on personal values related to meaningful contemporary health benefits are likely to resonate with young adults, as will opportunities to receive and share new information.

Obesity and type 2 diabetes disproportionately impact U.S. racial and ethnic minority communities and low-income populations. Improvements in implementing efficacious interventions to reduce the incidence of type 2 diabetes are underway (i.e., the National Diabetes Prevention Program), but challenges in effectively scaling-up successful interventions and reaching at-risk populations remain. In October 2017, the National Institutes of Health convened a workshop to understand how to (1) address socioeconomic and other environmental conditions that perpetuate disparities in the burden of obesity and type 2 diabetes; (2) design effective prevention and treatment strategies that are accessible, feasible, culturally relevant, and acceptable to diverse population groups; and (3) achieve sustainable health improvement approaches in communities with the greatest burden of these diseases. Common features of guiding frameworks to understand and address disparities and promote health equity were described. Promising research directions were identified in numerous areas, including study design, methodology, and core metrics; program implementation and scalability; the integration of medical care and social services; strategies to enhance patient empowerment; and understanding and addressing the impact of psychosocial stress on disease onset and progression in addition to factors that support resiliency and health.

Introduction: Middle-aged Hispanic women have the highest prevalence of overweight and lifetime risk for diabetes of all gender/racial groups. This study examines use of alternative medicine for weight loss and diabetes management among overweight and obese Mexican American women with or at risk for diabetes. Method: As part of a diabetes risk-reduction intervention targeting overweight and obese Hispanic women at a federally qualified health center in Hillsboro, Oregon, we administered a survey of different treatment modalities, including alternative medicine, traditional Mexican medicine, and home remedies to 85 Hispanic women. We also asked participants how often they disclosed their use of alternative methods to their providers. Results: Nearly all participants with diabetes (97%) reported using at least one alternative strategy for diabetes control, with home remedies, commercial weight-loss products, and herbal teas being the most endorsed. Most participants with diabetes and half of those without diabetes reported never telling their provider. Conclusion: This group of women reported a high prevalence of use of alternative methods for weight control and diabetes management. Yet most participants with diabetes never reported this use to a health care provider. To ensure patient safety, providers treating Hispanic women need to probe for complementary and alternative medicine practices.

Purpose This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations. Methods We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials. Results Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations. Conclusion While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

Persons of Hispanic/Latino descent may represent different ancestries, ethnic and cultural groups and countries of birth. In the U.S., the Hispanic/Latino population is projected to constitute 29% of the population by 2060. A personalized approach focusing on individual variability in genetics, environment, lifestyle and socioeconomic determinants of health may advance the understanding of some of the major factors contributing to the health disparities experienced by Hispanics/Latinos and other groups in the U.S., thus leading to new strategies that improve health care outcomes. However, there are major gaps in our current knowledge about how personalized medicine can shape health outcomes among Hispanics/Latinos and address the potential factors that may explain the observed differences within this heterogeneous group, and between this group and other U.S. demographic groups. For that purpose, the National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Food and Drug Administration (FDA), held a workshop in which experts discussed (1) potential approaches to study medical treatments and health outcomes among Hispanics/Latinos and garner the necessary evidence to fill gaps of efficacy, effectiveness and safety of therapies for heart, lung, blood and sleep (HLBS) disorders and conditions--and their risk factors; (2) research opportunities related to personalized medicine to improve knowledge and develop effective interventions to reduce health disparities among Hispanics/Latinos in the U.S.; and (3) the incorporation of expanded sociocultural and socioeconomic data collection and genetic/genomic/epigenetic information of Hispanic/Latino patients into their clinical assessments, to account for individual variability in ancestry; physiology or disease risk; culture; environment; lifestyle; and socioeconomic determinants of health. The experts also provided recommendations on: sources of Hispanic/Latino health data and strategies to enhance its collection; policy; genetics, genomics and epigenetics research; and integrating Hispanic/Latino health research within clinical settings.

The past two decades have witnessed many advances in the prevention, treatment, and control of diabetes mellitus (DM) and its complications. Increased screening has led to a greater recognition of type 2 diabetes mellitus (type 2 DM) and prediabetes; however, Hispanics/Latinos, the largest minority group in the US, have not fully benefited from these advances. The Hispanic/Latino population is highly diverse in ancestries, birth places, cultures, languages, and socioeconomic backgrounds, and it populates most of the Western Hemisphere. In the US, the prevalence of DM varies among Hispanic/Latino heritage groups, being higher among Mexicans, Puerto Ricans, and Dominicans, and lower among South Americans. The risk and prevalence of diabetes among Hispanics/Latinos are significantly higher than in non-Hispanic Whites, and nearly 40% of Hispanics/Latinos with diabetes have not been formally diagnosed. Despite these striking facts, the representation of Hispanics/Latinos in pharmacological and non-pharmacological clinical trials has been suboptimal, while the prevalence of diabetes in these populations continues to rise. This review will focus on the epidemiology, etiology and prevention of type 2 DM in populations of Latin American origin. We will set the stage by defining the terms Hispanic, Latino, and Latin American, explaining the challenges identifying Hispanics/Latinos in the scientific literature and databases, describing the epidemiology of diabetes-including type 2 DM and gestational diabetes mellitus (GDM)-and cardiovascular risk factors in Hispanics/Latinos in the US and Latin America, and discussing trends, and commonalities and differences across studies and populations, including methodology to ascertain diabetes. We will discuss studies on mechanisms of disease, and research on prevention of type 2 DM in Hispanics/Latinos, including women with GDM, youth and adults; and finalize with a discussion on lessons learned and opportunities to enhance research, and, consequently, clinical care oriented toward preventing type 2 DM in Hispanics/Latinos in the US and Latin America.

Background: Hispanic women are disproportionately affected by cardiometabolic disease risk factors including increased adiposity. Addressing barriers to dietary change is an important strategy for ensuring success of behavioral weight loss interventions. However, perceived barriers to healthy eating among Hispanic women have not been thoroughly studied, and how a type 2 diabetes (T2D) or prediabetes (preD) diagnosis and HbA1c levels are related to those perceptions are unknown. Objective: To examine the association of perceived barriers to healthy eating for weight loss with HbA1c and T2D status among Hispanic women. Methods: Participants (n=197; 86.9±16.6 kg; 36.6±6.5 kg/m 2 ) of De Por Vida , a culturally-tailored weight loss intervention for adult Hispanic women with or at risk for T2D, completed the Barriers to Healthy Eating (BHE) scale at baseline. The BHE scale was translated into Spanish and slightly modified for use with low-literacy participants. Possible BHE scores range from 22 to 110 for the overall scale, from 11 to 55 for the emotions subscale, from 8 to 40 for the daily mechanics subscale, and from 3 to 15 for the social support subscale, with higher scores indicating greater perceived barriers. Participants were categorized based on their baseline HbA1c concentration as follows: at risk for T2D (n=54; HbA1c Results: Among all participants, total BHE score was 65.3±20.7, and scores for the emotions, daily mechanics, and social support subscales were 33.3±11.7, 24.8±8.3, and 7.4±3.2, respectively. HbA1c concentrations were negatively correlated with BHE total (r=-.13; p=.06), emotional (r=-.14; p=.06), and social support scores (r=-.17; p=0.02). When HbA1c was examined as a categorical variable (i.e., T2D status) there were no significant associations with any BHE scale score. Conclusions: In general, participants’ rated their perceived barriers to healthy eating as relatively important problems to their ability to lose weight. There was no evidence that having a preD or T2D diagnosis was associated with their perception of barriers. Given the significant health and economic consequence of a T2D diagnosis, interventions should better address perceived barriers to healthy eating in the preD and T2D population. Funding source: NIH/NIDDK – 1R01DK099277.

The LIFE study was a randomized controlled trial assessing the impact of a self-acupressure intervention, Tapas Acupressure Technique® (TAT®), on weight-loss maintenance. The primary analysis showed no significant difference between TAT and social support (SS) for weight-loss maintenance, while exploratoryThe aim of the current study was to assess adherence to, and satisfaction with, the experimental self-acupressure intervention in the LIFE weight loss maintenance trial.This was a secondary analysis of adherence and satisfaction patterns in a large randomized controlled trial.The study was conducted at a prominent health maintenance organization in the Pacific Northwest.This study involved 142 obese participants who had lost10 pounds in a conventional weight-loss program and who were randomized to the experimental acupressure intervention.The experimental intervention (The outcome sought was self-reported satisfaction and frequency of TAT practice.Sixty-six percent of TAT participants attended at least 6 of 8 intervention sessions. More than 80% of participants reported practicing TAT at home, on average, at least 2 days per week. Sixty two percent reported practicing10 minutes per session, while 27% reported practicing 10-20 minutes per session. Higher satisfaction scores were significantly correlated with less weight regain (These data suggest moderate acceptance of, and adherence to, the TAT intervention. Further research is required to identify and achieve optimal home-practice levels of self-acupressure techniques.

The objective of this study is to examine the use of complementary and alternative medicine (CAM) for weight loss among Mexican-American women. Cross-sectional survey of different CAM modalities, including traditional Mexican medicine therapies. The sample was drawn from women participating in a weight-loss program in Portland, Oregon. Sample consisted of 31 adult Mexican-American women. Most respondents reported using some form of CAM for weight loss, with most reporting using herbs and teas (70 %), home remedies (61 %) and massage (55 %). Mexican-American women report using a wide range of CAM therapies for weight loss. Understanding their patterns of use will enhance cultural competence of health care professionals and help address their medical needs.

This study assessed the feasibility of a culturally-appropriate weight-loss intervention targeting obese Spanish-speaking Mexican women. This 12-month weight-loss program was based on behavioral interventions previously used successfully with English-speaking participants. Cultural adaptations included: female interventionists, minimal written materials, emphasis on group activities, focus on Mexican traditions and beliefs, and skill-building approach to food measurement. All sessions were conducted in Spanish. The study had few exclusionary criteria, which allowed participation of women with a wide range of literacy levels. Recruitment exceeded expectations, with 47 participants enrolling in the program. Not counting participants who became pregnant during the study, attendance at 6 and 12 months was 62 and 50 % respectively. Mean weight loss at 6 and 12 months was 5.3 and 7.2 kg, respectively, with a mean reduction in BMI of 4.0 and 5.5 kg/m(2) from baseline to 6 and 12 months, respectively. This pilot study shows that it is feasible to develop and implement culturally-appropriate behavioral lifestyle interventions for obesity treatment in Mexican-American women.

Objectives: The aim of this article is to present the rationale, study design, and methods of an ongoing randomized controlled trial assessing the efficacy of an energy psychology intervention, Tapas Acupressure Technique® (TAT®), to prevent weight regain following successful weight loss. Design: This is a randomized controlled trial. Settings/location: The study is being conducted at a large group-model health maintenance organization (HMO). Subjects: The study subjects are adult members of an HMO. Interventions: TAT is being compared to a self-directed social support comparison intervention. Outcome measures: The primary outcome measure is weight-loss maintenance at 6 and 12 months postrandomization. Conclusions: This randomized controlled trial will test the efficacy of an energy psychology intervention, TAT, by comparing it with a self-directed social support group intervention. This is, to our knowledge, the largest randomized controlled study to date of an energy psychology intervention. Po...

There is an urgent need for effective and accessible culturally-sensitive weight-loss interventions for the Mexican-American population. It is imperative that cultural factors be taken into account when designing weight-loss interventions targeting this population. As a first step in this direction, this study examined the experiences, concerns, and beliefs regarding diet, weight and weight loss of Mexican-American immigrant women. Focus groups were conducted with Mexican-American women (n = 25) between the ages of 20 and 63, from the Portland, Oregon metropolitan area. Major themes identified in the discussions included important lifestyle changes brought about by immigration, the challenges of adopting "American ways," lack of nutritional information, and the difficulties in making food choices given the complexities of the family context. Behavioral interventions must provide culturally-centered behavioral strategies addressing some of the difficulties identified in this study. Specific suggestions are provided for the development of weight-loss interventions for this population.

Objective: To determine the validity of adult body weights and heights recorded in electronic medical records (EMRs) in the course of routine medical care.Background: EMRs allow the potential use of data collected in the course of routine medical care for a variety of research applications in many fields including epidemiology and comparative effectiveness studies. However, researchers familiar with carefully controlled measurement protocols typically used in clinical trials may question the validity of data collected in the course of routine clinical care.Methods: Weights and heights collected during a research project that focused on weight gain during pregnancy were compared to weight and height measurements coincidently recorded in the research participant’s medical records. For weight measures (N=102), data recorded within ±14 days were compared, and for height measures (N=114), data recorded within ±5 years were compared. We assessed agreement between medical and research measurements using the concordance and intraclass correlation coefficients, and Bland and Altman’s limits of agreement.Findings: The mean research and medical record weight measurements were 99.3 kg and 99.2 kg, respectively. The concordance and intraclass correlation coefficients for weight had similar estimates of .999 and 95 percent confidence intervals [.998, .999]. The 95 percent limits of agreement were -1.5 kg and +1.7 kg. The mean research and medical height measurements were 1.646 m and 1.654 m, respectively, and the concordance and intraclass correlation coefficients for height were .941 and .942, respectively. The 95 percent limits of agreement were -.031 m and +.047 m.Conclusions: For pregnant women, body weights documented in the medical record are exchangeable with body weights recorded in a research setting. Height measurements recorded in the medical records were not in as close agreement as weights, but concordance between medical record and research height measurements are high enough to allow them to be used epidemiological and comparative effectiveness research.

Background/Aims The personal self-care and health habits of healthcare personnel may influence patients’ own health-related behaviors including smoking, physical activity, weight management, and alcohol consumption. This study describes the degree to which healthcare providers adhere to recommended health-enhancing behaviors, and whether adherence differs by occupation.

In the United States, ethnic minorities are overrepresented among the overweight and obese population, with Hispanic individuals being among the groups most at risk for obesity and obesity-related disease and disability. Most weight-loss interventions designed for the general population have been less successful with individuals from ethnic minorities and there is a pressing need to develop more effective interventions for these groups. This paper examines the importance of culture in the development of “culturally competent” weight-loss interventions for ethnic minority populations, and discusses specific culturally mediated factors that should be considered in the design and implementation of treatment interventions. While specifically focusing on Hispanic populations, we also address issues of relevance to other multiethnic societies.

Purpose. To assess the efficacy of an intervention designed to increase appropriate use of breast self-examination (BSE). Methods. Two-armed randomized clinical trial of cancer-control interventions in women that compared a BSE intervention program to a dietary intervention, which served as the control group. The study was conducted at a large health maintenance organization in Portland, Oregon. Participants were 616 female members of the health maintenance organization who were aged 40 to 70 years. The intervention consisted of a 30- to 45-minute individual counseling session that featured BSE instruction, training and practice with silicone models, identification of barriers to BSE, and problem-solving. This intervention was followed by two brief follow-up telephone calls. The study outcome measure was self-reported BSE practice, which included duration, frequency, and specific elements of exam. Results. The study had a 90% response rate. At the 1-year follow-up, χ2 analyses showed that significantly more individuals in the BSE intervention (59%) reported adequate BSE performance compared with those in the control group (12.2%; p < .001). Conclusions. This brief intervention was successful in encouraging women to perform adequate BSEs. Although the role of the BSE in patient care remains controversial, these results show that even brief intervention programs can be effective at encouraging self-screening for cancer. This intervention could easily be modified to target other screening practices (e.g., skin or testicular cancer screening) that are associated with reduced cancer morbidity and mortality.

To conduct a review of published studies that have addressed the effectiveness of weight-loss interventions for Hispanic individuals in the United States, identify key components of effective interventions for this population, and provide a set of recommendations for the development of effective treatment programs.Online bibliographic databases were searched from 1980 to September 2006. STUDY INCLUSION/EXCLUSION CRITERIA: Two key search dimensions ("Latino" or "Mexican-American" or "Hispanic" or "Spanish-speaker"; and "weight-loss" or "weight-reduction" or "obesity treatment" or "diet intervention") were used to search for articles.The methods and findings of all retrieved articles were evaluated, and summary outcome data were taken from published results.The limited number of published articles found, and the lack of identifying information on key variables (eg, manner in which subjects were determined to be "Hispanic," level of acculturation, socioeconomic status [SES], number of years living in the United States, country of origin, etc) precluded conducting a formal meta-analysis on the available outcome data.The review identified only three controlled intervention studies specifically targeting Hispanic populations for weight-loss; most of the available studies were not randomized and did not assess key variables, such as acculturation, type of community of origin, level of education, etc. Most available "culturally sensitive" health-related interventions targeting Hispanic populations do not specify what made the interventions "culturally sensitive" beyond the translation of the materials into Spanish.Traditional weight-loss interventions developed for use on Anglo-American subjects do not appear to have been effective for Hispanic individuals. There is an urgent need to both develop effective interventions and to improve the methodologic thoroughness in the design, implementation, and reporting of such interventions for this population.

Background/Aims Mexican-American women are at particularly high risk for obesity and associated comorbidities. This pilot study tested the feasibility of a culturally-tailored weight-loss intervention aimed at obese Spanish-speaking Mexican-American women.

Background In the USA, 77% of Hispanic women age 20 and older are classified as overweight or obese. There is evidence that Hispanics tend to be less successful than non-Hispanic whites in standard weight-loss interventions. This study assessed the feasibility of a culturally-tailored behavioral weight-loss intervention specifically designed for Spanish-speaking women of Mexican origin.

Background Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. Methods Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. Results Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. Conclusions The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research. Trial Registration ClinicalTrials.gov: NCT00526565

Methods We performed a secondary analysis of 142 obese participants who had lost at least 10 pounds in a conventional weight loss program and who were randomized to the experimental weight loss maintenance intervention. This experimental intervention consisted of instruction and application of an energy psychology intervention, Tapas Acupressure Technique (TAT). TAT practice combined self-acupressure with a prescribed set of mental steps. Participants were advised to practice TAT at home daily. The main outcome measure was self reported frequency of TAT practice.