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BACKGROUND: Hepatocellular carcinoma (HCC) is a highly lethal cancer with few treatment options available to patients. Most HCC cases in Arizona, a state with a high proportion of Hispanic adults, have not been included in recent reports of HCC incidence. This study describes trends in HCC incidence and stage at diagnosis among Arizona residents between 2009-2017 and reports on racial and ethnic disparities for these outcomes. METHODS: The Arizona Cancer Registry was used to identify Arizonans aged 19 or older diagnosed with liver cell carcinoma diagnosed between 2009-2017. A total of 5043 cases were examined. Adjusted annual and 3-year HCC incidence rates (per 100,000) were examined for non-Hispanic White (NHW) and Hispanic adults. RESULTS: The total age-adjusted HCC incidence rate increased significantly between 2009-2012 and then declined significantly between 2012-2017. Across nearly all years, age-adjusted HCC incidence in Hispanic adults was twice that of NHW adults. Hispanic adults were more likely to be diagnosed at a later stage across all time periods. The disparity in 3-year age-adjusted HCC incidence rate between NHW and Hispanic adults decreased between 2009-2017. CONCLUSION: Whe total age-adjusted HCC incidence rate increased significantly between 2009-2012 and then declined significantly between 2012-2017. Across nearly all years, age-adjusted HCC incidence in Hispanic adults was twice that of NHW adults. Hispanic adults were more likely to be diagnosed at a later stage across all time periods. The disparity in 3-year age-adjusted HCC incidence rate between NHW and Hispanic adults decreased between 2009-2017.
Subject(s)
Carcinoma, Hepatocellular , Hispanic or Latino , Liver Neoplasms , White People , Humans , Arizona/epidemiology , Liver Neoplasms/epidemiology , Liver Neoplasms/ethnology , Female , Male , Carcinoma, Hepatocellular/ethnology , Carcinoma, Hepatocellular/epidemiology , Incidence , Hispanic or Latino/statistics & numerical data , Middle Aged , Adult , Aged , White People/statistics & numerical data , Health Status Disparities , Registries , Young Adult , Aged, 80 and overABSTRACT
BACKGROUND: Hispanics and American Indians (AI) have high kidney cancer incidence and mortality rates in Arizona. This study assessed: (1) whether racial and ethnic minority patients and patients from neighborhoods with high social vulnerability index (SVI) experience a longer time to surgery after clinical diagnosis, and (2) whether time to surgery, race and ethnicity, and SVI are associated with upstaging to pT3/pT4, disease-free survival (DFS), and overall survival (OS). METHODS: Arizona Cancer Registry (2009-2018) kidney and renal pelvis cases (n = 4592) were analyzed using logistic regression models to assess longer time to surgery and upstaging. Cox-regression hazard models were used to test DFS and OS. RESULTS: Hispanic and AI patients with T1 tumors had a longer time to surgery than non-Hispanic White patients (median time of 56, 55, and 45 days, respectively). Living in neighborhoods with high (≥75) overall SVI increased odds of a longer time to surgery for cT1a (OR 1.54, 95% CI: 1.02-2.31) and cT2 (OR 2.32, 95% CI: 1.13-4.73). Race and ethnicity were not associated with time to surgery. Among cT1a patients, a longer time to surgery increased odds of upstaging to pT3/pT4 (OR 1.95, 95% CI: 0.99-3.84). A longer time to surgery was associated with PFS (HR 1.52, 95% CI: 1.17-1.99) and OS (HR 1.63, 95% CI: 1.26-2.11). Among patients with cT2 tumor, living in high SVI neighborhoods was associated with worse OS (HR 1.66, 95% CI: 1.07-2.57). CONCLUSIONS: High social vulnerability was associated with increased time to surgery and poor survival after surgery.
Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Humans , Ethnicity , Arizona/epidemiology , Social Vulnerability , Minority Groups , Kidney Neoplasms/surgery , KidneyABSTRACT
OBJECTIVE: This study compared three ethnic/racial groups of informal cancer caregivers on social determinants of health and tested social determinants of health as predictors of psychological distress and caregiver burden. METHODS: This study was a secondary analysis of baseline data of a sequential multiple assignment randomized trial (SMART) testing symptom management interventions with caregiver-survivor dyads. Caregivers completed baseline measures of social determinants of health (SDoH), functional limitations, psychological distress, and caregiver burden. Hispanic, non-Hispanic White, and non-Hispanic other races caregivers were compared on these variables. Multivariate tests of associations between SDoH and caregiver burden and psychological distress were conducted in structural equation modeling with caregiver burden and psychological distress as latent variables. RESULTS: Hispanic caregivers reported significantly higher caregiver burden, specifically for finances, family, and schedules. Caregiver burden was significantly predicted by having income barely or not meeting needs, being female, socially isolated, married, Hispanic, and having poor physical functioning. Significant predictors of caregivers' psychological distress: being female, being socially isolated, and having poor physical functioning. CONCLUSION: Hispanic caregivers experience significant challenges associated with caregiver burden, especially if they are female, socially isolated, and have poor physical functioning. Assessment of these SDoH is important in caregiver health to provide supportive care during caregiving. CLINICAL TRIAL REGISTRATION NUMBER: NCT03743415 www.clinicaltrials.gov.
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INTRODUCTION AND OBJECTIVES: Various studies have identified single-nucleotide polymorphisms (SNPs) associated with nonalcoholic fatty liver disease (NAFLD) and related traits, including ones located in or near the LYPLAL1, GCKR, PPP1R3B, TM6SF2, MBOAT7, and PNPLA3 genes. However, these SNPs were identified primarily in populations of European ancestry. This study examined the associations of these previously identified SNPs with hepatic steatosis in a sample of Mexican-origin adults living in Southern Arizona. MATERIALS AND METHODS: A total of 307 Mexican-origin adults between the ages of 18 and 64 with a body mass index (BMI) of 25 kg/m2 or higher were genotyped at the following SNPs: rs12137855 (LYPLAL1), rs1260326 (GCKR), rs4240624 (PPP1R3B), rs58542926 (TM6SF2), rs641738 (MBOAT7), and rs738409 (PNPLA3). Hepatic steatosis was assessed by transient elastography (FibroScan®) with controlled attenuation parameter. Regression models examined the association between each of the six SNPs and hepatic steatosis. BMI was examined as a potential modifier of the genetic associations. RESULTS: Participants were, on average, 45 years old and mostly female (63%) with an overall mean hepatic steatosis of 288.1 dB/m. Models showed no associations between LYPLAL1, GCKR, PPP1R3B, TM6SF2, or MBOAT7 and hepatic steatosis. Only PNPLA3 was statistically significantly associated with hepatic steatosis in both unadjusted and adjusted models (p<0.01). There was no effect modification observed with BMI. CONCLUSIONS: SNPs associated with NAFLD in populations of European descent did not strongly contribute to hepatic steatosis in individuals of Mexican-origin, except for rs738409 (PNPLA3). Further efforts are necessary to explore additional SNPs that may be associated with NAFLD in this high-risk population.
Subject(s)
Non-alcoholic Fatty Liver Disease , Humans , Adult , Female , Adolescent , Young Adult , Middle Aged , Male , Non-alcoholic Fatty Liver Disease/diagnostic imaging , Non-alcoholic Fatty Liver Disease/epidemiology , Genetic Predisposition to Disease , Genotype , Risk Factors , Polymorphism, Single Nucleotide , LiverABSTRACT
CONTEXT: Many cancer survivors experience a lingering symptom burden after chemotherapy. OBJECTIVES: In this sequential multiple assignment randomized trial, we tested optimal sequencing of two evidence-based interventions for symptom management. METHODS: Survivors of solid tumors (N = 451) were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms. High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N = 282) or 12-week SMSH with eight weeks of Telephone Interpersonal Counseling (TIPC, N = 93) added during weeks one to eight. After four weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N = 30) or add TIPC (N = 31). Severity of depression and summed severity index of 17 other symptoms over weeks one to13 were compared between randomized groups and among three dynamic treatment regimes (DTRs): 1) SMSH for 12 weeks; 2) SMSH for 12 weeks with eight weeks of TIPC from week one; 3) SMSH for four weeks followed by SMSH+TIPC for eight weeks if no response to the SMSH alone on depression at week four. RESULTS: There were no main effects for randomized arms or DTRs, but there was a significant interaction of trial arm with baseline depression favoring SMSH alone during weeks one to four in the first randomization and SMSH+TIPC in the second randomization. CONCLUSION: The SMSH may represent a simple effective option for symptom management, adding TIPC only when there is no response to SMSH alone for people with elevated depression and multiple co-morbidities.
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Neoplasms , Humans , Neoplasms/drug therapy , Neoplasms/psychology , Comorbidity , Palliative Care , Treatment OutcomeSubject(s)
Neoplasms , Uterine Cervical Neoplasms , Uterine Neoplasms , Female , Humans , Arizona , Cervix UteriABSTRACT
Background: Risk factors for cardiometabolic diseases (e.g., type 2 diabetes, cardiovascular disease) can begin developing in childhood. Elevated body mass index (BMI) is associated with greater likelihood of developing such diseases; however, this relationship varies by race and ethnicity. Notably, Hispanics tend to have high rates of obesity and are disproportionately affected by type 2 diabetes. We aimed to determine if visceral adiposes tissue (VAT) is associated with cardiometabolic risk factors (i.e., triglycerides, cholesterol, insulin resistance, C-reactive protein, and blood pressure), independent of BMI percentile, in a sample of primarily Hispanic adolescent girls. Methods and results: A total of 337 girls (73% Hispanic) took part in the cross-sectional study. Hispanic girls generally had greater BMI percentile, VAT, and cardiometabolic risk factors compared to non-Hispanic girls. Multiple linear regression was used to assess the relationships between Dual-energy X-ray Absorptiometry (DXA)-derived VAT and cardiometabolic outcomes, controlling for BMI percentile (<85th percentile or ≥85th percentile), age, ethnicity (Hispanic/non-Hispanic), and Tanner stage. Significant interactions between VAT and BMI percentile were identified for almost all cardiometabolic outcomes. Upon stratification, the association between VAT and cardiometabolic outcomes was strongest in girls ≥85th BMI percentile, as compared to girls <85th percentile. However, VAT was only significantly associated with higher triglycerides (girls ≥85th percentile) and higher insulin resistance (both BMI percentiles) after stratification. Conclusion: VAT was associated with increased triglycerides and insulin resistance in girls with overweight or obesity. These findings warrant further investigation between VAT and cardiometabolic health in Hispanic adolescents who tend to accumulate more adipose tissue during adolescence.
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INTRODUCTION: This article aims to increase understanding of how Mexican immigrants respond to learning about non-alcoholic fatty liver disease (NAFLD), a spectrum disease with a heavy burden among Mexican-origin people. METHODOLOGY: This article presents findings from qualitative interviews (n = 26) that formed part of a mixed-methods study of foreign-born Mexican immigrants carried out in 2019 to 2020 in southern Arizona to assess NAFLD awareness. RESULTS: We documented common experiences of surprise, fear, and hope during study participation, all of which motivated research participants to reduce their NAFLD risk by seeking additional information, sharing it with others, and making lifestyle changes. DISCUSSION: Understanding how these emotional experiences are tied to cultural and historical factors-including Mexico's high rates of liver disease, participant's limited access to health care, and the ability to address the NAFLD risk with lifestyle changes-may promote the development of more effective and culturally congruent care in this population.
Subject(s)
Emigrants and Immigrants , Non-alcoholic Fatty Liver Disease , Culturally Competent Care , Emotions , Humans , Mexico , Non-alcoholic Fatty Liver Disease/complications , Non-alcoholic Fatty Liver Disease/epidemiologyABSTRACT
INTRODUCTION: Treatment delays are significantly associated with increased mortality risk among adult cancer patients; however, factors associated with these delays have not been robustly evaluated. This review and meta-analysis will evaluate factors associated with treatment delays among patients with five common cancers. METHODS AND ANALYSIS: Scientific databases including Ovid MEDLINE, Elsevier Embase, EBSCOhost CINAHL Plus Full Text, Elsevier Scopus and ProQuest Dissertations and Theses Global will be searched to identify relevant articles published between January 2000 and October 2021. Research articles published in the USA evaluating factors associated with treatment delay among breast, lung, prostate, cervical or colorectal adult cancer patients will be included. The primary outcome of the meta-analysis will be the pooled adjusted and unadjusted odds of treatment delay for patient, disease, provider and system-level factors defined according to specified time intervals. The secondary outcomes will be mean or median treatment delay for each cancer site according to first treatment and the influence of factors on the pooled mean treatment delay for each cancer site (via meta-regression analyses). Results from qualitative and mixed-methods studies will be narratively synthesised. Three reviewers will independently screen records generated from the search and two reviewers will independently extract data following a consensus agreement. Statistical heterogeneity will be assessed with a standard I2 test and funnel plots will be conducted to evaluate publication bias. Risk of bias will be assessed independently by two authors using validated tools according to the article's study design. ETHICS AND DISSEMINATION: Formal ethical approval is not required because the work is being carried out on publicly accessible studies. The findings of this review will be disseminated through a peer-reviewed scientific journal, academic conferences, social media, and key stakeholders. PROSPERO REGISTRATION NUMBER: CRD42021293131.
Subject(s)
Neoplasms , Time-to-Treatment , Adult , Humans , Meta-Analysis as Topic , Neoplasms/therapy , Research Design , Review Literature as Topic , Systematic Reviews as TopicABSTRACT
The incidence of nonalcoholic fatty liver disease (NAFLD) is highest among Mexican-origin (MO) adults. Few studies have estimated the prevalence of NAFLD in this subpopulation, particularly by sex and age. We assessed the prevalence of NAFLD in a community sample of MO adults residing in a border region of southern Arizona and determined risk factors associated with NAFLD. A total of 307 MO adults (n = 194 women; n = 113 men) with overweight or obesity completed an in-person study visit, including vibration-controlled transient elastography (FibroScan) for the assessment of NAFLD status. A continuous attenuation parameter score of ≥288 dB/m (≥5% hepatic steatosis) indicated NAFLD status. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for NAFLD. We identified 155 participants (50%) with NAFLD, including 52% of women and 48% of men; there were no sex differences in steatosis (men, 287.8 dB/m; women, 288.4 dB/m). Sex, age, patatin-like phospholipase domain containing 3 (PNPLA3) risk allele carrier status, comorbidities, and cultural and behavioral variables were not associated with NAFLD status. There was some evidence for effect modification of body mass index (BMI) by sex (Pinteraction = 0.08). The estimated OR for an increase in BMI of 5 kg/m2 was 3.36 (95% CI, 1.90, 5.91) for men and 1.92 (95% CI, 1.40, 2.64) for women. In post hoc analyses treating steatosis as a continuous variable in a linear regression, significant effect modification was found for BMI by sex (Pinteraction = 0.03), age (P = 0.05), and PNPLA3 risk allele carrier status (P = 0.02). Conclusion: Lifestyle interventions to reduce body weight, with consideration of age and genetic risk status, are needed to stem the higher rates of NAFLD observed for MO populations.
Subject(s)
Non-alcoholic Fatty Liver Disease , Adult , Female , Humans , Lipase/genetics , Male , Membrane Proteins/genetics , Non-alcoholic Fatty Liver Disease/epidemiology , Polymorphism, Single Nucleotide , Risk FactorsABSTRACT
Introduction: Mexican-origin women suffer disproportionate rates of nonalcoholic fatty liver disease (NAFLD) and research on how to tailor NAFLD treatment interventions for this population is lacking. Objectives: The purpose of this study was to assess awareness, knowledge, perceptions, and information sources related to NAFLD in a community-based sample of Mexican-origin women. Methods: This study employed a convergent parallel mixed-methods approach and consisted of a brief questionnaire (n = 194) and interviews (n = 26) among Mexican-origin women recruited from community-based settings including health fairs, churches, and community events. Participants were eligible if they identified as Mexican-origin, had a BMI ≥ 25 kg/m2, were 18-64 years of age, had the ability to speak, read, and write in English and/or Spanish, and provided informed consent. A purposeful sampling approach was used to recruit a subset of women (n = 26) with confirmed liver steatosis indicative of NAFLD (controlled attenuation parameter ≥280 dB/m) who completed the questionnaire. The twenty-six participants then completed one on one, in-depth semi-structured interviews to ascertain their knowledge and understanding of NAFLD. Results: Qualitative findings revealed low awareness of risk factors for liver disease, NAFLD specifically. Knowledge of liver disease tended to center around cirrhosis, a condition many participants reported was prevalent in their families. Quantitative and qualitative findings both found information sources for NAFLD and liver disease to be predominantly friends, family, and media. Interviews revealed a misperception related to NAFLD risk that liver disease was only caused by high alcohol intake. Conclusion: Low levels of NAFLD awareness and knowledge warrant the need for greater efforts to educate the general population, perhaps by integrating NAFLD education into existing type 2 diabetes educational campaigns and prevention interventions. Additionally, further elicitation research conducted in Mexican-origin adults is needed to elucidate key factors within behavioral-theory constructs that can be targeted in future interventions tailored to this unique population.
Subject(s)
Diabetes Mellitus, Type 2 , Non-alcoholic Fatty Liver Disease , Adult , Female , Health Education , Humans , Non-alcoholic Fatty Liver Disease/epidemiology , Risk Factors , Surveys and QuestionnairesABSTRACT
Background: Obesity rates in Hispanic women residing in the United States (U.S.) are disproportionately high, increasing the risk of obesity-related disease and mortality. The effectiveness of interventions targeting weight loss in this population remains largely unknown. Purpose: The purpose of this review was to systematically evaluate the evidence related to the effectiveness of weight loss interventions conducted among U.S. Hispanic women and provide guidance for future research. Methods: Bibliographic databases (n = 10, from each database's inception to July 2, 2019) were searched using the PRISMA guidelines for systematic reviews. Randomized controlled trials (RCTs) and quasi-experimental studies with weight change outcomes were included. Results were described in a narrative synthesis. Results: 5,423 articles were assessed for eligibility based on inclusion criteria; 15 studies were included in the final review. Nine trials were RCTs and six were quasi-experimental studies; all but six were pilot studies. Most studies recruited overweight or obese women with no existing medical conditions and did not follow participants beyond the intervention. All trials were delivered in-person. Intervention strategies and content and weight change outcomes were highly variable. Conclusions: RCTs with statistically powered sample sizes are needed to robustly test the effects of weight loss interventions in this population.
Subject(s)
Hispanic or Latino , Obesity , Weight Reduction Programs , Female , Hispanic or Latino/statistics & numerical data , Humans , Obesity/ethnology , Obesity/therapy , Program Evaluation , United StatesABSTRACT
Mexican-origin (MO) adults have among the highest rates of nonalcoholic fatty liver disease (NAFLD) placing them at increased risk of liver cancer. Evidence suggests that a single nucleotide polymorphism (SNP) in the PNPLA3 gene, rs738409, increases the risk and progression of NAFLD and may modify the relationship between certain dietary factors and liver steatosis. The purpose of this study was to identify whether interactions exist between specific dietary factors and rs738409 genotype status among MO adults in relation to levels of liver steatosis. We analyzed cross-sectional data from a sample of 288 MO adults. Participants completed at least two 24-h dietary recalls. Multiple linear regression was performed assuming an additive genetic model to test the main effects of several dietary variables on levels of hepatic steatosis, adjusting for covariates. To test for effect modification, the product of the genotype and the dietary variable was included as a covariate in the model. No significant association between dietary intake and level of hepatic steatosis was observed, nor any significant gene-diet interactions. Our findings suggest that dietary intake may have the same magnitude of protective or deleterious effect even among MO adults with high genetic risk for NAFLD and NAFLD progression.
Subject(s)
Diet , Lipase , Membrane Proteins , Non-alcoholic Fatty Liver Disease , Adult , Cross-Sectional Studies , Genetic Predisposition to Disease , Genotype , Humans , Lipase/genetics , Liver , Membrane Proteins/genetics , Mexico/epidemiology , Non-alcoholic Fatty Liver Disease/epidemiology , Non-alcoholic Fatty Liver Disease/genetics , Polymorphism, Single NucleotideABSTRACT
BACKGROUND: In the U.S., Hispanic women experience a disproportionate rate of obesity and obesity-related chronic diseases. At the same time, Hispanic women remain considerably underrepresented in behavioral weight loss interventions. The purpose of this review is to systematically evaluate the evidence related to the effectiveness of weight loss interventions among Hispanic women in the U.S. This review will identify elements of successful weight loss interventions as well as areas for future research. METHODS/DESIGN: The following databases will be searched to identify all relevant articles (from inception onwards): PubMed, Embase, Scopus, Web of Science (Science Citation Index and Social Sciences Citation Index), PsycINFO, CINAHL, Chicano Database, SPORTDiscus, CAB Abstracts, and Google Scholar. We will include randomized controlled trials and quasi-experimental studies of adult women (> 18 years) from Hispanic/Latino background living in the United States. Eligible interventions will target weight-related behaviors (including diet, physical activity, behavior modification and/or their combinations). The review's primary outcome will be weight change (expressed as change in lbs/kg or body mass index (BMI) (kg/m2)). Three reviewers will independently screen and select data and two will extract data. The methodological quality (or risk of bias) of individual studies will be appraised using the Effective Public Health Practice Project Quality Assessment Tool. A narrative synthesis will describe quality and content of the evidence. DISCUSSION: The aim of this systematic review is to critically examine existing weight loss interventions for Hispanic women in the U.S. and provide quality evidence for the effectiveness of these interventions on weight loss. Further, this review seeks to identify characteristics of effective interventions and suggest future directions for research efforts targeting weight loss in this population. This review will inform the development of future weight loss interventions for this population. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019119094.
Subject(s)
Obesity Management/methods , Obesity/therapy , Research Design , Systematic Reviews as Topic , Weight Loss , Behavior Therapy , Diet, Reducing , Exercise , Female , Health Behavior , Hispanic or Latino , Humans , United StatesABSTRACT
Approximately 83% of Hispanic men of Mexican origin are overweight or obese, which are both associated with increased risk of chronic disease and all-cause mortality. Consequently, men of Mexican origin have some of the highest prevalence rates of obesity-related comorbidities. Physical activity (PA) may be an important strategy for Hispanic men of Mexican origin in reducing incidence and risk factors of lifestyle diseases. The current study engaged Spanish-speaking, Hispanic men of Mexican origin aged 24-64 years with overweight/obesity to examine perspectives of health behaviors related to PA. A total of 14 in-depth semistructured individual interviews were completed between September and November of 2015 and data analyzed using an iterative deductive-inductive thematic assessment strategy. The men suggested that their PA was hindered by (a) work-related energy and time constraints, (b) socioeconomic status (SES) and the need to prioritize work, (c) adaptations to majority population lifestyle norms, and (d) perceived lack of suitable access to PA-promoting spaces. The men provided valuable insight for strategies to improve PA interventions such as (a) accurately accounting for current PA levels of participants, including occupational and transportation PA, (b) considerations of family dynamics that influence PA-based behavior change, and (c) considerations of economic and geographical constraints that can be remediated. To improve effectiveness, future PA-related intervention research with Hispanic men of Mexican origin should consider methods that (a) account for transportation and occupational PA to better tailor PA to individual needs, (b) consider sociocultural and socioeconomic influences, (c) account for social support and accountability, and (d) consider economic and geographical constraints.
Subject(s)
Exercise/psychology , Health Behavior , Men/psychology , Mexican Americans/psychology , Adult , Employment , Humans , Interviews as Topic , Male , Middle Aged , Obesity/ethnology , Overweight/ethnology , Socioeconomic FactorsABSTRACT
OBJECTIVE: To assess the feasibility and acceptability of a beverage intervention in Hispanic adults. DESIGN: Eligible individuals identified as Hispanic, were 18-64 years old and had BMI 30·0-50·0 kg/m2. Participants were randomized 2:2:1 to one of three beverages: Mediterranean lemonade (ML), green tea (GT) or flavoured water control (FW). After a 2-week washout period, participants were asked to consume 32 oz (946 ml) of study beverage daily for 6 weeks and avoid other sources of tea, citrus, juice and sweetened beverages; water was permissible. Fasting blood samples were collected at baseline and 8 weeks to assess primary and secondary efficacy outcomes. SETTING: Tucson, AZ, USA.ParticipantsFifty-two participants were recruited over 6 months; fifty were randomized (twenty-one ML, nineteen GT, ten FW). Study population mean (sd) age 44·6 (sd 10·2) years, BMI 35·9 (4·6) kg/m2; 78 % female. RESULTS: Forty-four (88 %) completed the 8-week assessment. Self-reported adherence was high. No significant change (95 % CI) in total cholesterol (mg/dl) from baseline was shown -1·7 (-14·2, 10·9), -3·9 (-17·2, 9·4) and -13·2 (-30·2, 3·8) for ML, GT and FW, respectively. Mean change in HDL-cholesterol (mg/dl) -2·3 (-5·3, 0·7; ML), -1·0 (-4·2, 2·2; GT), -3·9 (-8·0, 0·2; FW) and LDL-cholesterol (mg/dl) 0·2 (-11·3, 11·8; ML), 0·5 (-11·4, 12·4; GT), -9·8 (-25·0, 5·4; FW) were also non-significant. Fasting glucose (mg/dl) increased significantly by 5·2 (2·6, 7·9; ML) and 3·3 (0·58, 6·4; GT). No significant change in HbA1c was demonstrated. Due to the small sample size, potential confounders and effect modifiers were not investigated. CONCLUSIONS: Recruitment and retention figures indicate that a larger-scale trial is feasible; however, favourable changes in cardiometabolic biomarkers were not demonstrated.
Subject(s)
Beverages , Health Promotion/methods , Hispanic or Latino , Adolescent , Adult , Blood Glucose/analysis , Cholesterol/blood , Feasibility Studies , Female , Glycated Hemoglobin/analysis , Humans , Male , Middle Aged , Pilot Projects , Tea , Young AdultABSTRACT
BACKGROUND: In the U.S., Hispanics have among the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Identifying intervention strategies to reduce caloric intake and/or improve cardiometabolic health in Hispanics is critical to reducing morbidity and mortality among this large and growing population. Evidence exists to support diet-specific behavioral interventions, including beverage modifications, in reducing obesity-related health risks. However, the acceptability and feasibility of a beverage intervention in obese Hispanic adults has not been robustly evaluated. METHODS: The objective of this pilot study is to assess the feasibility and acceptability of a randomized, controlled beverage intervention in 50 obese Hispanic adults ages 18-64 over 8-weeks. Eligible participants were obese (30-50.0 kg/m2), between the ages 18-64, self-identified as Hispanic, and were able to speak, read, and write in either English and/or Spanish. Study recruitment was completed August 2017. Upon the completion of baseline assessments, participants will be randomized to either Mediterranean lemonade, Green Tea, or flavored water control. After completing a 2-week washout period, participants will be asked to consume 32 oz. per day of study beverage for 6-weeks while avoiding all other sources of tea, lemonade, citrus, juice, and other sweetened beverages; water is permissible. Primary outcomes will be recruitment, retention, and acceptability of the intervention strategies. Our study will also evaluate participant-reported tolerance and as an exploratory aim, assess safety/toxicity-related to renal and/or liver function. Fasting blood samples will be collected at baseline and 8-weeks to assess the primary efficacy outcomes: total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). Secondary outcomes include fasting glucose, hemoglobin A1c (HbA1c), and high-sensitivity C-reactive protein (hs-CRP). DISCUSSION: This pilot study will provide important feasibility, safety, and early efficacy data necessary to design a larger, adequately-powered randomized controlled trial. TRIAL REGISTRATION: NCT02911753 ( ClinicalTrials.gov ). Registered September 19, 2016. Last updated November 1, 2017.