Feasibility of Fit24, a Digital Diabetes Prevention Program for Hispanic Adolescents: Qualitative Evaluation Study.

BACKGROUND: Digital health interventions are promising for reaching and engaging high-risk youth in disease prevention opportunities; however, few digital prevention interventions have been developed for Hispanic youth, limiting our knowledge of these strategies among this population. OBJECTIVE: This study qualitatively assessed the feasibility and acceptability of Fit24, a 12-week goal-setting intervention that uses a Fitbit watch (Fitbit Inc) and theoretically grounded SMS text messages to promote physical activity and sleep among Hispanic adolescents (aged between 14 and 16 years) with obesity. METHODS: After completing the intervention, a subsample of youth (N=15) participated in an in-depth interview. We categorized the themes into dimensions based on participant perspectives using the Practical, Robust Implementation, and Sustainability Model (PRISM) framework. RESULTS: Participants shared positive perceptions of wearing the Fitbit and receiving SMS text messages. Youth were highly engaged in monitoring their behaviors and perceived increased activity and sleep. Almost all youth organically received social support from a peer or family member and suggested the use of a group chat or team challenge for integrating peers into future interventions. However, most youth also expressed the need to take personal responsibility for the change in their behavior. Barriers that impacted the feasibility of the study included the skin-irritating material on the Fitbit watch band and environmental barriers (eg, lack of resources and school schedules), that limited participation in activity suggestions. Additionally, sync issues with the Fitbit limited the transmission of data, leading to inaccurate feedback. CONCLUSIONS: Fit24 is a promising approach for engaging Hispanic youth in a diabetes prevention program. Strategies are needed to address technical issues with the Fitbit and environmental issues such as message timing. While integrating peer social support may be desired by some, peer support strategies should be mindful of youth's desire to foster personal motivation for behavior change. Findings from this study will inform future diabetes prevention trials of Fit24 and other digital health interventions for high-risk pediatric populations.

How Societal Forces of Change Are Transforming Youth Physical Activity Promotion in North America.

BACKGROUND: Climate change, increasing recognition of institutionalized discrimination, and the COVID-19 pandemic are large-scale, societal events (ie, forces of change) that affect the timing, settings, and modes of youth physical activity. Despite the impact that forces of change have on youth physical activity and physical activity environments, few studies consider how they affect physical activity promotion. METHODS: The authors use 2 established frameworks, the ecological model of physical activity and the youth physical activity timing, how, and setting framework, to highlight changes in physical activity patterns of youth in North America that have resulted from contemporary forces of change. RESULTS: North American countries-Canada, Mexico, and the United States-have faced similar but contextually different challenges for promoting physical activity in response to climate change, increasing recognition of institutionalized discrimination, and the COVID-19 pandemic. Innovative applications of implementation science, digital health technologies, and community-based participatory research methodologies may be practical for increasing and sustaining youth physical activity in response to these forces of change. CONCLUSIONS: Thoughtful synthesis of existing physical activity frameworks can help to guide the design and evaluation of new and existing physical activity initiatives. Researchers, practitioners, and policymakers are encouraged to carefully consider the intended and unintended consequences of actions designed to respond to forces of change.

U.S. Adolescent Rest-Activity patterns: insights from functional principal component analysis (NHANES 2011-2014).

BACKGROUND: Suboptimal rest-activity patterns in adolescence are associated with worse health outcomes in adulthood. Understanding sociodemographic factors associated with rest-activity rhythms may help identify subgroups who may benefit from interventions. This study aimed to investigate the association of rest-activity rhythm with demographic and socioeconomic characteristics in adolescents. METHODS: Using cross-sectional data from the nationally representative National Health and Nutrition Examination Survey (NHANES) 2011-2014 adolescents (N = 1814), this study derived rest-activity profiles from 7-day 24-hour accelerometer data using functional principal component analysis. Multiple linear regression was used to assess the association between participant characteristics and rest-activity profiles. Weekday and weekend specific analyses were performed in addition to the overall analysis. RESULTS: Four rest-activity rhythm profiles were identified, which explained a total of 82.7% of variance in the study sample, including (1) High amplitude profile; (2) Early activity window profile; (3) Early activity peak profile; and (4) Prolonged activity/reduced rest window profile. The rest-activity profiles were associated with subgroups of age, sex, race/ethnicity, and household income. On average, older age was associated with a lower value for the high amplitude and early activity window profiles, but a higher value for the early activity peak and prolonged activity/reduced rest window profiles. Compared to boys, girls had a higher value for the prolonged activity/reduced rest window profiles. When compared to Non-Hispanic White adolescents, Asian showed a lower value for the high amplitude profile, Mexican American group showed a higher value for the early activity window profile, and the Non-Hispanic Black group showed a higher value for the prolonged activity/reduced rest window profiles. Adolescents reported the lowest household income had the lowest average value for the early activity window profile. CONCLUSIONS: This study characterized main rest-activity profiles among the US adolescents, and demonstrated that demographic and socioeconomic status factors may shape rest-activity behaviors in this population.

The impact of a meditative movement practice intervention on short- and long-term changes in physical activity among breast cancer survivors.

PURPOSE: Tai Chi Easy (TCE) is a low-impact, meditative movement practice that is feasible for breast cancer survivors, even in the face of post-treatment symptoms, and may even serve as a gateway into developing an active lifestyle and improving overall physical activity (PA). In the context of a randomized controlled trial testing effects of an 8-week TCE intervention on breast cancer survivors' symptoms, we examined the short- (8-week) and long-term (9-month) impact on total PA compared to an educational control group. METHODS: Participants were recruited from two hospital systems, local community organizations, and different media platforms. Eligible participants were predominant non-Hispanic White (82%), college educated (92%), and middle- to high-income (65%), and most commonly reported stage 1 (40%) or 2 breast cancer (38%). After baseline assessments, participants were randomized to the 8-week TCE intervention (N=51) or education control (N=53). Weekly intervention TCE classes were led by a trained instructor. Weekly educational control classes focused on a series of readings and group discussions. Total PA and steps were objectively measured via accelerometry, and the international physical activity questionnaire was used to measure self-reported total PA. RESULTS: Multilevel mixed-effects linear regression models revealed no significant short- or long-term changes in objectively measured total PA or steps in either group; however, participants in the intervention reported short- and long-term changes in self-reported total PA. CONCLUSIONS: TCE is an appropriate PA strategy for survivors that may lead to modest improvements in PA; however, more research is needed to examine the long-term impact on PA as well as other physical and psychological outcomes (i.e., flexibility, mobility, stress). IMPLICATIONS FOR CANCER SURVIVORS: Low-impact, low-intensity activities like meditative movement practices are needed to assist survivors in overcoming post-treatment physical and psychological limitations to initiate a more active lifestyle.

Fit24, a digital health intervention to reduce type 2 diabetes risk among Hispanic youth: Protocol for a feasibility pilot study.

BACKGROUND: Poor physical activity (PA) and sleep behaviors in Hispanic adolescents contributes to increased risk for type 2 diabetes. Commonly owned digital devices and services like smartphones and text-messaging are highly used among adolescents and are promising intervention tools for reaching this age group. Personal activity trackers assess activity and sleep, making them ideal tools for addressing these behaviors. We propose to examine the feasibility of a 12-week intervention that uses theoretically grounded text messages and a Fitbit device to improve PA and sleep among Hispanic adolescents with obesity, as compared to a wait-list control group with a Fitbit device only. METHODS: Participants (N = 48; 14-16 years) will be randomized (1:1) to the intervention or wait-list control group. Youth in the intervention will receive a Fitbit Charge 5 and daily text messages. Youth in the wait-list control group will receive a Fitbit Charge 5 and information on PA and sleep guidelines. RESULTS: Feasibility will be examined by collecting process evaluation data on the following criteria: (1) recruit 48 Hispanic adolescents 14-16 years; (2) retain 85% of participants for post-assessments; (3) Fitbit wear ≥4 days/week and respond to 80% of text messages when prompted; (4) ≤10% technical issues; and (5) obtain 80% satisfaction from participants. DISCUSSION: This study will advance our knowledge on the feasibility of digital prevention strategies to promote PA and sleep behaviors to reduce T2D risk among Hispanic youth. If feasible, this approach has the potential to be a scalable, cost-effective diabetes prevention strategy among high-risk youth. TRIAL REGISTRATION: NCT04953442, registered on July 8, 2021.

Technology-Based Obesity Prevention Interventions Among Hispanic Adolescents in the United States: Scoping Review.

BACKGROUND: Given that today's adolescents are digital front-runners, technology-based obesity prevention strategies are age-appropriate for this population. The use of remote and wireless technologies may be suitable for extending the reach and engagement of obesity prevention efforts among high-risk Hispanic youths, as this subgroup is disproportionately affected by barriers that limit participation in traditional, in-person interventions. OBJECTIVE: The purpose of this scoping review was to examine the intervention and sample characteristics of technology-based obesity prevention interventions among Hispanic adolescents. We also examined feasibility criteria to assess the acceptability and appropriateness of technology-based strategies among Hispanic youths. METHODS: A comprehensive search of Embase and PubMed identified 7 studies that met the inclusion criteria. Data were extracted by 2 independent reviewers. RESULTS: Of the 7 included studies, half (n=4, 57%) used a randomized control trial design, with equal implementation in school (n=3, 43%) and clinic (n=4, 57%) settings. Studies commonly targeted improvements in diet (n=4, 57%) and physical activity (n=7, 100%), with only 1 (14%) study focused on sedentary behaviors. Just 2 (29%) studies reported the use of behavioral theories or models. Studies focused primarily on youths in early (n=5, 71%) or middle (n=6, 86%) adolescence, and there was limited information reported on socioeconomic status. Only 3 (43%) study conducted formative work, and few (n=3, 43%) reported on acceptability. Only 1 (14%) study reported that materials were available in Spanish and English, and only 1 (14%) study used culturally tailored content. Additionally, 3 (43%) studies used strategies that considered social determinants of health. CONCLUSIONS: To increase our understanding of the feasibility and effectiveness of technology-based obesity prevention strategies among Hispanic adolescents, there is a need for more feasibility studies that are theoretically grounded and comprehensively report on feasibility-related outcomes. Future studies should also leverage technology to simultaneously address multiple health behaviors beyond diet and physical activity. The result of this review can be used to guide the development of future technology-based obesity prevention strategies among Hispanic adolescents. TRIAL REGISTRATION: CliniclaTrials.gov NCT04953442; https://clinicaltrials.gov/ct2/show/NCT04953442.

Sustainability via Active Garden Education: The Sustainability Action Plan Model and Process.

Sustainability of intervention programming is challenging to achieve under real world conditions, since few models exist and many studies do not plan far beyond the funding period. Programming content in early care and education centers (ECECs) is often driven by guidelines. However, implementation is very sensitive to contextual factors, such as the setting and implementer (teacher) characteristics. This paper presents the model, definitions, and methodology used for the sustainability action plan capitalizing on a community-based participatory research (CBPR) approach, developed for a multi-site, multi-level garden-based childhood obesity prevention study, Sustainability via Active Garden Education (SAGE). The Ecologic Model of Obesity is applied to develop a sustainability action plan (SAP) and accompanying measures to link early care and education (ECE) environment, the community, policies, and classroom practices to an early childhood obesity prevention program. The SAGE SAP provides an example of how to iteratively evaluate and refine sustainability processes for an obesity prevention intervention utilizing CBPR approaches and will be applied to assess the sustainability of SAGE in a cluster randomized controlled trial. This SAP model can also help inform intervention delivery and scalability within ECECs.

Latin dance and Qigong/Tai Chi effects on physical activity and body composition in breast cancer survivors: A pilot study.

BACKGROUND: Breast cancer survivors (BCS), particularly Latina BCS, experience weight gain and reduced physical activity (PA) post-treatment increasing the risk for recurrence. There is a lack of evidence on the intensity and type of PA needed to engage cultural subgroups and improve clinical outcomes. This study developed and piloted two non-traditional PA interventions among a diverse sample of BCS. METHODS: Twenty BCS (65% Latina; age 25-75) participated in a 2-arm parallel group-randomized pilot study to test the effects of an 8-week Latin dance and Qigong/Tai Chi intervention on PA and body composition. A seven-day pedometer protocol was used to measure steps/week and a bioelectric impedence scale was used to assess BMI and %body fat. T-tests were used to examine preliminary outcomes across both interventions and within intervention arms. RESULTS: There were no significant changes in steps/week, BMI, or %body fat across or in each separate intervention. A small effect size for increase in steps/day was found among participants in the Qigong/Tai Chi arm (0.10) and low-to-moderate effect sizes for reductions in % body fat overall (0.36), and separately for participants in Latin dance (0.26) and Qigong/Tai Chi (0.46). CONCLUSION: Latin dance and Qigong/Tai Chi are engaging and acceptable PA modalities that are promising for improving PA and body fat among diverse, high-risk BCS. Our findings highlight the need to continue to reach and engage high-risk BCS, including Latina survivors, using novel, culturally-sensitive PA interventions. Future studies should extend and more rigorously test these novel approaches to improving outcomes associated with recurrence.

Organ fat in Latino youth at risk for type 2 diabetes.

PURPOSE: Obesity in youth increases the risk for type 2 diabetes (T2D) and elevated abdominal adipose tissue and organ fat may be particularly deleterious. The purpose of this study was to examine associations among measures of adiposity including total, visceral, and organ fat (hepatic and pancreatic) and whether these measures were independently associated with glycemia in Latino youth at risk for diabetes. METHODS: Latino adolescents (47 boys and 32 girls, 13.7 ± 1.4 years) with obesity (BMIz 2.3 ± 0.3) were assessed for total fat by DXA and visceral and organ fat by 3 T magnetic resonance imaging. Glycemic indicators included HbA1c, fasting glucose (FG), and 2-h glucose (2-HrG) following an oral glucose tolerance test. Pearson correlations and stepwise linear regression analyses controlling for age and sex were used to examine independent associations between adiposity and glycemia. RESULTS: Total fat was associated with visceral (r = 0.66, p = 0.001) and hepatic fat (r = 0.34, p < 0.01) while visceral fat was associated with hepatic (r = 0.42, p < 0.001) and pancreatic fat (r = 0.36, p < 0.001). In stepwise linear regression analysis, hepatic and pancreatic fat were significant predictors of FG, explaining 4.7% and 5.2% of the variance, respectively (total R2  = 0.14, p = 0.02). Hepatic fat was the only significant predictor of 2-HrG explaining 9.9% of the variance in the model (total R2  = 0.12, p = 0.03). No measure of adiposity was retained as a significant predictor of HbA1c. CONCLUSION: Hepatic and pancreatic fat were the only adiposity measures independently associated with glycemia but the small amount of variance explained underscores the need for additional T2D biomarkers in high risk youth.

Examining 24-Hour Activity and Sleep Behaviors and Related Determinants in Latino Adolescents and Young Adults With Obesity.

Background. Few studies have examined 24-hour activity and sleep behaviors and their contribution to type 2 diabetes (T2D) in Latino adolescents and young adults with obesity. Aim. This study included quantitative data on T2D risk and 24-hour activity and sleep behaviors and qualitative data on individual, social, and environmental behavioral determinants. Method. A 7 day, 24-hour, wrist-worn accelerometer protocol assessed moderate-to-vigorous physical activity (PA), sedentary behaviors (SB), sleep, and sleep regularity, in adolescents (N = 38; 12-16 years) and young adults (N = 22; 18-22 years). T2D-related outcomes included adiposity (BMI, BF%, waist circumference), fasting, and 2-hour glucose. A subsample of participants (N = 16 adolescents, N = 15 young adults) completed interviews to identify behavioral determinants. Results. High levels of PA were observed among adolescents (M = 103.8 ± 67.5 minutes/day) and young adults (M = 96.8 ± 78.8 minutes/day) as well as high levels of SB across both age groups (≥10 hours/day). Sleep regularity was negatively associated with adiposity (all ps < .05) in both age groups as well as fasting and 2-hour glucose in young adults (all ps < .05). Social support was associated with PA in both age groups as well as SB in younger youth. Auditory noises, lights, and safety inhibited sleep in both age groups. Conclusion. PA is critical for disease reduction, yet reducing SB and improving sleep are also important targets for reducing T2D risk in Hispanic adolescents and young adults. Future health promotion and disease prevention strategies should leverage qualitative findings regarding behavioral determinants.

Family-Based Obesity Prevention Interventions among Hispanic Children and Families: A Scoping Review.

This scoping review examined intervention and sample characteristics of family-based obesity prevention interventions among Hispanic youth. This review also examined the degree to which existing interventions were culturally-adapted, acknowledged social determinants of health (SDoH), and collaborated with community stakeholders. A comprehensive search across Medline Ovid, Embase, Scopus, PsycInfo, and Pubmed was used to identify 13 studies primarily based in the U.S. (92.3%). Data was extracted by two independent reviewers. Most used a randomized control trial design (69.2%), a behavior change theory (84.6%), and reported moderate to high (≥70%) retention (69.2%). Studies targeted improvements in physical activity (69.2%) and fruit and vegetable intake (92.3%) through nutrition education, cooking demonstrations, and tastings. Younger children from low socioeconomic backgrounds (61.5%) were well represented. Most interventions were culturally-adapted (69.2%), all studies reported collaboration with stakeholders, yet only half used strategies that acknowledged SDoH (46.2%). To increase our understanding of the underlying mechanisms by which family-based approaches can reach and engage Hispanic youth and families, future studies should rigorously evaluate theoretical constructs, family processes, and SDoH that influence program participation and health behaviors. This information will guide the design and development of future interventions aimed at reducing obesity disparities among Hispanic youth.

Associations between Screen-Based Activities, Physical Activity, and Dietary Habits in Mexican Schoolchildren.

Screen-based activities are associated with increased risk of obesity and contribute to physical inactivity and poor dietary habits. The primary aim of this study was to examine the associations among screen-based activities, physical activity, and dietary habits in school-aged children in Guadalajara, Puerto Vallarta, and Mexico City, Mexico. The secondary aim was to examine these associations across sex. The School Physical Activity and Nutrition survey was used to assess screen-based activities (TV watching, video game use, computer use), physical activity, and dietary habits. Organized activity/sports participation, unhealthy dietary habits, and household income were correlated with screen-based activities. While TV watching was associated with decreased participation in organized activity/sports participation, computer and video game use was associated with increased organized activity/sports participation. Boys engaged in more TV watching and video game use compared to girls. All screen-based activities were associated with age among boys; whereas video game and computer use were associated with higher income among girls. These findings suggest a need for sex- and age-specific strategies that acknowledge the differential use of screen-based activities across sex and age. Future research should continue to identify underlying correlates linking screen-based activities with health behaviors to inform strategies to reduce screen-time in Mexican children.

Opportunities to Address Obesity Disparities Among High-Risk Latino Children and Adolescents.

PURPOSE OF REVIEW: This review highlights obesity-related disparities among Latino children and adolescents, discusses the social determinants of health (SDoH) that drive disparities, and presents case studies of strategies for reducing disparities and promoting health equity. RECENT FINDINGS: Recommended strategies for reducing obesity-related disparities include the use of culturally grounded programming, multi-sector collaborations, and technology. We present two exemplar studies that demonstrate that integrating cultural values and enhancing the overall cultural fit of prevention programs can increase engagement among high-risk Latino families. We also examine the use of multi-sector collaborations to build community capacity and address key SDoH that impact health behaviors and outcomes. Our last example study demonstrates the utility of technology for engaging youth and extending the reach of prevention strategies in vulnerable communities. To address growing obesity-related disparities, there is an urgent need to develop and test these strategies among high-risk, vulnerable populations like Latino children and adolescents.

Perceptions of Family-Level Social Factors That Influence Health Behaviors in Latinx Adolescents and Young Adults at High Risk for Type 2 Diabetes.

Given that health behaviors occur within the context of familial social relationships, a deeper understanding of social factors that influence health behaviors in Latinx families is needed to develop more effective diabetes prevention programming. This qualitative study identified perceived family-level social factors that influence health behaviors in Latinx adolescents (12-16 years; N = 16) and young adults (18-24 years; N = 15) with obesity and explored differences in perceptions across sex and age. Participants completed an in-depth interview that was recorded, transcribed, and coded using thematic content analysis. Emergent themes central to health behaviors included: perceived parental roles and responsibilities, perceived family social support for health behaviors, and familial social relationships. Mom's role as primary caregiver and dad's role as a hard worker were seen as barriers to engaging in health behaviors among adolescent females and young adults, males and females. Adolescents perceived receiving more support compared to young adults and males perceived receiving more support compared to females. Health behaviors in both age groups were shaped through early familial social interactions around physical activity. These insights suggest that traditional gender roles, social support, and social interaction around health behaviors are critical components for family-based diabetes prevention programs in high-risk Latinx youth and young adults.

Theoretical Mediators of Diabetes Risk and Quality of Life Following a Diabetes Prevention Program for Latino Youth With Obesity.

PURPOSE: This study tested self-efficacy and social support for activity and dietary changes as mediators of changes in type 2 diabetes related outcomes following a lifestyle intervention among Latino youth. SETTING AND INTERVENTION: Latino adolescents (14-16 years) with obesity (BMI% = 98.1 ± 1.4) were randomized to a 3-month intervention (n = 67) that fostered self-efficacy and social support through weekly, family-centered sessions or a comparison condition (n = 69). MEASURES: Primary outcomes included insulin sensitivity and weight specific quality of life. Mediators included self-efficacy, friend, and family social support for health behaviors. Data was collected at baseline, 3-months, 6-months, and 12-months. ANALYSIS: Sequential path analysis was used to examine mediators as mechanisms by which the intervention influenced primary outcomes. RESULTS: The intervention had a direct effect on family (ß = 0.33, P < .01) and friend social support (ß = 0.22, P < .001) immediately following the intervention (3-months). Increased family social support mediated the intervention's effect on self-efficacy at 6-months (ß = 0.09, P < .01). However, social support and self-efficacy did not mediate long-term changes in primary outcomes (P > .05) at 12-months. CONCLUSIONS: Family social support may improve self-efficacy for health behaviors in high-risk Latino youth, highlighting the important role of family diabetes prevention. Fostering family social support is a critical intervention target and more research is needed to understand family-level factors that have the potential to lead to long-term metabolic and psychosocial outcome in vulnerable youth.

Stakeholder perspectives and sustainability of an integrated care model for the prevention and management of obesity: the Childhood Obesity Research Demonstration (CORD) project.

Although reliable strategies exist to promote healthy habits that reduce childhood obesity, the sustainability of these strategies remains an ongoing public health challenge. This study aimed to identify factors experienced in a large, multisite project aimed at reducing childhood obesity that might contribute to project sustainability. Hypothesized constructs underpinning sustainability included replicability, continuation of benefits, institutionalization, and community capacity. Key informants (n = 27) completed 60 min, in-depth interviews, which were audio recorded and transcribed. Transcripts were first coded using a combined deductive and inductive approach. Four major themes emerged (with numerous subthemes): developing partnerships, challenges to the sustainability of implemented programming, the importance of intervening in multiple settings, and ongoing implementation and evaluation strategies. Replicability of complex childhood obesity interventions is possible when there are strong partnerships. Benefits can continue to be conferred from programming, particularly when evidence-based strategies are used that employ best practices. Implementation is facilitated by institutionalization and policies that buffer challenges, such as staffing or leadership changes. Community capacity both enhances the sustainability of interventions and develops as a result of strengthening partnerships and policies that support childhood obesity programming.

Lessons Learned From Implementing of Garden Education Program in Early Child Care.

Background. Early childhood is a critical life period for promoting health behaviors, and early child care and education centers (ECECs) are critical settings, as 60% of U.S. children attend ECECs. Yet few programs or curricula that promote physical activity and nutrition in this setting exist. This study explored the acceptability, feasibility, and sustainability of the Sustainability via Active Garden Education (SAGE) program. Method. Preintervention interviews were conducted to inform the design of SAGE and postintervention interviews were conducted to evaluate the implementation of SAGE in the ECEC setting. A constant comparison approach was used to capture emergent themes on acceptability, feasibility, and sustainability from interviews. Participants. ECEC directors (N = 10, 90% female, 20% Hispanic, 30% African American). Results. Directors expressed that SAGE was acceptable and feasible as it was age-appropriate, engaging, and aligned with existing curricula and accreditation standards. Most directors reported that SAGE improved activity and nutrition related knowledge while building other social and academic skills (e.g., expanding vocabulary) that are critical to this important developmental period. Suggestions for improving the sustainability of the program included stronger parental involvement and opportunities for ECEC staff trainings.

Relationship of Circulating Endothelial Cells With Obesity and Cardiometabolic Risk Factors in Children and Adolescents.

Background Circulating endothelial cells (CECs) reflect early changes in endothelial health; however, the degree to which CEC number and activation is related to adiposity and cardiovascular risk factors in youth is not well described. Methods and Results Youth in this study (N=271; aged 8-20 years) were classified into normal weight (body mass index [BMI] percentage <85th; n=114), obesity (BMI percentage ≥95th to <120% of the 95th; n=63), and severe obesity (BMI percentage ≥120% of the 95th; n=94) catagories. CEC enumeration was determined using immunohistochemical examination of buffy coat smears and activated CEC (percentage of vascular cell adhesion molecule-1 expression) was assessed using immunofluorescent staining. Cardiovascular risk factors included measures of body composition, blood pressure, glucose, insulin, lipid profile, C-reactive protein, leptin, adiponectin, oxidized low-density lipoprotein cholesterol, carotid artery intima-media thickness, and pulse wave velocity. Linear regression models examined associations between CEC number and activation with BMI and cardiovascular risk factors. CEC number did not differ among BMI classes (P>0.05). Youth with severe obesity had a higher degree of CEC activation compared with normal weight youth (8.3%; 95% CI, 1.1-15.6 [P=0.024]). Higher CEC number was associated with greater body fat percentage (0.02 per percentage; 95% CI, 0.00-0.03 [P=0.020]) and systolic blood pressure percentile (0.01 per percentage; 95% CI, 0.00-0.01 [P=0.035]). Higher degree of CEC activation was associated with greater visceral adipose tissue (5.7% per kg; 95% CI, 0.4-10.9 [P=0.034]) and non-high-density lipoprotein cholesterol (0.11% per mg/dL; 95% CI, 0.01-0.21 [P=0.039]). Conclusions Methods of CEC quantification are associated with adiposity and cardiometabolic risk factors and may potentially reflect accelerated atherosclerosis as early as childhood.

Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population.

BACKGROUND/AIMS: Prediabetes and diabetes disproportionately impact Latino youth, yet few diabetes prevention programs have prioritized inclusion of this underrepresented population. This report describes the recruitment process, yields, associated costs, and phenotypic characteristics of Latino youth with obesity and prediabetes enrolled in a randomized controlled diabetes prevention study in the USA. METHODS: Recruitment efforts included referrals from clinics, community outlets, local media, and word of mouth with the goal of enrolling 120 Latino adolescents aged 12-16 with obesity (BMI > 95th percentile) and prediabetes. Prediabetes eligibility was determined by any of the following: HbA1c between 5.7 and 6.5%, fasting glucose between 100 and 125 mg/dL, or a 2-h glucose between 120 and 199 mg/dL following a 75-g oral glucose tolerance test (OGTT), but not meeting any of the diagnostic criteria for diabetes. Eligible participants were randomized 2:1 to either a 6-month community-based lifestyle intervention that included group nutrition and health education classes (1 day/week) and group exercise classes (2 days/week) or usual care control arm. Recruitment yields were determined by review of referral source in the study screening database. Recruitment costs were determined by an after-the-fact financial review of actual and in-kind costs. Participant phenotypic characteristics (i.e., demographics, anthropometrics, and biochemical data) were compared by recruitment strategy using a one-way ANOVA. RESULTS: Recruitment efforts covered 160 mile2 (414 km2) across 26 ZIP codes (postcode) in the Phoenix Metropolitan Area and yielded 655 referrals from clinics (n = 344), community (n = 143), media (n = 137), and word-of-mouth (n = 31). From this pool, 26% (n = 167) did not meet general, pre-screening eligibility criteria; 29% (n = 187) declined participation; and 10% (n = 64) were unable to be contacted. A total of 237 youth were invited to the clinical research unit to determine final eligibility. Following the OGTT, 52% (n = 122) met prediabetes criteria and 117 were subsequently randomized. Clinical recruitment yielded the highest number of referrals (53%; n = 344) while word-of-mouth yielded the highest proportion (35%; n = 11) of randomized participants per referred youth. There were no significant differences in anthropometric or biochemical measures among youth by recruitment strategy. Based upon final enrollment numbers, community recruitment was the costliest approach ($486/randomized participant) followed by clinical ($248/randomized participant) and media ($236/randomized participant). CONCLUSIONS: The ability to meet enrollment goals for a clinical trial of an underrepresented population required multiple recruitment strategies. Although strategies vary in yields and costs, it appears they produce similar phenotypical risk profiles of eligible youth. TRIAL REGISTRATION: ClinicalTrials.gov NCT02615353 . Registered on 26 November 2015.