Neighborhood environments and psychological distress 6-years later: results from the San Diego HCHS/SOL community and surrounding areas study.

PURPOSE: The current study examined associations of social and built features of neighborhood environments with psychological distress 6 years later and whether these associations were explained by stress and social factors, among Hispanic/Latino adults from the HCHS/SOL and SOL CASAS Ancillary Study. METHODS: In the SOL CASAS Ancillary Study, HCHS/SOL San Diego participants' baseline (2008-2011) home addresses were geocoded, neighborhoods were defined using 800 m radial buffers, and variables representing neighborhood socioeconomic deprivation, social disorder, walkability, and greenness were created. Psychological distress (anxiety and depression symptoms) and proposed pathway variables chronic stress, social support, and family cohesion were assessed at HCHS/SOL Visit 2 (2014-2017). RESULTS: On average, the population (n = 2785) was 39.47 years old, 53.3% were women, and 92.3% were of Mexican heritage. In complex survey regression analyses that accounted for sociodemographic covariates, the complex sampling design, and sample weights, greater baseline neighborhood socioeconomic deprivation predicted lower family cohesion at Visit 2 (B = -0.99, 95% CI [-1.97, -0.06]). Path models showed indirect associations of baseline neighborhood socioeconomic deprivation with Visit 2 psychological distress through family cohesion (MacKinnon's 95% CI depression [0.001, 0.026]; 3.9% of the variance accounted for; anxiety [0.00071, 0.019] 3.0% of the variance accounted for). CONCLUSIONS: Among adults of mostly Mexican heritage from the San Diego, CA area, neighborhood deprivation indirectly predicted later psychological distress through family cohesion. No other effects of neighborhood variables were observed.

Mi Puente (My Bridge) Care Transitions Program for Hispanic/Latino Adults with Multimorbidity: Results of a Randomized Controlled Trial.

BACKGROUND: Multimorbidity frequently co-occurs with behavioral health concerns and leads to increased healthcare costs and reduced quality and quantity of life. Unplanned readmissions are a primary driver of high healthcare costs. OBJECTIVE: We tested the effectiveness of a culturally appropriate care transitions program for Latino adults with multiple cardiometabolic conditions and behavioral health concerns in reducing hospital utilization and improving patient-reported outcomes. DESIGN: Randomized, controlled, single-blind parallel-groups. PARTICIPANTS: Hispanic/Latino adults (N=536; 75% of those screened and eligible; M=62.3 years (SD=13.9); 48% women; 73% born in Mexico) with multiple chronic cardiometabolic conditions and at least one behavioral health concern (e.g., depression symptoms, alcohol misuse) hospitalized at a hospital that serves a large, mostly Hispanic/Latino, low-income population. INTERVENTIONS: Usual care (UC) involved best-practice discharge processes (e.g., discharge instructions, assistance with appointments). Mi Puente ("My Bridge"; MP) was a culturally appropriate program of UC plus inpatient and telephone encounters with a behavioral health nurse and community mentor team who addressed participants' social, medical, and behavioral health needs. MAIN MEASURES: The primary outcome was 30- and 180-day readmissions (inpatient, emergency, and observation visits). Patient-reported outcomes (quality of life, patient activation) and healthcare use were also examined. KEY RESULTS: In intention-to-treat models, the MP group evidenced a higher rate of recurrent hospitalization (15.9%) versus UC (9.4%) (OR=1.91 (95% CI 1.09, 3.33)), and a greater number of recurrent hospitalizations (M=0.20 (SD=0.49) MP versus 0.12 (SD=0.45) UC; P=0.02) at 30 days. Similar trends were observed at 180 days. Both groups showed improved patient-reported outcomes, with no advantage in the Mi Puente group. Results were similar in per protocol analyses. CONCLUSIONS: In this at-risk population, the MP group experienced increased hospital utilization and did not demonstrate an advantage in improved patient-reported outcomes, relative to UC. Possible reasons for these unexpected findings are discussed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02723019. Registered on 30 March 2016.

The Effect of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Cardiometabolic Health Biomarkers: A Systematic Review of Randomized Controlled Trials.

OBJECTIVES: To assess the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) on cardiometabolic health biomarkers. METHOD: Cochrane CENTRAL, Embase, Medline, and PsycINFO were searched, and records were screened by two independent reviewers. Inclusion criteria were adult population, delivery of CBT-I, randomized controlled trial design, ≥1 cardiometabolic health outcome, and peer-review. Hedge's g effect sizes were calculated, and the quality of the evidence was appraised using the Cochrane Risk of Bias 2 tool. RESULTS: After screening 1649 records, 15 studies were included (total N = 2067). Inflammatory markers (CRP, IL-6, TNF-α), blood pressure (SBP, DBP), and glycemic regulation (HbA1c) were most frequently reported (in ≥3 studies each). HbA1c and CRP were reduced in the CBT-I group compared to the control group (in 3 studies each). Effects varied or were null for IL-6, TNF-α, SBP, and DBP. Six studies were judged as low, four as moderate, and five as high risk of bias. CONCLUSION: CBT-I was most consistently associated with improved HbA1c and CRP, which are relatively temporally stable, suggesting influences on enduring habits rather than short-term behavior changes. High risk of bias limits the interpretation of findings. Methodologically adequate studies are needed to better understand cardiometabolic effects of CBT-I.

Perceived neighborhood factors, health behaviors, and related outcomes in the Hispanic Community Health Study/Study of Latinos.

Hispanic/Latino populations may experience significant neighborhood disadvantage, but limited research has explored whether these factors affect their health behaviors. Associations between perceived neighborhood factors at Visit 1 and health behaviors and related outcomes at Visit 2 in the Hispanic Community Health Study/Study of Latinos were evaluated. Multivariable logistic regression assessed cross-sectional and longitudinal relationships between perceived neighborhood social cohesion (NSC, 5 items), and neighborhood problems (NP, 7 items), with cancer screening, current smoking, excessive/binge drinking, hypertension, obesity, physical activity, and poor diet by gender and birthplace. NSC and NP scores were converted into quartiles. Mean age of participants was 42.5 years and 62.1% were women. Perceived NP, but not perceived NSC, differed by gender (p < 0.001). In unstratified models, no significant associations were observed between perceived NSC and any health behavior, whereas greater perceived NP was associated with less adherence to colon cancer screening (moderate level: aOR = 0.68, 95% CI = 0.51, 090) and more physical activity (very high level: aOR = 1.34, 95% CI = 1.06, 1.69) compared to low perceived NP. Women with moderate perceived NP, versus low NP, had a lower odds of colon cancer screening at Visit 1 (aOR = 0.62, 95% CI = 0.43, 0.91) and higher odds of mammogram adherence at Visit 2 (aOR = 2.86, 95% CI = 1.44, 5.68). Men with high perceived NP had a higher odds of excessive or binge drinking at Visit 2 (aOR = 1.99, 95% CI = 1.19, 3.31). We conclude that perceived NP were significantly related to health behaviors among HCHS/SOL individuals. Perceptions of neighborhood environment may be considered modifiable factors of structural neighborhood environment interventions.

Neighborhood built environments and Hispanic/Latino adults' physical activity in the U.S.: The Hispanic community health study/study of Latinos community and surrounding areas study.

Despite experiencing health inequities, less is known about neighborhood environments and physical activity among Hispanic/Latino adults compared to other populations. We investigated this topic in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Hispanic/Latino adults in the San Diego, California area of the U.S. completed measures of overall moderate-to-vigorous physical activity (MVPA) via accelerometry and domain-specific MVPA via questionnaire at Visits 1 (2008-2011; n = 4086) and 2 (2014-2017; n = 1776), ~6 years apart. 800-m home neighborhood buffers were used to create objective measures of residential, intersection, and retail density, bus/trolley stops, greenness, parks, and recreation area at Visit 1. Regression models tested the association of each neighborhood feature with MVPA at Visit 1 and over 6 years, adjusting for individual characteristics and neighborhood socioeconomic deprivation. At Visit 1, those in neighborhoods with higher vs. lower retail density or recreation area (+1 vs. -1 standard deviation from the mean) engaged in 10% more overall MVPA and 12-22% more active transportation. Those in neighborhoods with higher vs. lower residential density engaged in 22% more active transportation. Those in neighborhoods with higher vs. lower greenness and park count engaged in 14-16% more recreational MVPA. Neighborhood features were unassociated with changes in MVPA over 6 years. Although changes in MVPA over time were similar across neighborhoods, Hispanic/Latino adults living in neighborhoods with design features supportive of walking and recreational activity (e.g., greater residential and retail density, more parks and recreation facilities) were consistently more active. Improving neighborhood environments appears important for supporting physical activity among Hispanic/Latino adults.

Associations of Sleep-disordered Breathing and Insomnia with Incident Hypertension and Diabetes. The Hispanic Community Health Study/Study of Latinos.

Rationale: Sleep disorders are associated with hypertension and diabetes, which are primary risk factors for cardiovascular diseases and mortality. It is important to understand these associations in Hispanic/Latino individuals, in whom cardiovascular death is the leading cause of mortality.Objectives: To investigate the prospective associations of sleep-disordered breathing (SDB) and insomnia with incident hypertension and diabetes among U.S. Hispanic/Latino people over 6 years of follow-up and to assess potential sex differences in these associations.Methods: Data from 11,623 Hispanic/Latino participants in the Hispanic Community Health Study/Study of Latinos (visit 1, 2008-2011; visit 2, 2014-2017) were analyzed using survey logistic regression models, adjusting for potential confounders.Measurements and Main Results: SDB (apnea-hypopnea index of 5 or more) and insomnia (Women's Health Initiative Insomnia Rating Scale of 9 or more) were measured at baseline. Incident hypertension (stage 2 or greater) and diabetes were defined according to national guidelines. In the target population, 52.6% were women, with a mean age of 41.1 ± 14.9 years at baseline. SDB was associated with 1.54 higher adjusted odds of incident hypertension (95% confidence interval [CI], 1.18-2.00) and 1.33 higher odds of incident diabetes (95% CI, 1.05-1.67) compared with no SDB. Insomnia was associated with incident hypertension (odds ratio, 1.37; 95% CI, 1.11-1.69) but not with diabetes. The association between insomnia and incident hypertension was stronger among men than among women.Conclusions: SDB was associated with incident hypertension and diabetes. Insomnia was associated with incident hypertension. These findings support the importance of sleep disorders as modifiable targets for disease prevention and reduction.

Marital Status and Gender Associated with Sleep Health among Hispanics/Latinos in the US: Results from HCHS/SOL and Sueño Ancillary Studies.

Poor sleep and different patterns of marital status among Hispanics/Latinos have been documented, yet the extent to which marital status is associated with sleep health and the moderating role of gender in this association among Hispanics/Latinos is poorly understood.Demographic and sleep data were obtained from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL: n= 16,415), an epidemiological cohort study, and the Sueño Study (n= 2,252) that is an ancillary to HCHS/SOL. Sleep duration, insomnia symptoms, daytime sleepiness, napping, and snoring were self-reported and drawn from HCHS/SOL. Sleep efficiency, sleep fragmentation, and inter-day stability were objectively assessed in the Sueño Study.Complex sample analyses indicated that being married or cohabiting was associated with better sleep health in general, including having normal sleep duration, fewer insomnia symptoms, and higher sleep efficiency (F> 2.804, p< .044). These associations were more prominent in objectively measured sleep indices and among females.Findings suggest being in a committed relationship associated with better sleep health in Hispanics/Latinos in the US, a diverse and under-represented population. Findings may have implications for tailoring sleep health interventions to at-risk populations who may less likely to be in a committed relationship.

Relationships of Sleep Duration, Midpoint, and Variability with Physical Activity in the HCHS/SOL Sueño Ancillary Study.

OBJECTIVE/BACKGROUND: Short and long sleep duration, later sleep midpoint, and greater intra-individual sleep variability are associated with lower physical activity, but previous research lacks objective and concurrent assessment of sleep and physical activity. This cross-sectional study examined whether sleep duration, midpoint, and variability in duration and midpoint were related to wrist actigraphy-measured physical activity. PARTICIPANTS: Participants were 2156 Hispanics/Latinos in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) Sueño Ancillary Study. METHODS: Participants wore Actiwatch devices to measure sleep and physical activity via the wrist for ≥5 days. Physical activity was defined as minutes/day in the upper quartile of the sampling distribution's non-sleep activity, capturing light to vigorous physical activity. RESULTS: An inverse linear relationship between sleep duration and physical activity was found such that each additional sleep hour related to 29 fewer minutes of physical activity (B = -28.7, SE = 3.8), p < .01). Variability in sleep midpoint was also associated with physical activity; with each 1-hr increase in variability there were 24 more minutes of physical activity (B = 24.2, SE = 5.6, p < .01). In contrast, sleep midpoint and variability in duration were not associated with physical activity. Sensitivity analyses identified an association of short sleep duration and greater variability in sleep duration with greater accelerometry-derived moderate-to-vigorous physical activity measured at the HCHS/SOL baseline (M = 2.1 years before the sleep assessment). CONCLUSIONS: Findings help clarify inconsistent prior research associating short sleep duration and sleep variability with greater health risks but also contribute novel information with simultaneous objective assessments.

Socioeconomic Adversity, Social Resources, and Allostatic Load Among Hispanic/Latino Youth: The Study of Latino Youth.

OBJECTIVE: We examined associations among socioeconomic adversity, social resources, and allostatic load in Hispanic/Latino youth, who are at high risk for obesity and related cardiometabolic risks. METHODS: Participants were 1343 Hispanic/Latino youth (51% male; ages 8-16 years) offspring of Hispanic Community Health Study/Study of Latinos participants. Between 2012 and 2014, youth underwent a fasting blood draw and anthropometric assessment, and youth and their enrolled caregivers provided social and demographic information. A composite indicator of allostatic load represented dysregulation across general metabolism, cardiovascular, glucose metabolism, lipid, and inflammation/hemostatic systems. Socioeconomic adversity was a composite of caregiver education, employment status, economic hardship, family income relative to poverty, family structure, and receipt of food assistance. Social resources were a composite of family functioning, parental closeness, peer support, and parenting style variables. RESULTS: Multivariable regression models that adjusted for sociodemographic factors, design effects (strata and clustering), and sample weights revealed a significant, positive, association between socioeconomic adversity and allostatic load (ß = .10, p = .035), and a significant, inverse association between socioeconomic adversity and social resources (ß = -.10, p = .013). Social resources did not relate to allostatic load and did not moderate or help explain the association of adversity with allostatic load (all p values > .05). CONCLUSIONS: Statistically significant, but small associations of socioeconomic adversity with both allostatic load and social resources were identified. The small effects may partially reflect range restriction given overall high socioeconomic adversity and high social resources in the cohort.

Innovative Diabetes Interventions in the U.S. Hispanic Population.

IN BRIEF In the United States, Hispanics have a 66% greater risk of developing type 2 diabetes and, once diagnosed, exhibit worse outcomes than non-Hispanic whites. It is therefore imperative to ensure that interventions meet the specific needs of this at-risk group. This article provides a selective review of the evidence on innovative, real-world approaches (both live and technology-based) to improving behavioral, psychosocial, and clinical outcomes in underserved Hispanics with type 2 diabetes. Key aspects of successful live interventions have included multimodal delivery, greater dosage/attendance, and at least some in-person delivery; effective technology-based approaches involved frequent but intermittent communication, bi-directional messaging, tailored feedback, multimodal delivery, and some human interaction. Across modalities, cultural tailoring also improved outcomes. Additional research is needed to address methodological limitations of studies to date and pinpoint the most efficacious components and optimal duration of interventions. Future efforts should also attend to variability within the U.S. Hispanic population to ensure acceptability and sustainability of interventions in this diverse group.

Sleep habits in adolescents with type 1 diabetes: Variability in sleep duration linked with glycemic control.

OBJECTIVE: To describe adolescents' sleep on school and weekend nights using multiple methods and to examine the links between sleep variability, quality, and duration with diabetes indicators. METHODS: Adolescents with type 1 diabetes (N = 65, mean age = 15.0, 52.3% female, mean HbA1c = 8.9% or 74 mmol/mol) wore an actigraph and kept daily diaries recording sleep, activities, and blood glucose monitoring (BGM) habits for at least 7 days. Average daily BGM and blood glucose (BG) levels were obtained through glucometer downloads. HbA1c was obtained as part of clinic visits. Adolescents completed a sleep quality questionnaire (Pittsburgh sleep quality index [PSQI]), and adolescents and caregivers reported on adherence to diabetes treatment. RESULTS: Adolescents reported a mean PSQI global score of 5.37, which is above the clinical cutoff for poor sleep quality. Actigraphy data revealed that mean adolescent total sleep time was 6:54 (h:min), and participants slept more on weekend nights than on school nights (P < .001). Additionally, variability in sleep duration was significantly related to HbA1c, frequency of BGM, and average BG. Total sleep time and self-reported sleep quality were not significantly associated with adherence or glycemic control. CONCLUSIONS: Few adolescents with type 1 diabetes met recommendations for sleep duration, and many reported poor sleep quality. We identified significant associations between variability in sleep duration with poorer glycemic control and less frequent BGM, supporting the need to consider sleep patterns as a modifiable factor that may affect adherence and glycemic control.

Maternal diabetes distress is linked to maternal depressive symptoms and adolescents' glycemic control.

OBJECTIVE: Mothers of youth with type 1 diabetes experience increased levels of stress and depression related to the burden of diabetes management, but the concept of diabetes distress, or distress linked specifically to diabetes and its management, has not been applied to mothers. The current study examined diabetes distress in relation to maternal depressive symptoms and adolescents' glycemic control. RESEARCH DESIGN AND METHODS: Mothers of youth with type 1 diabetes (age: 10-16) completed a measure of depressive symptoms and diabetes distress as part of a screening questionnaire. Adolescents' glycosylated hemoglobin (HbA1c) was obtained from medical records. RESULTS: Mothers' diabetes distress was strongly related to maternal depressive symptoms, and relationship-related diabetes distress was significantly associated with adolescents' HbA1c. In multivariate analyses, maternal depression was the only significant predictor of glycemic control. CONCLUSIONS: Given the links between mothers' diabetes distress, maternal depressive symptoms, and adolescents' glycemic control, diabetes distress may be important to consider when targeting both maternal and adolescent adjustment to type 1 diabetes.

Executive Function in Adolescents With Type 1 Diabetes: Relationship to Adherence, Glycemic Control, and Psychosocial Outcomes.

Objective: Impairments in executive function (EF) skills have been observed in youth with type 1 diabetes (T1D), and these skills are critical for following the complex treatment regimen. This study examines parent reports of EF in relation to measures of adherence, glycemic control (A1c), and psychosocial outcomes (depression and quality of life) in adolescents with T1D. A total of 120 adolescents (aged 13-17 years, 52.5% female, 87.5% White) with T1D and their parents completed questionnaires. Glucometers were downloaded and A1c was obtained during clinical visits at the time of enrollment. The prevalence of clinically significant elevated scores on specific EF skills ranged from 11 to 18.6%. In multivariate analyses, parent-reported EF deficits were associated with poorer adherence and lower quality of life, explaining 13 and 12% of the variance, respectively. Adolescents with T1D exhibit specific EF deficits that may negatively impact their quality of life and their ability to engage in self-management activities.

Social and built neighborhood environments and sleep health: The Hispanic Community Health Study/Study of Latinos Community and Surrounding Areas and Sueño Ancillary Studies.

STUDY OBJECTIVES: To test associations between neighborhood social, built, and ambient environment characteristics and multidimensional sleep health in Hispanic/Latino adults. METHODS: Data were from San Diego-based Hispanic/Latino adults mostly of Mexican heritage enrolled in the Hispanic Community Health Study/Study of Latinos (N = 342). Home addresses were geocoded to ascertain neighborhood characteristics of greenness, walkability (density of intersections, retail spaces, and residences), socioeconomic deprivation (e.g. lower income, lower education), social disorder (e.g. vacant buildings, crime), traffic density, and air pollution (PM 2.5) in the Study of Latinos Communities and Surrounding Areas Study. Sleep dimensions of regularity, satisfaction, alertness, timing, efficiency, and duration were measured by self-report or actigraphy approximately 2 years later. Multivariable regression models accounting for study design (stratification and clustering) were used to examine associations of neighborhood variables with individual sleep dimensions and a multidimensional sleep health composite score. RESULTS: Neighborhood characteristics were not significantly associated with the multidimensional sleep health composite, and there were few significant associations with individual sleep dimensions. Greater levels of air pollution (B = 9.03, 95% CI: 1.16, 16.91) were associated with later sleep midpoint, while greater social disorder (B = -6.90, 95% CI: -13.12, -0.67) was associated with earlier sleep midpoint. Lower walkability was associated with more wake after sleep onset (B = -3.58, 95% CI: -7.07, -0.09). CONCLUSIONS: Living in neighborhoods with lower walkability and greater air pollution was associated with worse sleep health, but otherwise findings were largely null. Future research should test these hypotheses in settings with greater variability and investigate mechanisms of these associations.

eHealth weight loss interventions for adults with low income: A systematic review.

OBJECTIVE: There is a tremendous opportunity for electronic health services (eHealth) to reach adults with low income who want to participate in weight loss interventions, but face barriers in access. This review (a) synthesizes and presents results from all studies evaluating the effectiveness of eHealth weight loss interventions for adults with low income and (b) describes the strategies used to tailor them to these groups. METHOD: Electronic databases were searched for studies examining the effectiveness of eHealth weight loss interventions designed for adults with low income and screened for eligibility by two independent reviewers. All experimental study designs were included. Data were extracted, results were qualitatively synthesized, and studies were assessed for quality. RESULTS: Nine studies met the inclusion criteria (N = 1,606 total participants). Four studies reported significant reductions in weight of small to moderate magnitude among participants in eHealth interventions (M weight loss = -2.2 kg; SD = 1.6). Many studies did not describe how they tailored the intervention for adults with low income; however, studies that achieved significant results tended to use more tailoring strategies. Most studies reported high retention rates. Three studies were rated as strong quality, four as moderate, and two as weak. CONCLUSIONS: Evidence is limited that eHealth weight loss interventions for this population are effective in achieving clinically and statistically significant weight reductions. While interventions that used more tailoring strategies tended to be more effective, studies that use the rigorous methodology and describe interventions in more depth could better elucidate whether eHealth interventions are an effective approach in this population. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Objective sleep and cardiometabolic biomarkers: results from the community of mine study.

Study Objectives: Examining multiple dimensions of sleep health may better capture associations between sleep and health risks, including cardiometabolic disease (CMD). Hispanics have elevated risk for inadequate sleep and CMD biomarkers. Few studies have explored whether associations between sleep and CMD differ by Hispanic ethnicity. Methods: Leveraging data from the Community of Mine (CoM) study, a cross-sectional investigation of 602 ethnically diverse participants, we derived accelerometer-measured sleep duration and efficiency, and self-reported sleep quality. Accelerometer-measured sleep exposures were analyzed both as continuous and categorical variables. Multivariate and quantile regression models were used to assess associations between sleep and CMD biomarkers (insulin resistance, systolic blood pressure, and low-density-lipoprotein cholesterol), controlling for age, sex, ethnicity, education, smoking status, and body mass index. We examined the potential effect modification of Hispanic ethnicity. Results: We observed mixed results based on CMD biomarkers and sleep exposure. Increased sleep duration was significantly related to low-density lipoprotein cholesterol in adjusted models (estimate = 0.06; 95% CI: 0.02, 0.11). Poor sleep efficiency was associated with greater insulin resistance in the adjusted quantile (estimate = 0.20; 95% CI: 0.04, 0.36) model at the 90th percentile. Self-reported sleep quality was not associated with CMD outcomes. There was no evidence of effect modification by Hispanic ethnicity. Conclusions: In this cohort, sleep health measures were found to have mixed and at times opposing effects on CMD outcomes. These effects did not demonstrate an interaction with Hispanic ethnicity.

Process evaluation of Dulce Digital-Me: an adaptive mobile health (mHealth) intervention for underserved Hispanics with diabetes.

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.

Type 2 diabetes disproportionately impacts ethnic minorities, including Hispanic individuals; however, these populations are often underrepresented in clinical research, especially in studies using digital technologies. The Dulce Digital-Me study was developed to provide diabetes self-management education and support using mobile health technologies with the goal of improving clinical outcomes by reducing barriers to accessing support. This analysis revealed that the Dulce Digital-Me study was successful at reaching the target population and engaging them with the intervention, while also delivering the study intervention with high fidelity. This process evaluation provides critical context for understanding the study's clinical outcomes and the potential for further dissemination.

Process evaluation of a medical assistant health coaching intervention for type 2 diabetes in diverse primary care settings.

Team-based models that use medical assistants (MAs) to provide self-management support for adults with type 2 diabetes (T2D) have not been pragmatically tested in diverse samples. This cluster-randomized controlled trial compares MA health coaching with usual care in adults with T2D and poor clinical control ("MAC Trial"). The purpose was to conduct a multi-method process evaluation of the MAC Trial using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Reach was assessed by calculating the proportion of enrolled participants out of the eligible pool and examining representativeness of those enrolled. Key informant interviews documented adoption by MA Health Coaches. We examined implementation from the research and patient perspectives by evaluating protocol adherence and the Patient Perceptions of Chronic Illness Care (PACIC-SF) measure, respectively. Findings indicate that the MAC Trial was efficient and effective in reaching patients who were representative of the target population. The acceptance rate among those approached for health coaching was high (87%). Both MA Health Coaches reported high satisfaction with the program and high levels of confidence in their role. The intervention was well-implemented, as evidenced by the protocol adherence rate of 79%; however, statistically significant changes in PACIC-SF scores were not observed. Overall, if found to be effective in improving clinical and patient-reported outcomes, the MAC model holds potential for wider-scale implementation given its successful adoption and implementation and demonstrated ability to reach patients with poorly controlled T2D who are at-risk for diabetes complications in diverse primary care settings.

Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes.

BACKGROUND: By 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant's individual needs with a greater focus on health behavior change. METHODS: This is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions. DISCUSSION: Our comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability. TRIAL REGISTRATION: NCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 .