Effect of Diets Varying in Iron and Saturated Fat on the Gut Microbiota and Intestinal Inflammation: A Crossover Feeding Study among Older Females with Obesity.

Obesity is considered an independent risk factor for colorectal cancer (CRC). Altered nutrient metabolism, particularly changes to digestion and intestinal absorption, may play an important role in the development of CRC. Iron can promote the formation of tissue-damaging and immune-modulating reactive oxygen species. We conducted a crossover, controlled feeding study to examine the effect of three, 3-week diets varying in iron and saturated fat content on the colonic milieu and systemic markers among older females with obesity. Anthropometrics, fasting venous blood and stool were collected before and after each diet. There was a minimum 3-week washout period between diets. Eighteen participants consumed the three diets (72% Black; mean age 60.4 years; mean body mass index 35.7 kg/m2). Results showed no effect of the diets on intestinal inflammation (fecal calprotectin) or circulating iron, inflammation, and metabolic markers. Pairwise comparisons revealed less community diversity between samples (beta diversity, calculated from 16S rRNA amplicon sequences) among participants when consuming a diet low in iron and high in saturated fat vs. when consuming a diet high in iron and saturated fat. More studies are needed to investigate if dietary iron represents a salient target for CRC prevention among individuals with obesity.

The association between neighborhood conditions and weight loss among older adults living in a large urban city.

To elucidate the role of neighborhood walkability and crime on weight loss, we examined data from older adults residing in Chicago who participated in a randomized controlled trial lifestyle intervention. Controlling for individual demographic characteristics and the intervention assignment, the neighborhood homicide rate was significantly associated with weight change. Participants who resided in neighborhoods above the 50th percentile of homicide rate actually gained weight between pre- and post-intervention. On the other hand, there was no significant relationship between the level of walkability and weight loss. Our findings suggest that the social environment related to neighborhood crime may play a more important role in weight loss than the built environment, such as walkability. Urban characteristics related to walkability, such as sidewalks, may increase physical activity, however, interventions aiming to increase physical activity to promote weight loss will benefit by addressing the neighborhood social environment that determines how people navigate space.

Navigated African American breast cancer patients as incidental change agents in their family/friend networks.

BACKGROUND: Patient navigation is an increasingly widespread intervention to address the persistent, severe, and disproportionate breast cancer (BC) burden that African Americans (AA) face. Navigation may have more widespread effects than previously estimated due to patient-driven diffusion of BC information. METHODS: This pilot study examined the network effects of a randomized controlled trial via recruitment of navigated and non-navigated AA BC patients as well as their network members. We estimated study arm differences in patient BC promotion (i.e., number of individuals to whom BC patients promote BC screening) and network BC screening (i.e., % BC screening among network members). RESULTS: Among our sample of 100 AA BC patients, navigated patients promoted BC screening to more individuals than non-navigated patients. BC patients were more likely to promote BC screening to children and individuals with whom they communicated more frequently. Some models further suggested more network BC screening among "navigated" network members relative to "non-navigated" network members. CONCLUSIONS: Navigated AA patients promoted BC screening more widely throughout their networks than non-navigated AA BC patients. There were also suggestive findings regarding increased BC screening among their network members. Our pilot study highlights the potential for social network analysis to improve the precision of intervention effect estimates and to inform future innovations (e.g., integrating navigation and network-based interventions) with multilevel effects on cancer health disparities.

Validation of a self-report home food availability checklist against in-home food inventories conducted in low-income Black/African American and Hispanic/Latinx households with preschool-age children.

Home food availability (HFA) checklists can be completed by self-report to assess the home food environment. Checklists developed for Black/African American (B/AA) and Hispanic/Latinx (H/L) households are seldom validated against objective approaches such as exhaustive in-home food inventories. This study validated a self-report HFA checklist developed for B/AA and H/L households (n = 97) against researcher-completed HFA checklists verified by exhaustive in-home food inventories. Mean estimates of sensitivity, specificity, and area of the receiver operating curve (ROC), and interrater agreement (Gwet AC1) were calculated to examine the accuracy and agreement of self-reported checklists against direct observation of individual food items. Mean differences in HFA food group scores were compared (self-report vs observed) to examine group-level relative validity. The predictive validity of this self-reported measure on observed scores and dietary intake were also examined with linear regression. The average values for ROC area (average of sensitivity and specificity) ranged from acceptable (0.76 for sweets) to excellent (0.81 for vegetables, fruits). Average interrater agreement values ranged from moderate (0.41-0.60: sweets) to substantial (0.61-0.79: vegetables, fruit, SSBs, savory foods). Self-reported mean scores, compared to observed scores, were higher for vegetables (mean diff: 1.04) and lower for sweets (mean diff: 0.38, p = 0.01), but regression analyses demonstrated that self-reported scores were good predictors of observed scores with absolute error (based on standard deviation of residuals) ranging from ±1.27 to 1.69 points. Self-reported scores also predicted multiple aspects of dietary intake but more so among H/L households. In conclusion, the HFA checklist obtained via self-report performed well based on multiple indicators of validity suggesting that this self-reported measure can be used to assess home food environments among of B/AA and H/L households.

Perspectives of multisectoral community stakeholders on Arab American cancer patients' needs and suggested interventions.

BACKGROUND: Multilevel barriers can arise after a cancer diagnosis, especially in underserved racial/ethnic minority patient populations, raising the need for diverse and contextually adapted interventions. However, limited data exists on Arab American (ArA) cancer patients' needs, partly due to their racial/ethnic misclassification as Whites. This study leveraged the perspectives of cancer survivors and community stakeholders (i.e., healthcare and community leaders) to identify ArA cancer patients' needs, as well as their preferred intervention strategies to address them. METHODS: Using a hybrid inductive-deductive content analysis approach, we analyzed qualitative data from interviews with 18 ArA community stakeholders recruited through community partners in Chicago. RESULTS: Participants associated cancer stigma to ArA patients' concealment of their diagnosis and aversion to cancer support groups. Economic and language barriers to treatment were emphasized. A lack of resources for ArA cancer patients was also noted and was partly attributed to their misclassification as White. In response to these needs, participants suggested peer mentorship programs to overcome privacy concerns, hospital-based patient navigation to address language and economic barriers in healthcare, diversification of the healthcare workforce to overcome language barriers, and community coalitions to recognize ArA as an ethnic group and increase cancer support resources. Such advocacy will be essential to accurately characterize patients' cancer burden and obtain funding to support community programs and resources. CONCLUSION: Our findings suggest that multilevel interventions at the patient, healthcare, and community levels are needed to address ArA cancer patients' needs.

Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.

This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m2, p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.

24-Month Outcomes of Primary Care Web-Based Depression Prevention Intervention in Adolescents: Randomized Clinical Trial.

BACKGROUND: Adolescent depression carries a high burden of disease worldwide, but access to care for this population is limited. Prevention is one solution to curtail the negative consequences of adolescent depression. Internet interventions to prevent adolescent depression can overcome barriers to access, but few studies examine long-term outcomes. OBJECTIVE: This study compares CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training), an internet-based intervention, to a general health education active control for depression onset at 12 and 24 months in adolescents presenting to primary care settings. METHODS: A 2-site randomized trial, blinded to the principal investigators and assessors, was conducted comparing Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training to health education to prevent depressive episodes in 369 adolescents (193 youths were randomly assigned to Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training and 176 to health education) with subthreshold depressive symptoms or prior depressive episodes. Participants were recruited from primary care settings in the United States. The primary outcome was the occurrence of a depressive episode, determined by the Depression Symptom Rating. The secondary outcome was functioning, measured by the Global Assessment Scale. RESULTS: In intention-to-treat analyses, the adjusted hazard ratio favoring Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training for first depressive episode was not statistically significant at 12 months (hazard ratio 0.77, 95% CI 0.42-1.40, P=.39) and 24 months (hazard ratio 0.87, 95% CI 0.52-1.47, P=.61). Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training provided preventive benefit for first depressive episode for those with mild hopelessness or at least moderate paternal monitoring at baseline. Global Assessment Scale scores improved comparably in both groups (intention-to-treat). CONCLUSIONS: A technology-based intervention for adolescent depression prevention implemented in primary care did not have additional benefit at 12 or 24 months. Further research is necessary to determine whether internet interventions have long-term benefit. TRIAL REGISTRATION: ClinicalTrials.gov NCT01893749; http://clinicaltrials.gov/ct2/show/NCT01893749.

Pre-diagnostic carbohydrate intake and treatment failure after radical prostatectomy for early-stage prostate cancer.

PURPOSE: An association between dietary carbohydrate intake and prostate cancer (PCa) prognosis is biologically plausible, but data are scarce. This prospective cohort study examined the relation between pre-diagnostic carbohydrate intake and treatment failure following radical prostatectomy for clinically early-stage PCa. METHODS: We identified 205 men awaiting radical prostatectomy and assessed their usual dietary intake of carbohydrates using the 110-item Block food frequency questionnaire. We also evaluated carbohydrate intake quality using a score based on the consumption of sugars relative to fiber, fat, and protein. Logistic regression analyzed their associations with the odds of treatment failure, defined as a detectable and rising serum prostate-specific antigen (PSA) or receiving androgen deprivation therapy (ADT) within 2 years. RESULTS: Sucrose consumption was associated with a higher odds and fiber consumption with a lower odds of ADT after accounting for age, race/ethnicity, body mass index, and tumor characteristics (odds ratio [OR] (95% confidence interval [CI]) 5.68 (1.71, 18.9) for 3rd vs. 1st sucrose tertile and 0.88 (0.81, 0.96) per gram of fiber/day, respectively). Increasing carbohydrate intake quality also associated with a lower odds of ADT (OR (95% CI) 0.78 (0.66, 0.92) per unit increase in score, range 0-12). CONCLUSIONS: Pre-diagnostic dietary carbohydrate intake composition and quality influence the risk of primary treatment failure for early-stage PCa. Future studies incorporating molecular aspects of carbohydrate metabolism could clarify possible underlying mechanisms.

Integrating a Medical Home in an Outpatient Dialysis Setting: Effects on Health-Related Quality of Life.

BACKGROUND: Integrating primary care has been proposed to reduce fragmented care delivery for patients with complex medical needs. Because of their high rates of morbidity, healthcare use, and mortality, patients with end-stage kidney disease (ESKD) may benefit from increased access to a primary care medical home. OBJECTIVE: To evaluate the effect of integrating a primary care medical home on health-related quality of life (HRQOL) for patients with ESKD receiving chronic hemodialysis. DESIGN: Before-after intervention trial with repeated measures at two Chicago dialysis centers. PARTICIPANTS: Patients receiving hemodialysis at either of the two centers. INTERVENTION: To the standard hemodialysis team (nephrologist, nurse, social worker, dietitian), we added a primary care physician, a pharmacist, a nurse coordinator, and a community health worker. The intervention took place from January 2015 through August 2016. MAIN MEASURES: Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures. KEY RESULTS: Of 247 eligible patients, 175 (71%) consented and participated; mean age was 54 years; 55% were men and 97% were African American or Hispanic. In regression analysis adjusted for individual visits with the medical home providers and other factors, there were significant improvements in four of five KDQOL domains: at 12 and 18 months, the Mental Component Score improved from baseline (adjusted mean 49.0) by 2.64 (p = 0.01) and 2.96 (p = 0.007) points, respectively. At 6 and 12 months, the Symptoms domain improved from baseline (adjusted mean = 77.0) by 2.61 (p = 0.02) and 2.35 points (p = 0.05) respectively. The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively. The Physical Component Score improved at 6 months only. CONCLUSIONS: Integrating primary care and enhancing care coordination in two dialysis facilities was associated with improvements in HRQOL among patients with ESKD who required chronic hemodialysis.

Does the built environment influence the effectiveness of behavioral weight management interventions?

Outcomes of behavioral lifestyle interventions for promoting weight loss vary widely across participants. The effectiveness of a weight management intervention may depend on a person's environmental context. This study compared short- and longer-term effects of a structured nationwide weight management program for people living in neighborhoods with different levels of walkability and different access to recreational places (parks, fitness facilities). Drawing on the health production model, we tested competing hypotheses for whether treatment effects of the program complement environmental supports or substitute for environmental constraints. We studied the US Department of Veterans Affairs (VA) MOVE! weight management program using VA electronic heath record data (2009-2014) and a difference-in-differences design with an inverse propensity score matched comparison group. A total of 114,256 program participants and 498,494 non-participants comprised the sample. Built environment features were measured within one-mile of each person's home. We estimated program effects on body mass index (BMI) for subgroups with different built environments at 6-, 12-, 18-, and 24-month follow-up using linear regressions with person and year fixed effects. At 6 months, the program reduced BMI by 0.4-0.6 kg/m2 among men and 0.3-0.5 kg/m2 among women. The effect diminished at 12, 18, and 24 months. The program effect did not vary significantly across subgroups with different walkability, park access, or fitness facility access. The MOVE! program was not sensitive to environmental context. Results did not lend support to either hypothesis that the MOVE! program complements or substitutes for a person's built environment to affect weight management outcomes.

Nutrition risk among an ethnically diverse sample of community-dwelling older adults.

OBJECTIVE: To assess the prevalence of nutritional risk among an ethnically diverse group of urban community-dwelling older adults and to explore if risk varied by race/ethnicity. DESIGN: Demographic characteristics, Katz's activities of daily living and health-care resource utilization were ascertained cross-sectionally via telephone surveys with trained interviewers. Nutrition risk and nutrition symptomology were assessed via the abridged Patient Generated Subjective Global Assessment (abPG-SGA); scores of ≥6 points delineated 'high' nutrition risk. Descriptive statistics and logistic regression analyses were conducted. SETTING: Urban.ParticipantsWhite, Black or Hispanic community-dwelling adults, ≥55 years of age, fluent in English or Spanish, residing in the city limits of Chicago, IL, USA. RESULTS: A total of 1001 participants (37 % white, 37 % Black, 26 % Hispanic) were surveyed. On average, participants were 66·9 years old, predominantly female and overweight/obese. Twenty-six per cent (n 263) of participants were classified as 'high' nutrition risk with 24, 14 and 31 % endorsing decreased oral intake, weight loss and compromised functioning, respectively. Black respondents constituted the greatest proportion of those with high risk scores, yet Hispanic participants displayed the most concerning nutrition risk profiles. Younger age, female sex, Black or Hispanic race/ethnicity, emergency room visits, eating alone and taking three or more different prescribed or over-the-counter drugs daily were significantly associated with high risk scores (P<0·05). CONCLUSIONS: One in four older adults living in an urban community prone to health disparities was classified as 'high' nutrition risk. Targeted interventions to promote healthy ageing are needed, especially for overweight/obese and minority community members.

The relationship between home- and individual-level diet quality among African American and Hispanic/Latino households with young children.

BACKGROUND: The quality of most Americans' diets is far from optimal. Given that many Americans consume a significant portion of calories in the home, intervening in this setting could be beneficial. However, the relationship between the home food environment and diet quality is not well understood. This study examined the relationship between diet quality at the individual level with home-level diet quality using an index that measures compliance with federal dietary guidance. METHODS: This was a cross sectional study that enrolled 97 African American and Hispanic/Latino low-income parent-child dyads. Diet quality at the individual level was assessed through two 24-h dietary recalls collected for parents and children, respectively. Diet quality at the home level was assessed with two home food inventories conducted in participants' homes. Diet quality scores at the home and individual levels were computed by applying the Healthy Eating Index-2010 (HEI-2010) to these data. Linear models adjusted for potential confounding factors were used to examine the relationship between diet quality at the home and individual levels. RESULTS: Total HEI-2010 scores from parents and children's diets were positively associated with HEI-2010 scores based on home food inventories (parent diet: ß: 0.36, 95% CI: 012-0.60; child diet: 0.38 95% CI: 013-0.62). Positive associations were also observed between individual level and home level subcomponent HEI-2010 scores for total fruit (parent: 0.55 95% CI: 0.16-0.94; child: 0.49 95% CI: 0.03-0.94), whole fruit (parent only: 0.41 95% CI: 0.07-0.74), greens and beans (parent only: 0.39 95% CI: 0.05-0.74), and whole grain (children only: 0.33 95% CI: 0.04-0.63). CONCLUSION: This study demonstrated that individual level diet quality was positively associated with home-level diet quality. Findings from this study can help us to address modifiable targets of intervention in the home to improve diet quality.

Health Behavior and Weight Changes Among Ethnic and Racial Minority Preschoolers and Their Parents: Associations Across 1 Year.

OBJECTIVE: To determine whether parent health behavior changes and feeding practices were associated with child changes in body mass index z-score and related health behaviors over the course of 1 year. METHODS: Anthropometric data from 590 child-parent dyads of ethnic/racial minority groups were collected at baseline, 14 weeks (postintervention), and 1-year follow-up. Additionally, parent screen time and feeding practices and child dietary consumption, diet quality, physical activity, and screen time were collected. RESULTS: Random effects growth models revealed that changes in child screen time moved in tandem with parent screen time from baseline to 14-week postintervention and from postintervention to 1-year follow-up. Greater parental monitoring predicted greater reduction in child calorie consumption at 1 year. CONCLUSIONS: Future studies should include innovative ways to explicitly involve parents in prevention efforts.

Confirmatory factor analysis and measurement invariance of the Child Feeding Questionnaire in low-income Hispanic and African-American mothers with preschool-age children.

Validation work of the Child Feeding Questionnaire (CFQ) in low-income minority samples suggests a need for further conceptual refinement of this instrument. Using confirmatory factor analysis, this study evaluated 5- and 6-factor models on a large sample of African-American and Hispanic mothers with preschool-age children (n = 962). The 5-factor model included: 'perceived responsibility', 'concern about child's weight', 'restriction', 'pressure to eat', and 'monitoring' and the 6-factor model also tested 'food as a reward'. Multi-group analysis assessed measurement invariance by race/ethnicity. In the 5-factor model, two low-loading items from 'restriction' and one low-variance item from 'perceived responsibility' were dropped to achieve fit. Only removal of the low-variance item was needed to achieve fit in the 6-factor model. Invariance analyses demonstrated differences in factor loadings. This finding suggests African-American and Hispanic mothers may vary in their interpretation of some CFQ items and use of cognitive interviews could enhance item interpretation. Our results also demonstrated that 'food as a reward' is a plausible construct among a low-income minority sample and adds to the evidence that this factor resonates conceptually with parents of preschoolers; however, further testing is needed to determine the validity of this factor with older age groups.

The association between neighborhood socioeconomic status and ovarian cancer tumor characteristics.

PURPOSE: Higher pathologic grade, suboptimal debulking surgery, and late-stage are markers of more aggressive and advanced ovarian cancer. Neighborhood socioeconomic status (SES) has been associated with more aggressive and advanced tumors for other cancer sites, and this may also be true for ovarian cancer. METHODS: We examined the association between neighborhood SES and ovarian cancer tumor characteristics using data on 581 women diagnosed with epithelial ovarian cancer in Cook County, Illinois. Two complementary measures (concentrated disadvantage and concentrated affluence) were used to estimate neighborhood SES. Prevalence differences and 95 % confidence intervals were estimated in logistic regression models adjusted for age and race. RESULTS: Greater disadvantage was associated with higher grade tumors (p = 0.03) and suboptimal debulking (p = 0.05) and marginally associated with later tumor stage (p = 0.20). Greater affluence was inversely associated with stage at diagnosis (p = 0.004) and suboptimal debulking (p = 0.03) and (marginally) with tumor grade (p = 0.21). CONCLUSION: Our findings suggest that lower SES, estimated by neighborhood SES, is associated with ovarian cancer tumor characteristics indicative of more advanced and aggressive disease.

Evaluating the initial impact of the revised Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) food packages on dietary intake and home food availability in African-American and Hispanic families.

OBJECTIVE: The present study assessed the impact of the 2009 food packages mandated by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) on dietary intake and home food availability in low-income African-American and Hispanic parent/child dyads. DESIGN: A natural experiment was conducted to assess if the revised WIC food package altered dietary intake, home food availability, weight and various lifestyle measures immediately (6 months) following policy implementation. SETTING: Twelve WIC clinics in Chicago, IL, USA. SUBJECTS: Two hundred and seventy-three Hispanic and African-American children aged 2-3 years, enrolled in WIC, and their mothers. RESULTS: Six months after the WIC food package revisions were implemented, we observed modest changes in dietary intake. Fruit consumption increased among Hispanic mothers (mean = 0·33 servings/d, P = 0·04) and low-fat dairy intake increased among Hispanic mothers (0·21 servings/d, P = 0·02), Hispanic children (0·34 servings/d, P < 0·001) and African-American children (0·24 servings/d, P = 0·02). Home food availability of low-fat dairy and whole grains also increased. Dietary changes, however, varied by racial/ethnic group. Changes in home food availability were not significantly correlated with changes in diet. CONCLUSIONS: The WIC food package revisions are one of the first efforts to modify the nutrition guidelines that govern foods provided in a federal food and nutrition assistance programme. It will be important to examine the longer-term impact of these changes on dietary intake and weight status.

A Scoping Review of Cancer Interventions with Arab Americans.

This scoping review provides an overview of cancer interventions implemented with Arab Americans across the cancer control continuum, including an examination of outcomes and implementation processes. The search strategy included database searching and reviewing reference lists and forward citations to identify articles describing interventions with Arab adults living in the US, with no restrictions on date of publication or research methodology. The review included 23 papers describing 12 unique cancer interventions. Most interventions focused on individual-level determinants of breast and cervical cancer screening; used non-quasi-experimental research designs to evaluate intervention effectiveness; and demonstrated improvements in short-term cancer screening knowledge. Implementation processes were less commonly described. Most interventions were culturally and linguistically tailored to communities of focus; were delivered in educational sessions in community settings; engaged with the community mostly for recruitment and implementation; and were funded by foundation grants. Suggestions for research and intervention development are discussed.

Primary care-based screening and recruitment for an adolescent depression prevention trial: Contextual considerations during a youth mental health crisis.

Background: Rising rates of adolescent depression in the wake of COVID-19 and a youth mental health crisis highlight the urgent need for accessible mental healthcare and prevention within primary care. Digital mental health interventions (DMHIs) may increase access for underserved populations. However, these interventions are not well studied in adolescents, nor healthcare settings. The purpose of this study was to identify barriers and facilitators to screening and recruitment activities for PATH 2 Purpose (P2P): Primary Care and Community-Based Prevention of Mental Disorders in Adolescents, a multi-site adolescent depression prevention trial comparing two digital prevention programs within four diverse health systems in two U.S. states. Method: This qualitative study is a component of a larger Hybrid Type I trial. We conducted semi-structured key informant interviews with clinical and non-clinical implementers involved with screening and recruitment for the P2P trial. Informed by the Consolidated Framework for Implementation Research (CFIR), interviews were conducted at the midpoint of the trial to identify barriers, facilitators, and needed adaptations, and to gather information on determinants that may affect future implementation. Findings: Respondents perceived the P2P trial as valuable, well aligned with the mission of their health systems. However, several barriers were identified, many of which stemmed from influences outside of the healthcare settings. Universal and site-specific outer setting influences (COVID-19 pandemic, youth mental health crisis, local community conditions) interacted with Inner Setting and Innovation domains to create numerous challenges to the implementation of screening and recruitment. Conclusion: Our findings emphasize the need for ongoing, comprehensive assessment of dynamic inner and outer setting contexts prior to and during implementation of clinical trials, as well as flexibility for adaptation to unique clinical contexts. The CFIR is useful for assessing determinants during times of rapid inner and outer setting change, such as those brought on by the COVID-19 pandemic, youth mental health crisis, and the corresponding exacerbation of resource strain within healthcare settings. Clinical trial registration: PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents https://www.clinicaltrials.gov/study/NCT04290754.

Adolescent mental health problems such as depression, anxiety, and suicidal behavior are prevalent, and have been increasing in the wake of the COVID-19 pandemic. In 2021, the Surgeon General declared a "youth mental health crisis," and the American Academy of Pediatrics issued a joint statement declaring a national youth mental health emergency. Accessible, affordable, evidence-based interventions are needed to prevent the development of depressive symptoms into major depressive disorder. The integration of digital mental health interventions (DMHIs) into primary care may reduce access barriers. Primary care clinical settings are well suited to identify individuals at-risk for developing depression, and facilitate preventive treatment planning. While preventive DMHIs for adolescents exist, more evidence is needed on their effectiveness, and how to best integrate them into healthcare. Our study team interviewed primary care-based staff, administrators, and clinical providers involved with implementing screening and recruitment activities for the P2P trial, a randomized controlled trial comparing the effectiveness of two digital depression prevention programs. Respondents shared experiences with trial recruitment in their settings, including perceived challenges. Our findings suggest that multiple factors influenced recruitment, including influences situated outside of the clinical settings, such as the COVID-19 pandemic and worsening adolescent mental health. These influences interacted with factors affecting recruitment inside of health clinics, such as demands on staff and provider time, and perceived importance of prevention programming versus other initiatives. Identifying these influencing factors during the trial helps to inform considerations for planning future integration of similar programs into primary care settings.

PATHway: Intervention optimization of a prevention program for adolescents at-risk for depression in the primary care setting.

With as many as 13% of adolescents diagnosed with depressive disorders each year, prevention of depressive disorders has become a key priority for the National Institute of Mental Health (NIMH). Currently, we have no widely available interventions to prevent these disorders. To address this need, we developed a multi-health system collaboration to develop and evaluate the primary care based technology "behavioral vaccine," Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy (CATCH-IT). The full CATCH-IT program demonstrated evidence of efficacy in prevention of depressive episodes in clinical trials. However, CATCH-IT became larger and more complex across trials, creating issues with adherence and scalability. We will use a multiphase optimization strategy approach to optimize CATCH-IT. The theoretically grounded components of CATCH-IT include: behavioral activation, cognitive-behavioral therapy, interpersonal psychotherapy, and parent program. We will use a 4-factor (2x2x2x2) fully crossed factorial design with N = 16 cells (25 per cell, after allowing 15% dropout) to evaluate the contribution of each component. Eligible at-risk youth will be high school students 13 through 18 years old, with subsyndromal symptoms of depression. The study design will enable us to eliminate non-contributing components while preserving efficacy and to optimize CATCH-IT by strengthening tolerability and scalability by reducing resource use. By reducing resource use, we anticipate satisfaction and acceptability will also increase, preparing the way for an implementation trial.