Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial.

BACKGROUND: Black adolescents with type 1 diabetes (T1D) are at increased risk for suboptimal diabetes health outcomes; however, evidence-based interventions for this population are lacking. Depression affects a high percentage of youth with T1D and increases the likelihood of health problems associated with diabetes. OBJECTIVE: Our aim was to test whether baseline levels of depression moderate the effects of a brief eHealth parenting intervention delivered to caregivers of young Black adolescents with T1D on youths' glycemic control. METHODS: We conducted a multicenter randomized controlled trial at 7 pediatric diabetes clinics located in 2 large US cities. Participants (N=149) were allocated to either the intervention group or a standard medical care control group. Up to 3 intervention sessions were delivered on a tablet computer during diabetes clinic visits over a 12-month period. RESULTS: In a linear mixed effects regression model, planned contrasts did not show significant reductions in hemoglobin A1c (HbA1c) for intervention adolescents compared to controls. However, adolescents with higher baseline levels of depressive symptoms who received the intervention had significantly greater improvements in HbA1c levels at 6-month follow-up (0.94%; P=.01) and 18-month follow-up (1.42%; P=.002) than those with lower levels of depression. Within the intervention group, adolescents had a statistically significant reduction in HbA1c levels from baseline at 6-month and 18-month follow-up. CONCLUSIONS: A brief, culturally tailored eHealth parenting intervention improved health outcomes among Black adolescents with T1D and depressive symptoms. TRIAL REGISTRATION: ClinicalTrials.gov NCT03168867; https://clinicaltrials.gov/study/NCT03168867.

Biomarker Predictors of Clinical Efficacy of the Anti-IgE Biologic, Omalizumab, in Severe Asthma in Adults: Results of the SoMOSA Study.

BACKGROUND: The anti-IgE monoclonal, omalizumab, is widely used for severe asthma. This study aimed to identify biomarkers that predict clinical improvement during one year of omalizumab treatment. METHODS: 1-year, open-label, Study of Mechanisms of action of Omalizumab in Severe Asthma (SoMOSA) involving 216 severe (GINA step 4/5) uncontrolled atopic asthmatics (≥2 severe exacerbations in previous year) on high-dose inhaled corticosteroids, long-acting ß-agonists, ± mOCS. It had two phases: 0-16 weeks, to assess early clinical improvement by Global Evaluation of Therapeutic Effectiveness (GETE), and 16-52 weeks, to assess late responses by ≥50% reduction in exacerbations or dose of maintenance oral corticosteroids (mOCS). All participants provided samples (exhaled breath, blood, sputum, urine) before and after 16 weeks of omalizumab treatment. RESULTS: 191 patients completed phase 1; 63% had early improvement. Of 173 who completed phase 2, 69% had reduced exacerbations by ≥50%, while 57% (37/65) on mOCS reduced their dose by ≥50%. The primary outcome 2, 3-dinor-11-ß-PGF2α, GETE and standard clinical biomarkers (blood and sputum eosinophils, exhaled nitric oxide, serum IgE) did not predict either clinical response. Five breathomics (GC-MS) and 5 plasma lipid biomarkers strongly predicted the ≥50% reduction in exacerbations (receiver operating characteristic area under the curve (AUC): 0.780 and 0.922, respectively) and early responses (AUC:0.835 and 0.949, respectively). In independent cohorts, the GC-MS biomarkers differentiated between severe and mild asthma. Conclusions This is the first discovery of omics biomarkers that predict improvement to a biologic for asthma. Their prospective validation and development for clinical use is justified. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).

Diabetes distress in urban Black youth with type 1 diabetes and their caregivers: associations with glycemic control, depression, and health behaviors.

OBJECTIVES: Adolescents with type 1 diabetes (T1D) and their caregivers endorse high diabetes distress (DD). Limited studies have documented the impact of DD on Black youth. The aims of the present study were to (1) describe DD among a sample of Black adolescents with T1D and their caregivers, (2) compare their DD levels with published normative samples, and (3) determine how DD relates to glycemic outcomes, diabetes self-management, parental monitoring of diabetes, and youth depressive symptoms. METHODS: Baseline data from a multicenter clinical trial were used. Participants (N = 155) were recruited from 7 Midwestern pediatric diabetes clinics. Hemoglobin A1c (HbA1c) and measures of DD, parental monitoring of diabetes care, youth depression and diabetes management behaviors were obtained. The sample was split into (1) adolescents (ages 13-14; N = 95) and (2) preadolescents (ages 10-12; N = 60). Analyses utilized Cohen's d effect sizes, Pearson correlations, t-tests, and multiple regression. RESULTS: DD levels in youth and caregivers were high, with 45%-58% exceeding either clinical cutoff scores or validation study sample means. Higher DD in youth and caregivers was associated with higher HbA1c, lower diabetes self-management, and elevated depressive symptoms, but not with parental monitoring of diabetes management. CONCLUSIONS: Screening for DD in Black youth with T1D and caregivers is recommended, as are culturally informed interventions that can reduce distress levels and lead to improved health outcomes. More research is needed on how systemic inequities contribute to higher DD in Black youth and the strategies/policy changes needed to reduce these inequities.

Utilization of electronic portal referrals to a community agency for children presenting with an asthma exacerbation to a pediatric emergency department.

PURPOSE: To evaluate referral rates and factors associated with referrals to a community agency for children evaluated for an asthma exacerbation at a pediatric emergency department (PED) and compare PED visits for asthma the following year between those referred and not referred. METHODS: We reviewed electronic health records of children 2-18 years evaluated in our PED from 01/01/2019 to 12/31/2019 with an ICD-10 diagnostic code for asthma (J45x) following the introduction of a portal where clinicians could refer children to a community agency focused on improving health outcomes for asthma. We abstracted data on demographics, PED visits, and hospitalizations and used multivariate logistic regression to evaluate factors associated with referrals. RESULTS: Of the 2262 charts analyzed, the majority of patients were male (61%), Black (76%), and held public insurance (71%). Only a minority of patients (n = 140, 6%) were referred. Age [6-12 years (AOR: 1.93, 95% CI: 1.21-3.08, p = .006), 13-18 years (AOR: 10.61, 95% CI: 6.53-17.24, p = .001)] and lifetime number of PED asthma visits [≥3 visits (AOR: 1.91, 95% CI, 1.01-3.62, p = .05)] were associated with referral. There was no significant difference in the mean number of PED visits in one year [referred: 0.59 (SD1.2) vs. not referred: 0.79 (SD1.3), t = 1.70, p = .09] between the two groups. CONCLUSION: The referral rate to community agency from PED for asthma is low. There was no difference in short-term PED utilization for asthma between those referred and not referred.

Evaluating barriers and facilitators to healthcare providers' use of an emergency department electronic referral portal for high-risk children with asthma using the Theoretical Domains Framework.

OBJECTIVE: Urban children with asthma are at risk for frequent emergency department (ED) visits and suboptimal asthma management. ED visits provide an opportunity for referrals to community-based asthma management services. Electronic medical record-based referral portals have been shown to improve quality of care but use of these portals by healthcare providers (HCPs) is variable. The purpose of the study was to investigate facilitators, barriers, and recommendations to improve the use of an electronic referral portal to connect children presenting with asthma exacerbations in an urban pediatric ED to community-based education and case management services. METHODS: The study was grounded in the Theoretical Domains Framework, an implementation provided the theoretical basis of the study. All ED HCPs were invited to complete qualitative interviews; twenty-three HCPs participated. Interviews were coded using directed content analysis. RESULTS: Facilitators to portal use included its relative ease of use and HCP beliefs regarding the importance of such referrals for preventive asthma care. Barriers included insufficient time to make referrals, lack of information regarding the community agency and challenges communicating the value of the referral to patients and/or their caregivers. CONCLUSIONS: Successfully engaging HCPs working in ED settings to use electronic portals to refer children with asthma to community agencies for health services may involve helping providers increase their comfort and knowledge of the external provider agency, ensuring organizational leaders support the need for preventive asthma care and provision of feedback to HCPs on the success of such referrals in meeting the needs of those families served.

Interventions Across the Translational Research Spectrum: Addressing Disparities Among Racial and Ethnic Minoritized Youth with Type 1 Diabetes.

Racial and ethnic minoritized youth with type 1 diabetes (T1D) are at elevated risk for health disparities. Few intervention studies have been conducted for these youth and evidence to support best practices to address their needs is lacking. Existing evidence supports the use of brief trials of diabetes technology with structured support from clinic staff, culturally tailored interventions such as language-congruent clinical care, and use of community health workers as promising directions to improve health outcomes. Clinicians and researchers should work collaboratively with community members to improve the quality of T1D intervention science for racial and ethnic minoritized youth.

Racial Residential Segregation and the Health of Black Youth With Type 1 Diabetes.

OBJECTIVES: Black youth with type 1 diabetes (T1D) are at heightened risk for suboptimal glycemic control. Studies of neighborhood effects on the health of youth with T1D are limited. The current study investigated the effects of racial residential segregation on the diabetes health of young Black adolescents with T1D. METHODS: A total of 148 participants were recruited from 7 pediatric diabetes clinics in 2 US cities. Racial residential segregation (RRS) was calculated at the census block group level based on US Census data. Diabetes management was measured via self-report questionnaire. Hemoglobin A1c (HbA1c) information was gathered from participants during home-based data collection. Hierarchical linear regression was used to test the effects of RRS while controlling for family income, youth age, insulin delivery method (insulin pump versus syringe therapy), and neighborhood adversity. RESULTS: HbA1c was significantly associated with RRS in bivariate analyses, whereas youth-reported diabetes management was not. In hierarchical regression analyses, whereas family income, age, and insulin delivery method were all significantly associated with HbA1c in model 1, only RRS, age, and insulin delivery method were significantly associated with HbA1c in model 2. Model 2 explained 25% of the variance in HbA1c (P = .001). CONCLUSIONS: RRS was associated with glycemic control in a sample of Black youth with T1D and accounted for variance in HbA1c even after controlling for adverse neighborhood conditions. Policies to reduce residential segregation, along with improved screening for neighborhood-level risk, hold the potential to improve the health of a vulnerable population of youth.

Naturalistically observed interpersonal problems and diabetes management in older adolescents and young adults with type 1 diabetes.

OBJECTIVE: This study investigated the links between naturalistically observed and self-reported interpersonal problems, diabetes management, and glucose levels in older adolescents and young adults with type 1 diabetes. DESIGN: Sixty-eight older adolescents and young adults (aged 17-20 years) participated in a cross-sectional study that consisted of three home visits and a daily diary segment. MAIN OUTCOME MEASURES: Participants wore the Electronically Activated Recorder (EAR) for four days to capture interpersonal problems and wore a continuous glucose monitor for blood glucose levels. Researchers also collected HbA1c values, conducted an interview to assess diabetes management, and collected participant-reported severity of interpersonal problems. RESULTS: High EAR-observed interpersonal problems were associated with poor diabetes management. Multiple regression analyses revealed that high EAR-observed interpersonal problems continued to explain variance in poor diabetes management after including self-reported interpersonal problems and covariates. CONCLUSION: These findings corroborate literature suggesting that negative interactions are associated with type 1 diabetes management. This study is the first to use the EAR to capture naturalistically observed interactions in this population and identify its utility beyond self-reports. These findings highlight the importance of considering naturalistically observed interactions when developing interventions to promote better diabetes management in older adolescents and young adults.

The effect of an mHealth intervention for adolescents with Type 1 diabetes and their parents.

BACKGROUND: Past research has demonstrated that adolescents with Type 1 diabetes (T1D) typically have a decline in health outcomes as they begin to assume more self-management activities. Mobile app interventions have been suggested as one possible way to improve this behavior. PURPOSE: The primary aim of this study was to address declines in health outcomes by pilot testing the satisfaction, use and feasibility of an app-based family communication intervention aimed to assist in adolescent self-management of T1D. METHODS: Thirty-three adolescent-parent pairs were enrolled in and completed the 12-week pilot study. Participants were randomized 2:1 to intervention (app use) or control group. Pre/post quantitative and qualitative data were collected, including HbA1c and surveys. Paired-sample t-tests and ANOVA statistics were conducted. RESULTS: The parents and adolescents reported high satisfaction with the app, and that it was easy to use. Results showed HbA1c stability in the intervention group and significant worsening in the control group. There were also significant improvements in adherence to diabetes management and quality of life for the parents in the intervention group. The adolescents did not show any improvement in quality-of-life measures. CONCLUSION: This study suggests that the app intervention is acceptable, shows promise for improving health outcomes for adolescents with T1D, and may improve family communication. The public health implications of this work are that app interventions have a potential role in positively influencing chronic disease outcomes. Additional research with a more extensive and diverse sample is needed to determine generalizability.

The Language We Use: Providers' Perceptions About Families.

Implicitly-held unconscious associations and attitudes may not align with the beliefs we hold outwardly or explicitly but can affect our professional perceptions, decisions, and actions. In a phenomenological study identifying strategies used to support families in vulnerable circumstances, we conducted nine focus groups to examine how early interventionists (EIs) described families and children, the language they used, and how they used it. Thematic qualitative analysis revealed three themes about families: perceptions of parenting, perceptions of capability, and perceptions of priorities. How EIs characterized families and their interactions with families were both reflective of and counter to family-centeredness and, at times, indicative of implicit bias. This study addresses a critical gap in the field, given the lack of empirical research available about implicit bias in early childhood intervention professionals. Implications for personnel preparation and practice change are discussed to begin the necessary work of moving the field toward more culturally sustaining practices.

An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study.

BACKGROUND: Type 1 diabetes (T1D) affects more than 165,000 individuals younger than 20 years in the United States of America. The transition from parent management to parent-child team management, with the child taking on increased levels of self-care, can be stressful and is associated with a deterioration in self-management behaviors. Therefore, a mobile app intervention, MyT1DHero, was designed to facilitate diabetes-specific positive parent-adolescent communication and improve diabetes-related outcomes. The MyT1DHero intervention links an adolescent with T1D and their parent through 2 separate app interfaces and is designed to promote positive communication regarding T1D management. OBJECTIVE: The aim of this pilot study was to determine (1) the initial efficacy of the MyT1DHero intervention in improving diabetes outcomes in adolescents, specifically the hemoglobin A1c (HbA1c) levels, diabetes care adherence, and quality of life, and (2) the adolescents' overall satisfaction with this intervention. METHODS: This pilot study included 30 adolescent-parent pairs who used the MyT1DHero app in a 12-week single-arm clinical trial. Participants were recruited from the local pediatric endocrinology subspecialty clinic via snowball sampling. HbA1c levels, diabetes care adherence, quality of life, family conflict, and satisfaction levels were measured and analyzed using paired sample two-sided t tests and linear regression analyses. RESULTS: The final analysis included 25 families. The mean age of the adolescents was 12.28 (SD 1.62) years. Half of the participants (13/25) reported a diabetes diagnosis of less than 5 years. After 12 weeks of the intervention, diabetes care adherence significantly improved (before the study: mean 3.87 [SD 0.59]; after the study: mean 4.19 [SD 0.65]; t21=-2.52, P=.02, d=0.52) as did quality of life (before the study: mean 4.02 [SD 0.84]; after the study: mean 4.27 [SD 0.73]; t24=2.48, P=.01, d=0.32). HbA1c levels (before the study: mean 8.94 [SD 1.46]; after the study: mean 8.87 [SD 1.29]; t24=0.67, P=.51, d=0.04) and family conflict (before the study: mean 2.45 [SD 0.55]; after the study: mean 2.61 [SD 0.45]; t23=0.55, P=.14, d=0.32) changed in the hypothesized direction, but the change was not significant. However, higher use of the mobile app was associated with more improvement in HbA1c levels (F1,20=9.74, P<.005; R2=0.33). Overall, the adolescents were satisfied with the app intervention. CONCLUSIONS: In a 12-week pilot study of the mobile app intervention designed to facilitate parent-adolescent communication for improving diabetes outcomes, significant benefits were demonstrated in self-care adherence and quality of life. A randomized controlled trial with a longer intervention is needed to replicate these findings and to determine the stability of the intervention effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628.

Development of the Motivational Interviewing Coach Rating Scale (MI-CRS) for health equity implementation contexts.

OBJECTIVE: The field of implementation science emphasizes efficient and effective fidelity measurement for research outcomes and feedback to support quality improvement. This paper reports on such a measure for motivational interviewing (MI), developed with rigorous methodology and with diverse samples. METHOD: Using item response theory (IRT) methods and Rasch modeling, we analyzed coded (a) recordings (n = 99) of intervention sessions in a clinical trial of African American adolescents with obesity; (b) standard patient interactions (n = 370) in an implementation science study with youth living with HIV; and (c) standard patient interactions (n = 172) in a diverse community sample. RESULTS: These methods yielded a reliable and valid 12-item scale on several indicators using Rausch modeling including single construct dimensionality, strong item-session maps, good rating scale functionality, and item fit after revisions. However, absolute agreement was modest. The 12 items yielded thresholds for 4 categories: beginner, novice, intermediate and advanced. CONCLUSIONS: The 12-item Motivational Interviewing Coach Rating Scale is the first efficient and effective fidelity measure appropriate with diverse ethnic groups, with interventions that are MI only or interventions that integrate MI with other interventions, and with adolescents and families as well as adults. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Optimizing Recruitment of Black Adolescents into Behavioral Research: A Multi-Center Study.

OBJECTIVES: Adolescents of color are underrepresented in behavioral health research. Study aims were to quantify the amount and types of outreach effort needed to recruit young Black adolescents with type 1 diabetes and their primary caregiver into a clinical trial evaluating a parenting intervention and to determine if degree of recruitment difficulty was related to demographic, diabetes-related, or family characteristics. METHODS: Data were drawn from a multi-center clinical trial. Participants (N = 155) were recruited from seven pediatric diabetes clinics. Contact log data were used to quantify both number/type of contacts prior to study enrollment as well as length of time to enrollment. Families were coded as having expedited recruitment (ER) or prolonged recruitment (PR). Baseline study data were used to compare ER and PR families on sociodemographic factors, adolescent diabetes management and health status and family characteristics such as household organization and family conflict. RESULTS: Mean length of time to recruit was 6.6 months and mean number of recruitment contacts was 10.3. Thirty-nine percent of the sample were characterized as PR. These families required even higher levels of effort (mean of 9.9 months to recruit and 15.4 contacts). There were no significant between-group differences on any baseline variable for ER and PR families, with the exception of family income. CONCLUSIONS: Researchers need to make persistent efforts in order to successfully enroll adolescents of color and their caregivers into clinical trials. Social determinants of health such as family resources may differentiate families with prolonged recruitment within such samples.

Phase I Trial of DNA Methyltransferase Inhibitor Guadecitabine Combined with Cisplatin and Gemcitabine for Solid Malignancies Including Urothelial Carcinoma (SPIRE).

PURPOSE: Preclinical data indicate that DNA methyltransferase inhibition will circumvent cisplatin resistance in various cancers. PATIENT AND METHODS: SPIRE comprised a dose-escalation phase for incurable metastatic solid cancers, followed by a randomized dose expansion phase for neoadjuvant treatment of T2-4a N0 M0 bladder urothelial carcinoma. The primary objective was a recommended phase II dose (RP2D) for guadecitabine combined with gemcitabine and cisplatin. Treatment comprised 21-day gemcitabine and cisplatin cycles (cisplatin 70 mg/m2, i.v., day 8 and gemcitabine 1,000 mg/m2, i.v., days 8 + 15). Guadecitabine was injected subcutaneously on days 1-5, within escalation phase cohorts, and to half of 20 patients in the expansion phase. Registration ID: ISRCTN 16332228. RESULTS: Within the escalation phase, dose-limiting toxicities related predominantly to myelosuppression requiring G-CSF prophylaxis from cohort 2 (guadecitabine 20 mg/m2, days 1-5). The most common grade ≥3 adverse events in 17 patients in the dose-escalation phase were neutropenia (76.5%), thrombocytopenia (64.7%), leukopenia (29.4%), and anemia (29.4%). Addition of guadecitabine to gemcitabine and cisplatin in the expansion phase resulted in similar rates of severe hematologic adverse events, similar cisplatin dose intensity, but modestly reduced gemcitabine dose intensity. Radical treatment options after chemotherapy were not compromised. Pharmacodynamics evaluations indicated guadecitabine maximal target effect at the point of cisplatin administration. Pharmacokinetics were consistent with prior data. No treatment-related deaths occurred. CONCLUSIONS: The guadecitabine RP2D was 20 mg/m2, days 1-5, in combination with gemcitabine and cisplatin and required GCSF prophylaxis. Gene promoter methylation pharmacodynamics are optimal with this schedule. Addition of guadecitabine to gemcitabine and cisplatin was tolerable, despite some additional myelosuppression, and warrants further investigation to assess efficacy.

Toward the Development of a Culturally Humble Intervention to Improve Glycemic Control and Quality of Life among Adolescents with Type-1 Diabetes and Their Families.

Type-1 Diabetes (T1D) is a prevalent and costly disorder associated with substantial morbidity that differentially impacts low-income and/or minority adolescents and their families. The primary study objective was to develop a guiding model to inform culturally humble interventions for Mid-southern youth with T1D presenting with multiple correlates of suboptimal glycemic control and their families. In order to develop a clinic specific guiding model, conceptualizations of health, the need/type of intervention thought to be most helpful, the optimal structure, and strategies to improve the cultural/regional fit was ascertained from (A) youth with T1D (n = 13) and caregivers (n = 11) via qualitative interviews and, (B) pediatric endocrinologists and nurse practitioners (n = 6), and (C) nurses, diabetes educators, dietitians, and social workers (n = 9) via focus groups. Qualitative themes were synthesized to guide the treatment development model whereby Quality of Life and Glycemic Control would be directly enhanced by interventions to promote Coping, Support, Education, and Improved Psychosocial Functioning and indirectly through improved Adherence and T1D Autonomy delivered in a culturally humble way that affirms youths' T1D identify. These finding suggest that existing evidence-based treatments may provide a great fit for low-income, and/or minority youth with T1D and their families living in the mid-south, provided these interventions are delivered in culturally humble manner.

Managing Outliers in Adolescent Food Frequency Questionnaire Data.

OBJECTIVE: The goal of this study was to explore the impact of 5 decision rules for removing outliers from adolescent food frequency questionnaire (FFQ) data. DESIGN: This secondary analysis used baseline and 3-month data from a weight loss intervention clinical trial. PARTICIPANTS: African American adolescents (n = 181) were recruited from outpatient clinics and community health fairs. VARIABLES MEASURED: Data collected included self-reported FFQ and mediators of weight (food addiction, depressive symptoms, and relative reinforcing value of food), caregiver-reported executive functioning, and objectively measured weight status (percentage overweight). ANALYSIS: Descriptive statistics examined patterns in study variables at baseline and follow-up. Correlational analyses explored the relationships between FFQ data and key study variables at baseline and follow-up. RESULTS: Compared with not removing outliers, using decision rules reduced the number of cases and restricted the range of data. The magnitude of baseline FFQ-mediator relationships was attenuated under all decision rules but varied (increasing, decreasing, and reversing direction) at follow-up. Decision rule use increased the magnitude of change in FFQ estimated energy intake and significantly strengthened its relationship with weight change under 2 fixed range decision rules. CONCLUSIONS AND IMPLICATIONS: Results suggest careful evaluation of outliers and testing and reporting the effects of different outlier decision rules through sensitivity analyses.

Effects of family and neighborhood risks on glycemic control among young black adolescents with type 1 diabetes: Findings from a multi-center study.

While individual and family risk factors that contribute to health disparities in children with type 1 diabetes have been identified, studies on the effects of neighborhood risk factors on glycemic control are limited, particularly in minority samples. This cross-sectional study tested associations between family conflict, neighborhood adversity and glycemic outcomes (HbA1c) in a sample of urban, young Black adolescents with type 1 diabetes(mean age = 13.4 ± 1.7), as well as whether neighborhood adversity moderated the relationship between family conflict and HbA1c. Participants (N = 128) were recruited from five pediatric diabetes clinics in two major metropolitan US cities. Diabetes-related family conflict was measured via self-report questionnaire (Diabetes Family Conflict Scale; DFCS). Neighborhood adversity was calculated at the census block group level based on US census data. Indictors of adversity were used to calculate a neighborhood adversity index (NAI) for each participant. Median family income was $25,000, suggesting a low SES sample. In multiple regression analyses, DFCS and NAI both had significant, independent effects on glycemic control (ß = 0.174, P = 0.034 and ß = 0.226 P = 0.013, respectively) after controlling for child age, family socioeconomic status and insulin management regimen. Tests of effects of the NAI and DFCS interaction on HbA1c found no significant moderating effects of neighborhood adversity. Even within contexts of significant socioeconomic disadvantage, variability in degree of neighborhood adversity predicts diabetes-related health outcomes in young Black adolescents with type 1 diabetes. Providers should assess social determinants of health such as neighborhood resources that may impact adolescents' ability to maintain optimal glycemic control.

Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy.

BACKGROUND: Poor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults' focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults' innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities. OBJECTIVE: This research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A1c (HbA1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA1c≥9.0%). METHODS: A question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults' gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome. RESULTS: A total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023. CONCLUSIONS: At the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D. TRIAL REGISTRATION: ClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20191.

Physical Activity as a Predictor of Changes in Systolic Blood Pressure for African-American Adolescents Seeking Treatment for Obesity.

PURPOSE: The aim of the study was to examine changes in systolic blood pressure (SBP) and whether physical activity and obesity status predicted SBP change for African-American adolescents (n = 181) participating in a behavioral weight control trial. METHODS: Data were collected at baseline, 7 months (end-of-treatment), and 9 months (2-month follow-up). RESULTS: Nearly half of adolescents achieved clinically significant SBP reductions at 7 and 9 months. Significantly, fewer adolescents had elevated SBP at 7 and 9 months compared with baseline (both p < .001). Changes in percent overweight and moderate-to-vigorous activity predicted changes in SBP over time. CONCLUSIONS: Obesity reduction and increases in moderate-to-vigorous physical activity may predict short-term, clinically meaningful reductions in SBP for African American adolescents with obesity.

Outcomes From a Sequential Multiple Assignment Randomized Trial of Weight Loss Strategies for African American Adolescents With Obesity.

BACKGROUND: Minority adolescents are at highest risk for obesity and extreme obesity; yet, there are few clinical trials targeting African American adolescents with obesity. PURPOSE: The purpose of the study was to develop an adaptive family-based behavioral obesity treatment for African American adolescents using a sequential multiple assignment randomized trial (SMART) design. METHODS: Fit Families was a SMART where 181 African American adolescents (67% female) aged 12-17 were first randomized to office-based versus home-based behavioral skills treatment delivered from a Motivational Interviewing foundation. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based behavioral skills treatment or contingency management with voucher-based reinforcement for adolescent weight loss and for caregiver adherence to the program. All interventions were delivered by community health workers. The primary outcome was treatment retention and percent overweight. RESULTS: All adolescents reduced percent overweight by -3.20%; there were no significant differences in percent overweight based on treatment sequence. Adolescents receiving home-based delivery in Phase 1 and contingency management in Phase 2 completed significantly more sessions than those receiving office-based treatment and continued skills without CM (M = 8.03, SD = 3.24 and M = 6.62, SD = 2.95, respectively). The effect of contingency management was strongest among older and those with lower baseline confidence. Younger adolescents experienced greater weight reductions when receiving continued skills (-4.90% compared with -.02%). CONCLUSIONS: Behavioral skills training can be successfully delivered to African American adolescents with obesity and their caregivers by community health workers when using a home-based service model with incentives. More potent interventions are needed to increase reductions in percent overweight and may need to be developmentally tailored for younger and older adolescents.