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BackgroundDespite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children. ObjectiveThe aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention. MethodsWe created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children. ResultsRecruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date. ConclusionsIf the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world. Trial RegistrationClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547 International Registered Report Identifier (IRRID)PRR1-10.2196/17877

BackgroundLow levels of moderate-to-vigorous physical activity are associated with adverse health consequences. ObjectiveThe intent of the study was to determine the feasibility and efficacy of a 12-week physical activity promotion program targeting children, which was delivered to parents through mobile phones. MethodsPotential participants were recruited through advertisements placed in the newspaper, local hospitals and schools, and an email listserv. Sedentary children aged 6-10 years were randomly assigned to a minimal (MIG) or intensive (IIG) intervention group. Parents in the MIG were given a goal to increase (within 1 month) and maintain their child’s activity at 6000 pedometer steps/day above their baseline levels and to monitor their child’s steps daily. Parents in the IIG were given the same steps/day and monitoring goals, in addition to text messages and articles containing additional behavioral strategies (based on the Social Cognitive Theory) designed to promote their child’s physical activity. The intervention components were delivered via mobile phone. Anthropometrics, body composition, and questionnaires were administered in a clinic. Children wore a New Lifestyles pedometer (NL-1000) each day throughout the intervention and parents were to monitor their child’s step counts daily. ResultsOut of 59 children who screened for the study, a total of 27 children (mean age 8.7, SD 1.4 years; 56%, 15/27 female; 59%, 16/27 African American) were enrolled and completed the study. Overall, 97.90% (2220/2268; 98.20%, 1072/1092 for MIG; 97.60%, 1148/1176 for IIG) of expected step data were successfully entered by the parent or study coordinator. Parents in the MIG and IIG were sent approximately 7 and 13 text messages per week, respectively, averaged over the course of the study. IIG parents accessed an average of 6.1 (SD 4.4) articles over the course of the intervention and accessed a fewer number of articles in the last month compared to the first 2 months of the study (P=.002). Children in both the MIG and IIG significantly increased their physical activity, averaged over 12 weeks, by 1427.6 (SD 583.0; P=.02) and 2832.8 (SD 604.9; P

Background: Young children with Type 1 diabetes (T1D) are at risk for extreme blood glucose variability, a risk factor for suboptimal glycated hemoglobin A1c (HbA1c) and long-term health complications. We know that a reciprocal relationship exists between sleep and glycemic outcomes in older youth with T1D; however, little research has examined objective sleep in young children (<7 years) with T1D.Purpose: This study examines bidirectional associations between sleep behaviors and glycemic variability in young children with T1D.Methods: Thirty-nine young children with T1D (Mage 4.33 ± 1.46 years; MHbA1c 8.10 ± 1.06%) provided accelerometry data to objectively measure sleep onset latency, number of nighttime awakenings, and total sleep time. We also assessed HbA1c, average blood glucose, and glycemic variability (i.e., standard deviation of blood glucose from device downloads). We evaluated bidirectional relationships using multilevel modeling in SAS, with weekday/weekend as a Level 2 moderator.Results: Children averaged 8.5 ± 1.44 hr of sleep per night, but only 12.8% met current sleep recommendations. Children experienced more nighttime awakenings, higher blood glucose, and more glycemic variability on weekends. Sleep onset latency and nighttime awakenings predicted greater glycemic variability on weekends, and weekend glycemic variability predicted increased nighttime awakenings.Conclusions: Most young children with T1D did not meet sleep recommendations. Young children experienced more nighttime awakenings, higher blood glucose, and increased glycemic variability on weekends only, when routines may be less predictable. Findings suggest that one way families of young children with T1D may be able to decrease glycemic variability is to keep consistent routines on weekdays and weekends. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of a new video‐based telehealth intervention to reduce hypoglycemia fear in parents of young children with type 1 diabetes. Methods: We randomized 42 parents to either immediate treatment (reducing emotional distress for childhood hypoglycemia in parents, REDCHiP; n = 22) or a waitlist control (WAITLIST; n = 21) condition. REDCHiP parents completed a 10‐session video‐based telehealth intervention, while WAITLIST parents continued in usual care. After 14‐weeks, WAITLIST parents completed the telehealth treatment. We examined for between group changes in parental hypoglycemia fear and parenting stress (n = 18 per condition), 3‐month maintenance of treatment effects for parents randomized to REDCHiP (n = 15), and pre‐post changes for the entire sample (n = 36). Results: Mostly mothers participated (97.6%). They reported a mean age of 35.2 ± 5.0 years at pre‐treatment. Children were 4.4 ± 1.4 years old and 59.5% boys. Between group comparisons showed a significant reduction in hypoglycemia fear (P =.04) and a trend toward reduction in parenting stress‐frequency (P =.092) for REDCHiP parents compared to WAITLIST parents. After the three‐month maintenance period, REDCHiP parents reported significant reductions in hypoglycemia fear, parenting stress‐frequency, and parenting stress‐difficulty (P's <.01) compared to pre‐treatment. When all parents received the telehealth treatment, we also observed significant reductions in hypoglycemia fear, parenting stress‐frequency, and parenting stress‐difficulty (P's <.001), and sensitivity analyses revealed a significant reduction in child glycated hemoglobin for children who entered the treatment above target (P <.05). Conclusion: Our new video‐based telehealth intervention appears to reduce hypoglycemia fear and parenting stress and may help parents of very young children with T1D to better achieve optimal child glycemic control when children are above target. [ABSTRACT FROM AUTHOR]

Objective: We examined how parent and youth responsibility for type 1 diabetes (T1D) care is related to adherence and glycemic outcomes, namely, glycemic variability and risk of glycemic excursions.Methods: One hundred thirty-five parent-youth dyads (10-16 years old; diagnosed with T1D for at least 6 months) participated in this study. Percent responsibility of T1D care attributed to the youth, parent, or shared was measured using the Diabetes Family Responsibility Questionnaire. We collected youth's hemoglobin A1c (HbA1c) and glucometer downloads to examine relationships between responsibility and HbA1c, frequency of blood glucose monitoring (self-monitoring blood glucose, SMBG), risk of glycemic excursions, and actual glycemic variability using bivariate correlations and path analysis.Results: Participants reported shared responsibility for almost half of T1D self-care tasks. Bivariate correlations showed shared responsibility was associated with less variability, whereas parent responsibility was associated with greater glycemic variability and risk for glycemic excursions. Youth responsibility was associated with lower frequency of SMBG. The path analyses confirmed our correlational findings (ps<.05) and better characterized interactions with age for youth-reported responsibility.Conclusions: Our results support the hypothesis that shared T1D responsibility is associated with better diabetes outcomes in youth. [ABSTRACT FROM AUTHOR]

ADA guidelines recommend regularly screening teens for depression. We examined sensitivity and specificity of the long and short-form of the Patient Health Questionnaire (PHQ) to identify depressive disorders in teens with T1D against a gold-standard diagnostic interview. Teens (N=100; Mean age = 15.0 ± 1.7; 60% Male; 87% white; Mean HbA1c = 8.88 ± 1.8%) completed the PHQ-9 electronically. We used the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS DSM-5) depression module to determine whether the teen met criteria for any depressive disorder (DD; e.g., major depression, dysthymia, adjustment disorder-depressed mood, bipolar). We compared teens' pre-existing PHQ cut-off scores (PHQ-9 ≥ 10; PHQ-2 ≥ 3) to KSADS results. Per KSADS, 15% of teens met criteria for current DD, 11% endorsed past DD, and 25% endorsed past/present suicidal ideation (SI). Only 6% and 8% of teens exceeded PHQ-9 and PHQ-2 cut-off scores, respectively, and 10% endorsed current SI on PHQ item 9. Sensitivity and specificity outcomes are in Table 1. The PHQ-9 and PHQ-2 showed low sensitivity and high false negative rates. Lower cut-offs or alternative screening measures may be indicated to reliably identify DD in teens with T1D. High rates of reported SI, even by teens who did not meet full criteria for DD, highlight the importance of screening for suicidality and/or treating subthreshold depressive symptoms. Disclosure: A.M. Marker: None. R. McDonough: None. A. Egan: None. M.A. Clements: Advisory Panel; Self; Glooko, Inc. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Medtronic. S.R. Patton: None. [ABSTRACT FROM AUTHOR]

Background: Greater knowledge about nutrition and carbohydrate counting are associated with improved glycemic control and quality of life in youth with type 1 diabetes (T1D). However, limited assessments of nutrition and carbohydrate knowledge have been developed, and existing measures can be time-consuming, overly broad, or not conducive to routine clinical use. To fill this gap, we developed and examined the feasibility of administering the electronic Nutrition and Carbohydrate Counting Quiz (eNCQ)., Method: Ninety-two caregivers and 70 youth with T1D (mean age 12.5 years; mean time since diagnosis 5 years; English speaking) completed the 19-item eNCQ via tablet during a routine clinical visit. Completion time and item completion rates were used to assess feasibility. Relationships between eNCQ scores and patient demographics, diabetes management, and health outcomes were examined., Results: Participants took 10 minutes, on average, to complete the eNCQ. Total and Carbohydrate subscale scores (youth report) were negatively correlated with youth hemoglobin A1c (total r = -.38, carbohydrate r = -.38, Ps < .05), indicating that greater nutrition knowledge related to better glycemic control. Nutrition knowledge scores were generally high, but knowledge was negatively related to time since diabetes diagnosis ( r = -.276, P < .05)., Conclusions: Findings support feasibility of the eNCQ to assess nutrition knowledge in routine clinical care. Following additional acceptability and validity testing, the eNCQ may identify families in need of further nutrition education. Nutrition assessment is particularly indicated for youth over one year since T1D diagnosis, as these families displayed lower nutrition knowledge and may need continuing education to maintain diabetes-specific nutrition knowledge over time.

Background: Family-based behavioral treatments are effective ways to promote children's weight management through healthy eating and exercise. However, programs typically have high attrition and low attendance. The aim of this study was to obtain in-depth caregiver input on barriers and facilitators to participate in a family-based, behavioral childhood obesity treatment program., Methods: Three focus groups were facilitated among 21 parents/guardians at 2 school-based health centers and 1 federally qualified health center. Audio recordings were transcribed and uploaded into NVivo software to assist in thematic coding., Results: Focus group participants were females aged 18-57 years, of whom 71% were black, and 81% were not married. Participants listed numerous barriers: lack of time, frustration from prior unsuccessful weight-loss attempts, and the perceived cost of healthy foods and exercise options. Facilitators included a convenient location, a supportive weight-loss program leader, and rewards for the child's progress., Conclusion: Future interventions should incorporate caregivers' perspectives to develop sustainable, feasible strategies for the treatment of childhood obesity.