The Maintain High Blood Glucose subscale of the child hypoglycemia fear survey: proposed preliminary cut points for screening youth with type 1 diabetes.

OBJECTIVE: To improve the clinical utility of the Maintain High Blood Glucose subscale of the Hypoglycemia Fear Surveys (HFS) by identifying clinically meaningful cut points associated with glycemic outcomes. METHODS: Youth (N = 994; 13.96 ± 2.3 years) with type 1 diabetes and their caregivers (N = 1,111; 72% female) completed the Child or Parent version of the HFS. Modal Score Distribution, Standard Deviation Criterion, and Elevated Item Criterion approaches were used to identify proposed preliminary cut points for the Maintain High Blood Glucose subscale. The association between proposed preliminary cut points was examined with youth glycemic outcomes. RESULTS: A cut point of ≥7 for the Maintain High Blood Glucose subscale on the Child HFS was associated with a greater percentage of blood glucose readings >180 mg/dl (p < .01), higher mean blood glucose (p < .001), and a higher hemoglobin A1c (p < .05). In subsequent multiple regression analyses, controlling for other factors associated with glycemia, the significant association between scores above ≥7 and higher mean blood glucose and higher hemoglobin A1c remained. A clinically useful cut point was not identified for caregivers. However, elevated youth scores on the Maintain High Blood Glucose subscale were positively associated with elevated caregiver scores (phi = .171, p < .001). CONCLUSIONS: The proposed preliminary cut point for the Maintain High Blood Glucose subscale will aid the type 1 diabetes care team in identifying youth whose behaviors may be contributing to their suboptimal glycemia.

Structures and Strategies for Retaining an International Pediatric Cohort from Birth: Lessons from The Environmental Determinants of Diabetes in the Young (TEDDY) Study.

Background: Retention of study participants in observational studies is essential to maintaining the representativeness of the population, minimizing selection bias, and assuring sufficient statistical power. The aim of this report is to describe the structures and strategies used to retain participants in The Environmental Determinants of Diabetes in the Young (TEDDY) Study, an observational study of children at increased genetic risk for type 1 diabetes followed in an intense protocol with frequent clinic visits from birth until age 15. Methods: A systematic review of methodologies used to retain research subjects identified four domains: barrier reduction strategies; community building strategies; follow-up/reminder strategies; and tracing strategies. Independent reviewers categorized the retention strategies implemented by the TEDDY Study into each of these domains. Strategies not fitting into any of these categories were placed into a fifth category unique to TEDDY. Results: TEDDY identified over one hundred retention strategies used during the 15 years of follow-up; most could be categorized in these domains. Those unique to TEDDY included (1) study organization and structures to support retention; (2) efforts to meet the changing developmental needs of the TEDDY population, (3) implementation of efforts to address protocol challenges in real-time; and (4) employment of a re-engagement protocol for those who had dropped out of the study. Conclusion: Pediatric cohort studies should include strategies, structures, and resources addressing retention at the study's initiation. It is recommended that child and parent engagement in addition to the developmental needs of the child be an integrated focus of all strategies. Putting mechanisms in place to address protocol and retention challenges in real time would facilitate effectively addressing challenges as they arise. Trial registration: ClinicalTrials.gov Identifier: NCT00279318.

A Community Health Center Childhood Obesity Program for Latino Families from an Agricultural Community: Mental Health and Physical Activity Outcomes.

The purpose of this study was to evaluate the impact of an ongoing multidisciplinary childhood obesity intervention, within a federally qualified health center, on mental health and physical activity outcomes with Latino children from an agricultural community. The program was evaluated using attendance and parent-reports of child mental health and physical activity levels. Paired t-tests and chi squared tests were used to examine pre-post change in outcomes. There were 100 total participants. The mean age was 9.40 years, and the mean BMI percentile was 97.39. Significant post-intervention improvements were observed in mental health externalizing and internalizing problems (p <.0001) and in weekly physical activity frequency (p =.0131) and duration (p = .0280). Childhood obesity interventions should target mental health problems as well as obesity as the two are closely related. Community health centers may be ideal settings for interventions as they can facilitate access to needed services for high-risk populations.

Factors assessed in the first year of a longitudinal study predict subsequent study visit compliance: the TEDDY study.

BACKGROUND: Compliance with a study protocol is central to meeting its research goals. In longitudinal research studies, data loss due to missed visits limit statistical power and introduce bias. The Environmental Determinants of Diabetes in the Young (TEDDY) study is a longitudinal multinational (US, Finland, Germany, and Sweden) investigation of children at risk for type 1 diabetes (T1D) that seeks to identify the environmental triggers of islet autoimmunity and T1D. The purpose of the current study was to identify sociodemographic variables and maternal characteristics assessed in the first year of TEDDY that were associated with study visit compliance in the subsequent 3 years. METHODS: Sociodemographic variables, maternal life-style behaviors, post-partum depression, maternal reactions to the child's T1D risk, and study-related variables were collected at child-age 6 months and 15 months. Multiple linear regression was used to examine the association of these variables to study visit compliance in the subsequent 3 years. RESULTS: Study visit compliance was highest in Sweden (p > 0.001), in children who were their mother's first child (p > 0.001), and whose mothers were older (p > 0.001) and more satisfied with the TEDDY study (p > 0.001). Father participation was also associated with better study visit compliance (p > 0.001). In contrast, children whose mothers smoked (p > 0.001), suffered from post-partum depression (p = 0.034), and were more anxious about their child's T1D risk (p = 0.002), completed fewer visits. Father's study satisfaction was also associated with study visit compliance (p = 0.029); however, it was not significant in models that included maternal study satisfaction. CONCLUSIONS: Sociodemographic variables, maternal characteristics-including study satisfaction-and fathers' participation in the first year of a longitudinal study were associated with subsequent study visit compliance in a sample of children genetically at-risk for T1D followed for 4 years. This information can inform future strategies designed to improve study visit compliance in longitudinal pediatric studies. TRIAL REGISTRATION: NCT00279318, 06/09/2004.