Durability of Changes in Biomarkers of Cardiometabolic Disease: 1-Year Family-Based Intervention in Children with Obesity.

Background: The sustainability of health benefits in response to lifestyle-based interventions remains unclear in children with overweight and obesity, and cardiometabolic disease (CMD). We determined the changes in novel biomarkers of CMD in a 1-year family-based intervention (FBI) program, during 6-month active monitoring phase and at 12-month follow-up. Methods: Children with an age-adjusted body mass index (BMI) percentile ≥85 (N = 130; age 8-11 years) were recruited for a 1-year (6-month monitored and 6-month unmonitored) randomized controlled FBI program. Anthropometry and selected biomarkers of CMD were measured in 87 participants, randomly allocated to intervention (INT) and education-only (EDU) groups, at baseline, immediately after a 6-month active intervention or control period, and at 12-month unmonitored follow-up. Results: Samples from 87 participants (age 10.00 ± 0.11 years and Tanner stage ≤3) with obesity (BMI%ile = 97.45 ± 0.15) were available. Overall intervention effect (between groups), was observed for total (T) and high molecular weight (HMW) adiponectin, ratio of total to HMW adiponectin, fibrinogen, and interleukin (IL)-6 (P < 0.05 for all). However, between-group beneficial changes after adjusting for baseline levels were limited to BMI percentile, T and HMW adiponectin and their ratio, IL-6, and fibrinogen (P < 0.05 for all) mainly during the 6-month period of monitored intervention. Changes in traditional risk factors such as lipids and triglycerides were inconsistent. During the 6-month follow-up period, the changes in biomarkers leveled-off, except for T and HMW adiponectin, IL-6, and fibrinogen that continued to show benefits (P < 0.05) from the 6- to 12-month follow-up. Conclusions: The FBI program beneficially altered novel biomarkers of CMD during the monitored intervention phase in school-age children with obesity, but they mostly moved back toward baseline during the unmonitored follow-up phase. The changes in novel biomarkers of CMD appear to be more sensitive compared to the traditional risk factors. The study implies the need for refinements in lifestyle-based approaches in the preservation of cardiovascular health and calls for robust biomarkers to monitor the changes. The study was registered at ClinicalTrials.gov (NCT01146314).

Effects of Mixed Carotenoids on Adipokines and Abdominal Adiposity in Children: A Pilot Study.

Context: Carotenoids have been implicated in the regulation of adipocyte metabolism. Objective: To compare the effects of mixed-carotenoid supplementation (MCS) versus placebo on adipokines and the accrual of abdominal adiposity in children with obesity. Design and Setting: Randomized (1:1), double-blind, placebo-controlled intervention trial to evaluate the effects of MCS over 6 months in a subspecialty clinic. Participants: Twenty (6 male and 14 female) children with simple obesity [body mass index (BMI) > 90%], a mean age (± standard deviation) of 10.5 ± 0.4 years, and Tanner stage I to V were enrolled; 17 participants completed the trial. Intervention: MCS (which contains ß-carotene, α-carotene, lutein, zeaxanthin, lycopene, astaxanthin, and γ-tocopherol) or placebo was administered daily. Main Outcome Measures: Primary outcomes were change in ß-carotene, abdominal fat accrual (according to magnetic resonance imaging), and BMI z-score; secondary outcomes were adipokines and markers of insulin resistance. Results: Cross-sectional analysis of ß-carotene showed inverse correlation with BMI z-score, waist-to-height ratio, visceral adipose tissue, and subcutaneous adipose tissue (SAT) at baseline. MCS increased ß-carotene, total adiponectin, and high-molecular-weight adiponectin compared with placebo. MCS led to a greater reduction in BMI z-score, waist-to-height ratio, and SAT compared with placebo. The percentage change in ß-carotene directly correlated with the percentage change in SAT. Conclusions: The decrease in BMI z-score, waist-to-height ratio, and SAT and the concomitant increase in the concentration of ß-carotene and high-molecular-weight adiponectin by MCS suggest the putative beneficial role of MCS in children with obesity.

Validation of a self-report version of the diabetes self-management profile.

Inadequate treatment adherence impedes achievement of glycemic control targets in type 1 diabetes (T1D). Valid and reliable measurement of treatment adherence is a prerequisite to rigorous evaluation of pertinent interventions. The diabetes self-management profile (DSMP), a structured interview measure of T1D adherence, is valid and reliable but it requires trained interviewers, it is labor intensive to administer and it is burdensome for research participants. We adapted the DSMP interview to create the DSMP-self-report questionnaire (DSMP-SR) for completion by parents and youth ≥11 yr old. The DSMP-SR was obtained during a cross-sectional study of 151 youth within the age range of 8 to <18 yr with T1D [male, 50.7%; racial minorities, 23%; mean age, 13.9 yr; T1D duration, 5.5 yr; hemoglobin A1c (HbA1c), 8.7%] and a parent of each. Parents and youth ≥11 yr old completed the DSMP-SR independently. The DSMP-SR had sound internal consistency (Cronbach's α: youth, 0.82; parent, 0.80), and parent-youth agreement, (r = 0.60, p < 0.001) and significant associations with HbA1c (r = -0.35 for youth and -0.46 for parents, p < 0.001), PedsQL quality of life scale (youth: r = -0.41, p < 0.001; parent: r = -0.40, p < 0.001) and, for parents but not youth, the Revised Diabetes Family Conflict Scale (r = -0.47, p < 0.001). Higher DSMP-SR scores were associated with lower HbA1c, better quality of life, and less family conflict. The DSMP-SR has similar psychometric properties to those reported elsewhere for the DSMP, yielding a convenient measure of T1D adherence.

Youth and parent knowledge and communication about major complications of type 1 diabetes: associations with diabetes outcomes.

OBJECTIVE: Previously, we studied clinicians' and parents' perspectives about what, when, and how youth with type 1 diabetes (T1D) and parents should be taught about major complications (MC) of T1D. Results showed that this topic creates considerable anxiety among youth and parents, that there is a perceived need to tailor these experiences to each patient's circumstances, and that there is considerable variability in opinions about appropriate MC education. Prior studies did not measure youths' or parents' actual knowledge of complications, how they cope with that knowledge, or how these variables relate to T1D outcomes. The current study addresses these gaps. RESEARCH DESIGN AND METHODS: This article reports a cross-sectional study of 151 8- to 18-year-old youths with T1D and their parents in which their knowledge of MC (nephropathy, retinopathy, neuropathy, and cardiovascular disease) was ascertained by structured interview. Family communication about MC was assessed using a questionnaire validated in this study. Regression analyses explored youth age, parent and youth MC knowledge, and positive family communication about MC as predictors of T1D outcomes (hemoglobin A(1c), treatment adherence, quality of life, and family conflict about T1D). RESULTS: Parental MC knowledge was not associated with any T1D outcome; greater youth MC knowledge predicted better treatment adherence. More frequent optimistic family communication about MC was associated with more favorable status on all outcomes. CONCLUSIONS: Optimistic family communication about MC, more so than MC knowledge, predicted favorable T1D outcomes. Longitudinal studies are needed to confirm these associations and to evaluate pertinent psychoeducational interventions.

Physician identification and management of psychosocial problems in primary care.

Often the burden of identifying children with behavioral or developmental problems is left up to the primary care physician (PCP). However, previous literature shows that PCPs consistently underidentify children with developmental/behavioral problems in pediatric primary care. For the current study, questionnaires containing three vignettes followed by questions addressing common psychosocial problems, general questions about their practice and training, and the Physician Belief Scale were distributed to physicians. Results indicated that physicians were better at identifying severe problems, had more difficulty identifying psychosocial problems with mild symptomatology, and tended to refer to a medical specialist or mental health professional more often for severe problems, depression or a developmental problem. Physicians tended to view treating psychosocial problems favorably.

Dyadic measures of the parent-child relationship during the transition to adolescence and glycemic control in children with type 1 diabetes.

To identify aspects of family behavior associated with glycemic control in youth with type 1 diabetes mellitus during the transition to adolescence, the authors studied 121 9- to 14-year-olds (M = 12.1 yrs) and their parents, who completed the Diabetes Family Conflict Scale (DFCS) and the Diabetes Family Responsibility Questionnaire (DFRQ). From the DFRQ, the authors derived 2 dyadic variables, frequency of agreement (exact parent and child concurrence about who was responsible for a task) and frequency of discordance (opposite parent and child reports about responsibility). The authors divided the cohort into Younger (n = 57, M = 10.6 yrs) and Older (n = 64, M = 13.5 yrs) groups. Family conflict was significantly related to glycemic control in the entire cohort and in both the Younger and Older groups. However, only in the Younger group was Agreement related to glycemic control, with higher Agreement associated with better glycemic control. Findings suggest that Agreement about sharing of diabetes responsibilities may be an important target for family-based interventions aiming to optimize glycemic control in preteen youth.

Youth and parent education about diabetes complications: health professional survey.

OBJECTIVE: Avoiding complications is paramount in diabetes management, but little is known about how, when, and what diabetes professionals disclose to parents and youths about this topic. RESEARCH DESIGN AND METHOD: Pediatric diabetes experts (n = 534) were surveyed about their practices and attitudes regarding informing parents and youth about long-term diabetic complications. RESULTS: Professionals reported giving more information to parents, older children, and children with longer diabetes duration than younger or newly diagnosed children. Principal components analysis was completed to identify measurement factors of the attitudes about information sharing and variables affecting decision-making sections of the survey. These factor scores served as predictor variables in hierarchical multiple regression analyses. More information sharing was associated with more diabetes clinical activity, stronger sense of professional responsibility to disclose this information, less sensitivity about the emotional impact of this teaching, greater concern about exposure to inaccurate information, and less consideration of the family context (R(2) = 0.282, p < or = 0.0001). Greater propensity to share information about complications was found among health care providers who reported that they gave less consideration to such variables as the family's prior experience with diabetes in other family members or the child's duration of diabetes or the presence of psychiatric disorders in the child or family members. CONCLUSIONS: Patient characteristics and professionals' attitudes were associated with experts' willingness to inform families about long-term diabetic complications. Further research should explore how these practice variations affect coping with diabetes.

A multisite trial of a clinic-integrated intervention for promoting family management of pediatric type 1 diabetes: feasibility and design.

The feasibility of a family-based clinic-integrated behavioral intervention to improve family management of type 1 diabetes was evaluated. In each of four clinical sites, 30-32 families (a total of 122) were randomized to intervention or usual care comparison groups. The WE*CAN intervention, based on family problem-solving methods, was delivered during three routine clinic visits by trained 'Health Advisors'. Of eligible families across the four sites, 83% agreed to participate, of whom 96% completed the baseline, mid-term, and postintervention assessments. Families participated in an average of 2.85 intervention sessions over an 8-month period. The intervention was integrated into the clinic setting without impairing clinic flow and was implemented with fidelity and consistency across sites by trained non-professionals. The findings provide evidence of the feasibility of conducting a multisite trial to evaluate the effects of a clinic-integrated problem-solving intervention to improve family management. Many lessons were learned that provide guidance for recruitment, measurement, and intervention for the larger clinical trial.

Diabetes complications in youth: qualitative analysis of parents' perspectives of family learning and knowledge.

OBJECTIVE: Youth with type 1 diabetes face long-term risks of health complications of the disease. Little is known about patients' and parents' knowledge, acquisition of information, and family communication regarding these complications. This paper reports qualitative analyses of parental focus-group discussions of this topic. RESEARCH DESIGN AND METHODS: A total of 47 participants (30 mothers, 14 fathers, and 3 others) representing 33 children between the ages of 8 and 18 years with type 1 diabetes participated in 1 of 13 focus groups. Open-ended questions focused on the type and amount of information about long-term complications presented to parents by health care professionals at different time points, as well as the way that information was presented. Questions also elicited details about parent-child communication and exposure to misconceptions about diabetes complications. RESULTS: Qualitative analysis of the transcribed focus groups revealed that participants experienced significant anxiety about diabetes complications, with a shift from concern about daily management tasks to concern about long-term complications over time. Participants desired a flexible, collaborative educational approach, especially regarding the timing and type of information, relative to the child's age and duration of diabetes. Many parents wanted more sensitive communication and emotional support from health care providers. Motivating children appeared to be a particular challenge; family burnout with regard to diabetes care over time was reported. Knowledge was gained in many ways, yet misinformation was uncommon. CONCLUSIONS: Obtaining information about long-term complications is an important process that changes over the course of the disease and with the child's developmental level. More research is needed, especially regarding youth knowledge, learning, and beliefs about diabetes complications.

Randomized, controlled trial of Behavioral Family Systems Therapy for Diabetes: maintenance and generalization of effects on parent-adolescent communication.

We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes (BFST-D) intervention. Families of 104 adolescents with diabetes were randomized to standard care (SC) or to 6 months of an educational support group (ES) or BFST-D. Family communication and problem-solving skills were assessed at 0, 6, 12, and 18 months by independent rating of videotaped family problem-solving discussions. BFST-D improved individual communication of adolescents and mothers, but not fathers. BFST-D significantly improved quality of family interaction compared to SC (10 of 12 comparisons) and ES (6 of 12 comparisons). Changes in family communication were differentially associated with changes in glycemic control, adherence, and family conflict. BFST-D improved family communication and problem solving relative to SC and modestly relative to ES.

Randomized trial of behavioral family systems therapy for diabetes: maintenance of effects on diabetes outcomes in adolescents.

OBJECTIVE: Studies showing that family communication and conflict resolution are critical to effective management of type 1 diabetes in adolescents have stimulated interest in evaluating psychological treatments targeting these processes. Previous trials have shown that Behavioral Family Systems Therapy (BFST) improved parent-adolescent relationships but not treatment adherence or glycemic control. This study evaluates a revised intervention, BFST for Diabetes (BFST-D), modified to achieve greater impact on diabetes-related family conflict, treatment adherence, and metabolic control. RESEARCH DESIGN AND METHODS: A sample of 104 families of adolescents with inadequate control of type 1 diabetes was randomized to either remain in standard care (SC) or to augmentation of that regimen by 12 sessions of either a multifamily educational support (ES) group or 12 sessions of BFST-D over 6 months. Pertinent measures were collected at baseline and at follow-up evaluations at 6, 12, and 18 months. RESULTS: BFST-D was significantly superior to both SC and ES in effects on A1C, while effects on treatment adherence and family conflict were equivocal. Improvement in A1C appeared to be mediated by improvement in treatment adherence. A significantly higher percentage of BFST-D youth achieved moderate or greater improvement (>0.5 SD) in treatment adherence compared with the SC group at each follow-up and the ES group at 6 and 18 months. Change in treatment adherence correlated significantly with change in A1C at each follow-up. CONCLUSIONS: These results support the efficacy of BFST-D in improving A1C, but further research is needed to identify the mechanisms of this effect and to achieve cost-effective dissemination of the intervention.

Effects of behavioral family systems therapy for diabetes on adolescents' family relationships, treatment adherence, and metabolic control.

BACKGROUND: Behavioral family systems therapy (BFST) for adolescents with diabetes has improved family relationships and communication, but effects on adherence and metabolic control were weak. We evaluated a revised intervention, BFST for diabetes (BFST-D). METHODS: One hundred and four families were randomized to standard care (SC) or to 12 sessions of either an educational support group (ES) or a BFST-D over 6 months. Family relationships, adherence, glycosylated hemoglobin (HbA1c), and health care utilization were measured at baseline and after treatment. RESULTS: BFST-D significantly improved family conflict and adherence compared to SC and ES, especially among those with baseline HbA1c > or = 9.0%. BFST-D and ES significantly improved HbA1c compared to SC among those with baseline HbA1c > or = 9.0%. CONCLUSIONS: The revised intervention (BFST-D) improved family conflict and treatment adherence significantly, while both ES and BFST-D reduced HbA1c significantly, particularly among adolescents with poor metabolic control. Clinical translation of BFST-D requires further study.

The psychologic context of pediatric diabetes.

During the past few decades, there has been an explosion of behavioral science research on family management of pediatric diabetes. This article distills the major conclusions from that literature, emphasizing how primary care providers can apply these findings in clinical practice.