Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes.

AIMS: Examine barriers for taking glucose-lowering oral medications, associated baseline characteristics, strategies used, and the adherence impact in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study. METHODS: We studied youth prescribed oral diabetes medications over two years (N = 611, 583, and 525 at 6, 12, and 24 months). Clinicians documented barriers (e.g. forgetting, routines, other concerns) in the subsample that reported missed doses (N = 423 [69.2%], 422 [72.4%], and 414 [78.9%] at 6, 12, and 24 months, respectively). Adherence strategies were also assessed (e.g. family, schedule, reminder device) using standard questions. Logistic regression was used to analyze associations with medication adherence. RESULTS: Those missing doses were not different from the total sample (61.5% female, 13.9 ±â€¯2.0 years, >80% racial/ethnic minorities). No baseline demographic or clinical predictors of barriers to medication adherence were identified. Among those for whom barriers were assessed, "forgetting" with no reason named (39.3%) and disruptions to mealtime, sleep, and schedule (21.9%) accounted for the largest proportion of responses. Family support was the primary adherence strategy identified by most youth (≥50%), followed by pairing the medication regimen with daily routines (>40%); the latter strategy was associated with significantly higher adherence rates (p = 0.009). CONCLUSIONS: Family supported medication adherence was common in this mid-adolescent cohort, but self-management strategies were also in evidence. Findings are similar to those reported among youth with other serious chronic diseases. Prospective studies of multi-component family support and self-management interventions for improving medication adherence are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT00081328.

Long-term changes in dietary and food intake behaviour in the Diabetes Prevention Program Outcomes Study.

AIMS: To compare change in dietary intake, with an emphasis on food groups and food intake behaviour, over time across treatment arms in a diabetes prevention trial and to assess the differences in dietary intake among demographic groups within treatment arms. METHODS: Data are from the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Participants were randomized to a lifestyle intervention (n = 1079), metformin (n = 1073) or placebo (n = 1082) for an average of 3 years, after which the initial results regarding the benefits of the lifestyle intervention were released and all participants were offered a modified lifestyle intervention. Dietary intake was assessed using a food frequency questionnaire at baseline and at 1, 5, 6 and 9 years after randomization. RESULTS: Compared with the metformin and placebo arms, participants in the lifestyle arm maintained a lower total fat and saturated fat and a higher fibre intake up to 9 years after randomization and lower intakes of red meat and sweets were maintained for up to 5 years. Younger participants had higher intakes of poultry and lower intakes of fruits compared with their older counterparts, particularly in the lifestyle arm. Black participants tended to have lower dairy and higher poultry intakes compared with white and Hispanic participants. In the lifestyle arm, men tended to have higher grain, fruit and fish intakes than women. CONCLUSIONS: Changes in nutrient intake among participants in the lifestyle intervention were maintained for up to 9 years. Younger participants reported more unhealthy diets over time and thus may benefit from additional support to achieve and maintain dietary goals.

Reference gene validation for qPCR on normoxia- and hypoxia-cultured human dermal fibroblasts exposed to UVA: is ß-actin a reliable normalizer for photoaging studies?

Data normalization of gene expression on human dermal fibroblasts (HDF) exposed to UVA has commonly been done using either GAPDH or ß-actin as reference genes without any validation of their expression stability. Since this aspect, important for accurate normalization, has been overlooked, we aimed to establish a suitable set of reference genes for studies on UVA-treated HDF cultured under both standard atmospheric oxygen tension (normoxia, 21%) and under a physiological, low oxygen tension for these cells (hypoxia, 5%). The stability of six commonly used reference genes was assessed using the geNorm and NormFinder softwares subsequent to reverse-transcription quantitative real-time PCR (RT-qPCR). GAPDH/SDHA were found to be the most stable genes under normoxia, while SDHA/TBP or HPRT1/ß2M were the most stable ones under hypoxia in HDF exposed to 18 J/cm(2) UVA. ß-Actin was always the most unstable reference gene. To emphasize the importance of selecting the most stably expressed reference genes for obtaining reliable results, mRNA expression levels of MMP-1 and COL1A1 were analyzed vs the best reference genes and the worst one. These reference genes are hence recommended for future qPCR analyses in studies concerning photo-damage on UVA-treated HDF.

Rationale, design and methods of the HEALTHY study behavior intervention component.

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data informed the development of the behavior intervention component. Principles of social learning and health-related behavior change were incorporated. One element of the behavior intervention component was a sequence of peer-led, teacher-facilitated learning activities known as FLASH (Fun Learning Activities for Student Health). Five FLASH modules were implemented over five semesters of the HEALTHY study, with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade. Each module contained sessions that were designed to be delivered on a weekly basis to foster self-awareness, knowledge, decision-making skills and peer involvement for health behavior change. FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity. Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student's lifestyle change choices. Family outreach strategies included the delivery of newsletters and supplemental packages with materials to promote healthy behavior in the home environment during school summer and winter holiday breaks. In conclusion, the HEALTHY behavior intervention component, when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns, is a feasible and acceptable mechanism for delivering age-appropriate social learning for healthy eating and physical activity among an ethnically diverse group of middle school students across the United States.

First versus repeat treatment with a lifestyle intervention program: attendance and weight loss outcomes.

OBJECTIVE: Following unblinding of the Diabetes Prevention Program (DPP) results, a 16-session lifestyle intervention program was offered to all study participants, including those who had initially been randomized to lifestyle treatment. This study compares the effects of the lifestyle program between participants who had previous exposure and those who had not. DESIGN: A 16-session behavioral intervention was conducted in groups at each of the 27 DPP sites during a transitional (bridge) period from the DPP trial to the DPP Outcomes Study (DPPOS). Session participation for this 6-month behavioral weight loss program was confirmed by originally randomized treatment groups. SUBJECTS AND MEASUREMENTS: Independently assessed weight measurements were available within a 7-month period before and after the program for 2808 ethnically diverse participants. RESULTS: Participants from the lifestyle group in the DPP were the least likely to attend a repeat offering of a 16-session behavioral weight loss program conducted in groups. Weight loss during the transitional lifestyle program was strongly related to the duration of attendance in the three groups that were participating in the program for the first time (metformin, placebo and troglitazone), but not related to amount of earlier weight loss. CONCLUSION: Individuals who were naive to the behavioral program lost a greater amount of weight and this was strongly related to their degree of participation. A second exposure to a behavioral weight loss program resulted in unsatisfactory low attendance rates and weight loss.

In vitro photostability and photoprotection studies of a novel 'multi-active' UV-absorber.

This paper reports on the synthesis and properties of a new UV-absorber (OC-NO) based on the most popular UV filter worldwide, ethylhexyl methoxycinnamate (OMC) in which the methoxy group has been replaced with a pyrrolidine nitroxide bearing antioxidant activity. This sunscreen active has therefore both UV-absorbing and antioxidant properties which could ideally address both the UV-B and UV-A skin photo-damage. For broad-spectrum coverage, the combinations of OC-NO with two commonly used UV-A absorbers (BMDBM and DHHB) were also studied. The results obtained reveal that OC-NO: (a) is as photostable as OMC after UV-A exposure; (b) acts as free radical scavenger as demonstrated by EPR and chemical studies; (c) reduces UV-A and UV-A+BMDBM induced lipid peroxidation in liposomes and cells, measured as reduced TBARS levels and increased C11-BODIPY red fluorescence, respectively; (d) has comparable antioxidant activity to that of vitamin E and BHT commonly used in skin care formulations; (e) is non-cytotoxic to human skin fibroblasts as assessed with the MTT assay when exposed to increasing doses of UV-A; and (f) OC-NO+DHHB is a promising, photostable broad spectrum UV-filter combination that concomitantly reduces UV-induced free radical damage. These results suggest that nitroxide/antioxidant-based UV-absorbers may pave the way for the utilization of 'multi-active' ingredients in sunscreens thereby reducing the number of ingredients in these formulations.

Intraoperative localization of subcortical brain lesions.

BACKGROUND: Some brain tumors may grow immediately beneath the cortical surface without distorting its appearance. Intraoperative image guidance promotes safe resection. We have developed MRI-based corticotopography (MRI-bct), to localize lesions during surgery, using simple, non-dedicated equipment, to match a three-dimensional reconstruction with the corresponding appearance of the brain cortex. METHODS: Forty-six patients underwent resection of subcortical brain lesions, aided by MRI-bct. The lesions had a maximum diameter less than 3 cm, were subcortical but no deeper than the floor of the nearest cerebral sulcus. Each patient had a volumetric MRI scan with and without contrast administration. Data sets were transferred to a laptop personal computer and processed using a rendering software. At operation, the three-dimensional model of the brain, including a surface overlay of the lesion, was matched to the exposed brain surface. After its exact relationship with the overlying sulcal pattern was defined, the lesion was localized and resected. In selected patients, the procedure was coupled with functional brain mapping. RESULTS: Data processing took from 10 to 15 min and could be done whenever convenient before operation. Surface matching between the surgical field and the reformatted MRI always required less than 5 min and was done near the operating table. In all patients, the lesion was identified at the first attempt, through a small corticotomy, regardless of the brain shift after dural opening. CONCLUSIONS: MRI-bct is a practical, time-saving neuronavigational aid ideal for localizing superficial lesions underlying the cerebral cortex because it unmistakably characterizes the adjacent sulcal anatomy.

BOLD signal sign and transient vessels volume variation.

The purpose of this work was to investigate the relation between BOLD signal sign and transient vessels volume variation induced by apnea. This stimulus consisting of breath holding after inspiration is able to induce a light slowing down in venous blood flow like in a sort of Valsalva maneuver. We observed diffuse negative BOLD responding areas at cortical level and a stronger negative response in correspondence of the main sinuses. These phenomena seem to be unrelated to a specific neural activity, appearing to be expressions of a mechanical variation in the hemodynamics. Our study suggests that particular care must be considered in the interpretation of fMRI findings, especially when patients with vascular-related cerebral diseases are involved.

Lifestyle intervention in overweight individuals with a family history of diabetes.

OBJECTIVE: To assess the effect of lifestyle intervention over 2 years on changes in weight, coronary heart disease (CHD) risk factors, and incidence of diabetes in overweight individuals with a parental history of diabetes. RESEARCH DESIGN AND METHODS: Participants (n = 154), who were 30-100% over ideal body weight, had one or both parents with diabetes, and were currently nondiabetic, were randomly assigned to 2-year treatments focused on diet (decreasing calories and fat intake), exercise (goal of 1,500 kcal/week of moderate activity), or the combination of diet plus exercise or to a no-treatment control group. Subjects were reassessed at 6 months, 1 year, and 2 years. RESULTS: At 6 months, the groups differed significantly on measures of eating, exercise, and fitness; weight losses in the diet and diet-plus-exercise groups were significantly greater than in the exercise and control conditions. Weight losses were associated with positive changes in CHD risk factors. After 6 months, there was gradual deterioration of behavioral and physiological changes, so that at 2 years, almost no between-group differences were maintained. Differences between groups in risk of developing diabetes were of borderline significance (P = 0.08). Strongest predictors were impaired glucose tolerance at baseline, which was positively related to risk of developing diabetes, and weight loss from baseline to 2 years, which was negatively related; in all treatment groups, a modest weight loss of 4.5 kg reduced the risk of type 2 diabetes by approximately 30% compared with no weight loss. CONCLUSIONS: Although initially successful, the interventions studied here were not effective in producing long-term changes in behavior, weight, or physiological parameters. However, weight loss from 0 to 2 years reduced the risk of developing type 2 diabetes. Since modest weight loss significantly reduced risk of type 2 diabetes, further research is needed to determine how best to increase the percentage of subjects achieving at least a modest weight loss.

The effects of health beliefs on weight loss in individuals at high risk for NIDDM.

OBJECTIVE: To determine whether perceived risk and other health beliefs held by individuals at high risk for developing NIDDM predict weight loss and behavior change during a behavioral weight loss program to reduce the risk of NIDDM. RESEARCH DESIGN AND METHODS: Health beliefs and objective risk factors for diabetes were examined in 154 overweight men and women with a family history of NIDDM. The effects of these factors on adherence, dietary intake, weight loss, and changes in glucose levels were examined in a subset of 79 of these subjects who participated in a 2-year behavioral weight control program. RESULTS: Those subjects who perceived themselves at highest risk of developing diabetes had a stronger family history of the disease and were more likely to be women than subjects considering themselves at more moderate risk. These participants also rated diabetes as a more serious disease, but were less likely to believe that weight loss would lower their risk. None of these health beliefs were related to attendance at meetings, dietary intake, weight loss, or fasting glucose, but higher perceived seriousness predicted larger reductions in BMI at 1 year. Of the objective risk factors for NIDDM, higher baseline BMI predicted larger weight losses throughout the program, and a stronger family history of diabetes was related to greater weight regain after an initial weight loss. CONCLUSIONS: Perceived risk of developing diabetes and other health beliefs did not predict performance in a behavioral weight loss program. These data suggest that efforts to modify health beliefs by educating high-risk individuals about their risk and benefits of weight loss may not be effective in improving long-term weight loss results.

Weight cycling, psychological health, and binge eating in obese women.

This study examined the relationship between weight cycling and psychological health in 120 obese women. Weight cycling was defined in 2 ways by retrospective self-report: total lifetime weight loss and total number of weight cycles > or = 20 lbs (> or = 9.07 kg). Psychological self-report measures assessed psychiatric symptoms, eating behavior, mood, stress, and perceptions of physical health. Of the 52 associations between weight cycling and psychological parameters, 8 were significant, with the most consistent association being between weight cycling and binge eating. Binge eating was also strongly associated with psychological distress, as found in previous studies. After adjusting for binge eating, however, weight cycling was independently related to only one of the psychological measures: perceived physical health.

The effects of a subjective monitoring task in the physiological measure of genital response to erotic stimulation.

Instrumentation has been developed which promises to further our understanding of the relationship between cognitive and physiological factors in the sexual arousal process. Past research has examined this relationship by continuous measurement of genital response, and discrete posttest measurement of subjective arousal. The self-report or "cognitive lever" allows individuals to rate feelings of arousal continuously throughout a stimulus interval by positioning a lever device along a calibrated scale. In this way, structural patterns of physiological and cognitive response can be examined. However, since attention has been shown to be an important cognitive operation in the processing of sexual stimuli, there is concern that this subjective measuring task may confound laboratory assessment by altering genital responsivity through distractive or possibly facilitative mechanisms. In order to test the methodological limitations of the cognitive lever, 14 male and female college students were exposed to duplicate viewings of erotic videotapes while alternately using and not using the self-report device. Results indicated that lever usage was not obtrusive in females, but was in males to the point of altering physiological response. In addition, the study took advantage of the continuous, concurrent measurements and examined patterns of convergence and divergence between the two. Results of correlational analyses indicated, in line with past research, that for men greater degrees of erection result in significantly higher subjective-objective agreement. Patterns for women as a group were much less clear, with only two significant correlations appearing. Finally, the limitations of the cognitive lever were discussed.