Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial.

OBJECTIVE: To assess the association of proxies of behavioral adherence to the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) lifestyle program with changes in glycemic control and obesity in a multi-ethnic sample of youth with type 2 diabetes. METHODS: The TODAY clinical trial included an intensive lifestyle intervention to promote weight reduction. Adherence was assessed with measures of attendance at intervention sessions and rates of self-monitoring of diet and physical activity by participants and their caregivers. The relation between participant characteristics and consistency of proxies of adherence were examined across 3 phases of intervention. RESULTS: A total of 234 TODAY youth were randomized to the lifestyle program. Overall rate of session attendance was approximately 60% of planned sessions. Participants with an adequate dose of session attendance (≥75% attended) did not differ from those who attended <75% of sessions in glycemic control, but did have significantly greater reductions in percent overweight compared with those who attended fewer than 75% of sessions. Rates of self-monitoring were low and additional analysis was not possible. CONCLUSIONS: Rates of session attendance were moderate in a lifestyle program for youth with type 2 diabetes, but levels of self-monitoring, considered a key lifestyle change behavior, were low. Glycemic control was not significantly associated with session attendance but reductions in percent overweight were. Given the salience of program attendance and self-monitoring to lifestyle weight management established in other populations, future research is needed to understand, develop, and promote strategies and interventions targeting weight loss to achieve improved glycemic control in youth diagnosed with type 2 diabetes.

Structure to utilize interventionists' implementation experiences of a family-based behavioral weight management program to enhance the dissemination of the standardized intervention: The TODAY study.

Background For a 2- to 6-year period, interventionists for the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) randomized clinical trial delivered a family-based, behavioral weight-loss program (the TODAY Lifestyle Program) to 234 youth with type 2 diabetes. Interventionists held at least a bachelor's degree in psychology, social work, education, or health-related field and had experience working with children and families, especially from diverse ethnic and socioeconomic backgrounds. This article describes the administrative and organizational structure of the lifestyle program and how the structure facilitated collaboration among study leadership and lifestyle interventionists on the tailoring of the program to best suit the needs of the trial's diverse patient population. Methods During the pilot phase and throughout the duration of the trial, the interventionists' experiences in delivering the intervention were collected in a variety of ways including membership on study committees, survey responses, session audio recordings, and feedback during in-person trainings. Results The experiences of interventionists conveyed to study leadership through these channels resulted in decisions to tailor the lifestyle intervention's delivery location and ways to supplement the standardized educational materials to better address the needs of a diverse patient population. Conclusion The methods used within the TODAY study to encourage and utilize interventionists' experiences while implementing the lifestyle program may be useful to the design of future multi-site, clinical trials seeking to tailor behavioral interventions in a standardized, and culturally and developmentally sensitive manner.

Peak systolic blood pressure on a graded maximal exercise test and the blood pressure response to an acute bout of submaximal exercise.

Blood pressure (BP) is immediately reduced after aerobic exercise (postexercise hypotension [PEH]). Whether peak systolic BP on a maximal graded exercise stress test (GEST) relates to PEH is not known. This study examined associations between peak systolic BP on a GEST and PEH. Subjects were 50 men (mean +/- SEM age 43.8 +/- 1.3 years) with elevated BP (145.3 +/- 1.5/85.9 +/-1.1 mm Hg). Men completed a GEST and 3 experiments: nonexercise control and 2 cycle bouts at 40% (LIGHT) and 60% (MODERATE) of maximal oxygen consumption. After the experiments, subjects left the laboratory wearing ambulatory BP monitors. Peak systolic BP on a GEST was categorized into tertiles: low (n = 17, 197.4 +/- 2.0 mm Hg), medium (n = 16, 218.4 +/- 1.4 mm Hg), and high (n = 17, 248.9 +/- 2.8 mm Hg). Repeated-measures analysis of variance tested if BP differed over time and among experimental conditions and peak systolic BP groups. In men with high peak systolic BP, systolic BP was reduced by 7.3 +/- 2.6 mm Hg after LIGHT and by 5.0 +/- 2.2 mm Hg after MODERATE compared with nonexercise control over 10 hours, with the more apparent effects seen after LIGHT (p <0.05). In men with low peak systolic BP, systolic BP was reduced by 6.3 +/- 2.3 mm Hg after MODERATE compared with nonexercise control over 10 hours (p <0.05). In men with medium peak systolic BP, systolic BP was not different after exercise compared with nonexercise control over 10 hours (p >or=0.05). Men with high peak systolic BP had decreased systolic BP to the greatest extent after LIGHT, whereas men with low peak systolic BP reduced systolic BP after MODERATE. In conclusion, the findings of this study suggest that peak systolic BP on a GEST may be used to characterize which men with hypertension will have decreased systolic BP after acute submaximal aerobic exercise.

Sedentary behavior and physical activity in youth with recent onset of type 2 diabetes.

OBJECTIVE: With the rise of type 2 diabetes in youth, it is critical to investigate factors such as physical activity (PA) and time spent sedentary that may be contributing to this public health problem. This article describes PA and sedentary time in a large cohort of youth with type 2 diabetes and compares these levels with other large-scale investigations. METHODS: The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) trial is a study in 699 youth, recruited from 15 US clinical centers, aged 10 to 17 years with <2 years of type 2 diabetes and a BMI ≥85th percentile. RESULTS: In comparison with the subset of the NHANES cohort who were obese (BMI ≥95th percentile), TODAY youth spent significantly more time being sedentary (difference averaging 56 minutes per day; P < .001) as assessed by accelerometry. Although moderate to vigorous activity levels in both obese cohorts for all age groups were exceptionally low, younger TODAY boys were still significantly less active than similarly aged NHANES youth. Comparisons between the TODAY girls and other investigations suggest that the TODAY girls also had relatively lower PA and fitness levels. CONCLUSIONS: Adolescents with type 2 diabetes from the large TODAY cohort appear to be less physically active and tend to spend more time being sedentary than similarly aged youth without diabetes identified from other large national investigations. Treatment efforts in adolescents with type 2 diabetes should include decreasing sitting along with efforts to increase PA levels.

Self-reported dietary intake of youth with recent onset of type 2 diabetes: results from the TODAY study.

Despite the widely recognized importance of diet in managing diabetes, few studies have documented usual dietary intake in young people with type 2 diabetes. The objectives of our study were to assess dietary intake among a large, ethnically diverse cohort of young people with type 2 diabetes and compare intake to current recommendations. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study is a multicenter randomized clinical trial of 699 youth aged 10 to 17 years. At baseline, following a run-in period that included standard diabetes education, diet was assessed using a food frequency questionnaire between 2004 and 2009. Analysis of variance and nonparametric tests were used to compare mean and median nutrient intakes; logistic regression was used to compare the odds of meeting predefined dietary intake recommendation cutpoints between subgroups of age, sex, and race-ethnicity. Percent of energy from saturated fat was consistently 13% to 14% across all subgroups-substantially exceeding national recommendations. Overall, only 12% of youth met Healthy People 2010 guidelines for intake of <10% of energy from saturated fat and only 1% of youth met American Diabetes Association recommendations for intake of <7% of energy from saturated fat. Dietary intake fell substantially below other Healthy People 2010 targets; only 3% met calcium intake goals, 11% met fruit consumption goals, 5% met vegetable consumption goals, and 67% met grain intake goals. Overall, dietary intake in this large cohort of young people with type 2 diabetes fell substantially short of recommendations, in ways that were consistent by sex, age, and race-ethnicity. The data suggest a critical need for better approaches to improve dietary intake of these young people.