Weight change in the management of youth-onset type 2 diabetes: the TODAY clinical trial experience.

BACKGROUND: The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial documented that metformin plus rosiglitazone, but not metformin plus lifestyle intervention, provided superior durability of glycemic control relative to metformin monotherapy. OBJECTIVES: We examined weight changes among TODAY participants that completed at least 6 months of treatment, evaluated predictors of lifestyle outcome, and examined whether weight changes were related to cardiometabolic outcomes across treatment arms. METHODS: The 595 youth with type 2 diabetes, (85.1% of randomized participants aged 11-17 years) completed assessments of weight-related and cardiometabolic measures at months 0, 6, 12 and 24. Repeated measures models were used to investigate associations over time. RESULTS: Lifestyle intervention did not enhance outcome relative to metformin alone and no predictors of response to lifestyle treatment were identified. However, changes in percent overweight across treatment arms were associated with changes in multiple cardiometabolic risk factors, and decreases of ≥ 7% in overweight were associated with significant benefits over 24 months. CONCLUSIONS: Although adjunctive intensive lifestyle intervention did not improve weight-related outcomes, weight changes in the full TODAY sample were associated with small, but significant improvements in cardiometabolic status, highlighting the importance of optimizing weight management in youth with T2DM.

Cardio-metabolic risk screening among adolescents: understanding the utility of body mass index, waist circumference and waist to height ratio.

BACKGROUND: Few studies have assessed how well body mass index (BMI), waist circumference (WC), or waist to height ratio (WtHR) perform in identifying cardio-metabolic risk among youth. OBJECTIVE: The objective of this study was to evaluate the utility of BMI and WC percentiles and WtHR to distinguish adolescents with and without cardio-metabolic risk. METHODS: A cross-sectional analysis of data from 6097 adolescents aged 10-13 years who participated in the HEALTHY study was conducted. Receiver operating characteristic curves determined the discriminatory ability of BMI and WC percentiles and WtHR. RESULTS: The discriminatory ability of BMI percentile was good (area under the curve [AUC] ≥ 0.80) for elevated insulin and clustering of ≥3 risk factors, with optimal cut-points of 96 and 95, respectively. BMI percentile performed poor to fair (AUC = 0.57-0.75) in identifying youth with the majority of individual risk factors examined (elevated glucose, total cholesterol, low-density lipoprotein, blood pressure, triglycerides and high-density lipoprotein). WC percentile and WtHR performed similarly to BMI percentile. CONCLUSIONS: The current definition of obesity among US children performs well at identifying adolescents with elevated insulin and a clustering of ≥3 cardio-metabolic risk factors. Evidence does not support WC percentile or WtHR as superior screening tools compared with BMI percentile for identifying cardio-metabolic risk.

Process evaluation results from the HEALTHY nutrition intervention to modify the total school food environment.

The process evaluation of HEALTHY, a large multi-center trial to decrease type 2 diabetes mellitus in middle school children, monitored the implementation of the intervention to ascertain the extent that components were delivered and received as intended. The purpose of this article is to report the process evaluation findings concerning the extent to which the HEALTHY nutrition intervention was implemented during the HEALTHY trial. Overall, the observed fidelity of implementing nutrition strategies improved from baseline to the end of the study. By the last semester, all but two nutrition process evaluation goals were met. The most challenging goal to implement was serving high fiber foods, including grain-based foods and legumes. The easiest goals to implement were lowering the fat content of foods offered and offering healthier beverages. The most challenging barriers experienced by research dietitians and food service staff were costs, availability of foods and student acceptance. Forming strong relationships between the research dietitians and food service staff was identified as a key strategy to meet HEALTHY nutrition goals.

Cardiovascular risk factors in multi-ethnic middle school students: the HEALTHY primary prevention trial.

OBJECTIVE: The objective of this study was to examine the effects of an integrated, multi-component, school-based intervention programme on cardiovascular disease (CVD) risk factors among a multi-ethnic cohort of middle school students. METHODS: HEALTHY was a cluster randomized, controlled, primary prevention trial. Middle school was the unit of randomization and intervention. Half of the schools were assigned to an intervention programme consisting of changes in the total school food environment and physical education classes, enhanced by educational outreach and behaviour change activities and promoted by a social marketing campaign consisting of reinforcing messages and images. Outcome data reported (anthropometrics, blood pressure and fasting lipid levels) were collected on a cohort of students enrolled at the start of 6th grade (∼11-12 years old) and followed to end of 8th grade (∼13-14 years old). RESULTS: Forty-two middle schools were enrolled at seven field centres; 4363 students provided both informed consent and CVD data at baseline and end of study. The sample was 52.7% female, 54.5% Hispanic, 17.6% non-Hispanic Black, 19.4% non-Hispanic White and 8.5% other racial/ethnic combinations, and 49.6% were categorized as overweight or obese (body mass index ≥ 85th percentile) at baseline. A significant intervention effect was detected in the prevalence of hypertension in non-Hispanic Black and White males. The intervention produced no significant changes in lipid levels. CONCLUSIONS: The prevalence of some CVD risk factors is high in minority middle school youth, particularly males. A multi-component, school-based programme achieved only modest reductions in these risk factors; however, promising findings occurred in non-Hispanic Black and White males with hypertension.

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

The HEALTHY study was a randomized, controlled, multicenter and middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Here we describe the design of the HEALTHY nutrition intervention component that was developed to modify the total school food environment, defined to include the following: federal breakfast, lunch, after school snack and supper programs; a la carte venues, including snack bars and school stores; vending machines; fundraisers; and classroom parties and celebrations. Study staff implemented the intervention using core and toolbox strategies to achieve and maintain the following five intervention goals: (1) lower the average fat content of foods, (2) increase the availability and variety of fruits and vegetables, (3) limit the portion sizes and energy content of dessert and snack foods, (4) eliminate whole and 2% milk and all added sugar beverages, with the exception of low fat or nonfat flavored milk, and limit 100% fruit juice to breakfast in small portions and (5) increase the availability of higher fiber grain-based foods and legumes. Other nutrition intervention component elements were taste tests, cafeteria enhancements, cafeteria line messages and other messages about healthy eating, cafeteria learning laboratory (CLL) activities, twice-yearly training of food service staff, weekly meetings with food service managers, incentives for food service departments, and twice yearly local meetings and three national summits with district food service directors. Strengths of the intervention design were the integration of nutrition with the other HEALTHY intervention components (physical education, behavior change and communications), and the collaboration and rapport between the nutrition intervention study staff members and food service personnel at both school and district levels.