Middle-School Based Primary Prevention Trial of Type 2 Diabetes

2014-08-27 03:39:12 | BioPortfolio


HEALTHY is a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students are recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools are randomized to receive an intervention that integrates four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


In response to increases in incident cases of type 2 diabetes in American children and youth, NIDDK has funded a multi-site primary prevention trial designed to moderate risk for type 2 diabetes in middle school aged children. In pilot studies, it was found that an indicator of adiposity, a body mass index greater than the 85th percentile for gender and age, is the most prevalent, modifiable risk factor for diabetes in this age group. In addition, indicators of insulin resistance and dysglycemia, elevated mean fasting insulin and glucose levels, can be assessed to determine if the intervention is capable of reducing these risk factors for diabetes in middle school aged children.

The trial is conducted at 7 field centers in 42 middle schools randomly assigned to intervention or control. Following student recruitment and baseline data collection in the first semester of 6th grade (2006), the intervention is implemented in the second semester of 6th grade (2007) and continues throughout 7th (school year 2007-2008) and 8th (school year 2008-2009) grades. All students are exposed to components of the intervention, which are implemented school-wide or grade-wide; however, only students who provide appropriate informed consent and assent participate in data collection and evaluation. The primary objective of the trial is to determine if, at the end of the 8th grade, the intervention significantly impacts the risk for developing type 2 diabetes compared to control.

Six pilot studies were performed to collect data to guide the development of an intervention (see appendix 14.2). The prior studies focused on:

- Establishing the feasibility of recruiting students and obtaining physical and physiological measurements, including fasting and 2-hour post glucose load blood draws (early 2003).

- Evaluating a physical education (PE) class program designed to increase moderate-to-vigorous physical activity (late 2003).

- Testing the ability of a nutrition intervention to change food and beverage offerings in school food service and vending (early 2004).

- Implementing a program that integrated the PE class and food service nutrition interventions with a communications and awareness campaign (fall 2004).

- Determining the feasibility of a behavior change intervention, delivered through in-class and other school settings and family outreach, to accomplish self monitoring and goal setting (fall 2005).

- Evaluating PE class activities targeting 7th and 8th graders and a training and support program to motivate PE teacher buy-in and adherence (fall 2005).

Formative research has been conducted to inform the creation of all intervention components.

Based on a comprehensive review of the literature and the pilot study results, a robust multi-component intervention has been developed that impacts the environment and lifestyle choices of middle school children. The intervention consists of the following integrated components:

- changes in the nutritional quality of food and beverage offerings throughout the total school food environment, including cafeteria meals and programs, a la carte, and vending machines;

- changes in the physical education (PE) program, equipment, and teacher training to increase both participation and number of minutes spent in moderate-to-vigorous physical activity when implemented by PE teachers in PE class;

- brief classroom activities designed to increase knowledge, enhance decision making skills, promote peer involvement and interaction, and enhance social influence;

- individual and group behavior change initiatives aimed at promoting healthier behaviors through self monitoring, goal setting, and problem solving;

- family outreach to involve parents/guardians and family members by providing information and strategies to support youth in accomplishing behavioral goals; and

- school-wide communications to enhance and promote changes in nutrition, activity, and behavior.

In addition to the primary objective of affecting risk for T2D, major secondary objectives are to: further understand and characterize the etiology of risk of T2D in this age group; evaluate the ability of the intervention to influence lifestyle changes and choices both in and out of school; determine the cost-effectiveness of the intervention; compare academic performance, attendance, and comportment in intervention versus control schools; and describe the influence of non-study changes in the school environment that affect student nutrition and physical activity. Finally, data are collected to evaluate the degree to which the components of the intervention are delivered and administered as planned.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Type 2 Diabetes


integrated program of nutrition, activity, behavior, and promotion


University of California at Irvine
United States


Active, not recruiting


National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:39:12-0400

Clinical Trials [7175 Associated Clinical Trials listed on BioPortfolio]

ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity

Preventing the onset of pediatric obesity and diabetes in Latino families" The investigators will conduct a randomized controlled trial of a family-based community centered intervention. ...

Taking Action Together- A Diabetes Prevention Program

The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would...

The Nutrition Challenge: A Health Promotion Campaign

The purpose of the challenge is to see if we, as the nutrition experts, can follow the dietary and physical activity guidelines promoted to the public. We have an opportunity to "practice ...

Populational Program of Physical Activity and Healthy Eating Promotion: the "Life of Health" Study

This is a population-based "natural experiment" study aimed to examine the effect of a multi-approach intervention focused on physical activity and healthy eating promotion to individuals ...

Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes

The purpose of the study is to assess the effectiveness of motivational interviewing in promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the completion ...

PubMed Articles [30289 Associated PubMed Articles listed on BioPortfolio]

Integrated personalized diabetes management improves glycemic control in patients with insulin-treated type 2 diabetes: Results of the PDM-ProValue study program.

Globally, many patients with insulin-treated type-2 diabetes are suboptimally controlled. The PDM-ProValue study program evaluated whether integrated personalized diabetes management (iPDM) has the po...

Which Patients with Type 2 Diabetes Will Have Greater Compliance to Participation in the Diabetes Conversation Map™ Program? A Retrospective Cohort Study.

To investigate the characteristics of participants in the Diabetes Conversation Map™ (Map™) program who had higher vs. lower compliance to the program, to determine if program tailoring and monito...

A web-based program to improve treatment adherence in patients with type 2 diabetes: Development and study protocol.

Many patients with type 2 diabetes mellitus (T2DM) sub-optimally adhere to core treatment recommendations, such as healthy diets, sufficient physical activity and pharmacological support. This paper d...

Factors Influencing Participation in the YMCA Diabetes Prevention Program: A DNP Project.

Pre-diabetes is the underlying pathology for type 2 diabetes. The Diabetes Prevention Program is a proven, effective strategy to control or prevent type 2 diabetes; however, there is limited data on w...

A Cluster-Randomized Trial on Small Incentives to Promote Physical Activity.

There has been limited research investigating whether small financial incentives can promote participation, behavior change, and engagement in physical activity promotion programs. This study evaluate...

Medical and Biotech [MESH] Definitions

Component of the NATIONAL INSTITUTES OF HEALTH. It conducts and supports basic and applied research for a national program in diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; and kidney, urologic, and hematologic diseases. It was established in 1948.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

A severe type of hyperlipidemia, sometimes familial, that it is characterized by the elevation of both plasma CHYLOMICRONS and TRIGLYCERIDES contained in VERY-LOW-DENSITY LIPOPROTEINS. Type V hyperlipoproteinemia is often associated with DIABETES MELLITUS and is not caused by reduced LIPOPROTEIN LIPASE activity as in HYPERLIPOPROTEINEMIA TYPE I .

Evaluation and measurement of nutritional variables in order to assess the level of nutrition or the NUTRITIONAL STATUS of the individual. NUTRITION SURVEYS may be used in making the assessment.

More From BioPortfolio on "Middle-School Based Primary Prevention Trial of Type 2 Diabetes"

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial