Middle-School Based Primary Prevention Trial of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      HEALTHY was 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 were recruited at
      start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the
      schools were randomized to receive an intervention that integrated four components: the
      school nutrition environment, physical education class activities, behavior change
      initiatives, and educational and promotional communications activities.
    

Detailed description: 
      In response to increases in incident cases of type 2 diabetes in American children and youth,
      NIDDK 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, was 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, were assessed to determine if the intervention was capable of reducing these risk
      factors for diabetes in middle school aged children.

      The trial was 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 was implemented in the second semester
      of 6th grade (2007) and continued throughout 7th (school year 2007-2008) and 8th (school year
      2008-2009) grades. All students were exposed to components of the intervention, which were
      implemented school-wide or grade-wide; however, only students who provided appropriate
      informed consent and assent participated in data collection and evaluation. The primary
      objective of the trial was to determine if, at the end of the 8th grade, the intervention
      significantly impacted 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.
      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 was 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 was developed to impact the environment and lifestyle choices of
      middle school children. The intervention consisted 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
      were 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 were collected to evaluate the degree to which the
      components of the intervention were delivered and administered as planned.
    

Intervention name(s): integrated program of nutrition, activity, behavior, and promotion
Intervention type(s): Behavioral
Intervention description(s): implemented across 5 half-year periods: winter/spring 2007, fall 2007, winter/spring 2007, fall 2008, winter/spring 2008
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomized trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 2 diabetes risk factors; obesity; prevention; adolescence; school based