HEALTHY: Middle-School Based Primary Prevention Trial of Type 2 Diabetes

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00458029

Collaborator

George Washington University (Other)

4,603

Enrollment

Locations

Arms

Actual Duration (Months)

575.4

Patients Per Site

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: integrated program of nutrition, activity, behavior, and promotion	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4603 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomized trialCluster randomized trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)

Actual Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: School based intervention Integration of activities, events, and programs affecting total school food service environment, physical education class, behavior change, promotion, and communications	Behavioral: integrated program of nutrition, activity, behavior, and promotion implemented across 5 half-year periods: winter/spring 2007, fall 2007, winter/spring 2007, fall 2008, winter/spring 2008
No Intervention: Control Observational control

Arm

Intervention/Treatment

Experimental: School based intervention

Integration of activities, events, and programs affecting total school food service environment, physical education class, behavior change, promotion, and communications

Behavioral: integrated program of nutrition, activity, behavior, and promotion

implemented across 5 half-year periods: winter/spring 2007, fall 2007, winter/spring 2007, fall 2008, winter/spring 2008

No Intervention: Control

Observational control

Outcome Measures

Primary Outcome Measures

Body mass index (BMI) >= 85th percentile, adjusted for gender and age [baseline, end of 7th grade, end of study]
Fasting glucose (mg/dL) [baseline, end of study]
Fasting insulin (mU/mL) [baseline, end of study]

Secondary Outcome Measures

Lipids (total cholesterol, HDL, LDL, triglycerides) [baseline, end of study]
Other laboratory indicators of diabetes and obesity risk, such as HbA1c [baseline, end of study]
Blood pressure [baseline, end of study]
Waist circumference [baseline, end of study]
Physical activity [baseline, end of study]
Sedentary behavior [baseline, end of study]
Fitness [baseline, end of study]
Daily nutritional intake [baseline, end of study]
PE class activity level (MVPA by heart rate monitor) [baseline, end of 7th grade, end of study]
Quality-adjusted life years saved (QALYS) [baseline, end of 7th grade, end of study]
Total school food environment amounts and nutrients [baseline, end of 7th grade, end of study]
Grade and school level state standardized test score pass rates [end of 6th, 7th, 8th grades]
Grade and school level attendance rates [end of 6th, 7th, 8th grades]
Grade and school level comportment rates (i.e., referral to administrative offices for disciplinary action) [end of 6th, 7th, 8th grades]
Costs associated with intervention delivery and administration [once per intervention semester (5 x)]
Decisions, policies, and activities at the school, local, state, or federal level that influence the school environment for nutrition and physical activity [once per year (3 x)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Middle school student body is at least 50% minority (defined as African American, Hispanic/Latino, and/or Native American) and/or greater than 50% eligible for free or reduced lunch.
Middle school annual school-wide attrition from all causes is <= 25% (estimate determined from data provided by the school).
Middle school expected cohort size at end of study is at least 50 per school determined by applying 50% anticipated enrollment rate and annual school-wide attrition rate over 3 years.
Student able to participate in the school's standard PE program.
Student's parent/guardian has provided informed consent for the child to participate in data collection and evaluation procedures.
Student has provided informed assent to participate in data collection and evaluation procedures.

Exclusion Criteria: (none specified)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at Irvine	Irvine	California	United States	92868
2	George Washington University Biostatistics Center	Rockville	Maryland	United States	20852
3	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
4	Oregon Health & Science University	Portland	Oregon	United States	97239
5	Temple University	Philadelphia	Pennsylvania	United States	19140
6	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
7	Baylor College of Medicine	Houston	Texas	United States	77030
8	University of Texas Health Science Center	San Antonio	Texas	United States	78210

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
George Washington University

Investigators

Principal Investigator: Gary D Foster, PhD, Temple University
Principal Investigator: Kathryn Hirst, PhD, George Washington University Biostatistics Center