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

April 28, 2020 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4603

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92868
        • University of California at Irvine
    • Maryland
      • Rockville, Maryland, United States, 20852
        • George Washington University Biostatistics Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University Of North Carolina At Chapel Hill
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78210
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

George Washington University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 9, 2007

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01DK061230-HEALTHY
  • U01DK061230 (U.S. NIH Grant/Contract)
  • U01DK061223 (U.S. NIH Grant/Contract)
  • U01DK061231 (U.S. NIH Grant/Contract)
  • U01DK061249 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/healthy/?query=healthy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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