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Type 2 DiabetesHEALTHYNCT00458029

Middle-School Based Primary Prevention Trial of Type 2 Diabetes

A study testing integrated program of nutrition, activity, behavior, and promotion in people with Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
integrated program of nutrition, activity, behavior, and promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,603 participants
Where
8 sitesUnited States
Study dates
Aug 2006to Feb 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of California at Irvine

    Irvine, California, 92868

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • George Washington University Biostatistics Center

    Rockville, Maryland, 20852

  • University of Texas Health Science Center

    San Antonio, Texas, 78210

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Type 2 Diabetes
Being tested
integrated program of nutrition, activity, behavior, and promotion
Keywords
type 2 diabetes risk factors, obesity, prevention, adolescence, school based
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • integrated program of nutrition, activity, behavior, and promotionBehavioural

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

Study groups in NCT00458029
Study groupRoleWhat they receive
School based interventionExperimentalIntegration of activities, events, and programs affecting total school food service environment, physical education class, behavior change, promotion, and communications
Receives: Behavioral: integrated program of nutrition, activity, behavior, and promotion
ControlNo interventionObservational control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass index (BMI) >= 85th percentile, adjusted for gender and age

    Measured: baseline, end of 7th grade, end of study

  2. Fasting glucose (mg/dL)

    Measured: baseline, end of study

  3. Fasting insulin (mU/mL)

    Measured: baseline, end of study

Secondary outcomes (16)

  1. Lipids (total cholesterol, HDL, LDL, triglycerides)

    Measured: baseline, end of study

  2. Other laboratory indicators of diabetes and obesity risk, such as HbA1c

    Measured: baseline, end of study

  3. Blood pressure

    Measured: baseline, end of study

  4. Waist circumference

    Measured: baseline, end of study

  5. Physical activity

    Measured: baseline, end of study

  6. Sedentary behavior

    Measured: baseline, end of study

  7. Fitness

    Measured: baseline, end of study

  8. Daily nutritional intake

    Measured: baseline, end of study

  9. PE class activity level (MVPA by heart rate monitor)

    Measured: baseline, end of 7th grade, end of study

  10. Quality-adjusted life years saved (QALYS)

    Measured: baseline, end of 7th grade, end of study

  11. Total school food environment amounts and nutrients

    Measured: baseline, end of 7th grade, end of study

  12. Grade and school level state standardized test score pass rates

    Measured: end of 6th, 7th, 8th grades

  13. Grade and school level attendance rates

    Measured: end of 6th, 7th, 8th grades

  14. Grade and school level comportment rates (i.e., referral to administrative offices for disciplinary action)

    Measured: end of 6th, 7th, 8th grades

  15. Costs associated with intervention delivery and administration

    Measured: once per intervention semester (5 x)

  16. Decisions, policies, and activities at the school, local, state, or federal level that influence the school environment for nutrition and physical activity

    Measured: once per year (3 x)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2007 (estimated)
  2. Study startAug 2006
  3. Primary completionJun 2009
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized trial
Masking
None (open label)
Enrolment
4,603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00458029
Sponsor's protocol ID
U01DK061230-HEALTHY
Other IDs
U01DK061230, U01DK061223, U01DK061231, U01DK061249
Acronym
HEALTHY
Status last verified
Apr 2020
First submitted
5 Apr 2007
Last updated
30 Apr 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/healthy/?query=healthy

Publications

  • HEALTHY Study Group; Hirst K, Baranowski T, DeBar L, Foster GD, Kaufman F, Kennel P, Linder B, Schneider M, Venditti EM, Yin Z. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S4-20. doi: 10.1038/ijo.2009.112.

    PubMed 19623188

  • Drews KL, Harrell JS, Thompson D, Mazzuto SL, Ford EG, Carter M, Ford DA, Yin Z, Jessup AN, Roullet JB; HEALTHY Study Group. Recruitment and retention strategies and methods in the HEALTHY study. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S21-8. doi: 10.1038/ijo.2009.113.

    PubMed 19623184

  • Gillis B, Mobley C, Stadler DD, Hartstein J, Virus A, Volpe SL, El ghormli L, Staten MA, Bridgman J, McCormick S; HEALTHY Study Group. Rationale, design and methods of the HEALTHY study nutrition intervention component. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S29-36. doi: 10.1038/ijo.2009.114.

    PubMed 19623185

  • McMurray RG, Bassin S, Jago R, Bruecker S, Moe EL, Murray T, Mazzuto SL, Volpe SL; HEALTHY Study Group. Rationale, design and methods of the HEALTHY study physical education intervention component. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S37-43. doi: 10.1038/ijo.2009.115.

    PubMed 19623187

  • Venditti EM, Elliot DL, Faith MS, Firrell LS, Giles CM, Goldberg L, Marcus MD, Schneider M, Solomon S, Thompson D, Yin Z; HEALTHY Study Group. Rationale, design and methods of the HEALTHY study behavior intervention component. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S44-51. doi: 10.1038/ijo.2009.116.

    PubMed 19623189

  • DeBar LL, Schneider M, Ford EG, Hernandez AE, Showell B, Drews KL, Moe EL, Gillis B, Jessup AN, Stadler DD, White M; HEALTHY Study Group. Social marketing-based communications to integrate and support the HEALTHY study intervention. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S52-9. doi: 10.1038/ijo.2009.117.

    PubMed 19623190

  • Schneider M, Hall WJ, Hernandez AE, Hindes K, Montez G, Pham T, Rosen L, Sleigh A, Thompson D, Volpe SL, Zeveloff A, Steckler A; HEALTHY Study Group. Rationale, design and methods for process evaluation in the HEALTHY study. Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S60-7. doi: 10.1038/ijo.2009.118.

    PubMed 19623191

  • Baranowski T, Cooper DM, Harrell J, Hirst K, Kaufman FR, Goran M, Resnicow K; STOPP-T2D Prevention Study Group. Presence of diabetes risk factors in a large U.S. eighth-grade cohort. Diabetes Care. 2006 Feb;29(2):212-7. doi: 10.2337/diacare.29.02.06.dc05-1037.

    PubMed 16443862

  • Jago R, Harrell JS, McMurray RG, Edelstein S, El Ghormli L, Bassin S. Prevalence of abnormal lipid and blood pressure values among an ethnically diverse population of eighth-grade adolescents and screening implications. Pediatrics. 2006 Jun;117(6):2065-73. doi: 10.1542/peds.2005-1716.

    PubMed 16740849

  • Cullen KW, Hartstein J, Reynolds KD, Vu M, Resnicow K, Greene N, White MA; Studies to Treat or Prevent Pediatric Type 2 Diabetes Prevention Study Group. Improving the school food environment: results from a pilot study in middle schools. J Am Diet Assoc. 2007 Mar;107(3):484-9. doi: 10.1016/j.jada.2006.12.004.

    PubMed 17324667

  • Hartstein J, Cullen KW, Reynolds KD, Harrell J, Resnicow K, Kennel P; STOPP T2D Prevention Study Group. Impact of portion-size control for school a la carte items: changes in kilocalories and macronutrients purchased by middle school students. J Am Diet Assoc. 2008 Jan;108(1):140-4. doi: 10.1016/j.jada.2007.10.005.

    PubMed 18156001

  • Studies to Treat or Prevent Pediatric Type 2 Diabetes Prevention Study Group. Prevalence of the metabolic syndrome among a racially/ethnically diverse group of U.S. eighth-grade adolescents and associations with fasting insulin and homeostasis model assessment of insulin resistance levels. Diabetes Care. 2008 Oct;31(10):2020-5. doi: 10.2337/dc08-0411. Epub 2008 Jun 30.

    PubMed 18591405

  • Jago R, Baranowski T, Watson K, Bachman C, Baranowski JC, Thompson D, Hernandez AE, Venditti E, Blackshear T, Moe E. Development of new physical activity and sedentary behavior change self-efficacy questionnaires using item response modeling. Int J Behav Nutr Phys Act. 2009 Mar 31;6:20. doi: 10.1186/1479-5868-6-20.

    PubMed 19335875

  • Jago R, McMurray RG, Bassin S, Pyle L, Bruecker S, Jakicic JM, Moe E, Murray T, Volpe SL. Modifying middle school physical education: piloting strategies to increase physical activity. Pediatr Exerc Sci. 2009 May;21(2):171-85. doi: 10.1123/pes.21.2.171.

    PubMed 19556623

  • HEALTHY Study Group; Kaufman FR, Hirst K, Linder B, Baranowski T, Cooper DM, Foster GD, Goldberg L, Harrell JS, Marcus MD, Trevino RP. Risk factors for type 2 diabetes in a sixth- grade multiracial cohort: the HEALTHY study. Diabetes Care. 2009 May;32(5):953-5. doi: 10.2337/dc08-1774. Epub 2009 Feb 5.

    PubMed 19196888

Questions about this trial

What is this clinical trial studying?

A study testing integrated program of nutrition, activity, behavior, and promotion in people with Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index (BMI) >= 85th percentile, adjusted for gender and age (time frame: baseline, end of 7th grade, end of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00458029, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.

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