NCT00458029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,603

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

2.8 years

First QC Date

April 5, 2007

Last Update Submit

April 28, 2020

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes risk factorsobesitypreventionadolescenceschool based

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (2)

School based intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Observational control

Interventions

integrated program of nutrition, activity, behavior, and promotionBEHAVIORAL

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

School based intervention

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California at Irvine

Irvine, California, 92868, United States

Location

George Washington University Biostatistics Center

Rockville, Maryland, 20852, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78210, United States

Location

Related Publications (25)

  • 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.

    PMID: 19623188BACKGROUND

  • 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.

    PMID: 19623184BACKGROUND

  • 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.

    PMID: 19623185BACKGROUND

  • 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.

    PMID: 19623187BACKGROUND

  • 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.

    PMID: 19623189BACKGROUND

  • 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.

    PMID: 19623190BACKGROUND

  • 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.

    PMID: 19623191BACKGROUND

  • 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.

    PMID: 16443862RESULT

  • 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.

    PMID: 16740849RESULT

  • 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.

    PMID: 17324667RESULT

  • 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.

    PMID: 18156001RESULT

  • 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.

    PMID: 18591405RESULT

  • 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.

    PMID: 19335875RESULT

  • 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.

    PMID: 19556623RESULT

  • 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.

    PMID: 19196888RESULT

  • Baranowski T, Watson KB, Bachman C, Baranowski JC, Cullen KW, Thompson D, Siega Riz AM. Self efficacy for fruit, vegetable and water intakes: Expanded and abbreviated scales from item response modeling analyses. Int J Behav Nutr Phys Act. 2010 Mar 29;7:25. doi: 10.1186/1479-5868-7-25.

    PMID: 20350316RESULT

  • HEALTHY Study Group; Foster GD, Linder B, Baranowski T, Cooper DM, Goldberg L, Harrell JS, Kaufman F, Marcus MD, Trevino RP, Hirst K. A school-based intervention for diabetes risk reduction. N Engl J Med. 2010 Jul 29;363(5):443-53. doi: 10.1056/NEJMoa1001933. Epub 2010 Jun 27.

    PMID: 20581420RESULT

  • Jago R, Drews KL, McMurray RG, Thompson D, Volpe SL, Moe EL, Jakicic JM, Pham TH, Bruecker S, Blackshear TB, Yin Z. Fatness, fitness, and cardiometabolic risk factors among sixth-grade youth. Med Sci Sports Exerc. 2010 Aug;42(8):1502-10. doi: 10.1249/MSS.0b013e3181d322c4.

    PMID: 20139783RESULT

  • Marcus MD, Baranowski T, DeBar LL, Edelstein S, Kaufman FR, Schneider M, Siega-Riz AM, Staten MA, Virus A, Yin Z. Severe obesity and selected risk factors in a sixth grade multiracial cohort: the HEALTHY study. J Adolesc Health. 2010 Dec;47(6):604-7. doi: 10.1016/j.jadohealth.2010.04.017. Epub 2010 Jun 29.

    PMID: 21094439RESULT

  • Siega-Riz AM, El Ghormli L, Mobley C, Gillis B, Stadler D, Hartstein J, Volpe SL, Virus A, Bridgman J; HEALTHY Study Group. The effects of the HEALTHY study intervention on middle school student dietary intakes. Int J Behav Nutr Phys Act. 2011 Feb 4;8:7. doi: 10.1186/1479-5868-8-7.

    PMID: 21294869RESULT

  • Mietus-Snyder M, Drews KL, Otvos JD, Willi SM, Foster GD, Jago R, Buse JB; HEALTHY Study Group. Low-density lipoprotein cholesterol versus particle number in middle school children. J Pediatr. 2013 Aug;163(2):355-62. doi: 10.1016/j.jpeds.2013.01.012. Epub 2013 Feb 14.

    PMID: 23415622DERIVED

  • Buse JB, Kaufman FR, Linder B, Hirst K, El Ghormli L, Willi S; HEALTHY Study Group. Diabetes screening with hemoglobin A(1c) versus fasting plasma glucose in a multiethnic middle-school cohort. Diabetes Care. 2013 Feb;36(2):429-35. doi: 10.2337/dc12-0295. Epub 2012 Nov 27.

    PMID: 23193207DERIVED

  • Willi SM, Hirst K, Jago R, Buse J, Kaufman F, El Ghormli L, Bassin S, Elliot D, Hale DE; HEALTHY Study Group. Cardiovascular risk factors in multi-ethnic middle school students: the HEALTHY primary prevention trial. Pediatr Obes. 2012 Jun;7(3):230-9. doi: 10.1111/j.2047-6310.2011.00042.x. Epub 2012 Mar 28.

    PMID: 22461375DERIVED

  • Marcus MD, Foster GD, El Ghormli L, Baranowski T, Goldberg L, Jago R, Linder B, Steckler A, Trevino R. Shifts in BMI category and associated cardiometabolic risk: prospective results from HEALTHY study. Pediatrics. 2012 Apr;129(4):e983-91. doi: 10.1542/peds.2011-2696. Epub 2012 Mar 19.

    PMID: 22430457DERIVED

  • DeBar LL, Schneider M, Drews KL, Ford EG, Stadler DD, Moe EL, White M, Hernandez AE, Solomon S, Jessup A, Venditti EM; HEALTHY study group. Student public commitment in a school-based diabetes prevention project: impact on physical health and health behavior. BMC Public Health. 2011 Sep 20;11:711. doi: 10.1186/1471-2458-11-711.

    PMID: 21933431DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gary D Foster, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

  • Kathryn Hirst, PhD

    George Washington University Biostatistics Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized trial
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 9, 2007

Study Start

August 1, 2006

Primary Completion

June 1, 2009

Study Completion

February 1, 2011

Last Updated

April 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

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

More information

Locations

US(8)