NCT00746083

Brief Summary

The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/ obesity prevention program will have a healthier BMI-for-age z-score and body composition (body fat %), will consume a healthier diet, and engage in higher levels of physical activity compared to those that did not receive the intervention over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2001

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

September 2, 2008

Last Update Submit

August 14, 2019

Conditions

Overweight

Keywords

pediatricobesityAfrican Americanadolescentsinterventionhome-basedcommunity-based

Outcome Measures

Primary Outcomes (1)

  • BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis)

    2 years

Secondary Outcomes (1)

  • Physical Activity (accelerometry and self-report) Diet (Food frequency questionnaire)

    2 years

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Challenge!

Control group

NO INTERVENTION

Interventions

Challenge!BEHAVIORAL

Each adolescent in the intervention group received 12 lessons administered in adolescent's home or community by a "personal trainer" (a college-aged mentor). The lessons focused on behavior change relating to diet and physical activity and was based on social cognitive theory. At the end of each lesson the adolescent set a behavior change goal for themselves. The adolescents were taught how to track their goals and they discussed thir ability/inability to meet their goals at each meeting with their personal trainer.

Also known as: Obesity prevention, Goal setting, Diet, Physical activity
Intervention group

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages 11-16, willing to participate in a randomized controlled trial for health promotion

You may not qualify if:

  • Outside of age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

  • Snitker S, Le KY, Hager E, Caballero B, Black MM. Association of physical activity and body composition with insulin sensitivity in a community sample of adolescents. Arch Pediatr Adolesc Med. 2007 Jul;161(7):677-83. doi: 10.1001/archpedi.161.7.677.

    PMID: 17606831BACKGROUND

  • Mitola AL, Papas MA, Le K, Fusillo L, Black MM. Agreement with satisfaction in adolescent body size between female caregivers and teens from a low-income African-American community. J Pediatr Psychol. 2007 Jan-Feb;32(1):42-51. doi: 10.1093/jpepsy/jsl004. Epub 2006 Jun 8.

    PMID: 16762992BACKGROUND

  • Devonshire AL, Hager ER, Black MM, Diener-West M, Tilton N, Snitker S. Elevated blood pressure in adolescent girls: correlation to body size and composition. BMC Public Health. 2016 Jan 26;16:78. doi: 10.1186/s12889-016-2717-6.

    PMID: 26812968DERIVED

  • Black MM, Hager ER, Le K, Anliker J, Arteaga SS, Diclemente C, Gittelsohn J, Magder L, Papas M, Snitker S, Treuth MS, Wang Y. Challenge! Health promotion/obesity prevention mentorship model among urban, black adolescents. Pediatrics. 2010 Aug;126(2):280-8. doi: 10.1542/peds.2009-1832. Epub 2010 Jul 26.

    PMID: 20660556DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Human Challenge Trials as TopicOrganizational ObjectivesDietExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthOrganization and AdministrationHealth Services AdministrationNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maureen M Black, PhD

    University of Maryland School of Medicine, Department of Pediatrics, United States

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

April 1, 2001

Primary Completion

July 1, 2005

Study Completion

January 1, 2007

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

US(1)