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Challenge!, a Health Promotion/ Obesity Prevention Program for Teens

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Challenge!
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring pediatric, obesity, African American, adolescents, intervention, home-based, community-based

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Outside of age range

Sites / Locations

  • University of Maryland School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2008
Last Updated
August 14, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
Annie E. Casey Foundation, The Thomas Wilson Sanitarium for Children of Baltimore City, Johns Hopkins Bloomberg School of Public Health, University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT00746083
Brief Title
Challenge!, a Health Promotion/ Obesity Prevention Program for Teens
Official Title
Randomized Controlled Trial for Health Promotion/ Obesity Prevention Targeting Low-income, Urban, African-American Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Annie E. Casey Foundation, The Thomas Wilson Sanitarium for Children of Baltimore City, Johns Hopkins Bloomberg School of Public Health, University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Pediatric overweight is a major public health problem in the US, with the prevalence of overweight among children of all ages increasing dramatically over the past several decades. Interventions aimed at reducing the increased weight gain during adolescence have produced mixed results. Challenge! is a randomized controlled trial for health promotion/ obesity prevention targeting low-income, urban, African American adolescents. Healthy adolescents were recruited from an urban medical center and from local middle schools. Weight status was not part of the inclusion criteria. The intervention was home- and community-based and delivered one-on-one to each adolescent by a college-age "personal trainer". The intervention focused on goal-setting, consuming a healthy diet (increase fruits, vegetables, and water, and decrease high-fat snack and convenience foods), and increasing physical activity. We hypothesized that the teens enrolled in the intervention would have a healthier BMI-for-age z-score and a healthier body composition (body fat %) compared to those that did not receive the intervention over time. Additionally, we hypothesized that those enrolled in the intervention would consume healthier diets and have higher levels of physical activity compared to those that did not receive the intervention over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
pediatric, obesity, African American, adolescents, intervention, home-based, community-based

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Challenge!
Other Intervention Name(s)
Obesity prevention, Goal setting, Diet, Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Physical Activity (accelerometry and self-report) Diet (Food frequency questionnaire)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 11-16, willing to participate in a randomized controlled trial for health promotion Exclusion Criteria: Outside of age range
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen M Black, PhD
Organizational Affiliation
University of Maryland School of Medicine, Department of Pediatrics, United States
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17606831
Citation
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.
Results Reference
background
PubMed Identifier
16762992
Citation
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.
Results Reference
background
PubMed Identifier
26812968
Citation
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.
Results Reference
derived
PubMed Identifier
20660556
Citation
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.
Results Reference
derived

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Challenge!, a Health Promotion/ Obesity Prevention Program for Teens

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