- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00746083
Challenge!, a Health Promotion/ Obesity Prevention Program for Teens
Randomized Controlled Trial for Health Promotion/ Obesity Prevention Targeting Low-income, Urban, African-American Adolescents
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 11-16, willing to participate in a randomized controlled trial for health promotion
Exclusion Criteria:
- Outside of age range
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
|
Experimental: Intervention group
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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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical Activity (accelerometry and self-report) Diet (Food frequency questionnaire)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maureen M Black, PhD, University of Maryland School of Medicine, Department of Pediatrics, United States
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-21033
- R40MC00241, M01 RR16500
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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