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

This study has been completed.
Sponsor:
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
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00746083
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Overweight
Behavioral: Challenge!

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial for Health Promotion/ Obesity Prevention Targeting Low-Income, Urban, African-American Adolescents

Resource links provided by NLM:


Further study details as provided by University of Maryland:

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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical Activity (accelerometry and self-report) Diet (Food frequency questionnaire) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: April 2001
Study Completion Date: January 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group Behavioral: Challenge!
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:
  • Obesity prevention
  • Goal setting
  • Diet
  • Physical activity
No Intervention: Control group

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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Outside of age range
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746083

Locations
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Annie E. Casey Foundation
The Thomas Wilson Sanitarium for Children of Baltimore City
Johns Hopkins Bloomberg School of Public Health
University of Massachusetts, Worcester
Investigators
Principal Investigator: Maureen M Black, PhD University of Maryland School of Medicine, Department of Pediatrics, United States
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen M. Black, PhD, University of Maryland School of Medicine, Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00746083     History of Changes
Other Study ID Numbers: H-21033, R40MC00241, M01 RR16500
Study First Received: September 2, 2008
Last Updated: September 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
pediatric
obesity
African American
adolescents
intervention
home-based
community-based

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 15, 2014