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

Overweight Clinical Trial

Official title:

Randomized Controlled Trial for Health Promotion/ Obesity Prevention Targeting Low-income, Urban, African-American Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746083
• Other study ID #: H-21033
• Secondary ID: R40MC00241, M01
• Status: Completed
• Phase: N/A
• Start date: April 2001
• Est. completion date: January 2007

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: January 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Outside of age range

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Annie E. Casey Foundation, Johns Hopkins Bloomberg School of Public Health, The Thomas Wilson Sanitarium for Children of Baltimore City, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2006 Jun 8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical Activity (accelerometry and self-report) Diet (Food frequency questionnaire)		2 years