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

August 14, 2019 updated by: Maureen Black, University of Maryland, Baltimore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • Physical activity
  • Diet
  • Obesity prevention
  • Goal setting

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maureen M Black, PhD, University of Maryland School of Medicine, Department of Pediatrics, United States

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

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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