Skip to main content
OpenTrials
Completed

NCT Number: NCT03103269

Challenge! Adolescent Obesity Prevention

The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile) has more than tripled over the past 3 decades in the US. Overweight and physical inactivity disproportionately affect low- income, female, African American adolescents.

A prior health-promotion/ obesity-prevention program for adolescents developed and tested by our group (Challenge!) showed that adolescents who received the intervention were less likely to become overweight or obese over 2 years when compared to the control group. This intervention was administered one-on-one to adolescents in their homes or community by a college-aged mentor.

Schools are an ideal setting for interventions because the effect can be far-reaching and sustainable. School-based obesity-prevention interventions have thus far shown modest results.

The purpose of this study is to evaluate the impact of a multilevel intervention that includes both the Challenge program administered in a small group format after school using mentors and teachers and a school-wide environmental change on adolescent females' body composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade female students. The small group intervention is conducted over 12 weeks and includes goal setting focusing on healthy diet and physical activity, along with membership and weekly trips to the YMCA. The environmental intervention includes a Health and Activity Committee (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel, parents, and community members. The HAC develops school-wide health promotion messages and activities. Parents of participating 6th and 7th grade girls provide information on family variables. The hypotheses are that females who receive the small group or environmental intervention are at less risk of weight gain (overweight) than females in the control small group condition, that females in environmental schools are at less risk of weight gain (overweight) than females in the control environmental condition, and that females who receive both the small group and environmental intervention are at the lower risk of weight gain (overweight) than females who receive only the environmental or small group intervention or neither intervention.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore City Public Schools

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For small group intervention:

  • Female Adolescent
  • Grades 6 or 7
  • No health problems that would interfere with participation in physical education classes

For environmental intervention Health and Activity Committee:

Must be one of the following:

  • 8th grade female student
  • Parent or legal guardian of any student in the school
  • School personnel
  • Adult Community member (Self-identifies as member of specified community surrounding school)

Exclusion criteria

For small group intervention:

  • Male
  • Outside of the grade range 6-7 at recruitment
  • Participant will be excluded if they answer no to question 1 on the screening questionnaire (unable to read and understand questions written in English)
  • Participant will be excluded if they answer yes to questions 2 or 3 on screening form (fails health screening due to medical condition preventing them from engaging in physical activity)

For environmental intervention Health and Activity Committee:

  • Inability to speak or read English
  • Inability to attend meetings

Treatment and study plan

Challenge! Small Group Intervention

Behavioral

The Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA.

Challenge! Environmental Intervention

Other

The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.

Primary outcomes

  1. Change of Body Mass Index Percentile for Age and Sex for adolescent females

    Time frame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Secondary outcomes

  1. Change of Dietary Quality for adolescent females

    Time frame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

    Dietary quality will be assessed via the use of a Food Frequency Questionnaire.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Johns Hopkins Bloomberg School of Public Health
  • Robert Wood Johnson Foundation

Registry information

Official study title

Challenge! in Baltimore City Middle Schools

Acronym: Challenge

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Apr 6, 2017
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.