Challenge! Adolescent Obesity Prevention

Obesity Clinical Trial

— Challenge  

Official title:

Challenge! in Baltimore City Middle Schools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103269
• Other study ID #: HP-00040540
• Secondary ID: R01HD054727
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: January 2014

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Challenge! Small Group Intervention
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.

Other:
• Challenge! Environmental Intervention
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.

Locations

Country	Name	City	State
United States	Baltimore City Public Schools	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Johns Hopkins Bloomberg School of Public Health, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Body Mass Index Percentile for Age and Sex for adolescent females		Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Secondary	Change of Dietary Quality for adolescent females	Dietary quality will be assessed via the use of a Food Frequency Questionnaire.	Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up