Clinical trial NCT03103269: Challenge! Adolescent Obesity Prevention
Official title: Challenge! in Baltimore City Middle Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Prevention
Diet
Physical activity
Depression
Anxiety
Stages of change
Barriers
Perceptions
Environment
Eating Disorder
Self efficacy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Johns Hopkins Bloomberg School of Public Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-04-06
Enrollment: 789
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Body Mass Index Percentile for Age and Sex for adolescent females
timeFrame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Secondary outcomes:
measure: Change of Dietary Quality for adolescent females
timeFrame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Public Schools
state: Maryland
Study officials:
affiliation: University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division
name: Maureen M Black, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trude ACB, Armstrong B, Kramer Fiala Machado A, Wickwire EM, Covington LB, Wang Y, Hager E, Black MM. Waking up to sleep's role in obesity and blood pressure among Black adolescent girls in low-income, US urban communities: A longitudinal analysis. Sleep Health. 2022 Apr;8(2):200-207. doi: 10.1016/j.sleh.2021.12.001. Epub 2022 Feb 11.