Challenge! Adolescent Obesity Prevention

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Challenge! Small Group Intervention; Other: Challenge! Environmental Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03103269

R01HD054727 (U.S. NIH Grant/Contract)

HP-00040540

Details and patient eligibility

About

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.

Enrollment: 789 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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789 participants in 4 patient groups

Challenge! Small Group Intervention only

Experimental group

Description:

This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA. This group is in schools that were randomly assigned to NOT receive the Environmental Intervention.

Treatment:

Behavioral: Challenge! Small Group Intervention

Challenge! Small Group and Environmental Intervention

Experimental group

Description:

This group consists of participants who receive the Challenge! Small Group Intervention AND attend a school that is randomly assigned to receive an environmental intervention. This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA. 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.

Treatment:

Behavioral: Challenge! Small Group Intervention

Other: Challenge! Environmental Intervention

Environmental Intervention Only

Experimental group

Description:

This group consists of participants who do not receive the Challenge! Small Group Intervention but attend a school that is randomly assigned to receive an environmental intervention. This group does not receive the Challenge! Small Group 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.

Treatment:

Other: Challenge! Environmental Intervention

Control Group

No Intervention group

Description:

This group does not receive the Challenge! Small Group intervention and is in a school that is randomly assigned to NOT have the Environmental Intervention.