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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01315743
Other study ID # 0601S79069
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 2007
Est. completion date March 2009

Study information

Verified date October 2019
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this exploratory pilot study was to develop and test the acceptability and feasibility of an innovative alternative high school-based intervention to prevent further weight gain and/or promote weight loss among a sample of ethnically and economically diverse adolescents.


Description:

The goal of this exploratory pilot study was to develop and test the acceptability and feasibility of an innovative alternative high school-based intervention to prevent further weight gain and/or promote weight loss among a sample of ethnically and economically diverse adolescents. The proposed study will use a group randomized trial design and target boys and girls, ages 15-20 years old, attending six alternative high schools in the Minneapolis-St Paul metropolitan area. Alternative high schools are public or private schools that offer a nontraditional educational experience for at-risk students, such as dropouts, expelled students, truants and hard to reach learners who have not succeeded in regular school systems. Although low levels of physical activity (PA) and unhealthy dietary practices, behaviors regarded as a primary cause of the overweight/obesity epidemic among youth, are prevalent among teens attending alternative schools, school-based programs targeting these behaviors have not been tested and evaluated.

Three schools were randomized to the intervention/treatment condition and three schools to a minimal intervention/comparison condition. Social Cognitive Theory and ecological theory provided the theoretical basis for the multi-component intervention, which included 1) a classroom-based experiential curriculum that incorporated school, family and community-linked activities to promote physical activity, healthy eating and limited television viewing, 2) environmental modifications of food and beverage offerings and physical activity opportunities at school and 3) a teacher-guided, youth-directed health advisory council to promote and support physical activity, healthy eating and limited television viewing.

Student and school-level measurements were taken at baseline, 6 months post randomization and at the completion of the 18 month intervention. Student-level measures included a self-administered psychosocial survey, the 3-day Previous Day Physical Activity Report and moderate-to-vigorous physical activity levels of students as measured by an Actigraph accelerometer. School-level measures assessed the availability of physical activity opportunities and healthy foods at school.

Hypothesis: Adolescents attending alternative high schools will report high participation rates and a high degree of satisfaction with a multi-component school-based intervention targeting students' PA, diet and TV viewing practices.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 21 Years
Eligibility Inclusion Criteria:

Because this research is a group randomized trial, eligibility criteria were based primarily on school characteristics rather than student characteristics. Schools eligible for recruitment were required to: 1) identify as either an area learning center (ALC), alternative learning program (ALP) or contracted alternative, 2) be open year around (a requirement for all state ALCs; an option for ALPs), 3) enroll 11th and 12th grade students, 4) project a September 2006 enrollment of 75 students, 5) require student attendance on campus at least 10 hours/week and 6) have access to an indoor facility for physical activity. Therefore, all students attending a participating school were eligible to take part in the study and exclusion will occur only in case of parental or student denial of consent. Students and parents/guardians of students who were not fluent in English were not included in measurement.

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Exclusion Criteria: Alternative programs that serve primarily pregnant and disabled teens or function exclusively as day treatment programs for juvenile offenders were not eligible to participate in this study.Students and parents/guardians of students who were not fluent in English were not included in measurement.

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Team COOL
1) a classroom-based experiential curriculum that incorporated school, family and community-linked activities to promote physical activity, healthy eating and limited television viewing, 2) environmental modifications of food and beverage offerings and physical activity opportunities at school and 3) a teacher-guided, youth-directed health advisory council to promote and support physical activity, healthy eating and limited television viewing.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota