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Team COOL Pilot Study (Team COOL)

Primary Purpose

Multicomponent School Based Behavioral Intervention, Prevent Further Weight Gain and or Promote, Weight Loss Among Adolescents

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Team COOL
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multicomponent School Based Behavioral Intervention

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2011
    Last Updated
    October 30, 2019
    Sponsor
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01315743
    Brief Title
    Team COOL Pilot Study
    Acronym
    Team COOL
    Official Title
    Team COOL Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multicomponent School Based Behavioral Intervention, Prevent Further Weight Gain and or Promote, Weight Loss Among Adolescents

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Team COOL
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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. - 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. -

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21518437
    Citation
    Arcan C, Kubik MY, Fulkerson JA, Hannan PJ, Story M. Substance use and dietary practices among students attending alternative high schools: results from a pilot study. BMC Public Health. 2011 Apr 25;11:263. doi: 10.1186/1471-2458-11-263.
    Results Reference
    derived

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    Team COOL Pilot Study

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