- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315743
Team COOL Pilot Study (Team COOL)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Intervention
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0601S79069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Team COOL
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Aditi BunkerBoston University; Heidelberg University; Rutgers University; Fiji National University and other collaboratorsNot yet recruitingAggression | Depression | Food Insecurity | Dehydration | Sleep Quality | Hospitalization | Cognition | Diet Quality | Life Satisfaction | Systolic Blood Pressure | Diastolic Blood Pressure | Resting Heart Rate | Productivity | Blood Glucose Control | Heat-related Symptoms | Physician Diagnosed Heat-related Illnesses | Indoor... and other conditionsFiji
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Aditi BunkerLondon School of Hygiene and Tropical Medicine; Boston University; Heidelberg... and other collaboratorsNot yet recruitingAggression | Depression | Food Insecurity | Dehydration | Sleep Quality | Hospitalization | Cognition | Diet Quality | Health-related Quality of Life | Life Satisfaction | Systolic Blood Pressure | Diastolic Blood Pressure | Resting Heart Rate | Productivity | Blood Glucose Control | Heat-related Symptoms | Physician Diagnosed... and other conditionsMexico
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MediCool TechnologiesNot yet recruiting
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Aditi BunkerLondon School of Hygiene and Tropical Medicine; Wellcome Trust; Heidelberg University and other collaboratorsCompletedHeart Rate | Sleep Quantity | All-day Steps | Distance Walked | Active Minutes | Moderate-intensity Activity Minutes | Vigorous-intensity Activity Duration | Time in Sleep Stages | Awake Duration | Sleep ScoreNiue
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Aditi BunkerLondon School of Hygiene and Tropical Medicine; Boston University; Heidelberg... and other collaboratorsActive, not recruitingHeart Rate | Sleep Quantity | All-day Steps | Distance Walked | Active Minutes | Moderate-intensity Activity Minutes | Vigorous-intensity Activity Duration | Time in Sleep Stages | Awake Duration | Sleep ScoreBurkina Faso, India, Mexico, Niue
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The David Hide Asthma & Allergy Research CentreIsle of Wight NHS TrustCompleted
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Florida State UniversityUnited States Department of DefenseRecruitingTraumatic Brain Injury | Post Traumatic Stress DisorderUnited States
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Aditi BunkerLondon School of Hygiene and Tropical Medicine; Boston University; Heidelberg... and other collaboratorsRecruitingAggression | Depression | Food Insecurity | Dehydration | Sleep Quality | Hospitalization | Cognition | Diet Quality | Health-related Quality of Life | Life Satisfaction | Systolic Blood Pressure | Diastolic Blood Pressure | Resting Heart Rate | Productivity | Blood Glucose Control | Heat-related Symptoms | Physician Diagnosed... and other conditionsMexico, Burkina Faso, Fiji, India, Niue
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Aditi BunkerBoston University; Heidelberg University; Rutgers University; University of Auckland... and other collaboratorsActive, not recruitingAnxiety | Resilience | PTSD - Post Traumatic Stress Disorder | Eco-anxietyIndia
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Institut Supérieur des Sciences de la PopulationLondon School of Hygiene and Tropical Medicine; Boston University; Heidelberg... and other collaboratorsNot yet recruitingHeart Rate | Sleep Quantity | All-day Steps | Distance Walked | Active Minutes | Moderate-intensity Activity Minutes | Time in Sleep Stages | Awake Duration | Sleep ScoreBurkina Faso