Multicomponent School Based Behavioral InterventionPhase 1/2Team COOLNCT01315743
Team COOL Pilot Study
A Phase 1/2 study testing Team COOL in people with Multicomponent School Based Behavioral Intervention and Prevent Further Weight Gain and or Promote, run by University of Minnesota.
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. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Multicomponent School Based Behavioral Intervention, Prevent Further Weight Gain and or Promote, Weight Loss Among Adolescents
- What is being tested?
- Team COOL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
- -
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Multicomponent School Based Behavioral Intervention, Prevent Further Weight Gain and or Promote, Weight Loss Among Adolescents
- Being tested
- Team COOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team COOLBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Team COOL |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multicomponent School Based Behavioral InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315743
- Sponsor's protocol ID
- 0601S79069
- Acronym
- Team COOL
- Status last verified
- Oct 2019
- First submitted
- 14 Mar 2011
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21518437
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team COOL Pilot Study
- ClinicalTrials.gov ID
- NCT01315743
- Acronym / sponsor ID
- Team COOL / 0601S79069
- Conditions
- Multicomponent School Based Behavioral Intervention, Prevent Further Weight Gain and or Promote, Weight Loss Among Adolescents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Team COOL |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team COOL1) 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. | Behavioural | Intervention |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Derived from this study: PubMed 21518437Arcan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Team COOL in people with Multicomponent School Based Behavioral Intervention and Prevent Further Weight Gain and or Promote, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.