Unspecified Adult Solid Tumor, Protocol SpecificNCT00301158
Promoting Physical Activity In After-School Programs for Urban Adolescents
A study testing exercise intervention, counseling intervention and educational intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Montclair State University at 1 site in United States.
Trial summary
RATIONALE: Physical activity may lower the risk of some types of cancer and other chronic diseases. PURPOSE: This clinical trial is studying ways to increase physical activity in urban adolescents who attend after-school programs. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- exercise intervention, counseling intervention and educational intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2008
- Phase
- Interventional
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
DISEASE CHARACTERISTICS:
- Noninstitutionalized, community-residing youth living in and attending after-school programs in New York City or Newark, NJ OR
- After-school program leaders at community agencies (i.e., adults) who participate in key informant interviews
PATIENT CHARACTERISTICS:
- Any racial or ethnic background
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Health and Nutrition Sciences at Montclair State University
Montclair, New Jersey, 07043
Amanda S. Birnbaum, PhD, MPH, 973-655-7115
About this study
Official title: Involving Adolescents in Physical Activity Promotion
RATIONALE: Physical activity may lower the risk of some types of cancer and other chronic diseases.
PURPOSE: This clinical trial is studying ways to increase physical activity in urban adolescents who attend after-school programs.
Read the detailed description
OBJECTIVES:
Primary
- Develop educational, promotional, and evaluation materials for use in promoting physical activity (PA) in community-based after-school programs by multiethnic, urban adolescents.
- Develop a series of workshops for promoting physical activities (PAs) that are "a good fit" in after-school programs for these participants.
- Determine a small set of feasibility tests as a first step towards pursuing funding for a full-scale experimental study.
- Development of print materials for a series of skills-building workshops for these participants.
- Development of evaluation materials, including self-report survey questions and structured interview protocols for qualitative assessment of participants' skills in identifying PAs that are a "good fit" for them.
OUTLINE: Youth participants will be assigned to one of two groups and may be involved in one or more research activities conducted during after-school hours at a community-based, after-school program site.
- Focus group: Participants, consisting of 5-8 adolescents per focus group, either all male or all female, attend a single audiotaped focus group with a trained moderator for 60 minutes. Participants complete an anonymous participant information form, and explore their perceptions of physical activity (PA), perceptions of audience segments among peers that would be appropriate for tailoring physical promotions, and responses to images and graphic designs for use in developing print materials. Some participants may also be eligible to participate in a second focus group and the survey if interested.
- One-on-one interview: Participants attend a one-on-one audiotaped individual interview with a trained interviewer for 60 minutes. Participants in the first set of interviews explore their perceptions of PA, their perceptions of the concept of finding PAs that are "a good fit", and their perceptions of audience segmentation for promoting PA. In the second set of interviews, participants test a protocol for qualitative assessment of adolescents' skills in assessing "good fit" of PA. Participants are involved in a series of visual and written scenarios depicting a variety of PAs, and use a structured interview format to identify the PA they most or least enjoy. Participants will also be asked to elaborate on criteria and experiences on which they based their decisions. Participants may also participate in the survey if interested.
- Survey: Participants complete a paper and pencil 60-minute questionnaire about PA behaviors, attitudes, environments, and person-physical activity skills (i.e., skills in finding PAs that are "a good fit"). Two weeks later, participants are asked to complete a second questionnaire.
- Key informant interview (adult): Participants attend a 60-minute, audiotaped interview with a trained interviewer that focuses on respondents' perceptions of the PA-related attitudes, behaviors, strengths, and barriers of the young adolescents who participate in their program, the respondents' experiences with promoting PA in their program participants, and respondents' suggestions for program elements and logistics to enhance the feasibility and effectiveness of after-school workshops to promote PA.
- Workshop pilot testing: After data collection from the above field work is completed, 1-2 workshop activities are conducted in cooperation with program leaders at community-based, after-school programs.
PROJECTED ACCRUAL: Approximately 420 participants (400 adolescents and 20 adults) will be accrued for this study.
- Being tested
- exercise intervention, counseling intervention, educational intervention, complementary or alternative medicine procedure
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
counseling interventionOther
educational interventionOther
complementary or alternative medicine procedureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior changes regarding physical activity by self-reported questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startSep 2004
- Primary completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 N/A
- Primary purpose
- Prevention
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montclair State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Amanda S. Birnbaum, PhD, MPH, Study chair, Montclair State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301158
- Sponsor's protocol ID
- CDR0000455588
- Other IDs
- MSUHNS-0003669, FWA00005270
- Status last verified
- Jun 2009
- First submitted
- 8 Mar 2006
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involving Adolescents in Physical Activity Promotion
- ClinicalTrials.gov ID
- NCT00301158
- Acronym / sponsor ID
- CDR0000455588
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Montclair State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2004
- Primary completion
- Aug 2008 (estimated)
- First posted
- 10 Mar 2006 (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.
RATIONALE: Physical activity may lower the risk of some types of cancer and other chronic diseases.
PURPOSE: This clinical trial is studying ways to increase physical activity in urban adolescents who attend after-school programs.
Detailed description
OBJECTIVES:
Primary
- Develop educational, promotional, and evaluation materials for use in promoting physical activity (PA) in community-based after-school programs by multiethnic, urban adolescents.
- Develop a series of workshops for promoting physical activities (PAs) that are "a good fit" in after-school programs for these participants.
- Determine a small set of feasibility tests as a first step towards pursuing funding for a full-scale experimental study.
- Development of print materials for a series of skills-building workshops for these participants.
- Development of evaluation materials, including self-report survey questions and structured interview protocols for qualitative assessment of participants' skills in identifying PAs that are a "good fit" for them.
OUTLINE: Youth participants will be assigned to one of two groups and may be involved in one or more research activities conducted during after-school hours at a community-based, after-school program site.
- Focus group: Participants, consisting of 5-8 adolescents per focus group, either all male or all female, attend a single audiotaped focus group with a trained moderator for 60 minutes. Participants complete an anonymous participant information form, and explore their perceptions of physical activity (PA), perceptions of audience segments among peers that would be appropriate for tailoring physical promotions, and responses to images and graphic designs for use in developing print materials. Some participants may also be eligible to participate in a second focus group and the survey if interested.
- One-on-one interview: Participants attend a one-on-one audiotaped individual interview with a trained interviewer for 60 minutes. Participants in the first set of interviews explore their perceptions of PA, their perceptions of the concept of finding PAs that are "a good fit", and their perceptions of audience segmentation for promoting PA. In the second set of interviews, participants test a protocol for qualitative assessment of adolescents' skills in assessing "good fit" of PA. Participants are involved in a series of visual and written scenarios depicting a variety of PAs, and use a structured interview format to identify the PA they most or least enjoy. Participants will also be asked to elaborate on criteria and experiences on which they based their decisions. Participants may also participate in the survey if interested.
- Survey: Participants complete a paper and pencil 60-minute questionnaire about PA behaviors, attitudes, environments, and person-physical activity skills (i.e., skills in finding PAs that are "a good fit"). Two weeks later, participants are asked to complete a second questionnaire.
- Key informant interview (adult): Participants attend a 60-minute, audiotaped interview with a trained interviewer that focuses on respondents' perceptions of the PA-related attitudes, behaviors, strengths, and barriers of the young adolescents who participate in their program, the respondents' experiences with promoting PA in their program participants, and respondents' suggestions for program elements and logistics to enhance the feasibility and effectiveness of after-school workshops to promote PA.
- Workshop pilot testing: After data collection from the above field work is completed, 1-2 workshop activities are conducted in cooperation with program leaders at community-based, after-school programs.
PROJECTED ACCRUAL: Approximately 420 participants (400 adolescents and 20 adults) will be accrued for this study.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| exercise intervention | Behavioural | – |
| counseling intervention | Other | – |
| educational intervention | Other | – |
| complementary or alternative medicine procedure | Procedure or surgery | – |
Primary outcome
Behavior changes regarding physical activity by self-reported questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Amanda S. Birnbaum, PhD, MPH study chair
Montclair State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, counseling intervention and educational intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Montclair State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior changes regarding physical activity by self-reported questionnaire. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2013.