AdolescentNCT00340795
Media-Smart Youth Program Evaluation Study
An observational study of Adolescent, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will evaluate the impact of a Media-Smart Youth (MSY) curriculum on adolescent knowledge and behavioral intent regarding media messages, nutrition, and physical activity. The study is part of the U.S. Government's efforts to fight obesity and increase physical activity among American youth. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2005to 7 Mar 2007
- Phase
- Observational
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth aged 11-13 are the primary participants in this study.
- All youth identified in either the treatment or control groups will be
- included in the study.
- At no point during the program implementation, including the data
- collection, will any participant be excluded from the group
- membership or activities.
Who cannot join
- Treatment subjects who have participated in less than seven lessons will be excluded from the treatment group for the purpose of analyzing program effects.
- They will, however, be included in intent-to-treat analyses to check for biases from excluding these participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Academy for Education Development
Washington D.C., District of Columbia
About this study
This study will evaluate the impact of a Media-Smart Youth (MSY) curriculum on adolescent knowledge and behavioral intent regarding media messages, nutrition, and physical activity. The study is part of the U.S. Government's efforts to fight obesity and increase physical activity among American youth. The MSY program seeks to empower adolescents to make healthful choices about nutrition and physical activity by helping them understand how media can influence their lives. This is important because it is estimated that young people view as many as 40,000 commercial messages a year on television alone, many of which promote unhealthy snack foods and beverages.
Youth between 11 and 13 years of age who are participating in selected after-school programs in the Washington, D.C., metropolitan area may be eligible for this study.
Participants are randomly assigned to either receive the MSY curriculum or serve as controls. Youth in the MSY group participate in a workshop consisting of 10 lessons and a creative project to create a media message for their peers on the topic of nutrition and physical activity. During the sessions, the young people receive information on nutrition and physical activity and learn about media production and how to critically examine the media. Youth in the control group participate in after-school programs unrelated to MSY. All participants fill out questionnaires measuring their knowledge, skills, and behavioral intent related to media analysis, nutrition and physical activity both at the start of the study and at its completion.
Read the detailed description
- Objectives of Study
The purpose of this study is to determine the impact of the Media-Smart Youth (MSY) curriculum on adolescent knowledge skills and behavioral intent in the areas of media analysis, nutrition, and physical activity. The study asks whether youth participating in the MSY curriculum 1) increase their skills in analyzing media messages; 2) increase their knowledge of the basic principles of healthful and nutritious foods and increase their skills and behavioral intent to make healthful food choices in real-life settings; and 3) increase their knowledge of the importance of daily physical activity in promoting health and increase their skills and behavioral intent to be more active in their daily lives.
- Study Design
The evaluation will use a group randomization design, in which 18 after-school programs will be randomly assigned to either receive the MSY curriculum or serve as controls. Nine youth-serving agencies running pre-existing structured after-school programs in the Washington, DC metropolitan area will be solicited to participate in the evaluation. For each agency, two program sites will be selected with each pair of sites matched for socioeconomic status, race and ethnicity, all factors that may affect the program outcomes. The sites will then be randomly assigned to either the treatment or control group. During the implementation of the MSY curriculum at the treatment sites, participants in the control sites will receive after-school programming unrelated to MSY. Fifteen youth in each after-school program, or 270 youth, will be recruited to participate in the study. Parental consent and youth assent will be obtained. At the end of the program implementation, program staff from the treatment and control sites will be offered training in implementing the MSY curriculum.
- Outcome Measures
The MSY program outcomes on knowledge, skills and behavioral intent related to media analysis, nutrition, and physical activity will be measured using a paper-and-pencil self-administered questionnaire (SAQ). All 270 youth will complete the SAQ pretest before the start of the MSY curriculum. Following the completion of the curriculum, all 270 youth will complete the SAQ posttest. For the treatment of after-school participants, data collection is incorporated into the MSY curriculum delivery. Following implementation of the MSY curriculum, the treatment group facilitators will be interviewed to identify any modifications made to the ascribed curriculum. Program directors of the control groups will also be interviewed to determine the general content of the program(s) in which the control youth participated.
- Conditions
- Adolescent
- Keywords
- Media Analysis, Nutrition, Physical Activity, After-School, Exercise
- Medical subject headings
- Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start4 Aug 2005
- Study completion7 Mar 2007
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 AdolescentStudies 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
- Observational
- Enrolment
- 0 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340795
- Sponsor's protocol ID
- 999905197
- Other IDs
- 05-CH-N197
- Status last verified
- 7 Mar 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Murray DM, Hannan PJ, Wolfinger RD, Baker WL, Dwyer JH. Analysis of data from group-randomized trials with repeat observations on the same groups. Stat Med. 1998 Jul 30;17(14):1581-600. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-n.
PubMed 9699231
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Media-Smart Youth Program Evaluation Study
- ClinicalTrials.gov ID
- NCT00340795
- Acronym / sponsor ID
- 999905197
- Conditions
- Adolescent
- Keywords
- Media Analysis, Nutrition, Physical Activity, After-School, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 4 Aug 2005
- Study completion
- 7 Mar 2007
- First posted
- 21 Jun 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.
This study will evaluate the impact of a Media-Smart Youth (MSY) curriculum on adolescent knowledge and behavioral intent regarding media messages, nutrition, and physical activity. The study is part of the U.S. Government's efforts to fight obesity and increase physical activity among American youth. The MSY program seeks to empower adolescents to make healthful choices about nutrition and physical activity by helping them understand how media can influence their lives. This is important because it is estimated that young people view as many as 40,000 commercial messages a year on television alone, many of which promote unhealthy snack foods and beverages.
Youth between 11 and 13 years of age who are participating in selected after-school programs in the Washington, D.C., metropolitan area may be eligible for this study.
Participants are randomly assigned to either receive the MSY curriculum or serve as controls. Youth in the MSY group participate in a workshop consisting of 10 lessons and a creative project to create a media message for their peers on the topic of nutrition and physical activity. During the sessions, the young people receive information on nutrition and physical activity and learn about media production and how to critically examine the media. Youth in the control group participate in after-school programs unrelated to MSY. All participants fill out questionnaires measuring their knowledge, skills, and behavioral intent related to media analysis, nutrition and physical activity both at the start of the study and at its completion.
Detailed description
- Objectives of Study
The purpose of this study is to determine the impact of the Media-Smart Youth (MSY) curriculum on adolescent knowledge skills and behavioral intent in the areas of media analysis, nutrition, and physical activity. The study asks whether youth participating in the MSY curriculum 1) increase their skills in analyzing media messages; 2) increase their knowledge of the basic principles of healthful and nutritious foods and increase their skills and behavioral intent to make healthful food choices in real-life settings; and 3) increase their knowledge of the importance of daily physical activity in promoting health and increase their skills and behavioral intent to be more active in their daily lives.
- Study Design
The evaluation will use a group randomization design, in which 18 after-school programs will be randomly assigned to either receive the MSY curriculum or serve as controls. Nine youth-serving agencies running pre-existing structured after-school programs in the Washington, DC metropolitan area will be solicited to participate in the evaluation. For each agency, two program sites will be selected with each pair of sites matched for socioeconomic status, race and ethnicity, all factors that may affect the program outcomes. The sites will then be randomly assigned to either the treatment or control group. During the implementation of the MSY curriculum at the treatment sites, participants in the control sites will receive after-school programming unrelated to MSY. Fifteen youth in each after-school program, or 270 youth, will be recruited to participate in the study. Parental consent and youth assent will be obtained. At the end of the program implementation, program staff from the treatment and control sites will be offered training in implementing the MSY curriculum.
- Outcome Measures
The MSY program outcomes on knowledge, skills and behavioral intent related to media analysis, nutrition, and physical activity will be measured using a paper-and-pencil self-administered questionnaire (SAQ). All 270 youth will complete the SAQ pretest before the start of the MSY curriculum. Following the completion of the curriculum, all 270 youth will complete the SAQ posttest. For the treatment of after-school participants, data collection is incorporated into the MSY curriculum delivery. Following implementation of the MSY curriculum, the treatment group facilitators will be interviewed to identify any modifications made to the ascribed curriculum. Program directors of the control groups will also be interviewed to determine the general content of the program(s) in which the control youth participated.
Study design
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Youth aged 11-13 are the primary participants in this study.
- All youth identified in either the treatment or control groups will be
- included in the study.
- At no point during the program implementation, including the data
- collection, will any participant be excluded from the group
Key exclusion criteria (2 listed)
- Treatment subjects who have participated in less than seven lessons will be excluded from the treatment group for the purpose of analyzing program effects.
- They will, however, be included in intent-to-treat analyses to check for biases from excluding these participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 2 Jul 2017.
- Background: PubMed 9699231Murray DM, Hannan PJ, Wolfinger RD, Baker WL, Dwyer JH. Analysis of data from group-randomized trials with repeat observations on the same groups. Stat Med. 1998 Jul 30;17(14):1581-600. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-n.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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?
The sponsor lists 6 inclusion and 2 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 2 Jul 2017. 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?
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 NCT00340795, 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 2 Jul 2017.