Health BehaviorPhase 4NCT00059527
Healthy Youth Places: A Program to Promote Nutrition and Physical Activity in Adolescents
A Phase 4 study testing Healthy Youth Places: a behavior change model in people with Health Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
To reduce the risk for chronic disease, adolescents should eat at least five servings of fruit and vegetables and be physically active daily. This study will implement and evaluate a school-based program to encourage adolescents to achieve and maintain a healthy diet and exercise regimen. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Healthy Youth Places: a behavior change model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 1999to May 2003
- Phase
- Phase 4
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Student attending sixth through eighth grades
- Participating middle school
Who cannot join
None listed.
About this study
Official title: Youth Environments Promoting Nutrition and Activity
To reduce the risk for chronic disease, adolescents should eat at least five servings of fruit and vegetables and be physically active daily. This study will implement and evaluate a school-based program to encourage adolescents to achieve and maintain a healthy diet and exercise regimen.
Read the detailed description
The Healthy Youth Places project will test if an intervention strategy that implements school environmental change, with both adult leader and youth participation, will influence and maintain adolescent fruit and vegetable consumption and physical activity.
The study will assess the effects of school environment and curriculum interventions promoting fruit and vegetable (F\&V) consumption, physical activity (PA), and their environmental determinants. The project will involve goal-setting and efficacy-building interventions designed to develop the skills and group efficacy of both adult school personnel and students. The adult-based interventions are designed to change the school environments through a school coalition assisted by a local coordinator. The youth interventions involve the participation of students in the processes of building the local health behavior environments and target both school lunch and after-school activity environments.
The project encourages adult and youth participation in the process of planning and implementing environmental change in targeted adolescent physical and social environments (school lunch place, after-school program place). Environmental change is defined as implemented practices, programs, and policies that promote critical elements (connection, autonomy, skill-building, healthy fruit and vegetable and physical activity norms). These critical elements are social environmental processes of behavior change.
Sixteen schools will be randomly assigned to either the experimental or the control (no treatment) condition. The health behavior of adolescents will be assessed during the sixth, seventh, eighth, and ninth grades. Measurement of F\&V and PA behaviors are the primary outcomes and will be assessed by self-report and verified by objective measures of school lunch purchases and physical activity monitoring. The impact of the program on personal, environmental, and behavioral determinants of F\&V and PA will also be measured.
- Conditions
- Health Behavior
- Being tested
- Healthy Youth Places: a behavior change model
- Keywords
- Physical Activity, Nutrition, Self Efficacy, Middle School, Intervention
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Youth Places: a behavior change modelBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate and Vigorous Physical Activity
Vigorous Physical Activity
Fruit and Vegetable Consumption
Secondary outcomes (1)
Self-efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2003 (estimated)
- Study startMar 1999
- Study completionMay 2003
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 Health BehaviorStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 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
- Investigators
- David A Dzewaltowski, Ph.D., Principal investigator, Community Health Institute, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059527
- Sponsor's protocol ID
- 5R01HD37367-3
- Other IDs
- 5R01HD037367
- Status last verified
- Aug 2005
- First submitted
- 28 Apr 2003
- Last updated
- 30 Oct 2014
- Results posted
- No
Publications
Dzewaltowski DA, Estabrooks PA, Johnston JA. Healthy youth places promoting nutrition and physical activity. Health Educ Res. 2002 Oct;17(5):541-51. doi: 10.1093/her/17.5.541.
PubMed 12408199
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Environments Promoting Nutrition and Activity
- ClinicalTrials.gov ID
- NCT00059527
- Acronym / sponsor ID
- 5R01HD37367-3
- Conditions
- Health Behavior
- Keywords
- Physical Activity, Nutrition, Self Efficacy, Middle School, Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 1999
- Study completion
- May 2003
- First posted
- 29 Apr 2003 (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.
To reduce the risk for chronic disease, adolescents should eat at least five servings of fruit and vegetables and be physically active daily. This study will implement and evaluate a school-based program to encourage adolescents to achieve and maintain a healthy diet and exercise regimen.
Detailed description
The Healthy Youth Places project will test if an intervention strategy that implements school environmental change, with both adult leader and youth participation, will influence and maintain adolescent fruit and vegetable consumption and physical activity.
The study will assess the effects of school environment and curriculum interventions promoting fruit and vegetable (F\&V) consumption, physical activity (PA), and their environmental determinants. The project will involve goal-setting and efficacy-building interventions designed to develop the skills and group efficacy of both adult school personnel and students. The adult-based interventions are designed to change the school environments through a school coalition assisted by a local coordinator. The youth interventions involve the participation of students in the processes of building the local health behavior environments and target both school lunch and after-school activity environments.
The project encourages adult and youth participation in the process of planning and implementing environmental change in targeted adolescent physical and social environments (school lunch place, after-school program place). Environmental change is defined as implemented practices, programs, and policies that promote critical elements (connection, autonomy, skill-building, healthy fruit and vegetable and physical activity norms). These critical elements are social environmental processes of behavior change.
Sixteen schools will be randomly assigned to either the experimental or the control (no treatment) condition. The health behavior of adolescents will be assessed during the sixth, seventh, eighth, and ninth grades. Measurement of F\&V and PA behaviors are the primary outcomes and will be assessed by self-report and verified by objective measures of school lunch purchases and physical activity monitoring. The impact of the program on personal, environmental, and behavioral determinants of F\&V and PA will also be measured.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Student attending sixth through eighth grades
- Participating middle school
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 |
|---|---|---|
| Healthy Youth Places: a behavior change model | Behavioural | – |
Primary outcome
Moderate and Vigorous Physical Activity
Vigorous Physical Activity
Fruit and Vegetable Consumption
1 secondary outcome
Self-efficacy
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 30 Oct 2014.
- Background: PubMed 12408199Dzewaltowski DA, Estabrooks PA, Johnston JA. Healthy youth places promoting nutrition and physical activity. Health Educ Res. 2002 Oct;17(5):541-51. doi: 10.1093/her/17.5.541.
- Click here for more information about the intervention frameworkLink provided by the sponsor.
- Click here for more information about the evaluation frameworkLink provided by the sponsor.
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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.
David A Dzewaltowski, Ph.D. principal investigator
Community Health Institute, Kansas State University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Healthy Youth Places: a behavior change model in people with Health Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 2 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 30 Oct 2014. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Moderate and Vigorous Physical Activity. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059527, 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 30 Oct 2014.