Pediatric ObesityNCT02886208
Health Outcomes of Teens Participating in Summer Employment Immersion Programs
A study testing Measurement in people with Pediatric Obesity and Prediabetic State, run by Indiana University.
Trial summary
This study is a collaboration between investigators and two community partners: a youth employment program and an urban farm. The community partners hire 300+ adolescents for summer jobs at various organizations. Approximately 120 adolescents will be employed with the urban farm site. Read more about this study
- Who is it for?
- Ages 15 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Prediabetic State
- What is being tested?
- Measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2016
- 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 15 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- employed by summer work program at urban farm
Who cannot join
- N/A
About this study
This study is a collaboration between investigators and two community partners: a youth employment program and an urban farm. The community partners hire 300+ adolescents for summer jobs at various organizations. Approximately 120 adolescents will be employed with the urban farm site. As one component of their program evaluation plan, investigators will evaluate change in BMI of participants. The investigators hypothesize that there will be a reduction in BMI of those participants working at the urban farm site.
Read the detailed description
The investigators will measure height/weight/BMI of all participants located at the urban farm site. Investigators will also collect demographic data as well as other social data (example: food security).
- Conditions
- Pediatric Obesity, Prediabetic State
- Being tested
- Measurement
- Medical subject headings
- Pediatric Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementBehavioural
The intervention consists of diabetes prevention education sessions focusing on increasing physical activity and decreasing the intake of sugared drinks while increasing intake of fruits and vegetables. The 2-hr sessions occur weekly for 6 weeks. Height and weight is measured for each consenting participant at baseline and after 6 weeks. Participants are also asked to complete a short questionnaire to collect demographic and knowledge data. Outcome measures include: BMI, knowledge of physical activity and dietary habits conducive to diabetes prevention, and feelings of food insecurity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This study has a single arm. All participants in a summer employment program at an urban farm in Indianapolis, IN are invited to participate. Receives: Behavioral: Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara S. Hannon, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886208
- Sponsor's protocol ID
- 1604487508
- Status last verified
- Feb 2019
- First submitted
- 29 Aug 2016
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published in a medical journal. There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes of Teens Participating in Summer Employment Immersion Programs
- ClinicalTrials.gov ID
- NCT02886208
- Acronym / sponsor ID
- 1604487508
- Conditions
- Pediatric Obesity, Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Sep 2016 (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 is a collaboration between investigators and two community partners: a youth employment program and an urban farm. The community partners hire 300+ adolescents for summer jobs at various organizations. Approximately 120 adolescents will be employed with the urban farm site. As one component of their program evaluation plan, investigators will evaluate change in BMI of participants. The investigators hypothesize that there will be a reduction in BMI of those participants working at the urban farm site.
Detailed description
The investigators will measure height/weight/BMI of all participants located at the urban farm site. Investigators will also collect demographic data as well as other social data (example: food security).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MeasurementThis study has a single arm. All participants in a summer employment program at an urban farm in Indianapolis, IN are invited to participate. |
Who may qualify
- Ages
- 15 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- employed by summer work program at urban farm
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| MeasurementThe intervention consists of diabetes prevention education sessions focusing on increasing physical activity and decreasing the intake of sugared drinks while increasing intake of fruits and vegetables. The 2-hr sessions occur weekly for 6 weeks. Height and weight is measured for each consenting participant at baseline and after 6 weeks. Participants are also asked to complete a short questionnaire to collect demographic and knowledge data. Outcome measures include: BMI, knowledge of physical activity and dietary habits conducive to diabetes prevention, and feelings of food insecurity. | Behavioural | Intervention |
Primary outcome
BMI
Time frame: 6 weeks
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 20 Feb 2019.
- Individual participant dataSharing planned: No. Data will be published in a medical journal. There is no plan to make individual participant data available.
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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 study testing Measurement in people with Pediatric Obesity and Prediabetic State, run by Indiana University.
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 1 inclusion and 1 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 20 Feb 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.
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?
BMI (time frame: 6 weeks). 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 20 Feb 2019.