Childhood ObesityNCT02289313
Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center
A study testing Healthy Youth Living Program in people with Childhood Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
Approximately one third of the children and adolescents in the United States are either overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic groups and households with low socioeconomic status and low parental education. Read more about this study
- Who is it for?
- Ages 12 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Healthy Youth Living Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 17 Jun 2015
- 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 12 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Rochester Alternative Learning Center students ages 12 years to 20 years
- Parents/guardians of ALC students
- ALC staff.
Who cannot join
- Inability to assent or consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Development of a Youth Healthy Living Program at the Rochester Alternative Learning Center
Approximately one third of the children and adolescents in the United States are either overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic groups and households with low socioeconomic status and low parental education. The Alternative Learning Center (ALC) within Rochester School District 535 provides viable educational options for students who are experiencing difficulty in regular educational systems. A greater proportion of students at ALC are minorities, qualify for free and reduced lunch and receive special education services. These children are likely to have unique barriers to physical activity and healthy eating.
Specific Aims:
Read more
Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors related to physical activity and eating in ALC students.
Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy lifestyle.
Read the detailed description
Investigators will assess the relationship between BMI and ethnicity, socioeconomic variables and behaviors related to nutrition and physical activity among 200 ALC students. Investigators will also conduct 6 gender stratified (3 boys, 3 girls) focus groups with students (n=24), up to 3 focus groups with their parents (n=24) and one focus group with staff and volunteers in order to understand perceived barriers towards healthy weight/nutrition/physical activity. Investigators will then utilize this information to co-develop a healthy living program at ALC. Investigators will finally test the feasibility of the program they develop over a period of 3 months in ALC students. Study findings will inform further research to test the efficacy and validity of the program developed at ALC in a subsequent school based trial with the future goal of obtaining funding for cluster randomized controlled trials among other schools in the region.
- Conditions
- Childhood Obesity
- Being tested
- Healthy Youth Living Program
- Keywords
- obesity prevention, CBPR, high risk youth, school health
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Youth Living ProgramBehavioural
Physical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners.
| Study group | Role | What they receive |
|---|---|---|
| Youth Healthy Living Program | Experimental | Youth attending the Rochester Alternative Learning Center (ALC) will be enrolled in a youth healthy living program at the ALC. Receives: Behavioral: Healthy Youth Living Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviors related to healthy eating and physical activity
Adoption of healthy eating choices by Rochester Alternative Learning Center students.
Measured: 3 months
Secondary outcomes (1)
Weight and BMI
After students participate in the healthy living program we will measure weight and BMI to evaluate change
Measured: 6 and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion6 Mar 2015
- Study completion17 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester Alternative Learning Center
- Responsible party
- Principal investigator, Seema Kumar, Mayo Clinic
- Investigators
- Seema Kumar, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289313
- Sponsor's protocol ID
- 14-004474
- Status last verified
- Dec 2021
- First submitted
- 9 Nov 2014
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Youth Healthy Living Program at the Rochester Alternative Learning Center
- ClinicalTrials.gov ID
- NCT02289313
- Acronym / sponsor ID
- 14-004474
- Conditions
- Childhood Obesity
- Keywords
- obesity prevention, CBPR, high risk youth, school health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Rochester Alternative Learning Center
- Study start
- Nov 2014
- Primary completion
- 6 Mar 2015 (actual)
- Study completion
- 17 Jun 2015 (actual)
- First posted
- 13 Nov 2014 (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.
Approximately one third of the children and adolescents in the United States are either overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic groups and households with low socioeconomic status and low parental education. The Alternative Learning Center (ALC) within Rochester School District 535 provides viable educational options for students who are experiencing difficulty in regular educational systems. A greater proportion of students at ALC are minorities, qualify for free and reduced lunch and receive special education services. These children are likely to have unique barriers to physical activity and healthy eating.
Specific Aims:
Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors related to physical activity and eating in ALC students.
Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy lifestyle.
Detailed description
Investigators will assess the relationship between BMI and ethnicity, socioeconomic variables and behaviors related to nutrition and physical activity among 200 ALC students. Investigators will also conduct 6 gender stratified (3 boys, 3 girls) focus groups with students (n=24), up to 3 focus groups with their parents (n=24) and one focus group with staff and volunteers in order to understand perceived barriers towards healthy weight/nutrition/physical activity. Investigators will then utilize this information to co-develop a healthy living program at ALC. Investigators will finally test the feasibility of the program they develop over a period of 3 months in ALC students. Study findings will inform further research to test the efficacy and validity of the program developed at ALC in a subsequent school based trial with the future goal of obtaining funding for cluster randomized controlled trials among other schools in the region.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth Healthy Living Program | Experimental | Behavioral: Healthy Youth Living ProgramYouth attending the Rochester Alternative Learning Center (ALC) will be enrolled in a youth healthy living program at the ALC. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Rochester Alternative Learning Center students ages 12 years to 20 years
- Parents/guardians of ALC students
- ALC staff.
Key exclusion criteria (1 listed)
- Inability to assent or consent to participate in the study.
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 Living ProgramPhysical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners. | Behavioural | Youth Healthy Living Program |
Primary outcome
Behaviors related to healthy eating and physical activity
Time frame: 3 months
Adoption of healthy eating choices by Rochester Alternative Learning Center students.
1 secondary outcome
Weight and BMI
Time frame: 6 and 12 months after intervention
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 16 Dec 2021.
- Mayo Clinic Clinical TrialsLink 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.
Seema Kumar, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Youth Living Program in people with Childhood Obesity, run by Mayo Clinic 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 3 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 16 Dec 2021. 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.
What does the primary outcome measure?
Behaviors related to healthy eating and physical activity (time frame: 3 months). 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 16 Dec 2021.