Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Youth Living Program
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring obesity prevention, CBPR, high risk youth, school health
Eligibility Criteria
Inclusion criteria:
- Rochester Alternative Learning Center students ages 12 years to 20 years
- Parents/guardians of ALC students
- ALC staff.
Exclusion criteria:
- Inability to assent or consent to participate in the study.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Youth Healthy Living Program
Arm Description
Youth attending the Rochester Alternative Learning Center (ALC) will be enrolled in a youth healthy living program at the ALC.
Outcomes
Primary Outcome Measures
Behaviors related to healthy eating and physical activity
Adoption of healthy eating choices by Rochester Alternative Learning Center students.
Secondary Outcome Measures
Weight and BMI
After students participate in the healthy living program we will measure weight and BMI to evaluate change
Full Information
NCT ID
NCT02289313
First Posted
November 9, 2014
Last Updated
December 1, 2021
Sponsor
Mayo Clinic
Collaborators
Rochester Alternative Learning Center
1. Study Identification
Unique Protocol Identification Number
NCT02289313
Brief Title
Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center
Official Title
Development of a Youth Healthy Living Program at the Rochester Alternative Learning Center
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 6, 2015 (Actual)
Study Completion Date
June 17, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Rochester Alternative Learning Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
obesity prevention, CBPR, high risk youth, school health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Youth Healthy Living Program
Arm Type
Experimental
Arm Description
Youth attending the Rochester Alternative Learning Center (ALC) will be enrolled in a youth healthy living program at the ALC.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Youth Living Program
Intervention Description
Physical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners.
Primary Outcome Measure Information:
Title
Behaviors related to healthy eating and physical activity
Description
Adoption of healthy eating choices by Rochester Alternative Learning Center students.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight and BMI
Description
After students participate in the healthy living program we will measure weight and BMI to evaluate change
Time Frame
6 and 12 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Rochester Alternative Learning Center students ages 12 years to 20 years
Parents/guardians of ALC students
ALC staff.
Exclusion criteria:
Inability to assent or consent to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seema Kumar, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center
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