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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02289313
Other study ID # 14-004474
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date June 17, 2015

Study information

Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date June 17, 2015
Est. primary completion date March 6, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy Youth Living Program
Physical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Rochester Alternative Learning Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behaviors related to healthy eating and physical activity Adoption of healthy eating choices by Rochester Alternative Learning Center students. 3 months
Secondary Weight and BMI After students participate in the healthy living program we will measure weight and BMI to evaluate change 6 and 12 months after intervention
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