NCT02289313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2015

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

November 9, 2014

Last Update Submit

December 1, 2021

Conditions

Keywords

obesity preventionCBPRhigh risk youthschool health

Outcome Measures

Primary Outcomes (1)

  • Behaviors related to healthy eating and physical activity

    Adoption of healthy eating choices by Rochester Alternative Learning Center students.

    3 months

Secondary Outcomes (1)

  • Weight and BMI

    6 and 12 months after intervention

Study Arms (1)

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.

Behavioral: Healthy Youth Living Program

Interventions

Physical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners.

Youth Healthy Living Program

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Rochester Alternative Learning Center students ages 12 years to 20 years
  • Parents/guardians of ALC students
  • ALC staff.

You may not qualify if:

  • Inability to assent or consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seema Kumar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 9, 2014

First Posted

November 13, 2014

Study Start

November 1, 2014

Primary Completion

March 6, 2015

Study Completion

June 17, 2015

Last Updated

December 16, 2021

Record last verified: 2021-12

Locations