Development of a Youth Healthy Living Program With Unders... | NCT02289313

Studies
Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center

NCT02289313

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Dec 16, 2021Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Childhood Obesity

Interventions

Healthy Youth Living Program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Mar 6, 2015Actual

Completion Date

Jun 17, 2015Actual

First Submitted Date

Nov 9, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2021

Last Update Posted Date

Dec 16, 2021Actual

Name	Class
Rochester Alternative Learning Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Healthy Youth Living Program	Behavioral	Physical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Behaviors related to healthy eating and physical activity	Adoption of healthy eating choices by Rochester Alternative Learning Center students.	3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seema Kumar, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided