MedDataX Logo

Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools

NCT ID: NCT02329015

Last Updated: 2016-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the academic and psycho-social benefits of a yoga-informed health and wellness program (HWP) to a standard physical education program for middle and high school students within New York City (NYC) schools.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Approximately 100 students at a public New York City High School will be randomized at the level of class into either the experimental (yoga-informed health and wellness program) or control arm (physical education class). Students will receive two classes per week of approximately 45 minutes throughout the academic year. Data will be collected in September 2014 and February and May of 2015.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Behavior

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stress alternative complementary self-regulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Health and Wellness program

Behavioral intervention

Group Type EXPERIMENTAL

Yoga-informed Health and Wellness Program

Intervention Type BEHAVIORAL

The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June).

Physical Education Class

Behavioral intervention

Group Type ACTIVE_COMPARATOR

Physical Education Class

Intervention Type BEHAVIORAL

Standard physical education

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yoga-informed Health and Wellness Program

The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June).

Intervention Type BEHAVIORAL

Physical Education Class

Standard physical education

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • Male or female students attending NYC schools

Exclusion Criteria

* Lack of permission to attend physical education class
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Long Island University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marshall Hagins

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marshall Hagins, PhD

Role: PRINCIPAL_INVESTIGATOR

Long Island University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eastside Community High School

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SONIMA001

Identifier Type: -

Identifier Source: org_study_id