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Wellness Program Implementation: School & Student Toolkits

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02277496
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : December 4, 2018
Information provided by (Responsible Party):
Judith Wylie-Rosett, Albert Einstein College of Medicine

Brief Summary:

The project is designed to evaluate a participatory implementation model in HealthCorps (HC) high schools and to assess outcomes within and across school settings . The behavioral objectives from the 2010 Dietary Guidelines to address obesity in youth include: 1) decreasing sugary beverage intake; 2) increasing frequency of breakfast; 3) increasing vegetable and fruit intake to 2½ cups per day;4) decreasing frequency of fast food meals;5) becoming physically active (goal of 1 hour per day); and 6) reducing sedentary behavior time (<2 hour day). The study is employing system dynamics modeling (SDM) to assess wellness programming options and to evaluate the program implementation within the context of diverse school ecologies. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used to guide SDM development and validation.

The Specific Aims are:

  1. To use PAR (Participatory Action Research) methods to refine the school wellness program model and toolkit components that address institutional/community level program implementation barriers and individual level barriers to achieving healthy lifestyle recommendations.
  2. To assess the effectiveness of program components using process evaluation techniques guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) model.
  3. To evaluate implementation with system dynamics modeling to facilitate dissemination. The simulation analysis will apply the RE-AIM framework to address: Reach (participation rates), effectiveness (outcomes), adoption (acceptability), implementation (intervention fidelity), and maintenance (sustainability of lifestyle changes by students and programs by schools), in order to facilitate refining the toolkits and training program for dissemination to other school setting and diverse educational venues.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Toolkit Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14520 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: During the 2014-2015 school year a 2-arm design was used to compare outcomes between intervention and comparison schools. Subsequent years utilized a single-arm design to analyse trends between and within intervention schools only.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Wellness Program Implementation: School & Student Toolkits
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: HC toolkit intervention students
HC students will receiveeExperimental wellness education via a toolkit approach to address the 2010 Dietary Guidelines for reducing obesity in youth. The specific recommendations include: 1) reducing intake of sugary beverages, 2) increasing intake of fruits and vegetables, 3) increasing frequency of eating breakfast, 4) decreasing fast and junk food choices, 5) increasing physical activity to 1 hour/day, and 6) decreasing screen time to 2 hours per day.
Behavioral: Toolkit Intervention
The toolkit intervention consists of strategies and activities to engage students (student toolkit) and school wellness councils (school toolkit) in addressing the six targeted behaviors of the 2010 Dietary Guidelines based on the principles of participatory action research. The intervention will promote goal setting and school-based food and physical promotion activities led by students as well as school wellness network development.
Other Name: Student and School Toolkits

No Intervention: Comparison Schools
During the 2014-2015 school year, control schools were utilized to compare outcomes.

Primary Outcome Measures :
  1. Key Behaviors [ Time Frame: 12 months ]
    The primary dependent variables will be the following key behaviors: physical activity, sugary beverage consumptions, fruit and vegetable consumptions and breakfast eating. Scores of these primary study outcomes will be measured annually by administering the high school survey and analyzed cross-sectionally.

Secondary Outcome Measures :
  1. Effect of weight changes [ Time Frame: 12 months ]
    The investigators will conduct exploratory analysis to test the effect of weight changes on behavior changes, regardless of intervention assignments. To this end, the investigators will again apply mixed effects linear models in which the dependent variables will be changes in the behavior variables and independent variables will be indicator for direction of changes in BMI z-scores.

Other Outcome Measures:
  1. Effects of Goal Setting [ Time Frame: 12 months ]
    Student goal setting behaviors and perceived outcomes will be measured by the research team. This includes the type of goals, the quality of the goals (defined as S-specific, M-measurable, A-actiona oriented, R-realistic, and T-time bound), and the students' perceived success.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Students (grades 9-12).

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02277496

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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
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Principal Investigator: Judith Wylie-Rosett, EdD, RD Albert Einstein College of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Judith Wylie-Rosett, Assistant Professor, Albert Einstein College of Medicine Identifier: NCT02277496    
Other Study ID Numbers: 2013-2056
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Body Weight