Wellness Program Implementation: School & Student Toolkits

NCT02277496 | Completed DMC

• 1 other identifier: 2013-2056
• Study Type: interventional
• Target: 14,520
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Key Behaviors

  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.

  12 months

Secondary Outcomes (1)

• Effect of weight changes

  12 months

Other Outcomes (1)

• Effects of Goal Setting

  12 months

Study Arms (2)

HC toolkit intervention students

EXPERIMENTAL

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

Comparison Schools

NO INTERVENTION

During the 2014-2015 school year, control schools were utilized to compare outcomes.

Interventions

Toolkit Intervention BEHAVIORAL

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.

Also known as: Student and School Toolkits

HC toolkit intervention students

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Students (grades 9-12).

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• HealthCorps: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• Heo M, Jimenez CC, Lim J, Isasi CR, Blank AE, Lounsbury DW, Fredericks L, Bouchard M, Faith MS, Wylie-Rosett J. Effective nationwide school-based participatory extramural program on adolescent body mass index, health knowledge and behaviors. BMC Pediatr. 2018 Jan 16;18(1):7. doi: 10.1186/s12887-017-0975-9.

  PMID: 29338731 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Wylie-Rosett, EdD, RD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: October 29, 2014
• Study Start: July 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-01

Locations

US (1)