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Wellness Champions for Change (WCC)

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ClinicalTrials.gov Identifier: NCT03432715
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : November 9, 2020
Sponsor:
Collaborators:
United States Department of Agriculture (USDA)
University of Maryland, College Park
Boise State University
University of Southern California
Cornell University
Information provided by (Responsible Party):
Erin Hager, University of Maryland, Baltimore

Brief Summary:

The Wellness Champions for Change (WCC) study aims to reduce pediatric obesity among students who attend schools in Maryland by training teacher and student-led wellness teams to increase opportunities for physical activity and healthy eating at school.

The study uses a cluster randomized design to allocate 6 schools (3 elementary, 3 middle) in 5 school systems to one of 3 arms: "A" (teacher and student training), "B" (teacher training only), and "C") (delayed teacher training/control). Approximately 36 3rd/6th graders and their caregivers ("evaluation cohort"), 15 4th/7th graders ("student leaders"), and 20 teachers from each school will be recruited in the spring before the intervention. All schools will identify a teacher "Wellness Champion" who will coordinate intervention activities. In "A" and "B" schools, wellness champions will attend a training to learn how to build a wellness team and create more opportunities for students to make healthy choices. In "A" schools, student leaders ("Student Wellness Champions") will meet weekly during lunch with a health educator to receive training as peer leaders and help the Wellness Champion with wellness initiatives. Student leaders in "B" and "C" schools will receive a monthly general Adolescent Health Curriculum. To assess the impact of the teacher and student-led interventions, the evaluation cohort will be followed for 2.5 years, with measures including: anthropometry (height/weight), 7-day accelerometry (physical activity), and validated questionnaires to assess healthy eating. Student leaders will be followed for 1.5 years to assess the impact of their participation, with measures including: anthropometry, 7-day accelerometry, validated questionnaires to assess healthy eating, and validated questionnaires and focus groups to assess leadership/advocacy skills. Teachers will complete validated questionnaires to investigate their perceptions of the school environment, classroom practices, and role modeling skills. Prior to data collection and analysis, participants will be assigned an identification number, and all documents linking participant information to identification numbers will be locked/ password-protected.


Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: Student Wellness Champions Behavioral: Teacher Wellness Champions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A portion of participating schools will receive a Student Wellness Champion curriculum, training for their wellness team, as well as technical assistance provided by a Wellness Specialist (WCC-S Group). Other participating schools will only receive the training and technical assistance (WCC Group) and some will solely receive resources (Control Group). The process to determine which school receives which intervention is completely random, and will not be decided until after baseline data collection.
Masking: Single (Outcomes Assessor)
Masking Description: All data collectors are masked.
Primary Purpose: Prevention
Official Title: Approaches to Enhancing Wellness Policy Implementation in Schools to Promote Healthy Behaviors and Prevent Obesity
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Wellness Champions for Change + Students
Schools randomized to the WCC+S arm will receive both the Teacher Intervention and the Student Wellness Champion Intervention.
Behavioral: Student Wellness Champions

Student Wellness Champions participate in a training to, develop a rapport, and build trust with the wellness specialist. SWCs will meet once/week during lunch. The SWC's will receive a health education/ health literacy curriculum in order to be well-versed on the importance of being active and eating healthy foods and how to communicate health information to key stakeholders to enact policy change and to fellow students to enact behavior change. These students will work with the Wellness Specialist and Wellness Champion to implement wellness policies and practices.

Target policies/practices will be presented as a menu of options. The mechanisms used to enact change are based in the tenets of health literacy anchored in nutrition and PA promotion. Components of the curriculum include raising awareness of school system's local wellness policies and improving student skills surrounding the five standards of health literacy, using examples/activities linked to the local wellness policy.


Behavioral: Teacher Wellness Champions

Schools will be asked to identify a Wellness Champion (WC), someone at the school who is passionate about creating a healthy school environment. All WC's will be asked to attend a Wellness Champions for Change (WCC) training, led by a Wellness Specialist (health educator part of our study team). The WC's will learn about the skills necessary to make health promoting changes to the School Environment.

Following the WCC training, the Wellness Champion will receive technical assistance from the Wellness Specialist. The Wellness Specialist will work with the Wellness Champion and the school's Wellness Team to conduct a needs assessment, and develop and implement a school action plan. The Wellness Specialist will provide support and resources to the Wellness Champion and the school to help them work towards their goals. All Wellness Champions in a given school system will meet monthly, as a group, with their Wellness Specialist to discuss progress, pitfalls, and successes.


Experimental: Wellness Champions for Change
Schools randomized to the WCC+S arm will receive only the Teacher Intervention.
Behavioral: Teacher Wellness Champions

Schools will be asked to identify a Wellness Champion (WC), someone at the school who is passionate about creating a healthy school environment. All WC's will be asked to attend a Wellness Champions for Change (WCC) training, led by a Wellness Specialist (health educator part of our study team). The WC's will learn about the skills necessary to make health promoting changes to the School Environment.

Following the WCC training, the Wellness Champion will receive technical assistance from the Wellness Specialist. The Wellness Specialist will work with the Wellness Champion and the school's Wellness Team to conduct a needs assessment, and develop and implement a school action plan. The Wellness Specialist will provide support and resources to the Wellness Champion and the school to help them work towards their goals. All Wellness Champions in a given school system will meet monthly, as a group, with their Wellness Specialist to discuss progress, pitfalls, and successes.


No Intervention: Control
The control group will not receive either intervention. Schools will be given a modified SWC curriculum as well as the teacher training at the end of the data collection period.



Primary Outcome Measures :
  1. Overweight/obesity [ Time Frame: 5 years ]
    BMI-for-age z-score (calculated based on measured height and weight; self-reported gender and date of birth)

  2. In-school diet behaviors [ Time Frame: 5 years ]
    Dietary screener (Patterns of Diet at School: PODS)

  3. Minutes per day in Moderate-Vigorous Physical Activity [ Time Frame: 5 years ]
    Accelerometry (Actical); placed on the ankle


Secondary Outcome Measures :
  1. School environment specific to healthy eating and physical activity [ Time Frame: 5 years ]
    School audit

  2. School environment specific to healthy eating and physical activity [ Time Frame: 5 years ]
    Survey (Perceptions of the Environment At School: PEAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Student attends a school that the Wellness Champions for Change Study has selected for the intervention year
  • Student is enrolled in the correct grade during spring recruitment
  • Student has the ability to read and write in English
  • Student has the ability to complete grade level surveys independently
  • Student has a participant caregiver

Exclusion Criteria:

  • Student has a health problem that would interfere with participation in physical education classes
  • Student is enrolled in a special education class (Health Leaders/SWC only)
  • Another student in the same grade living in the same household or who shares the same primary caregiver is already enrolled in the study (Evaluation Cohort Only)

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 ClinicalTrials.gov identifier (NCT number): NCT03432715


Contacts
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Contact: Erin R Hager, PhD 4107060213 ehager@som.umaryland.edu
Contact: Rachel J Deitch, MS 4107066133 rdeitch@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 20201
Contact: Rachel J Deitch, MS    410-706-6133    rdeitch@som.umaryland.edu   
Contact: Erin R Hager, PhD    4107060213    ehager@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland, Baltimore
United States Department of Agriculture (USDA)
University of Maryland, College Park
Boise State University
University of Southern California
Cornell University
Investigators
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Principal Investigator: Erin R Hager, PhD University of Maryland, College Park
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erin Hager, Associate Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03432715    
Other Study ID Numbers: HP-00067626
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erin Hager, University of Maryland, Baltimore:
School
Policy
Nutrition
Physical Activity
Local Wellness Policy
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight