NCT03432715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,773

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

4.6 years

First QC Date

February 2, 2018

Last Update Submit

February 9, 2022

Conditions

Obesity, Childhood

Keywords

SchoolPolicyNutritionPhysical ActivityLocal Wellness Policy

Outcome Measures

Primary Outcomes (3)

  • Overweight/obesity

    BMI-for-age z-score (calculated based on measured height and weight; self-reported gender and date of birth)

    5 years

  • In-school diet behaviors

    Dietary screener (Patterns of Diet at School: PODS)

    5 years

  • Minutes per day in Moderate-Vigorous Physical Activity

    Accelerometry (Actical); placed on the ankle

    5 years

Secondary Outcomes (2)

  • School environment specific to healthy eating and physical activity

    5 years

  • School environment specific to healthy eating and physical activity

    5 years

Study Arms (3)

Wellness Champions for Change + Students

EXPERIMENTAL

Schools randomized to the WCC+S arm will receive both the Teacher Intervention and the Student Wellness Champion Intervention.

Behavioral: Student Wellness ChampionsBehavioral: Teacher Wellness Champions

Wellness Champions for Change

EXPERIMENTAL

Schools randomized to the WCC+S arm will receive only the Teacher Intervention.

Behavioral: Teacher Wellness Champions

Control

NO INTERVENTION

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.

Interventions

Student Wellness ChampionsBEHAVIORAL

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.

Wellness Champions for Change + Students
Teacher Wellness ChampionsBEHAVIORAL

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.

Wellness Champions for ChangeWellness Champions for Change + Students

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 20201, United States

Location

Related Publications (2)

  • Kuhn AP, Choudhary A, Zemanick A, Lane H, Armstrong B, Wang Y, Deitch R, Hager ER. Student perceptions of U.S. based school day physical activity best practices in relation to accelerometer-based sedentary behavior and activity. Prev Med Rep. 2024 Dec 16;49:102944. doi: 10.1016/j.pmedr.2024.102944. eCollection 2025 Jan.

    PMID: 39807184DERIVED

  • Pulling Kuhn A, Kim E, Lane HG, Wang Y, Deitch R, Turner L, Hager ER, Parker EA. Associations between elementary and middle school teachers' physical activity promoting practices and teacher- and school-level factors. Int J Behav Nutr Phys Act. 2021 May 19;18(1):66. doi: 10.1186/s12966-021-01129-4.

    PMID: 34011376DERIVED

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Erin R Hager, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All data collectors are masked.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 14, 2018

Study Start

May 26, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)