Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03432715
Status:
COMPLETED
Last Update Posted:
2022-02-28
First Post:
2018-02-02
Brief Title:
Wellness Champions for Change
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Approaches to Enhancing Wellness Policy Implementation in Schools to Promote Healthy Behaviors and Prevent Obesity
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WCC
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 trainingcontrol Approximately 36 3rd6th graders and their caregivers evaluation cohort 15 4th7th 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 25 years with measures including anthropometry heightweight 7-day accelerometry physical activity and validated questionnaires to assess healthy eating Student leaders will be followed for 15 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 leadershipadvocacy 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
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 trainingcontrol Approximately 36 3rd6th graders and their caregivers evaluation cohort 15 4th7th 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 25 years with measures including anthropometry heightweight 7-day accelerometry physical activity and validated questionnaires to assess healthy eating Student leaders will be followed for 15 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 leadershipadvocacy 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
Detailed Description:
The long-term goal of this project is to create health promoting school environments that support healthy growth and development of children in order to prevent obesity The approach for creating health promoting school environments involves the school-level implementation of existing Local Wellness Policies LWPs Implementation science suggests that policy implementation may occur through diffusion letting it happen dissemination helping it happen or implementation making it happen Since LWPs were initially mandated in 2006 most school systems have relied on a diffusion or dissemination approach to LWP implementation leading to limited implementation on the school-level We propose a school-level LWP implementation strategy making it happen that relies on educatingtraining teachers and students to be wellness champions Through this proposed study the impact of a school-level intervention to enhance LWP implementation WCC and the added benefit of training students to be wellness champions WCC-students WCC-S on student-level outcomes diet physical activity PA and obesity will be examined through a randomized controlled trial
Objectives are presented at the student and student wellness champion level
Student Objectives
Aim 1 To determine the impact of a school-based intervention Wellness Champions for Change WCC to enhance implementation of LWPs on health behaviors diet and PA and weight status of elementary and middle school students through a randomized controlled trial
Hypothesis 1 WCC will have a positive impact on health behaviors of students compared to control
Aim 2 To examine the added impact of a student-led school-based intervention Wellness Champions for Change-Students WCC-S on health behaviors diet and PA and weight status of elementary and middle school students through a randomized controlled trial
Hypothesis 2 WCCWCC-S will have a greater impact on health behaviors of students compared to WCC and control
Aim 3 To examine factors in the home and school-neighborhood environments that moderate the impact of WCCWCC-S on health behavior diet and PA and weight status change of elementarymiddle school students
Hypothesis 3 Students living in a moderately health-promoting home and school-neighborhood environment will experience a greater change in health behaviors when exposed to WCC or WCCWCC-S compared to students in high or low health-promoting environments
Aim 4 To examine the reach and fidelity of WCC and WCC-S when disseminated via eXtension through an online continuing education credit model for teachers and a toolkit for students
Hypothesis 4 WCC and WCC-S dissemination schools will experience positive changes in LWP implementation
Student Wellness Champion Objectives
One part of our study involves developing a Student Wellness Champions curriculum WCC-S group to train 5th and 8th graders in diverse schools across Maryland to make policy and environmental changes that create a health-promoting environment in their schools We plan to evaluate individual and organizational outcomes for the 5th and 8th grade student wellness champions
Aim 1 To assess the individual effectiveness of WCC-S to improve student wellness champions youth advocacy health literacy and public health literacy constructs and changes in diet and physical activity behaviors andor weight status compared to control students
Aim 2 To asses organizational effectiveness of WCC-S to improve school level LWP implementation and environmental change compared to control or WCC-only schools
Aim 3 To describe reach adoption implementation and maintenance factors including- reach and representativeness of student champions extent to which the intervention reaches other students in WCC-S schools representativeness of adopting schools compared to non-adopting schools implementation fidelity barriers and challenges of implementation of training and goal achievement which intervention aspects if any are institutionalized
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
In the spring prior to the intervention all participating schools will be asked to select a group of about 15 students 4th graders in elementary schools 7th graders in middle schools to be a part of a Health Leader group that begins the following year when the same students are 5th graders in elementary 8th graders in middle school Students can either be nominated by teachers or write a few sentences on why the student thinks it is important to make hisher school a healthier place At the beginning of the next school year the health leaders that attend schools randomized to WCC-S will become Student Wellness Champions These students will meet with a Wellness Specialist member of our project team once a week during lunch to 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 administration and teachers to enact policy change and to fellow students to enact behavior change These students will work with the Wellness Specialist and staff members from their school to implement wellness policies and practices Health leaders that attend schools randomized to the WCC or control schools will remain Health Leaders and will have the opportunity to participate in an Adolescent Health Curriculum taught by the Wellness Specialist during their 5th or 8th grade year These students will meet once a month during lunch and the curriculum will focus on general public health topics including dental health stress management and hygiene At the end of the year participants will also have the opportunity to participate in a public health leadership workshop
Schools randomized to WCC-S and WCC will select a teacher to become the Wellness Champion WC This person may be a teacher or other school leader nurse counselor etc who is passionate about creating a healthy school environment The wellness champions will attend a Wellness Champions for Change training prior to the start of the intervention During the training the Wellness Champion will work with a Wellness Specialist to set achievable LWP implementation goals and design a plan for implementing those goals over the academic year Furthermore this training will equip the Wellness Champion to build a school-level wellness team assess the schools wellness environment develop monitor and report a school LWP action plan and conduct wellness activities that align with the LWP
Following the training the Wellness Champion will work with the schools wellness team to develop and implement a school LWP action plan All Wellness Champions in a given school system will meet monthly as a group with the Wellness Specialist to discuss progress pitfalls and successes bi-monthly in-person andor bi-monthly by phone In addition all Wellness Champions will receive year-long technical assistance from the Wellness Specialist that focuses on implementing and monitoring LWPs at the school-level The WCC intervention will formally last for one school year with schools continually followed for an additional year to assess sustainability
In order to measure the success of the intervention evaluations on a group of 36 students from all participating schools will be conducted recruited as 3rd grade students in elementary school and 6th grade students in middle schools These students will become members of the Evaluation Cohort and will be asked to be followed for 25 years
Objectives are presented at the student and student wellness champion level
Student Objectives
Aim 1 To determine the impact of a school-based intervention Wellness Champions for Change WCC to enhance implementation of LWPs on health behaviors diet and PA and weight status of elementary and middle school students through a randomized controlled trial
Hypothesis 1 WCC will have a positive impact on health behaviors of students compared to control
Aim 2 To examine the added impact of a student-led school-based intervention Wellness Champions for Change-Students WCC-S on health behaviors diet and PA and weight status of elementary and middle school students through a randomized controlled trial
Hypothesis 2 WCCWCC-S will have a greater impact on health behaviors of students compared to WCC and control
Aim 3 To examine factors in the home and school-neighborhood environments that moderate the impact of WCCWCC-S on health behavior diet and PA and weight status change of elementarymiddle school students
Hypothesis 3 Students living in a moderately health-promoting home and school-neighborhood environment will experience a greater change in health behaviors when exposed to WCC or WCCWCC-S compared to students in high or low health-promoting environments
Aim 4 To examine the reach and fidelity of WCC and WCC-S when disseminated via eXtension through an online continuing education credit model for teachers and a toolkit for students
Hypothesis 4 WCC and WCC-S dissemination schools will experience positive changes in LWP implementation
Student Wellness Champion Objectives
One part of our study involves developing a Student Wellness Champions curriculum WCC-S group to train 5th and 8th graders in diverse schools across Maryland to make policy and environmental changes that create a health-promoting environment in their schools We plan to evaluate individual and organizational outcomes for the 5th and 8th grade student wellness champions
Aim 1 To assess the individual effectiveness of WCC-S to improve student wellness champions youth advocacy health literacy and public health literacy constructs and changes in diet and physical activity behaviors andor weight status compared to control students
Aim 2 To asses organizational effectiveness of WCC-S to improve school level LWP implementation and environmental change compared to control or WCC-only schools
Aim 3 To describe reach adoption implementation and maintenance factors including- reach and representativeness of student champions extent to which the intervention reaches other students in WCC-S schools representativeness of adopting schools compared to non-adopting schools implementation fidelity barriers and challenges of implementation of training and goal achievement which intervention aspects if any are institutionalized
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
In the spring prior to the intervention all participating schools will be asked to select a group of about 15 students 4th graders in elementary schools 7th graders in middle schools to be a part of a Health Leader group that begins the following year when the same students are 5th graders in elementary 8th graders in middle school Students can either be nominated by teachers or write a few sentences on why the student thinks it is important to make hisher school a healthier place At the beginning of the next school year the health leaders that attend schools randomized to WCC-S will become Student Wellness Champions These students will meet with a Wellness Specialist member of our project team once a week during lunch to 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 administration and teachers to enact policy change and to fellow students to enact behavior change These students will work with the Wellness Specialist and staff members from their school to implement wellness policies and practices Health leaders that attend schools randomized to the WCC or control schools will remain Health Leaders and will have the opportunity to participate in an Adolescent Health Curriculum taught by the Wellness Specialist during their 5th or 8th grade year These students will meet once a month during lunch and the curriculum will focus on general public health topics including dental health stress management and hygiene At the end of the year participants will also have the opportunity to participate in a public health leadership workshop
Schools randomized to WCC-S and WCC will select a teacher to become the Wellness Champion WC This person may be a teacher or other school leader nurse counselor etc who is passionate about creating a healthy school environment The wellness champions will attend a Wellness Champions for Change training prior to the start of the intervention During the training the Wellness Champion will work with a Wellness Specialist to set achievable LWP implementation goals and design a plan for implementing those goals over the academic year Furthermore this training will equip the Wellness Champion to build a school-level wellness team assess the schools wellness environment develop monitor and report a school LWP action plan and conduct wellness activities that align with the LWP
Following the training the Wellness Champion will work with the schools wellness team to develop and implement a school LWP action plan All Wellness Champions in a given school system will meet monthly as a group with the Wellness Specialist to discuss progress pitfalls and successes bi-monthly in-person andor bi-monthly by phone In addition all Wellness Champions will receive year-long technical assistance from the Wellness Specialist that focuses on implementing and monitoring LWPs at the school-level The WCC intervention will formally last for one school year with schools continually followed for an additional year to assess sustainability
In order to measure the success of the intervention evaluations on a group of 36 students from all participating schools will be conducted recruited as 3rd grade students in elementary school and 6th grade students in middle schools These students will become members of the Evaluation Cohort and will be asked to be followed for 25 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None