- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01467284
School Worksite Weight Gain Prevention Intervention Study
July 17, 2014 updated by: Stephenie Lemon, University of Massachusetts, Worcester
The proposed site-level randomized trial will test the effectiveness of a work site intervention based on an ecological framework at preventing weight gain among high school employees in Massachusetts.
The investigators hypothesis is that the intervention will positively impact healthy dietary patterns and physical activity, perceived organizational commitment, coworker influences, social support, self-efficacy, and self-control, which in turn will positively mediate or moderate the positive associations between the intervention and the primary outcomes (change in weight, BMI, and waist circumference).
If effective, the intervention is designed to be generalizable to high school settings across the country and has the potential to reduce the morbidity, mortality and economic costs of overweight and obesity in this important population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
844
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- work at least 15 hours per week, or approximately half of the school week,
- only work at one school participating in the study,
- not be in a "leadership" position in the school (e.g. principals and vice-principals)
- be able to stand up
- speak English
- plan to be employed at the school for the next 24 months
Exclusion Criteria:
- work less than 15 hours per week
- work at more than one participating school
- work in a "leadership" position (e.g. principal or vice-principal)
- does not speak English
- unable to stand up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Step Ahead
Promotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level.
|
Promotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level.
|
|
ACTIVE_COMPARATOR: Basic Intervention
Promotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention.
|
Promotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
High school employee change in weight
Time Frame: 24 months post-baseline
|
Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in weight among high school employees in Massachusetts
|
24 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
High school employee change in BMI
Time Frame: 24 months post-baseline
|
Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in BMI among high school employees in Massachusetts
|
24 months post-baseline
|
|
High School employee change in waist circumference
Time Frame: 23 months post-baseline
|
Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in waist circumference among high school employees in Massachusetts
|
23 months post-baseline
|
|
Weight management behaviors
Time Frame: 24 months post-baseline
|
Test the effectiveness of a worksite intervention compared to the control condition on physical activity and healthy eating behaviors among high school employees in Massachusetts.
|
24 months post-baseline
|
|
High school employee absenteeism
Time Frame: 24 months post-baseline
|
Test the effectiveness of a work site intervention based on an ecological framework at preventing absenteeism among high school employees in Massachusetts.
|
24 months post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephenie Lemon, PhD, University of Massachusetts, Worcester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang ML, Haughton CF, Frisard C, Pbert L, Geer C, Lemon SC. Perceived weight status and weight change among a U.S. adult sample. Obesity (Silver Spring). 2017 Jan;25(1):223-228. doi: 10.1002/oby.21685. Epub 2016 Nov 15.
- Alker HJ, Wang ML, Pbert L, Thorsen N, Lemon SC. Impact of school staff health on work productivity in secondary schools in Massachusetts. J Sch Health. 2015 Jun;85(6):398-404. doi: 10.1111/josh.12266.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
October 7, 2011
First Submitted That Met QC Criteria
November 3, 2011
First Posted (ESTIMATE)
November 8, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01CA132941 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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