Worcester, Massachusetts 01655

  • Obesity

Purpose:

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.


Criteria:

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 is Available At:


Original ID:

R01 CA132941


NCT ID:

NCT01467284


Secondary ID:


Study Acronym:


Brief Title:

School Worksite Weight Gain Prevention Intervention Study


Official Title:

School Worksite Weight Gain Prevention Intervention Study


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Massachusetts, Worcester


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

844


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stephenie Lemon, PhD
Principal Investigator
University of Massachusetts, Worcester

Study Dates

Start Date:July 2009
Completion Date:June 2014
Completion Type:Actual
Primary Completion Date:June 2014
Primary Completion Type:Actual
Verification Date:July 2014
Last Changed Date:July 17, 2014
First Received Date:October 7, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:High school employee change in weight
Time Frame:24 months post-baseline
Safety Issues:False
Description:Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in weight among high school employees in Massachusetts
Outcome Type:Secondary Outcome
Measure:High school employee change in BMI
Time Frame:24 months post-baseline
Safety Issues:False
Description:Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in BMI among high school employees in Massachusetts
Outcome Type:Secondary Outcome
Measure:High School employee change in waist circumference
Time Frame:23 months post-baseline
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Weight management behaviors
Time Frame:24 months post-baseline
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:High school employee absenteeism
Time Frame:24 months post-baseline
Safety Issues:False
Description:Test the effectiveness of a work site intervention based on an ecological framework at preventing absenteeism among high school employees in Massachusetts.

Study Interventions

Intervention Type:Behavioral
Name:Basic Intervention
Description: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.
Arm Name:Basic Intervention
Intervention Type:Behavioral
Name:Step Ahead
Description: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.
Arm Name:Step Ahead

Study Arms

Study Arm Type:Active Comparator
Arm Name:Basic Intervention
Description: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.
Study Arm Type:Experimental
Arm Name:Step Ahead
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Massachusetts, Worcester

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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