School Worksite Weight Gain Prevention Intervention Study

Obesity Clinical Trial

Official title:

School Worksite Weight Gain Prevention Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467284
• Other study ID #: R01CA132941
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 7, 2011
• Last updated: July 17, 2014
• Start date: July 2009
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 844
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Weight Gain

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High school employee change in weight	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	No
Secondary	High school employee change in BMI	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	No
Secondary	High School employee change in waist circumference	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	No
Secondary	Weight management behaviors	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	No
Secondary	High school employee absenteeism	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	No