School Worksite Weight Gain Prevention Intervention Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephenie Lemon, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01467284
First received: October 7, 2011
Last updated: July 17, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Obesity
Behavioral: Step Ahead
Behavioral: Basic Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: School Worksite Weight Gain Prevention Intervention Study

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • High school employee change in weight [ Time Frame: 24 months post-baseline ] [ Designated as safety issue: No ]
    Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in weight among high school employees in Massachusetts


Secondary Outcome Measures:
  • High school employee change in BMI [ Time Frame: 24 months post-baseline ] [ Designated as safety issue: No ]
    Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in BMI among high school employees in Massachusetts

  • High School employee change in waist circumference [ Time Frame: 23 months post-baseline ] [ Designated as safety issue: No ]
    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

  • Weight management behaviors [ Time Frame: 24 months post-baseline ] [ Designated as safety issue: No ]
    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.

  • High school employee absenteeism [ Time Frame: 24 months post-baseline ] [ Designated as safety issue: No ]
    Test the effectiveness of a work site intervention based on an ecological framework at preventing absenteeism among high school employees in Massachusetts.


Enrollment: 844
Study Start Date: July 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Behavioral: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467284

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Stephenie Lemon, PhD University of Massachusetts, Worcester
Principal Investigator: Lori Pbert, PhD University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Stephenie Lemon, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01467284     History of Changes
Other Study ID Numbers: R01 CA132941
Study First Received: October 7, 2011
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Obesity
Workplace
Intervention
Diet
Exercise

Additional relevant MeSH terms:
Obesity
Weight Gain
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 28, 2014