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

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.

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

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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