Move and Moderate in Balance (MOVE'M)

December 6, 2011 updated by: Fred Hutchinson Cancer Center

Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study

H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Our overall objective is to develop and evaluate an intervention that will maintain or decrease body mass index; specifically, we will recruit and randomize 30 worksites to a two year intervention in which we will:

  • Influence the worksite environment, including policies and procedures, by increasing worksite access to healthy foods and physical activity opportunities
  • Promote individual behavior change, through increasing awareness of energy balance; building a physical activity intervention that will promote increased levels of energy expenditure through the combination of increased daily physical activity and regular, structured exercise; and building a dietary intervention that will promote decreased calorie intake.

Our primary aim is to:

1) Evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites.

Our secondary aims are to:

  1. Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention
  2. Assess changes in individual level physical activity and energy intake attributable to the intervention
  3. Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and
  4. Estimate the cost-effectiveness of the intervention in controlling weight.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

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

    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)

Exclusion Criteria:

  • Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
Time Frame: At study conclusion
At study conclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
Time Frame: At study conclusion
At study conclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shirley AA Beresford, PhD, Fred Hutchinson Cancer Center
  • Study Director: Anne McTiernan, MD, PhD, Fred Hutchinson Cancer Center

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

September 1, 2005

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHCRC-6334
  • U54CA116847 (U.S. NIH Grant/Contract)

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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